Η αγορά της ΕΕ
Η ΕΕ είναι τελωνειακή ένωση — τα 27 κράτη μέλη της αποτελούν ενιαίο έδαφος για τελωνειακούς σκοπούς.
Αυτό σημαίνει ότι
- δεν καταβάλλονται δασμοί για εμπορεύματα που διακινούνται μεταξύ κρατών μελών της ΕΕ
- Τα κράτη μέλη της ΕΕ εφαρμόζουν κοινό δασμολόγιο για εμπορεύματα που εισάγονται από χώρες εκτός της ΕΕ
- τα εμπορεύματα που έχουν εισαχθεί νόμιμα μπορούν να κυκλοφορούν σε ολόκληρη την ΕΕ χωρίς περαιτέρω τελωνειακούς ελέγχους.
Οι επιχειρήσεις εντός και εκτός της ΕΕ επωφελούνται από
- μια αγορά για τα προϊόντα τους με πάνω από 400 εκατομμύρια καταναλωτές
- ευκολότερη πρόσβαση σε ευρύ φάσμα προμηθευτών και καταναλωτών
- χαμηλότερο μοναδιαίο κόστος
- μεγαλύτερες εμπορικές ευκαιρίες.
Μετά την καταβολή των τελωνειακών δασμών και τον έλεγχο των όρων εισαγωγής, τα εισαγόμενα εμπορεύματα μπορούν να κυκλοφορούν ελεύθερα στην ΕΕ χωρίς περαιτέρω τελωνειακούς ελέγχους.
Το τελωνειακό έδαφος της Ένωσης περιλαμβάνει τα εδάφη των ακόλουθων κρατών μελών
- Βέλγιο,
- Βουλγαρία,
- Κροατία,
- ΤΣΕΧΙΚΗ ΔΗΜΟΚΡΑΤΙΑ,
- Δανία, εκτός από τις Φερόες Νήσους και τη Γροιλανδία,
- Γερμανία, εκτός από τη νήσο Heligoland και το έδαφος του Büsingen,
- Εσθονία,
- Ιρλανδία,
- Ελλάδα,
- Ισπανία, εκτός από τη Θέουτα και τη Μελίλια,
- Γαλλία, εκτός από τη Νέα Καληδονία, το Saint-Pierre και το Miquelon, τις νήσους Wallis και Futuna, τη Γαλλική Πολυνησία και τα Γαλλικά Νότια και Ανταρκτικά Εδάφη, αλλά συμπεριλαμβανομένων των υπερπόντιων διαμερισμάτων της Γουαδελούπης, της Γαλλικής Γουιάνας, της Μαρτινίκας, της Μαγιότ και των Νήσων Ρεϊνιόν,
- Ιταλία, εκτός από τους δήμους Livigno και Campione d’Italia και τα εθνικά ύδατα της λίμνης Lugano που βρίσκονται μεταξύ της όχθης και των πολιτικών συνόρων της περιοχής μεταξύ Ponte Tresa και Porto Ceresio,
- Κύπρος (εν αναμονή της διευθέτησης του κυπριακού προβλήματος, η εφαρμογή του κοινοτικού κεκτημένου αναστέλλεται στις περιοχές στις οποίες η κυβέρνηση της Κυπριακής Δημοκρατίας δεν ασκεί αποτελεσματικό έλεγχο),
- Λετονία,
- Λιθουανία,
- Λουξεμβούργο,
- Ουγγαρία,
- Μάλτα,
- οι Κάτω Χώρες στην Ευρώπη,
- Αυστρία,
- Πολωνία,
- Πορτογαλία,
- Ρουμανία,
- Σλοβενία,
- η Σλοβακική Δημοκρατία,
- Φινλανδία,
- Σουηδία.
Το τελωνειακό έδαφος της Ένωσης περιλαμβάνει τα χωρικά ύδατα, τα εσωτερικά ύδατα και τον εναέριο χώρο των κρατών μελών, εκτός από τα χωρικά ύδατα, τα εσωτερικά ύδατα και τον εναέριο χώρο των εδαφών που βρίσκονται εκτός του τελωνειακού εδάφους της Ένωσης.
Το έδαφος του πριγκιπάτου του Μονακό, συμπεριλαμβανομένων των χωρικών υδάτων, των εσωτερικών θαλάσσιων υδάτων και του εναέριου χώρου, μολονότι βρίσκεται εκτός του εδάφους της Ένωσης, θεωρείται επίσης μέρος του τελωνειακού εδάφους της Ένωσης.
ΕΕ
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Αυστρία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Austria is a member of the European Union (EU) since 01/01/1995.
2. Currency
The Euro (EUR) is the official currency in Austria since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Bundesministerium für Finanzen (Federal Ministry of Finance)Johannesgasse 5
1010 Wien
Tel: (+43) (0) 50 233 233 / (+43) (0) 50 233 790
Contact: steuerombudsdienst@bmf.gv.at
Website: https://www.bmf.gv.at/themen/zoll.html
Bundesministerium für Finanzen (Federal Ministry of Finance)
Steuern und Zölle (Excise and Customs)
Johannesgasse 5
1010 Wien
Tel: (+43) (0) 50 233 740
Contact: zollinfo@bmf.gv.at
Website: https://www.bmf.gv.at/themen/zoll.html
4. Import Procedure
The Single Administrative Document - SAD (Einheitspapier - SAD) must be submitted electronically using e-zoll - (e-Services of the Federal Ministry of Finance). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Austria.
5. Trade Regime and Import Licenses
Import licences for agricultural products
AgrarMarkt Austria - AMA (Austrian Agricultural Market Agency)Dresdner Straße 70
1200 Wien
Tel: (+43) 1 33 151 209
Contact: lizenzen@ama.gv.at
Website: https://www.ama.at/intro
Licences for iron, steel and aluminium products
Bundesministerium für Arbeit und Wirtschaft - BMAW (Federal Ministry for Labour and Economy)Sektion V - EU und internationale Marktstrategien (Section V - EU and international market strategies)
Abteilung V/2 - Exportkontrolle (Department V/2 - Export control)
Stubenring 1
1010 Wien
Tel: (+43) 1 71 100 80 5115
Contact: exportkontrolle@bmaw.gv.at
Website: https://www.bmaw.gv.at/
Import licences for wine
Bundesministerium für Land- und Forstwirtschaft, Regionen und Wasserwirtschaft -BML (Federal Ministry of Agriculture, Forestry, Regions, and Water Management)Sektion II - Landwirtschaft und ländliche Entwicklung (Section II - Agriculture and Rural Development)
Abteilung II/7 - Obst, Gemüse, Wein, Sonderkulturen (Department II/7 - Fruit, Vegetables, Wine, Special Crops)
Stubenring 1
1010 Wien
Tel: (+43) 1 71 100 60 2865
Contact: service@bml.gv.at
Website: https://www.bml.gv.at
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz (Federal Ministry of Social Affairs, Health, Care and Consumer Protection)Sektion III - Konsumentenpolitik und Verbrauchergesundheit (Section III - Consumer Policy and Consumer Health)
Gruppe III/B - Verbrauchergesundheit und Veterinärwesen (Group III/B - Consumer Health and Veterinary)
Abteilung III/B/13 - Lebensmittelsicherheit und Verbraucherinnen- und Verbraucherschutz; Kontrolle, Hygiene und Qualität (Department III/B/13 - Food safety and consumer protection control, hygiene, and quality)
Stubenring 1
1010 Wien
Tel: (+43) 1 71 100 64 4836 / (+43) 1 71 100 64 4544
Contact: iiisl@sozialministerium.at
Website: https://www.sozialministerium.at/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Bundesamt für Ernährungssicherheit - BAES (Federal Authority for Food Safety)Österreichische Agentur für Gesundheit und Ernährungssicherheit - AGES (Austrian Agency for Health and Food Safety)
Fachbereich Pflanzengesundheit (Plant Health Department)
Spargelfeldstraße 191
1220 Wien
Tel: (+43) 5 0555 33301
Contact: pflanzenschutzdienst@baes.gv.at
Website: https://www.baes.gv.at/
Bundesamt für Wald (Federal Forest Agency)
Seckendorff-Gudent-Weg 8
1131 Wien
Tel: (+43) 1 878 382 214
Contact: bundesamt@bfw.gv.at
Website: https://www.bundesamt-wald.at/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz (Federal Ministry of Social Affairs, Health, Care and Consumer Protection)Sektion III - Konsumentenpolitik und Verbrauchergesundheit (Section III - Consumer Policy and Consumer Health)
Gruppe III/B - Verbrauchergesundheit und Veterinärwesen (Group III/B - Consumer Health and Veterinary)
Abteilung III/B/13 - Lebensmittelsicherheit und Verbraucherinnen- und Verbraucherschutz; Kontrolle, Hygiene und Qualität (Department III/B/13 - Food safety and consumer protection control, hygiene, and quality)
Stubenring 1
1010 Wien
Tel: (+43) 1 71 100 64 4836 / (+43) 1 71 100 64 4544
Contact: iiisl@sozialministerium.at
Website: https://www.sozialministerium.at/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Bundesamt für Ernährungssicherheit - BAES (Federal Authority for Food Safety)Österreichische Agentur für Gesundheit und Ernährungssicherheit - AGES (Austrian Agency for Health and Food Safety)
Fachbereich für Futtermittel (Department for Feedingstuffs)
Spargelfeldstraße 191
1220 Wien
Tel: (+43) 5 0555 32358
Contact: futtermittel@baes.gv.at
Website: https://www.baes.gv.at/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Bundesministerium für Land- und Forstwirtschaft, Regionen und Wasserwirtschaft -BML (Federal Ministry of Agriculture, Forestry, Regions, and Water Management)Sektion II - Landwirtschaft und ländliche Entwicklung (Section II - Agriculture and Rural Development)
Abteilung II/7 - Obst, Gemüse, Wein, Sonderkulturen (Department II/7 - Fruit, Vegetables, Wine, Special Crops)
Stubenring 1
1010 Wien
Tel: (+43) 1 71 100 60 2865
Contact: service@bml.gv.at
Website: https://www.bml.gv.at
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Bundesministerium für Klimaschutz, Umwelt, Energie, Mobilität, Innovation und Technologie - BMK (Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology)Sektion V - Umwelt und Kreislaufwirtschaft (Department V - Environment and Circular Economy)
Abteilung V/5 - Chemiepolitik und Biozide (Division V/5 - Chemicals Policy and Biocides)
Radetzkystraße 2
Postfach 201
1000 Wien
Tel: (+43) 1 711 00 61 2330
Contact: v5@bmk.gv.at
Website: https://www.bmk.gv.at/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Bundesministerium für Klimaschutz, Umwelt, Energie, Mobilität, Innovation und Technologie - BMK (Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology)Abteilung V/10 - Nationalparks / Natur- und Artenschutz (Division V/10 - National Parks/Nature Conservation & Species Protection)
Stubenbastei 5
1010 Wien
Tel: (+43) 1 71 100 61 1401
Contact: v10@bmk.gv.at
Website: https://www.bmk.gv.at/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals, detergents and persistent organic pollutants
Bundesministerium für Klimaschutz, Umwelt, Energie, Mobilität, Innovation und Technologie - BMK (Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology)Sektion V - Umwelt und Kreislaufwirtschaft (Department V - Environment and Circular Economy)
Abteilung V/5 - Chemiepolitik und Biozide (Division V/5 - Chemicals Policy and Biocides)
Radetzkystraße 2
Postfach 201
1000 Wien
Tel: (+43) 1 711 00 61 2330
Contact: v5@bmk.gv.at
Website: https://www.bmk.gv.at/
Fertilisers
Österreichische Agentur für Gesundheit und Ernährungssicherheit - AGES (Austrian Agency for Health and Food Safety)Fachbereich Düngemittel (Department Fertilizer)
Spargelfeldstraße 191
1220 Wien
Tel: (+43) 5 0555 32352
Contact: duengemittel@baes.gv.at
Website: https://www.baes.gv.at/
D. Control and management of waste
Bundesministerium für Klimaschutz, Umwelt, Energie, Mobilität, Innovation und Technologie - BMK (Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology)Sektion V - Umwelt und Kreislaufwirtschaft (Department V - Environment and Circular Economy)
Abteilung V/6 - Abfallvermeidung, -verwertung und -beurteilung (Division V/6 - Waste Prevention, Recovery and Assessment)
Stubenbastei 5
Postfach 201
1010 Wien
Tel: (+43) 1 71 100 61 3538 / (+43) 1 71 1000
Contact: servicebuero@bmk.gv.at / v6@bmk.gv.at
Website: https://www.bmk.gv.at/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Austrian Standards International (None)Heinestraße 38
1020 Wien
Tel: (+43) 1 213 000
Contact: office@austrian-standards.at
Website: https://www.austrian-standards.at/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Bundesamt für Eich- und Vermessungswesen (Federal Office of Metrology and Surveying)Schiffamtsgasse 1-3
1020 Wien
Tel: (+43) 1 21 110 82 3715
Contact: marktueberwachung@bev.gv.at
Website: https://www.bev.gv.at/
Materials and articles intended to come into contact with foodstuffs
Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz (Federal Ministry of Social Affairs, Health, Care and Consumer Protection)Sektion III - Konsumentenpolitik und Verbrauchergesundheit (Section III - Consumer Policy and Consumer Health)
Gruppe III/B - Verbrauchergesundheit und Veterinärwesen (Group III/B - Consumer Health and Veterinary)
Abteilung III/B/13 - Lebensmittelsicherheit und Verbraucherinnen- und Verbraucherschutz; Kontrolle, Hygiene und Qualität (Department III/B/13 - Food safety and consumer protection control, hygiene, and quality)
Stubenring 1
1010 Wien
Tel: (+43) 1 71 100 64 4836 / (+43) 1 71 100 64 4544
Contact: iiisl@sozialministerium.at
Website: https://www.sozialministerium.at/
Österreichische Agentur für Gesundheit und Ernährungssicherheit - AGES (Austrian Agency for Health and Food Safety)
Geschäftsfeld Lebensmittelsicherheit (Food Safety Business Department)
Spargelfeldstraße 191
1220 Wien
Tel: (+43) 5 05 553 2600
Contact: lebensmittel.wien@ages.at
Website: https://www.ages.at/
12. Labelling
The contents of the labelling must be at least in German. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Βέλγιο
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Kingdom of Belgium is one of the six founding Member States of the European Union (EU) as it took part in the ratification of the Treaties of Rome, which established the European Communities and became effective in 1958.
2. Currency
The Euro (EUR) is the official currency in Belgium since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Douanes et accises (Customs and Excises)Services centraux (Central Services)
North Galaxy
Boulevard du Roi Albert II, 33 bte 37
1030 Bruxelles
Tel: (+32) 2 572 57 57
Contact: info.douane@minfin.fed.be
Website: https://finances.belgium.be/fr/douanes_accises
4. Import Procedure
The Single Administrative Document - SAD (Document Administratif Unique / Enig Document) must be submitted electronically using PLDA - PaperLess Douanes et Accises - (Paperless Customs and Excises system). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Belgium.
5. Trade Regime and Import Licenses
Import licences for agricultural products in Brussels
Bruxelles Economie et Emploi (Brussels Economy and Employment)Place Saint-Lazare 2
1035 Bruxelles
Tel: (+32) 2 800 32 63
Contact: https://economie-emploi.brussels/contact
Website: https://economie-emploi.brussels/import-export-produits-agricoles
Licences for iron, steel and aluminium products
Service Public Fédéral Economie, PME, Classes Moyennes et Energie (Federal Public Service for Economy, SMEs, Self-Employed and Energy)Direction Générale des Analyses économiques et de l'Economie internationale (Directorate‑General for Economic Analysis and International Economy)
Division Economie Internationale (International Economy Division)
City Atrium
Rue du Progrès 50
1210 Bruxelles
Tel: (+32) 8 001 20 33
Contact: info.eco@economie.fgov.be / https://digital.belgium.be/iaf/hil/economie/contact/
Website: https://economie.fgov.be/fr
Import licences for agricultural products in Flanders
Agentschap voor Landbouw en Visserij (Agriculture and Fisheries Agency)Koning Albert II-laan 15, bus 360
1210 Bruxelles
Tel: (+32) 2 214 48 48 / (+32) 2 552 77 72
Contact: info@lv.vlaanderen.be / interventie@lv.vlaanderen.be / comunicaciones@lv.vlaanderen.be
Website: https://lv.vlaanderen.be/
Import licences for agricultural products in Wallonia
Service Public de Wallonie Agriculture, Ressources Naturelles et Environnement (Public Service of Wallonia for Agriculture, Natural Ressources and Environment)Organisme payeur de Wallonie - OPW (Walloon Paying Agency)
Chaussée de Louvain, 14
5000 Namur
Tel: (+32) 8 123 21 32
Contact: certificats.opw@spw.wallonie.be
Website: https://agriculture.wallonie.be/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Agence Fédérale pour la Sécurité de la Chaîne Alimentaire - AFSCA (Federal Agency for the safety of the Food Chain)Direction Générale du Contrôle (Directorate-General for Control)
Boulevard du Jardin Botanique 55
1000 Bruxelles
Tel: (+32) 2 211 84 00
Contact: DGCO@favv-afsca.be
Website: https://favv-afsca.be/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Agence Fédérale pour la Sécurité de la Chaîne Alimentaire - AFSCA (Federal Agency for the safety of the Food Chain)Direction Générale du Contrôle (Directorate-General for Control)
Boulevard du Jardin Botanique 55
1000 Bruxelles
Tel: (+32) 2 211 84 00
Contact: DGCO@favv-afsca.be
Website: https://favv-afsca.be/
8. Food and feed safety and marketing standards
The competent authorities for official inspections in the field of animal nutrition and food safety and for controlling the marketing standards of certain agricultural and fishery products are:
Agence Fédérale pour la Sécurité de la Chaîne Alimentaire - AFSCA (Federal Agency for the Safety of the Food Chain)Direction Générale de la Politique de Contrôle (Directorate-General for Control Policy)
Direction de Transformation et Distribution des denrées alimentaires (Directorate of Transformation and Supply of Foodstuffs)
Boulevard du Jardin Botanique 55
1000 Bruxelles
Tel: (+32) 2 211 87 14 / (+32) 2 211 85 77
Contact: S3.pccb@favv-afsca.be
Website: https://favv-afsca.be/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Federal Public Service for Health, Food Chain Safety and Environment)Direction Générale Environnement (Directorate-General for the Environment)
Avenue Galilée 5/2
1210 Bruxelles
Tel: (+32) 2 524 97 97
Contact: info_environment@health.fgov.be
Website: https://www.health.belgium.be/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Federal Public Service for Health, Food Chain Safety and Environment)Direction Générale Environnement (Directorate-General for the Environment)
Service Affaires multilatérales et Stratégiques - AMSZ (Multilateral and Strategic Affairs Department)
Cellule CITES (CITES Unit)
Avenue Galilée 5/2
1210 Bruxelles
Tel: (+32) 2 524 97 97
Contact: cites@environnement.belgique.be
Website: https://www.health.belgium.be/fr/animaux-et-vegetaux/animaux/cites-et-especes-menacees/les-publications-permis-certificats-et-tarifs
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Federal Public Service for Health, Food Chain Safety and Environment)Direction Générale Animaux, Végétaux et Alimentation (Directorate-General for Animals, Plants and Food)
Service Produits Phytopharmaceutiques et Engrais (Service for Plant Protection Products and Fertilisers)
Avenue Galilée 5/2
1210 Bruxelles
Tel: (+32) 2 524 97 97
Contact: fytoweb@sante.belgique.be
Website: https://fytoweb.be/
Dangerous chemicals, detergents and persistent organic pollutants
Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Federal Public Service for Health, Food Chain Safety and Environment)Direction Générale Environnement (Directorate-General for the Environment)
Service Maîtrise des Risques (Risk Management Office)
Avenue Galilée 5/2
1210 Bruxelles
Tel: (+32) 2 524 97 97
Contact: info@environment.belgium.be
Website: https://www.health.belgium.be/
D. Control and management of waste
Brussels
Institut Bruxellois pour la Gestion de l'Environnement - IBGE (Brussels Institute for Management of the Environment)Avenue du Port, 86 c
1000 Bruxelles
Tel: (+32) 2 775 75 75
Contact: info@environnement.brussels
Website: https://environnement.brussels/
General surveillance
Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Federal Public Service for Health, Food Chain Safety and Environment)Direction Générale Environnement (Directorate-General for the Environment)
Avenue Galilée 5/2
1210 Bruxelles
Tel: (+32) 2 524 97 97
Contact: info_environment@health.fgov.be
Website: https://www.health.belgium.be/
Flanders
Openbare Vlaamse Afvalstoffenmaatschappij - OVAM (Public Waste Agency of Flanders)Stationsstraat 110
2800 Mechelen
Tel: (+32) 1 528 42 84
Contact: info@ovam.be
Website: https://ovam.vlaanderen.be/
Wallonia
Service Public de Wallonie Agriculture, Ressources Naturelles et Environnement (Public Service of Wallonia for Agriculture, Natural Ressources and Environment)Avenue Prince de Liège, 15
5100 Jambes Namur
Tel: (+32) 8 133 51 16 / (+32) 8 133 51 57
Contact: dgarne@spw.wallonie.be / directiongenerale.environnement@spw.wallonie.be
Website: http://environnement.wallonie.be/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Bureau de Normalisation - NBN (Standardisation Office)Rue de Joseph II, 40 - boîte 6
1000 Bruxelles
Tel: (+32) 2 738 01 11
Contact: info@nbn.be / https://www.nbn.be/en/contact
Website: https://www.nbn.be/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Agence Fédérale pour la Sécurité de la Chaîne Alimentaire - AFSCA (Federal Agency for the Safety of the Food Chain)Direction Générale de la Politique de Contrôle (Directorate-General for Control Policy)
Direction de Transformation et Distribution des denrées alimentaires (Directorate of Transformation and Supply of Foodstuffs)
Boulevard du Jardin Botanique 55
1000 Bruxelles
Tel: (+32) 2 211 87 14 / (+32) 2 211 85 77
Contact: S3.pccb@favv-afsca.be
Website: https://favv-afsca.be/
Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement (Federal Public Service for Health, Food Chain Safety and Environment)
Direction Générale Animaux, Végétaux et Alimentation (Directorate-General for Animals, Plants and Food)
Service Denrées Alimentaires, Aliments pour Animaux et autres Produits de Consommation (Department of Food Products, Feedingstuff and other Consumer Goods)
Avenue Galilée 5/2
1210 Bruxelles
Tel: (+32) 2 524 97 97
Contact: apf.food@health.fgov.be
Website: https://www.health.belgium.be/
Packaging sizing
Service Public Fédéral Economie, PME, Classes Moyennes et Energie (Federal Public Service for Economy, SMEs, Self-Employed and Energy)Direction Générale de la Qualité et de la Sécurité (Directorate-General for Quality and Safety)
Division Métrologie (Metrology Division)
North Gate III
Boulevard du Roi Albert II, 16
1000 Bruxelles
Tel: (+32) 800 120 33
Contact: metrology.approvals@economie.fgov.be
Website: https://economie.fgov.be/fr
12. Labelling
The contents of the labelling must be at least in the official language of the region where the product is commercialised. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.)
Βουλγαρία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Bulgaria is a member of the European Union (EU) since 01/01/2007.
2. Currency
The Bulgarian Lev (BGN) is the official currency in Bulgaria.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Agentzia Mitnici (National Customs Agency)47 G.S. Rakovski Str.
1202 Sofia
Tel: (+359) 2 9859 4528
Contact: ServiceDesk@customs.bg
Website: https://customs.bg/wps/portal/agency-en/home
4. Import Procedure
The Single Administrative Document - SAD (Edinen administrativen dokument - EAD) must be submitted electronically using E-Portal na Agentsiya Mitnitsi - (e-Services of the Bulgarian Customs Agency). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Svobodna bezmitna zona - Burgas
- Svobodna zona - Vidin
- Svobodna bezmitna zona - Dragoman
- Svobodna zona - Plovdiv
- Svobodna zona - Rousse
- Svobodna zona - Svilengrad
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Ministerstvo na Ikonomikata i industriata (Ministry of Economy and Industry)Direktorat Registrirane, Litsenzirane i Kontrol (Registration, Licenses and Control Directorate)
12 Knyaz Alexander I Str.
1052 Sofia
Tel: (+359) 2 940 70 08
Contact: kd.markov@mi.government.bg
Website: https://www.mi.government.bg/en/department/registration-licensing-and-control/
Import licences for agricultural products
Ministerstvo na zemedelieto i hranite i hranite (Ministry of Agriculture and Food)Direktsia Darzhavni Pomoshti i Regulatsii (Marketing and Control Directorate)
55 Hristo Botev Blvd.
1040 Sofia
Tel: (+359) 2 985 11 545
Contact: press@mzgar.government.bg / minister@mzh.government.bg
Website: https://www.mzh.government.bg/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Balgarska Agentzia po Bezopasnost na Hranite (Bulgarian Food Safety Agency)Direktsia Granichen Kontrol (Border Control Directorate)
15 Pencho Slaveikov Blvd. A
1606 Sofia
Tel: (+359) 2 915 98 68 / (+359) 2 915 98 72
Contact: bfsa@bfsa.bg / ceo@bfsa.bg
Website: https://bfsa.egov.bg/wps/portal/bfsa-web-en/home
7. Plant Health
The competent authorities for phytosanitary inspections are:
Balgarska Agentzia po Bezopasnost na Hranite (Bulgarian Food Safety Agency)Direktsia Produkti za Rastitelna Zashtita, Torove i Kontrol (Plant Protection Preparations, Fertilizers and Control Directorate)
15 Pencho Slaveikov Blvd. A
1606 Sofia
Tel: (+359) 2 917 37 17 / (+359) 2 917 37 05
Contact: bfsa@bfsa.bg / ceo@bfsa.bg
Website: https://bfsa.egov.bg/wps/portal/bfsa-web-en/home
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Balgarska Agentzia po Bezopasnost na Hranite (Bulgarian Food Safety Agency)Direktsia Kontrol na Hranite (Foodstuffs Control Directorate)
15 Pencho Slaveikov Blvd. A
1606 Sofia
Tel: (+359) 2 915 98 44 / (+359) 2 915 98 31
Contact: bfsa@bfsa.bg / ceo@bfsa.bg
Website: https://bfsa.egov.bg/wps/portal/bfsa-web-en/home
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Balgarska Agentzia po Bezopasnost na Hranite (Bulgarian Food Safety Agency)Direktsia Granichen Kontrol (Border Control Directorate)
15 Pencho Slaveikov Blvd. A
1606 Sofia
Tel: (+359) 2 915 98 68 / (+359) 2 915 98 72
Contact: bfsa@bfsa.bg / ceo@bfsa.bg
Website: https://bfsa.egov.bg/wps/portal/bfsa-web-en/home
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Control of plants, fruits and vegetables
Balgarska Agentzia po Bezopasnost na Hranite (Bulgarian Food Safety Agency)Direktsia Rastitelna Zashtita i Kontrol na Kachestvoto na Presni Plodove i Zelenchutsi (Plant Protection and Quality Control of Fresh Fruits and Vegetables Directorate)
15 Pencho Slaveikov Blvd. A
1606 Sofia
Tel: (+359) 2 917 37 03 / (+359) 2 917 37 34
Contact: bfsa@bfsa.bg / ceo@bfsa.bg
Website: https://bfsa.egov.bg/wps/portal/bfsa-web-en/home
Control of food of animal origin
Ministerstvo na zemedelieto i hranite i hranite (Ministry of Agriculture and Food)Direktsia Zhivotnovadstvo (Livestock Directorate)
Otdel Zhivotnovudstvo i Genetichni Resursi (Livestock and Genetic Resources Section)
55 Hristo Botev Blvd.
1040 Sofia
Tel: (+359) 2 985 11 321 / (+359) 2 985 11 322
Contact: info@mzgar.government.bg
Website: https://www.mzh.government.bg/bg/ministerstvo/struktura/direkciya-zhivotnovdstvo/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministerstvo na Okolnata Sreda i Vodite (Ministry of Environment and Water)Direktsia Opazvane Chistotata na Vuzdukha (Protection of Air Purity Directorate)
22 Mariya Luiza Blvd.
1000 Sofia
Tel: (+359) 2 940 63 05
Contact: angelov@moew.government.bg
Website: https://www.moew.government.bg/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerstvo na Okolnata Sreda i Vodite (Ministry of Environment and Water)Direktsia Nacionalna sluzhba za zashtita na prirodata (National Nature Protection Directorate)
Otdel Biologichno Raznoobrazie (Biodiversity Division)
22 Mariya Luiza Blvd.
1000 Sofia
Tel: (+359) 2 940 61 51
Contact: nnpsf@moew.government.com
Website: https://www.moew.government.bg/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals and fertilisers
Balgarska Agentzia po Bezopasnost na Hranite (Bulgarian Food Safety Agency)Direktsia Produkti za Rastitelna Zashtita, Torove i Kontrol (Plant Protection Preparations, Fertilizers and Control Directorate)
15 Pencho Slaveikov Blvd. A
1606 Sofia
Tel: (+359) 2 917 37 17 / (+359) 2 917 37 05
Contact: bfsa@bfsa.bg / ceo@bfsa.bg
Website: https://bfsa.egov.bg/wps/portal/bfsa-web-en/home
Dangerous chemicals, detergents and persistent organic pollutants
Ministerstvo na Okolnata Sreda i Vodite (Ministry of Environment and Water)Direktsia Ekologichna otsenka, otsenka na vuzdeistvieto vurkhu okolnata sreda i predotvratyavane na zamursyavaneto (Directorate for Environmental Assessment, Environmental Impact Assessment and Pollution Prevention)
Otdel Kompleksni Razreshitelni i Opasni Veshtestva (Complex Permits and Dangerous Substances Department)
67 William Gladstone Str.
1000 Sofia
Tel: (+359) 2 940 62 27
Contact: tzheleva@moew.government.bg
Website: https://www.moew.government.bg/
Detergents
Ministerstvo na Zdraveopazvaneto (Ministry of Health)5 Sveta Nedelia Square
1000 Sofia
Tel: (+359) 2 930 11 71 / (+359) 2 930 11 76
Contact: delovodstvo@mh.government.bg
Website: https://www.mh.government.bg/
D. Control and management of waste
General surveillance
Izpalnitelna Agentzia po Okolnata Sreda (Executive Environment Agency)136 Tsar Boris III Blvd.
1618 Sofia
Tel: (+359) 2 955 90 11
Contact: iaos@eea.government.bg
Website: http://eea.government.bg/
Ministerstvo na Okolnata Sreda i Vodite (Ministry of Environment and Water)
Direktsia Upravlenie na Otpadacite i Opazvane na Pochvite (Waste Management and Soil Protection Directorate)
67 William Gladstone Str.
1000 Sofia
Tel: (+359) 2 940 65 05
Contact: d.stoyanova@moew.government.bg
Website: https://www.moew.government.bg/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Bulgarski Institut za Standartizatzia (Bulgarian Institute for Standardization - BDS)Izgrev Complex
13 Lachezar Stanchev Str.
1797 Sofia
Tel: (+359) 2 817 45 23 / (+359) 2 817 45 04
Contact: info@bds-bg.org
Website: https://www.bds-bg.org/bg/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Darzhavna Agentzia za Metrologichen i Tehnicheski Nadzor (State Agency for Metrological and Technical Surveillance - SAMTS)52 G.M. Dimitrov Blvd. A
1797 Sofia
Tel: (+359) 2 980 63 17
Contact: damtn@damtn.government.bg
Website: https://www.damtn.government.bg/
Materials and articles intended to come into contact with foodstuffs
Nacionalen Tzentar po Obshtestveno Zdrave i Analizi (National Center of Public Health and Analyses)Direktsia Obshtestveno Zdrave i Zdraven Risk (Public Health and Health Risk Directorate)
15 Akad. Ivan Evst. Geshov Blvd.
1431 Sofia
Tel: (+359) 2 805 63 56
Contact: v.kamburova@ncpha.government.bg
Website: https://ncpha.government.bg/
12. Labelling
The contents of the labelling must be at least in Bulgarian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Κροατία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Croatia is a member of the European Union (EU) since 01/07/2013.
2. Currency
The Euro (EUR) is the official currency in Croatia since 01/01/2023.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Carinska Uprava Republike Hrvatske (Customs Administration of the Republic of Croatia)Alexandera Von Humboldta 4a
10 000 Zagreb
Tel: (+385) 0 8001 222 / (+385) 1 6211 300
Contact: ured-ravnatelja@carina.hr / javnost@carina.hr
Website: https://carina.gov.hr/
4. Import Procedure
The Single Administrative Document - SAD (Jedinstvena carinska deklaracija - JCD) must be submitted electronically using the e-Carina - (e-Services of Customs Administration of the Republic of Croatia). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Slobodna zona Zagreb
- Slobodna zona Luka Rijeka - Škrljevo
- Slobodna zona Kukuljanovo nije aktivna
- Krapinsko - zagorska slobodna zona
- Podunavska slobodna zona Vukovar
- Slobodna zona Osijek
- Slobodna zona Splitsko - dalmatinska
- Slobodna zona luke Ploče
- Slobodna zona luke Pula
- Slobodna zona luke Rijeka
- Slobodna zona luke Split
5. Trade Regime and Import Licenses
Import licences for agricultural products
Agencija za Plaćanja u Poljoprivredi, Ribarstvu i Ruralnom Razvoju (Paying Agency for Agriculture, Fisheries and Rural Development)Ulica grada Vukovara 269d
10 000 Zagreb
Tel: (+385) 1 6002 700 / (+385) 1 6002 742
Contact: info@apprrr.hr
Website: https://www.apprrr.hr/
Licences for iron, steel and aluminium products
Ministarstvo gospodarstva, poduzetništva i obrta (Ministry of Economy, Entrepreneurship and Crafts)Služba za mjere trgovinske politike (Division for Trade Policy Measures)
Ulica grada Vukovara 78
10 000 Zagreb
Tel: (+385) 1 6106 111
Contact: info@mingo.hr
Website: https://mingor.gov.hr/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministarstvo poljoprivrede (Ministry of Agriculture)Uprava za veterinarstvo i sigurnost hrane (Directorate for Veterinary and Food Safety)
Planinska 2a
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6443 540
Contact: uprava.veterinarstva@mps.hr
Website: http://veterinarstvo.hr/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministarstvo poljoprivrede (Ministry of Agriculture)Uprava za hranu i fitosanitarnu politiku (Directorate of Food and Phytosanitary Policy)
Ulica grada Vukovara 78
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6106 692
Contact: uprava.hrane@mps.hr
Website: https://poljoprivreda.gov.hr/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministarstvo poljoprivrede (Ministry of Agriculture)Uprava poljoprivrede i prehrambene industrije (Directorate of Agriculture and Food Industry)
Ulica grada Vukovara 78
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6106 724
Contact: uprava.poljoprivrede@mps.hr
Website: https://poljoprivreda.gov.hr/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministarstvo poljoprivrede (Ministry of Agriculture)Uprava za veterinarstvo i sigurnost hrane (Directorate for Veterinary and Food Safety)
Planinska 2a
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6443 540
Contact: uprava.veterinarstva@mps.hr
Website: https://poljoprivreda.gov.hr/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministarstvo poljoprivrede (Ministry of Agriculture)Uprava poljoprivrede i prehrambene industrije (Directorate of Agriculture and Food Industry)
Ulica grada Vukovara 78
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6106 724
Contact: uprava.poljoprivrede@mps.hr
Website: https://poljoprivreda.gov.hr/
Ministarstvo poljoprivrede (Ministry of Agriculture)
Uprava ribarstva (Fishing Directorate)
Alexandera von Humboldta 4b
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6443 185
Contact: uprava.ribarstva@mps.hr
Website: https://poljoprivreda.gov.hr/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministarstvo zaštite okoliša i energetike (Ministry of Environment and Energy)Uprava za klimatske aktivnosti, održivi razvoj i zaštitu zraka, tla i od svjetlosnog onečišćenja (Directorate for Climate Activities, Sustainable Development and Protection of Air and Soil and from Light Pollution)
Radnička cesta 80
10 000 Zagreb
Tel: (+385) 1 3717 111 / (+385) 1 3717 131
Contact: pitanja@mzoip.hr / tena.cukli@mzoe.hr
Website: https://mingor.gov.hr/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministarstvo gospodarstva i održivog razvoja (Ministry of Economy and Sustainable Development)Uprava za zaštitu prirode (Directorate for Nature Protection)
Radnička cesta 80
10 000 Zagreb
Tel: (+385) 1 3717 111 / (+385) 1 4866 102
Contact: pitanja@mzoip.hr / snjezana.starcevic@mzoe.hr
Website: https://mingor.gov.hr/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Ministarstvo poljoprivrede (Ministry of Agriculture)Uprava poljoprivrede i prehrambene industrije (Directorate of Agriculture and Food Industry)
Ulica grada Vukovara 78
10 000 Zagreb
Tel: (+385) 1 6106 111 / (+385) 1 6106 724
Contact: upiti.gradjana@mps.hr / uprava.poljoprivrede@mps.hr
Website: https://poljoprivreda.gov.hr/
Dangerous chemicals, detergents and persistent organic pollutants
Ministarstvo zdravstva (Ministry of Health)Uprava za sanitarnu inspekciju (Directorate of Sanitary Inspection)
Odjel za kemikalije i biocidne proizvode (Directorate of Chemicals and Biocidal Preparations)
Ksaver 200a
10 000 Zagreb
Tel: (+385) 1 4607 555 / (+385) 1 4607 619
Contact: pitajtenas@miz.hr / ivana.vrhovacfilipovic@miz.hr
Website: https://zdravlje.gov.hr/
D. Control and management of waste
Agencija za zaštitu okoliša (Environmental Agency of the Republic of Croatia)Radnicka cesta 80/7
10 000 Zagreb
Tel: (+385) 1 4886 840
Contact: zavod@mingor.hr
Website: https://www.haop.hr/
Ministarstvo gospodarstva i održivog razvoja (Ministry of Economy and Sustainable Development)
Uprava za procjenu utjecaja na okoliš i održivo gospodarenje otpadom (Directorate for Environmental Impact Assessment and Sustainable Waste Management)
Radnička cesta 80
10 000 Zagreb
Tel: (+385) 1 3717 111 / (+385) 1 3717 125
Contact: pitanja@mzoip.hr / javostvo@mingor.hr
Website: https://mingor.gov.hr/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Hrvatski zavod za norme (Croatian Standards Institute)Ulica grada Vukovara 78
10 000 Zagreb
Tel: (+385) 1 6106 095
Contact: hzn@hzn.hr
Website: https://www.hzn.hr/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Hrvatski zavod za javno zdravstvo (Croatian Institute for Public Health)Odjel za predmete opće uporabe i zaštitu od buke (Department of Materials and articles intended to come into contact with food)
Rockefellerova 7
10 000 Zagreb
Tel: (+385) 1 4863 222
Contact: info@hzjz.hr
Website: https://www.hzjz.hr/
Packaging sizing
Državni zavod za mjeriteljstvo (State Office for Metrology)Capraška 6
10 000 Zagreb
Tel: (+385) 1 5630 000
Contact: pisarnica@dzm.hr
Website: https://dzm.gov.hr/
12. Labelling
The contents of the labelling must be at least in Croatian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Κύπρος
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Cyprus is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Cyprus since 01/01/2008.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Ypourgeio Oikonomikon (Ministry of Finance)Karaoli M. & Auksentiou Gr. Corner
1439 Nicosia
Tel: (+357) 22 601 713 / (+357) 22 602 723
Contact: headquarters@customs.mof.gov.cy / registry@mof.gov.cy
Website: https://mof.gov.cy/
4. Import Procedure
The Single Administrative Document - SAD (Eniaío Dioikitikó Éntypo - EDE) must be submitted electronically using THISEAS - olokliroméno sýstima michanográfisis tou Tmímatos Teloneíon - (Customs Department integrated IT system). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Cyprus.
5. Trade Regime and Import Licenses
Import licences for agricultural products
Kypriakos Organismos Agrotikon Pliromon (Cyprus Agricultural Payments Organization - CAPO)Michael Koutsofta Street 20
2000 Nicosia
P.O. Box 16102
CY - 2086
Tel: (+357) 22 557 777 / (+357) 77 771 999
Contact: info@capo.gov.cy / commissioner@capo.gov.cy
Website: http://www.capo.gov.cy/
Licences for iron, steel and aluminium products
Ypourgeio Energeias, Emporiou kai Viomichanias (Ministry of Energy, Commerce and Industry)Ypiresia Eboriou (Trade Service)
Andrea Araouzou Street 6
1421 Nicosia
Tel: (+357) 22 867 123
Contact: ts@meci.gov.cy
Website: https://www.trade.gov.cy/gr/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Ktiniatrikon Ypiresion (Department of Veterinary Services)
1417 Nicosia
Tel: (+357) 22 805 241 / (+357) 22 805 216
Contact: director@vs.moa.gov.cy
Website: http://www.moa.gov.cy/moa/vs/vs.nsf/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Georgias (Department of Agriculture)
Tomeas Nomothesion (Division of Legislation)
Klados Fytoygeias kai Emporikon Prodiagrafon Georgikon Proionton (Plant Health and Quality Control Service Section)
Louki Akrita
1412 Nicosia
Tel: (+357) 22 408 626 / (+357) 22 408 630
Contact: inspection@da.moa.gov.cy
Website: http://www.moa.gov.cy/moa/da/da.nsf/All/FA0E238E72C7E168C225879C00424D07?OpenDocument
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ypourgeio Ygeias (Ministry of Health)Iatrikes Ypiresies kai Ypiresies Dimosias Ygeias (Medical and Public Health Services)
Ygeionomiki Ypiresia (Public Health Services)
Prodromou 1 and Chilonos 17
1449 Nicosia
Tel: (+357) 22 605 554
Contact: healthservices@mphs.moh.gov.cy
Website: https://www.moh.gov.cy/moh/mphs/phs.nsf/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Georgias (Department of Agriculture)
Tomeas Orizontion Kladon (Division of Horizontal Sections)
Klados Ergastiriakon Analyseon (Analytical Laboratories Section)
Louki Akrita
1412 Nicosia
Tel: (+357) 22 408 595 / (+357) 22 408 600
Contact: laboratories@da.moa.gov.cy
Website: http://www.moa.gov.cy/moa/da/da.nsf/analylaboratories_en/analylaboratories_en?opendocument
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)
Tmima Ktiniatrikon Ypiresion (Department of Veterinary Services)
1417 Nicosia
Tel: (+357) 22 805 241 / (+357) 22 805 216
Contact: director@vs.moa.gov.cy
Website: http://www.moa.gov.cy/moa/vs/vs.nsf/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Control of plants, fruits and vegetables
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Georgias (Department of Agriculture)
Tomeas Nomothesion (Division of Legislation)
Klados Fytoygeias kai Emporikon Prodiagrafon Georgikon Proionton (Plant Health and Quality Control Service Section)
Louki Akrita
1412 Nicosia
Tel: (+357) 22 408 626 / (+357) 22 408 630
Contact: inspection@da.moa.gov.cy
Website: http://www.moa.gov.cy/moa/da/da.nsf/All/FA0E238E72C7E168C225879C00424D07?OpenDocument
Control of food of animal origin
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Ktiniatrikon Ypiresion (Department of Veterinary Services)
1417 Nicosia
Tel: (+357) 22 805 241 / (+357) 22 805 216
Contact: director@vs.moa.gov.cy
Website: http://www.moa.gov.cy/moa/vs/vs.nsf/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Perivallontos (Department of Environment)
Tomeas Klimatikis Allagis kai Energias (Department of Climate Change and Energy)
28th Oktovriou Ave. 20-22
2414 Nicosia
P.O. Box 27658
2432 Nicosia
Tel: (+357) 22 408 907 / (+357) 22 408 909 / (+357) 22 408 910 / (+357) 22 408 911
Contact: info@environment.moa.gov.cy / director@environment.moa.gov.cy
Website: http://www.moa.gov.cy/moa/environment/environmentnew.nsf/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Perivallontos (Department of Environment)
Prostasia tis Fysis kai Biopoikilotitas (Protection of Nature and Biodiversity)
28th Oktovriou Ave. 20-22
2414 Nicosia
P.O. Box 27658
2432 Nicosia
Tel: (+357) 22 408 907 / (+357) 22 408 909 / (+357) 22 408 910 / (+357) 22 408 911
Contact: info@environment.moa.gov.cy / director@environment.moa.gov.cy
Website: http://www.moa.gov.cy/moa/environment/environmentnew.nsf/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Persistent organic pollutants
Ypourgeio Ergasias, Pronoias kai Koinonikon Asfaliseon (Ministry of Labour, Welfare and Social Insurance)Tmima Epitheorisis Ergasias (Department of Labour Inspection)
Apellis Street 12
1080 Nicosia
Tel: (+357) 22 405 623 / (+357) 22 405 630
Contact: info@dli.mlsi.gov.cy
Website: https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/
Dangerous chemicals
Ypourgeio Ergasias, Pronoias kai Koinonikon Asfaliseon (Ministry of Labour, Welfare and Social Insurance)Tmima Epitheorisis Ergasias (Department of Labour Inspection)
Tomeas Chimikis Prostasias, Aktinoprostasias kai Poiotitas Aera (Department of Chemical Protection, Radiation Protection and Air quality)
Klados Chimikis Prostasias (Section of Chemical Protection)
Apellis Street 12
1080 Nicosia
Tel: (+357) 22 405 623 / (+357) 22 405 608 / (+357) 22 405 609 / (+357) 22 405 611
Contact: info@dli.mlsi.gov.cy / tkyprianidou@dli.mlsi.gov.cy
Website: https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/
Fertilisers
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Georgias (Department of Agriculture)
Tomeas Orizontion Kladon (Division of Horizontal Sections)
Klados chrisis gis kai ydatos (Land and Water Use Section)
Zinonos Chr. Sozou Street 29-31
1075 Nicosia
Tel: (+357) 22 760 564 / (+357) 22 763 547
Contact: soilwater@da.moa.gov.cy / aavraam@da.moa.gov.cy
Website: http://www.moa.gov.cy/moa/da/da.nsf/landwateruse_en/landwateruse_en?opendocument
Detergents
Ypourgeio Ygeias (Ministry of Health)Iatrikes Ypiresies kai Ypiresies Dimosias Ygeias (Medical and Public Health Services)
Ygeionomiki Ypiresia (Public Health Services)
Prodromou 1 and Chilonos 17
1449 Nicosia
Tel: (+357) 22 605 554
Contact: healthservices@mphs.moh.gov.cy
Website: https://www.moh.gov.cy/moh/mphs/phs.nsf/
D. Control and management of waste
Ypourgeio Georgias, Agrotikis Anaptyxis kai Perivallontos (Ministry of Agriculture, Rural Development and Environment)Tmima Perivallontos (Department of Environment)
28th Oktovriou Ave. 20-22
2414 Nicosia
P.O. Box 27658
2432 Nicosia
Tel: (+357) 22 408 907 / (+357) 22 408 909 / (+357) 22 408 910 / (+357) 22 408 911
Contact: info@environment.moa.gov.cy / director@environment.moa.gov.cy
Website: http://www.moa.gov.cy/moa/environment/environmentnew.nsf/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Kypriakos Organismos Typopoiisis (Cyprus Organization for Standardization)Kosta Anaxagora and Lemesou Av. 30, 3rd floor
2014 Nicosia
P.O. Box 16197
CY - 2086
Tel: (+357) 22 411 411 / (+357) 22 411 413 / (+357) 22 411 414
Contact: cystandards@cys.org.cy
Website: https://www.cys.org.cy/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Ypourgeio Energeias, Emporiou kai Viomichanias (Ministry of Energy, Commerce and Industry)Ypiresia Metron kai Stathmon (Section of Weights and Measures)
Agiou Artemiou Street 6
2200 Geri Nicosia
Tel: (+357) 22 867 100 / (+357) 22 369 844
Contact: perm.sec@meci.gov.cy
Website: https://meci.gov.cy/en/departments-services/weights-and-measures-service
Materials and articles intended to come into contact with foodstuffs
Ypourgeio Ygeias (Ministry of Health)Geniko Chimeio tou Kratous (General Chemical State Laboratory)
Kimonos Street 44
1451 Nicosia
P.O. Box 28648
2081 Nicosia
Tel: (+357) 22 809 115 / (+357) 22 809 112
Contact: info@sgl.moh.gov.cy
Website: https://www.moh.gov.cy/moh/sgl/sgl.nsf/contact_gr/contact_gr
Ypourgeio Ygeias (Ministry of Health)
Iatrikes Ypiresies kai Ypiresies Dimosias Ygeias (Medical and Public Health Services)
Prodromou 1 and Chilonos 17
1449 Nicosia
Tel: (+357) 22 605 300 / (+357) 22 605 301
Contact: healthservices@mphs.moh.gov.cy
Website: https://www.moh.gov.cy/moh/mphs/mphs.nsf/
12. Labelling
The contents of the labelling must be at least in Greek. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Τσεχική Δημοκρατία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Czech Republic is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Czech Crown (CZK) is the official currency in the Czech Republic.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Celní správa ČR (Customs Administration of the Czech Republic)Budějovická 7
140 00 Praha 4
Tel: (+420) 261 331 111
Contact: podatelna@cs.mfcr.cz
Website: http://www.cs.mfcr.cz
4. Import Procedure
The Single Administrative Document - SAD (Jednotný Správní Doklad - JSD) must be submitted electronically using Informační systémy - (Information System of Czech Customs Administration). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Free zone Ostrava akciová společnost
- GRADDO, a.s.
- Free zone Pardubice a.s.
- Merka Spedition, s.r.o.
- ESCES spol. s.r.o.
- SPEDQUICK s.r.o.
- B.F.C.W. Logistics s.r.o.
- B.F.C.W. Logistics s.r.o.
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Ministerstvo průmyslu a obchodu (Ministry of Industry and Trade)Licenční správa (Licensing Administration)
Na Františku 32
110 15 Praha 1
Tel: (+420) 224 851 111
Contact: posta@mpo.cz
Website: https://www.mpo.cz/
Import licences for agricultural products
Státní zemědělský intervenční fond - SZIF (State Agricultural Intervention Fund)Ve Smečkách 33
110 00 Praha 1
Tel: (+420) 222 871 620
Contact: info@szif.cz
Website: https://www.szif.cz/cs
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Státní veterinární správa ČR (State Veterinary Administration of the Czech Republic)Odbor vnějších vztahů, kontroly dovozu a vývozu (Section of External Relations, Control of Exports and Imports)
Slezská 100/7
120 56 Praha 2
Tel: (+420) 227 010 189 / (+420) 227 010 186
Contact: epodatelna@svscr.cz
Website: https://www.svscr.cz/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ústřední kontrolní a zkušební ústav zemědělský (Central Institute for Supervising and Testing in Agriculture)Odbor ochrany proti škodlivým organizmům (Division of Protection against Harmful Organisms)
Zemědělská 1A
CZ-613 00 Brno
Tel: (+420) 545 110 438
Contact: karantena@ukzuz.cz
Website: https://eagri.cz/public/web/ukzuz/portal/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Státní Zemědělská a Potravinářská Inspekce (Czech Agriculture and Food Inspection Authority)Odbor kontroly, laboratoří a certifikace (Control, Laboratories and Certification Department)
Květná 15
603 00 Brno
Tel: (+420) 543 540 213
Contact: sekret.oklc@szpi.gov.cz
Website: https://www.szpi.gov.cz/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ústřední kontrolní a zkušební ústav zemědělský (Central Institute for Supervising and Testing in Agriculture)Odbor krmiv (Division of Feedingstuffs)
Za Opravnou 4/4
150 00 Praha 5
Tel: (+420) 257 294 240
Contact: podatelna@ukzuz.cz
Website: https://eagri.cz/public/web/ukzuz/portal/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Státní Zemědělská a Potravinářská Inspekce (Czech Agriculture and Food Inspection Authority)Květná 15
603 00 Brno
Tel: (+420) 543 540 111 / (+420) 542 426 625
Contact: sekret.ur@szpi.gov.cz / epodatelna@szpi.gov.cz / info@zavinac.gifszpi.gov.cz
Website: https://www.szpi.gov.cz/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministerstvo životního prostředí (Ministry of Environment of the Czech Republic)Odbor ochrany ovzduší (Department of Air Protection)
Vršovická 1442/65
100 10 Praha 10
Tel: (+420) 267 122 837 / (+420) 267 122 517
Contact: info@mzp.cz
Website: https://www.mzp.cz/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerstvo životního prostředí (Ministry of Environment of the Czech Republic)Odbor mezinárodní ochrany biodiverzity (Department of International Protection of Biodiversity)
Oddělení výkonného orgánu CITES (Unit for the CITES Management Authority)
Vršovická 1442/65
100 10 Praha 10
Tel: (+420) 267 122 480 / (+420) 267 122 125
Contact: cites@mzp.cz
Website: https://www.mzp.cz/en/cites
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Ministerstvo zemědělství ČR (Ministry of Agriculture of the Czech Republic)Odbor rostlinných komodit (Plant Commodities Department)
Těšnov 65/17
110 00 Praha 1
Tel: (+420) 221 813 024 / (+420) 221 813 024
Contact: info@mze.cz / posta@mze.cz
Website: https://eagri.cz/
Ústřední kontrolní a zkušební ústav zemědělský (Central Institute for Supervising and Testing in Agriculture)
Oddělení hnojiv (Department of Fertilisers)
Za Opravnou 4/4
150 00 Praha 5
Tel: (+420) 257 294 214
Contact: hnojiva@ukzuz.cz
Website: https://eagri.cz/public/web/ukzuz/portal/
Dangerous chemicals, detergents and persistent organic pollutants
Ministerstvo životního prostředí (Ministry of Environment of the Czech Republic)Odbor environmentálních rizik a ekologických škod (Department of Environmental Hazards and Environmental Damages)
Vršovická 1442/65
100 10 Praha 10
Tel: (+420) 267 122 219
Contact: info@mzp.cz
Website: https://www.mzp.cz/
D. Control and management of waste
Ministerstvo životního prostředí (Ministry of Environment of the Czech Republic)Odbor odpadů (Department of Waste)
Vršovická 1442/65
100 10 Praha 10
Tel: (+420) 267 122 576 / (+420) 267 122 216
Contact: info@mzp.cz
Website: https://www.mzp.cz/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Ministerstvo zdravotnictví ČR (Ministry of Health of the Czech Republic)Odbor ochrany verejného zdraví (Department of Public Health Protection)
Palackého náměstí 4
128 01 Praha 2
Tel: (+420) 224 971 111
Contact: mzcr@mzcr.cz
Website: https://www.mzcr.cz/
Státní zdravotní ústav (National Institute of Public Health)
Oddělení pro chemickou bezpečnost výrobků (Department of Chemical Product Safety)
Šrobárova 49/48
100 00 Praha 10
Tel: (+420) 267 082 554
Contact: zdravust@szu.cz
Website: https://szu.cz/
12. Labelling
The contents of the labelling must be at least in Czech. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Δανία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Kingdom of Denmark is a member of the European Union (EU) since 01/01/1973.
2. Currency
The Danish Kroner (DKK) is the official currency in Denmark.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Skatteministeriet (Ministry of Taxation)Skatteforvaltningen (Customs and Tax Administration)
Toldstyrelsen (Customs Agency)
Slet Parkvej 1
8310 Tranbjerg J
Tel: (+45) 72 22 12 12 / (+45) 72 22 12 02
Contact: https://info.skat.dk/data.aspx?oid=DK_8544&x=76015
Website: https://www.toldst.dk/
4. Import Procedure
The Single Administrative Document - SAD (Det administrative enhedsdokument - SAD) must be submitted electronically using Toldsystemet - (Customs Sytems). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Københavns Frihavn
5. Trade Regime and Import Licenses
Import licences for steel and textile products
Erhvervsministeriet (Ministry of Industry, Business and Financial Affairs)Erhvervsstyrelsen (Danish Business Authority)
Dahlerups Pakhus
Langelinie Allé 17
2100 København Ø
Tel: (+45) 35 29 10 00 / (+45) 72 20 00 30
Contact: erst@erst.dk
Website: https://erhvervsstyrelsen.dk/
Import licences for agricultural products
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Landbrugs- og Fiskeristyrelsen (Danish Agricultural and Fisheries Agency)
Nyropsgade 30
1780 København V
Tel: (+45) 72 18 56 06
Contact: mail@lfst.dk
Website: https://lfst.dk/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Fødevarestyrelsen (Danish Veterinary and Food Administration)
Stationsparken 31-33
2600 Glostrup
Tel: (+45) 72 27 69 00
Contact: email@fvst.dk
Website: https://www.foedevarestyrelsen.dk/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Landbrugs- og Fiskeristyrelsen (Danish Agricultural and Fisheries Agency)
Planter & Biosikkerhed (Plants & Biosecurity)
Nyropsgade 30
1780 København V
Tel: (+45) 72 18 56 00
Contact: mail@lfst.dk / planterogbiosikkerhed-@lfst.dk
Website: https://lfst.dk/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Fødevarestyrelsen (Danish Veterinary and Food Administration)
Stationsparken 31-33
2600 Glostrup
Tel: (+45) 72 27 69 00
Contact: email@fvst.dk
Website: https://www.foedevarestyrelsen.dk/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Landbrugs- og Fiskeristyrelsen (Danish Agricultural and Fisheries Agency)
Nyropsgade 30
1780 København V
Tel: (+45) 72 18 56 06
Contact: mail@lfst.dk
Website: https://lfst.dk/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Landbrugs- og Fiskeristyrelsen (Danish Agricultural and Fisheries Agency)
Nyropsgade 30
1780 København V
Tel: (+45) 72 18 56 06
Contact: mail@lfst.dk
Website: https://lfst.dk/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Miljø- og Ligestillingministeriet (Ministry of Environment and Gender Equality)Miljøstyrelsen (Danish Environmental Protection Agency)
Center for Sikker Kemi (Centre for Safe Chemicals)
Kemikalier and Biocider (Chemicals and Biocides Division)
Tolderlundsvej 5
5000 Odense C
Tel: (+45) 72 54 40 00 / (+45) 72 54 44 66
Contact: mst@mst.dk / info@mst.dk
Website: https://mst.dk/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Landbrugs- og Fiskeristyrelsen (Danish Agricultural and Fisheries Agency)
Planter & Biosikkerhed (Plants & Biosecurity)
Nyropsgade 30
1780 København V
Tel: (+45) 72 18 56 00
Contact: mail@lfst.dk / planterogbiosikkerhed-@lfst.dk
Website: https://lfst.dk/
Miljø- og Ligestillingministeriet (Ministry of Environment and Gender Equality)
Miljøstyrelsen (Danish Environmental Protection Agency)
CITES Sektion (CITES Section)
Tolderlundsvej 5
5000 Odense C
Tel: (+45) 72 54 24 23 / (+45) 72 54 40 00
Contact: mst@mst.dk / cites@mst.dk
Website: https://mst.dk/borger/natur-og-fritid/handel-med-truede-arter-cites
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Landbrugs- og Fiskeristyrelsen (Danish Agricultural and Fisheries Agency)
EU & Landbrug (EU & Agriculture)
Miljø & Erhvervsregulering (Environment & Business Regulation)
Nyropsgade 30
1780 København V
Tel: (+45) 72 18 56 00
Contact: mail@lfst.dk
Website: https://lfst.dk/
Dangerous chemicals, detergents and persistent organic pollutants
Miljø- og Ligestillingministeriet (Ministry of Environment and Gender Equality)Miljøstyrelsen (Danish Environmental Protection Agency)
Center for Sikker Kemi (Centre for Safe Chemicals)
Kemikalier and Biocider (Chemicals and Biocides Division)
Tolderlundsvej 5
5000 Odense C
Tel: (+45) 72 54 40 00 / (+45) 72 54 44 66
Contact: mst@mst.dk / info@mst.dk
Website: https://mst.dk/
D. Control and management of waste
Miljø- og Ligestillingministeriet (Ministry of Environment and Gender Equality)Miljøstyrelsen (Danish Environmental Protection Agency)
Center for Cirkulær Økonomi (Centre for Circular Economy)
Cirkulær omstilling (Circular Conversion)
Tolderlundsvej 5
5000 Odense C
Tel: (+45) 72 54 40 00 / (+45) 72 54 44 66
Contact: mst@mst.dk / info@mst.dk
Website: https://mst.dk/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Fonden Dansk Standard (Danish Standards Foundation)Göteborg Plads 1
2150 Nordhavn
Tel: (+45) 39 96 61 01
Contact: dansk.standard@ds.dk
Website: https://www.ds.dk/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Danmarks Nationale Metrologiinstitut (Danish National Metrology Institute)Kogle Allé 5
2970 Hørsholm
Tel: (+45) 77 30 58 00
Contact: https://dfm.dk/en/contact/
Website: https://dfm.dk/
Materials and articles intended to come into contact with foodstuffs
Ministeriet for Fødevarer, Landbrug of Fiskeri (Ministry of Food, Agriculture and Fisheries)Fødevarestyrelsen (Danish Veterinary and Food Administration)
Stationsparken 31-33
2600 Glostrup
Tel: (+45) 72 27 69 00
Contact: email@fvst.dk
Website: https://www.foedevarestyrelsen.dk/
12. Labelling
The contents of the labelling must be at least in Danish. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
13. Special territories
Greenland and the Faroe Islands form part of the Kingdom of Denmark, but are excluded from the European Customs territory.
Εσθονία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Estonia is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Estonia since 01/01/2011.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Maksu- ja Tolliamet (Estonian Tax and Customs Board)Lõõtsa 8a
15176 Tallinn
Tel: (+372) 880 0811 / (+372) 880 0812
Contact: emta@emta.ee / aktsiisid@emta.ee
Website: https://www.emta.ee/
4. Import Procedure
The Single Administrative Document - SAD (Ühtse Haldusdokumendi - SAD) must be submitted electronically using e-MTA - Maksu- ja Tolliameti e-teenused - (E-services of the Tax and Customs Board). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Muuga Free Zone
- Sillamäe Free Zone
- Paldiski Free Zone
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Majandus- ja Kommunikatsiooniministeerium (Ministry of Economic Affairs and Communications)Ettevõtluskeskkonna - ja tööatuse osakond (Entrepreneurship and Industry Department)
Suur-Ameerika 1
10122 Tallinn
Tel: (+372) 625 6342
Contact: info@mkm.ee
Website: https://www.mkm.ee/
Import licences for agricultural products
Põllumajanduse Registrite ja Informatsiooni Amet - PRIA (Estonian Agricultural Registers and Information Board - ARIB)Tähe 4
51010 Tartu
Tel: (+372) 737 1200
Contact: pria@pria.ee
Website: https://www.pria.ee/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Põllumajandus- ja Toiduamet (Estonian Agricultural and Food Board)Teaduse 2
Saku, Harjumaa 75501
Väike-Paala 3
Tallinn 11415
Tel: (+372) 605 1710
Contact: pta@pta.agri.ee
Website: https://pta.agri.ee/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Põllumajandus-ja Toiduamet (Estonian Agricultural and Food Board)Taimetervise ja paljundusmaterjali osakond (Plant Health and Plant Reproductive Department)
Teaduse 2
Saku, Harjumaa 75501
Väike-Paala 3
Tallinn 11415
Tel: (+372) 605 1710
Contact: pta@pta.agri.ee
Website: https://pta.agri.ee/
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Põllumajandus- ja Toiduamet (Estonian Agricultural and Food Board)Teaduse 2
Saku, Harjumaa 75501
Väike-Paala 3
Tallinn 11415
Tel: (+372) 605 1710
Contact: pta@pta.agri.ee
Website: https://pta.agri.ee/
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Regionaal- ja Põllumajandusministeerium (Ministry of Regional Affairs and Agriculture)Kalanduspoliitika osakond (Fisheries Economics Department)
Kalamajandus ja kalapüük (Fish Management and Fishing)
Lai tn 39 // Lai tn 41
15056 Tallinn
Tel: (+372) 625 6101 / (+372) 625 6181
Contact: info@agri.ee
Website: https://www.agri.ee/
Regionaal- ja Põllumajandusministeerium (Ministry of Regional Affairs and Agriculture)
Toiduohutuse osakond (Food Safety Area)
Lai tn 39 // Lai tn 41
15056 Tallinn
Tel: (+372) 625 6101 / (+372) 625 6154 / (+372) 625 6214 / (+372) 625 6509
Contact: info@agri.ee
Website: https://www.agri.ee/
Põllumajandus-ja Toiduamet (Estonian Agricultural and Food Board)
Taimetervise ja paljundusmaterjali osakond (Plant Health and Plant Reproductive Department)
Teaduse 2
Saku, Harjumaa 75501
Väike-Paala 3
Tallinn 11415
Tel: (+372) 605 1710
Contact: pta@pta.agri.ee
Website: https://pta.agri.ee/
Põllumajandus- ja Toiduamet (Estonian Agricultural and Food Board)
Teaduse 2
Saku, Harjumaa 75501
Väike-Paala 3
Tallinn 11415
Tel: (+372) 605 1710
Contact: pta@pta.agri.ee
Website: https://pta.agri.ee/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Eesti Keskkonnauuringute Keskus (Estonian Environmental Research Center)Marja 4d
10617 Tallinn
Tel: (+372) 611 2900
Contact: info@klab.ee
Website: http://klab.ee/
Kliimaministeerium (Ministry of Climate)
Elurikkuse ja Keskkonnakaitse põhiüksus (Biodiversity and Environment protection Unit)
Suur-Ameerika 1
10122 Tallinn
Tel: (+372) 626 2802
Contact: info@kliimaministeerium.ee
Website: https://kliimaministeerium.ee/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Kliimaministeerium (Ministry of Climate)Elurikkuse ja Keskkonnakaitse põhiüksus (Biodiversity and Environment protection Unit)
Suur-Ameerika 1
10122 Tallinn
Tel: (+372) 626 2802
Contact: info@kliimaministeerium.ee
Website: https://kliimaministeerium.ee/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Persistent organic pollutants
Keskkonnaagentuur (Estonian Environment Agency)Mustamäe tee 33
10616 Tallinn
Tel: (+372) 666 0901
Contact: kaur@envir.ee
Website: https://keskkonnaagentuur.ee/
Kliimaministeerium (Ministry of Climate)
Elurikkuse ja Keskkonnakaitse põhiüksus (Biodiversity and Environment protection Unit)
Suur-Ameerika 1
10122 Tallinn
Tel: (+372) 626 2802
Contact: info@kliimaministeerium.ee
Website: https://kliimaministeerium.ee/
Fertilisers
Regionaal- ja Põllumajandusministeerium (Ministry of Regional Affairs and Agriculture)Toiduohutuse osakond (Food Safety Area)
Lai tn 39 // Lai tn 41
15056 Tallinn
Tel: (+372) 625 6101 / (+372) 625 6154 / (+372) 625 6214 / (+372) 625 6509
Contact: info@agri.ee
Website: https://www.agri.ee/
Põllumajandus-ja Toiduamet (Estonian Agricultural and Food Board)
Taimekaitse ja Väetise osakond (Plant Protection and Fertilizer Department)
Teaduse 2
Saku, Harjumaa 75501
Väike-Paala 3
Tallinn 11415
Tel: (+372) 605 1710
Contact: pta@pta.agri.ee
Website: https://pta.agri.ee/
Dangerous chemicals and detergents
Terviseamet (Health Board)Paldiski mnt 81
10617 Tallinn
Tel: (+372) 794 3500
Contact: info@terviseamet.ee
Website: https://www.terviseamet.ee/et
D. Control and management of waste
Keskkonnaagentuur (Estonian Environment Agency)Mustamäe tee 33
10616 Tallinn
Tel: (+372) 666 0901
Contact: kaur@envir.ee
Website: https://keskkonnaagentuur.ee/
General surveillance
Kliimaministeerium (Ministry of Climate)Elurikkuse ja Keskkonnakaitse põhiüksus (Biodiversity and Environment protection Unit)
Suur-Ameerika 1
10122 Tallinn
Tel: (+372) 626 2802
Contact: info@kliimaministeerium.ee
Website: https://kliimaministeerium.ee/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Eesti Standardimis- ja Akrediteerumiskeskus MTÜ (Estonian Centre for Standardisation and Accreditation)Akadeemia tee 21/6, 2nd floor
12618 Tallinn
Tel: (+372) 605 5060 / (+372) 605 5050
Contact: info@evs.ee / standard@evs.ee
Website: https://www.evs.ee/et/
Tarbijakaitse ja Tehnilise Järelevalve Amet (Estonian Consumer Protection and Technical Surveillance Authority)
Endla 10a
10122 Tallinn
Tel: (+372) 667 2000
Contact: info@ttja.ee
Website: https://www.ttja.ee/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
AS Metrosert (Central Office of Metrology)Teaduspargi 8
12618 Tallinn
Tel: (+372) 5667 8866 / (+372) 508 1129
Contact: tallinn@metrosert.ee
Website: https://metrosert.ee/
Materials and articles intended to come into contact with foodstuffs
Regionaal- ja Põllumajandusministeerium (Ministry of Regional Affairs and Agriculture)Toiduohutuse osakond (Food Safety Area)
Lai tn 39 // Lai tn 41
15056 Tallinn
Tel: (+372) 625 6101 / (+372) 625 6154 / (+372) 625 6214 / (+372) 625 6509
Contact: info@agri.ee
Website: https://www.agri.ee/
12. Labelling
The contents of the labelling must be at least in Estonian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Φινλανδία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Finland is a member of the European Union (EU) since 01/01/1995.
The Finnish continental territory and the Åland Islands form part of the European Customs territory.
2. Currency
The Euro (EUR) is the official currency in Finland since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Tulli (Finnish Customs)PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
4. Import Procedure
The Single Administrative Document - SAD (Hallinnollinen Yhtenäisasiakirja - SAD) must be submitted electronically using TULLI Asiointipalvelut - (e-Services of the Finnish Customs). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Finland.
5. Trade Regime and Import Licenses
Import licences for agricultural products
Maa- ja Metsätalousministeriö (Ministry of Agriculture and Forestry)Ruokaosasto (Food Department)
Elintarviketurvallisuusyksikkö (Food Safety Unit)
Hallituskatu 3 A
PL 30
00023 Valtioneuvosto
Helsinki
Tel: (+358) 29 516 001 / (+358) 29 516 2305
Contact: kirjaamo.mmm@gov.fi
Website: https://mmm.fi/etusivu
Licences for iron, steel and aluminium products
Tulli (Finnish Customs)PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Maa- ja Metsätalousministeriö (Ministry of Agriculture and Forestry)Ruokaosasto (Food Department)
Eläin- ja kasvinterveyden yksikkö (Animal and Plant Health Unit)
Hallituskatu 3 A
PL 30
00023 Valtioneuvosto
Helsinki
Tel: (+358) 29 516 2436 / (+358) 29 516 001 / (+358) 29 516 2160 / (+358) 29 516 2280
Contact: kirjaamo.mmm@gov.fi
Website: https://mmm.fi/etusivu
Ruokavirasto (Finnish Food Authority)
PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400
Contact: kirjaamo@ruokavirasto.fi / rajatarkastus@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Tulli (Finnish Customs)
PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ruokavirasto (Finnish Food Authority)PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400
Contact: kirjaamo@ruokavirasto.fi / rajatarkastus@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Tulli (Finnish Customs)
PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ruokavirasto (Finnish Food Authority)PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400
Contact: kirjaamo@ruokavirasto.fi / rajatarkastus@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Tulli (Finnish Customs)
PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ruokavirasto (Finnish Food Authority)PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400
Contact: kirjaamo@ruokavirasto.fi / rajatarkastus@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Tulli (Finnish Customs)
PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ruokavirasto (Finnish Food Authority)PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400
Contact: kirjaamo@ruokavirasto.fi / rajatarkastus@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Tulli (Finnish Customs)
PL 512
00101 Helsinki
Tel: (+358) 295 5200
Contact: kirjaamo@tulli.fi
Website: https://tulli.fi/etusivu
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Suomen Ympäristökeskus - SYKE (Finnish Environment Institute - SYKE)Viranomaispalvelut (Authority services)
Latokartanonkaari 11
00790 Helsinki
Tel: (+358) 29 525 1406 / (+358) 29 525 1000 / (+358) 295 252 303
Contact: jaakko.mannio@ymparisto.fi / kirjaamo@syke.fi
Website: https://www.syke.fi/fi-FI
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Suomen Ympäristökeskus - SYKE (Finnish Environment Institute - SYKE)Viranomaispalvelut (Authority services)
Latokartanonkaari 11
00790 Helsinki
Tel: (+358) 29 525 1000 / (+358) 295 252 303
Contact: cites@syke.fi / kirjaamo@syke.fi
Website: https://www.ymparisto.fi/en/permits-and-obligations/trade-endangered-species-cites
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Maa- ja Metsätalousministeriö (Ministry of Agriculture and Forestry)Ruokaosasto (Food Department)
Eläin- ja kasvinterveyden yksikkö (Animal and Plant Health Unit)
Hallituskatu 3 A
PL 30
00023 Valtioneuvosto
Helsinki
Tel: (+358) 29 516 2026 / (+358) 29 516 001 / (+358) 29 516 2160 / (+358) 29 516 2280
Contact: kirjaamo.mmm@gov.fi
Website: https://mmm.fi/etusivu
Ruokavirasto (Finnish Food Authority)
Kasvien tuonti- ja lannoitejaosto (Plant Import and Fertiliser Section)
PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400 / (+358) 40 187 1670
Contact: kirjaamo@ruokavirasto.fi / lannoitevalvonta@ruokavirasto.fi / lannoite.ilmoitukset@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Persistent organic pollutants
Suomen Ympäristökeskus - SYKE (Finnish Environment Institute - SYKE)Viranomaispalvelut (Authority services)
Latokartanonkaari 11
00790 Helsinki
Tel: (+358) 29 525 1630 / (+358) 29 525 1000 / (+358) 295 252 303
Contact: timo.seppala@ymparisto.fi / kirjaamo@syke.fi
Website: https://www.syke.fi/fi-FI
Dangerous chemicals and detergents
Turvallisuus- ja Kemikaalivirasto - Tukes (Finnish Safety and Chemicals Agency - Tukes)Kemikaaliyksikkö (Chemicals Department)
Opastinsilta 12 B
PL 66
00521 Helsinki
Tel: (+358) 29 505 2000
Contact: kirjaamo@tukes.fi
Website: https://tukes.fi/etusivu
D. Control and management of waste
Suomen Ympäristökeskus - SYKE (Finnish Environment Institute - SYKE)Viranomaispalvelut (Authority services)
Latokartanonkaari 11
00790 Helsinki
Tel: (+358) 29 525 1437 / (+358) 29 525 1000 / (+358) 295 252 303
Contact: tfs@ymparisto.fi / kirjaamo@syke.fi
Website: https://www.syke.fi/fi-FI
General surveillance
Ympäristöministeriö (Ministry of the Environment)Aleksanterinkatu 4-10,
PL 35
00170 Helsinki
Tel: (+358) 29 516 001 / (+358) 50 431 6518
Contact: kirjaamo.ym@gov.fi
Website: https://ym.fi/etusivu
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
SFS Suomen Standardit Ry (SFS Finnish Standards)PL 130
00101 Helsinki
Tel: (+358) 9 149 9331
Contact: sfs@sfs.fi
Website: https://sfs.fi/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Ruokavirasto (Finnish Food Authority)PL 100
00027 Ruokavirasto
Tel: (+358) 29 530 0400
Contact: kirjaamo@ruokavirasto.fi / rajatarkastus@ruokavirasto.fi
Website: https://www.ruokavirasto.fi/
Packaging sizing
Teknologian tutkimuskeskus VTT Mikes (VTT Mikes Technical Research Centre of Finland)PL 1000
02044 VTT
Tel: (+358) 20 722 111
Contact: kirjaamo@vtt.fi
Website: https://www.vttresearch.com/en
12. Labelling
The contents of the labelling must be at least in Finnish. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Γαλλία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The French Republic is one of the six founding Member States of the European Union (EU) as it took part in the ratification of the Treaties of Rome, which established the European Communities and became effective in 1958.
The French continental territory, Corsica and the Overseas Departments (Guadalupe, Guyana, Martinique, Reunion and Mayotte) form part of the European Customs Territory.
2. Currency
The Euro (EUR) is the official currency in France since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Direction générale des Douanes et des Droits indirects (Directorate-General for Customs and Indirect Taxes)11, Rue des deux Communes
93558 Montreuil CEDEX
Tel: (+33) 1 72 40 78 50
Website: https://www.douane.gouv.fr/
4. Import Procedure
The Single Administrative Document - SAD (Document Administratif Unique - DAU) must be submitted electronically using DELTA - Dédouanement en Ligne par Traitement Automatisé - (Automated On Line Customs Clearance system). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in French.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Zone franche du Verdon - Port de Bordeaux
5. Trade Regime and Import Licenses
Import licences for agricultural products
Ministère de l'Agriculture et de la Souveraineté alimentaire (Ministry of Agriculture and Food Sovereignty)Établissements publics d'intervention (Establishments of public intervention)
Établissements National des Produits de l'Agriculture et de la Mer - FranceAgriMer (National Establishement for agricultural and sea products)
12, Rue Rol-Tanguy
93555 Montreuil Sous Bois CEDEX
Tel: (+33) 1 73 30 30 00
Contact: certificats-dce@franceagrimer.fr
Website: https://www.franceagrimer.fr/
Licences for iron, steel and aluminium products
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)Direction Générale des Entreprises - DGE (Directorate-General for Enterprise)
Service de l'Industrie (Industry Division)
67, rue Barbès
94201 Ivry-sur-Seine CEDEX
Tel: (+33) 1 40 04 04 04
Contact: https://www.entreprises.gouv.fr/contact
Website: https://www.entreprises.gouv.fr/fr/industrie-entreprise
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministère de l'Agriculture et de la Souveraineté alimentaire (Ministry of Agriculture and Food Sovereignty)Direction Générale de l'Alimentation - DGAL (Directorate-General for Food)
Service des actions sanitaires (Department of Health Activities)
Sous-direction de la Santé et du bien-être animal (Sub-directorate of Animal Health and Welfare)
251, Rue de Vaugirard
75732 Paris CEDEX 15
Tel: (+33) 1 49 55 84 83
Contact: https://agriculture.gouv.fr/questions-frequentes-contacts
Website: https://agriculture.gouv.fr/alimentation-animale
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministère de l'Agriculture et de la Souveraineté alimentaire (Ministry of Agriculture and Food Sovereignty)Direction Générale de l'Alimentation - DGAL (Directorate-General for Food)
Service des actions sanitaires (Department of Health Activities)
Sous-direction de la santé et de la protection des végétaux - CPO (Sub-directorate for plant health and protection)
251, Rue de Vaugirard
75732 Paris CEDEX 15
Tel: (+33) 1 49 55 81 48
Contact: https://agriculture.gouv.fr/questions-frequentes-contacts
Website: https://agriculture.gouv.fr/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes - DGCCRF (Directorate-General for Competition, Consumer Affairs and Suppression of Fraud)
59, Boulevard Vincent Auriol
75703 Paris CEDEX 13
Tel: (+33) 1 44 87 17 17
Contact: https://www.economie.gouv.fr/contact/contacter-la-dgccrf
Website: https://www.economie.gouv.fr/dgccrf
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministère de l'Agriculture et de la Souveraineté alimentaire (Ministry of Agriculture and Food Sovereignty)Direction Générale de l'Alimentation - DGAL (Directorate-General for Food)
Service des actions sanitaires (Department of Health Activities)
Sous-direction de la Santé et du bien-être animal (Sub-directorate of Animal Health and Welfare)
251, Rue de Vaugirard
75732 Paris CEDEX 15
Tel: (+33) 1 49 55 84 83
Contact: https://agriculture.gouv.fr/questions-frequentes-contacts
Website: https://agriculture.gouv.fr/alimentation-animale
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes - DGCCRF (Directorate-General for Competition, Consumer Affairs and Suppression of Fraud)
Service de la protection des consommateurs et de la régulation des marchés (Service for consumer protection and market regulation)
Sous-direction des produits et marchés agroalimentaires (Sub-division of Agri-Food Products and Markets)
59, Boulevard Vincent-Auriol
75703 Paris CEDEX 13
Tel: (+33) 1 44 87 17 17
Contact: https://www.economie.gouv.fr/contact/contacter-la-dgccrf
Website: https://www.economie.gouv.fr/dgccrf
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministère de la Transition Écologique et de la Cohésion des territoires (Ministry of Ecological Transition and Territorial Cohesion)Direction Générale de l'Energie et du Climat - DGEC (Directorate-General for Energy and Climate)
Service Climat et efficacité énergétique (Direction of climate and energy efficiency)
Sous-direction de l'efficacité énergétique et de la qualité de l'air (Department of energetics efficiency and air quality)
Bureau de la qualité de l'air (Air quality Bureau)
Arche de la Défense, Paroi Nord
92055 La Défense CEDEX
Tel: (+33) 1 40 81 21 22 / (+33) 1 40 81 93 18
Website: https://www.ecologie.gouv.fr/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministère de la Transition Écologique et de la Cohésion des territoires (Ministry of Ecological Transition and Territorial Cohesion)Direction Générale de l'Aménagement, du Logement et de la Nature (Directorate-General for Development, Housing and Nature)
Direction de l'eau et de la biodiversité (Directorate of Water and Biodiversity)
Sous-direction de la protection et de la restauration des écosystèmes terrestres (Sub-directorate for the Protection and Restoration of Terrestrial Ecosystem)
Arche Sud
92055 Paris la Défense CEDEX
Tel: (+33) 1 40 81 21 22
Contact: cites@developpement-durable.gouv.fr
Website: https://www.ecologie.gouv.fr/commerce-international-des-especes-sauvages-cites
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Pesticides and fertilisers
Ministère de l'Agriculture et de la Souveraineté alimentaire (Ministry of Agriculture and Food Sovereignty)Direction Générale de l'Alimentation - DGAL (Directorate-General for Food)
Service des actions sanitaires (Department of Health Activities)
Sous-direction de la santé et de la protection des végétaux - CPO (Sub-directorate for plant health and protection)
Bureau des intrants et du biocontrôle (Office of inputs and biocontrol)
251, Rue de Vaugirard
75732 Paris CEDEX 15
Tel: (+33) 1 49 55 81 89
Contact: https://agriculture.gouv.fr/questions-frequentes-contacts
Website: https://agriculture.gouv.fr/
Fertilisers
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes - DGCCRF (Directorate-General for Competition, Consumer Affairs and Suppression of Fraud)
59, Boulevard Vincent Auriol
75703 Paris CEDEX 13
Tel: (+33) 1 44 87 17 17
Contact: https://www.economie.gouv.fr/contact/contacter-la-dgccrf
Website: https://www.economie.gouv.fr/dgccrf
Detergents
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)Direction Générale des Entreprises - DGE (Directorate-General for Enterprise)
Service de l'Industrie (Industry Division)
Sous-direction de la chimie, des matériaux et des éco-industries (Chemical, Materials and Environmental Industries Division)
120, Rue de Bercy, Bâtiment Vauban
Télédoc 589
75572 Paris Cedex 12
Tel: (+33) 1 40 04 04 04
Contact: sdcme.dge@finances.gouv.fr
Website: https://www.entreprises.gouv.fr/fr
Ministère de la Transition Écologique et de la Cohésion des territoires (Ministry of Ecological Transition and Territorial Cohesion)
Direction Générale de l'Aménagement, du Logement et de la Nature (Directorate General for Development, Housing and Nature)
Direction de l'eau et de la biodiversité (Directorate of Water and Biodiversity)
Sous-direction de la Protection et de la Gestion de l'Eau, des Ressources Minérales et des Écosystèmes Aquatiques (Division for the Protection and Management of Water, Mineral Resources and Aquatic Ecosystems)
Bureau de la lutte contre les pollutions domestiques et industrielles (Bureau against domestic and industrial water waste)
Arche Sud
92055 Paris la Défense CEDEX
Tel: (+33) 1 40 81 21 22
Contact: earm4.deb.dgaln@developpement-durable.gouv.fr
Website: https://www.ecologie.gouv.fr/
Dangerous chemicals, detergents, pesticides and persistent organic pollutants
Ministère de la Transition Écologique et de la Cohésion des territoires (Ministry of Ecological Transition and Territorial Cohesion)Direction Générale de la Prévention des risques (Directorate-General for risk prevention)
Service des risques sanitaires liés à l'environnement, des déchets et des pollutions diffuses (Direction of health risks related to the environment, waste and diffuse pollution)
Sous-direction de la santé-environnement, des produits chimiques, de l'agriculture (Branch of environmental health, chemicals and agriculture)
Bureau des produits chimiques (Bureau for Chemicals)
Arche de la Défense, Paroi Nord
92055 La Défense CEDEX
Tel: (+33) 1 40 81 21 22
Contact: pierre.de-franclieu@developpement-durable.gouv.fr / Pic-import-export@developpement-durable.gouv.fr
Website: https://www.ecologie.gouv.fr/
D. Control and management of waste
Ministère de la Transition Écologique et de la Cohésion des territoires (Ministry of Ecological Transition and Territorial Cohesion)Direction Générale de la Prévention des risques (Directorate-General for risk prevention)
Service des risques sanitaires liés à l'environnement, des déchets et des pollutions diffuses (Direction of health risks related to the environment, waste and diffuse pollution)
Sous-direction des déchets et de l'économie circulaire (Sub-directorate of waste and the circular economy)
Bureau de la Planification et de la Gestion des Déchets (Bureau of Planning and Waste Management)
Grande Arche, Paroi Nord
92055 La Défense CEDEX
Tel: (+33) 1 40 81 21 22
Contact: bpgd.sddec.srsedpd.dgpr@developpement-dourable.gouv.fr
Website: https://www.ecologie.gouv.fr/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Association française de normalisation - AFNOR (French Standardisation Association)11, Rue Francis de Pressensé
93571 Saint-Denis la Plaine CEDEX
Tel: (+33) 1 41 62 80 00
Contact: https://www.afnor.org/contact/
Website: https://www.afnor.org
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Laboratoire National de Métrologie et d'Essais - LNE (National Laboratory of Metrology and Test)1, Rue Gaston Boissier
75724 Paris CEDEX 15
Tel: (+33) 1 40 43 37 00
Contact: info@lne.fr / https://www.lne.fr/fr/demande-information-generale
Website: https://www.lne.fr/fr
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)
Direction Générale des Entreprises - DGE (Directorate-General for Enterprise)
Service de la compétitivité, de l'innovation et du développement des entreprises (Competitiveness, Innovation and Business Development Department)
Sous-direction de la normalisation, de la réglamentation des produits et de la métrologie (Standardization, Product Regulation and Metrology Division)
Division Métrologie (Metrology Division)
61, Boulevard Vincent-Auriol
75703 Paris CEDEX 13
Tel: (+33) 1 44 97 30 04
Contact: https://www.entreprises.gouv.fr/contact
Website: https://metrologie.entreprises.gouv.fr/fr
Materials and articles intended to come into contact with foodstuffs
Ministère de l'Économie, des Finances et de la Souveraineté industrielle et numérique (Ministry of Economy, Finance and Industrial and Digital Sovereignty)Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes - DGCCRF (Directorate-General for Competition, Consumer Affairs and Suppression of Fraud)
59, Boulevard Vincent Auriol
75703 Paris CEDEX 13
Tel: (+33) 1 44 87 17 17
Contact: https://www.economie.gouv.fr/contact/contacter-la-dgccrf
Website: https://www.economie.gouv.fr/dgccrf
12. Labelling
The contents of the labelling must be at least in French. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
13. Special territories
The French Overseas Territories: Saint Pierre and Miquelon, Wallis and Futuna, French austral and Antarctic territories, New Caledonia and French Polynesia are not part of the European Customs Union. At this respect, they are considered as third countries.
Γερμανία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Federal Republic of Germany is one of the six founding Member States of the European Union (EU) as it took part in the ratification of the Treaties of Rome, which established the European Communities and became effective in 1958.
2. Currency
The Euro (EUR) is the official currency in Germany since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Bundesministerium der Finanzen (Federal Ministry of Finance)Generalzolldirektion (Directorate General of Customs)
Vaclav-Havel-Platz 6
53121 Bonn
Tel: (+49) 228 303 0
Contact: enquiries.english@zoll.de / poststelle.gzd@zoll.bund.de
Website: https://www.zoll.de
4. Import Procedure
The Single Administrative Document - SAD (Einheitspapiers - SAD) must be submitted electronically using the ATLAS - Automatisiertes Tarif- und Lokales Zollabwicklungssystem - (Automated Tariff and Local Customs Processing System). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Freihafen Bremerhaven
- Freihafen Cuxhaven
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Bundesamt für Wirtschaft und Ausfuhrkontrolle - BAFA (Federal Office for Economic Affairs and Export Control)Frankfurter Straße 29-35
65760 Eschborn
Tel: (+49) 619 6908 0
Contact: poststelle@bafa.bund.de
Website: https://www.bafa.de
Import licences for agricultural products
Bundesanstalt für Landwirtschaft und Ernährung - BLE (Federal Agency for Agriculture and Food)Deichmanns Aue 29
53179 Bonn
Tel: (+49) 228 6845 0
Contact: info@ble.de
Website: https://www.ble.de
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Bundesministerium für Ernährung und Landwirtschaft - BMEL (Federal Ministry of Food and Agriculture)Abteilung 3 Lebensmittelsicherheit, Tiergesundheit (Division 3 Food Safety, Animal Health)
Unterabteilung 31 Gesundheitlicher Verbraucherschutz - Sicherheit der Lebensmittelkette (Subdivision 31 Health-related Consumer Protection - Safety of the Food Chain)
Rochusstraße 1
53123 Bonn
Postfach 14 02 70
53107 Bonn
Tel: (+49) 228 99 529 4646
Contact: UAL31@bmel.bund.de
Website: https://www.bmel.de
7. Plant Health
The competent authorities for phytosanitary inspections are:
Bundesministerium für Ernährung und Landwirtschaft - BMEL (Federal Ministry of Food and Agriculture)Abteilung 7 Landwirtschaftliche Erzeugung, Gartenbau, Agrarsozialpolitik, Steuern, Agrarstatistik (Division 7 Agricultural Production, Horticulture, Agricultural Social Policy, Taxes, Agricultural Statistics)
Unterabteilung 71 Ökologische Lebensmittelwirtschaft, Pflanzliche Erzeugung, Gartenbau (Subdivision 71 Organic Food Economy, Plant Production, Horticulture)
Referat 714 Pflanzengesundheit, Phytosanitäre Angelegenheiten beim Export (Unit 714 Plant Health, Phytosanitary Affairs in Export)
Rochusstraße 1
53123 Bonn
Postfach 14 02 70
53107 Bonn
Tel: (+49) 228 99 529 3953
Contact: 714@bmel.bund.de
Website: https://www.bmel.de
Julius Kühn Institut - Bundesforschungsinstitut für Kulturpflanzen (Julius Kuhn Institute - Federal Research Centre for Cultivated Plants)
Institut für nationale und internationale Angelegenheiten der Pflanzengesundheit (Institute for National and International Plant Health)
Messeweg 11-12
38104 Braunschweig
Tel: (+49) 394 647 7501
Contact: ag@julius-kuehn.de
Website: https://www.julius-kuehn.de/ag
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Bundesministerium für Ernährung und Landwirtschaft - BMEL (Federal Ministry of Food and Agriculture)Abteilung 3 Lebensmittelsicherheit, Tiergesundheit (Division 3 Food Safety, Animal Health)
Unterabteilung 31 Gesundheitlicher Verbraucherschutz - Sicherheit der Lebensmittelkette (Subdivision 31 Health-related Consumer Protection - Safety of the Food Chain)
Referat 312 Lebensmittelüberwachung, Krisenmanagement (Unit 312 Food Control and Inspection, Crisis Management)
Rochusstraße 1
53123 Bonn
Postfach 14 02 70
53107 Bonn
Tel: (+49) 228 99 529 4466
Contact: 312@bmel.bund.de
Website: https://www.bmel.de
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL (Federal Office of Consumer Protection and Food Safety)Abteilung 1 Lebensmittelsicherheit (Division 1 Food Safety)
Referat 112 Futtermittel (Unit 112 Feed)
Gerichtstraße 49
13347 Berlin
Tel: (+49) 301 844 4000
Contact: poststelle@bvl.bund.de
Website: https://www.bvl.bund.de
Bundesministerium für Ernährung und Landwirtschaft - BMEL (Federal Ministry of Food and Agriculture)
Abteilung 3 Lebensmittelsicherheit, Tiergesundheit (Division 3 Food Safety, Animal Health)
Unterabteilung 31 Gesundheitlicher Verbraucherschutz - Sicherheit der Lebensmittelkette (Subdivision 31 Health-related Consumer Protection - Safety of the Food Chain)
Referat 315 Futtermittelsicherheit, Tierernährung (Unit 315 Feed Safety and Animal Nutrition)
Rochusstraße 1
53123 Bonn
Postfach 14 02 70
53107 Bonn
Tel: (+49) 228 99 529 4164
Contact: 315@bmel.bund.de
Website: https://www.bmel.de
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Bundesanstalt für Landwirtschaft und Ernährung - BLE (Federal Agency for Agriculture and Food)Abteilung 5 Agrarmarkt- und Außenhandelsregelungen, Kontrollverfahren, Bereederung, Fischerei (Division 5 Agricultural Market and Foreign Trade Regulations, Control Procedures, Ship management, Fisheries)
Referat 525 Vermarktungsnormen und Konformitätskontrollen (Unit 525 Conformity Checks and Marketing Standards)
Deichmanns Aue 29
53179 Bonn
Tel: (+49) 228 6845 0 / (+49) 228 6845 3357
Contact: info@ble.de
Website: https://www.ble.de
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz (Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection)Abteilung C Chemikaliensicherheit, Immissionsschutz und Verkehr (Division C Chemical Safety, Pollution Control and Traffic)
Unterabteilung C II Chemikaliensicherheit, Umwelt und Gesundheit (Subdivision C II Chemical Safety, Environment and Health)
Referat C II 1 Grundsatzfragen der Chemikaliensicherheit, Chemikalienrecht (Unit C II 1 Fundamental Aspects of Chemical Safety, Chemicals Legislation)
Robert-Schuman-Platz 3
53175 Bonn
Postfach 12 06 29
53048 Bonn
Tel: (+49) 228 99 305 2705 / (+49) 228 99 305 2732
Contact: poststelle@bmuv.bund.de
Website: https://www.bmuv.de
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Bundesamt für Naturschutz (Federal Agency for Nature Conservation)Abteilung I.3 3 Recht, Gentechnik, Artenschutzvollzug (Division I.3 Law, Genetic Engineering, Endangered Species Protection)
Konstantinstraße 110
53179 Bonn
Tel: (+49) 228 8491 1720
Contact: info@bfn.de / citesma@bfn.de
Website: https://www.bfn.de
Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz (Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection)
Abteilung N Naturschutz und nachhaltige Naturnutzung, Natürlicher Klimaschutz (Division N Nature Conservation and Sustainable use of Nature, Natural Climate Protection)
Unterabteilung N II Nachhaltige Naturnutzung (Subdivision N II Sustainable Use of Nature)
Referat N II 3 Naturschutz und Energie (Unit N II 3 Nature Conservation and Energy)
Robert-Schuman-Platz 3
53175 Bonn
Postfach 12 06 29
53048 Bonn
Tel: (+49) 228 99 305 2971
Contact: poststelle@bmuv.bund.de
Website: https://www.bmuv.de
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL (Federal Office of Consumer Protection and Food Safety)Abteilung 2 Pflanzenschutzmittel (Division 2 Plant Protection Products)
Bundesallee 51
38116 Braunschweig
Tel: (+49) 301 8444 99999
Contact: poststelle@bvl.bund.de
Website: https://www.bvl.bund.de
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin - BAuA (Federal Institute for Occupational Safety and Health)
Fachbereich 5 Bundesstelle für Chemikalien (Department 5 Federal Office for Chemicals)
Gruppe 5.4 Biozid-Produkte Desinfektionsmittel (Unit 5.4 Biocide Products Disinfectants)
Friedrich-Henkel-Weg 1-25
44149 Dortmund
Postfach 17 02 02
44061 Dortmund
Tel: (+49) 231 9071 2971
Contact: info-zentrum@baua.bund.de / chemg@baua.bund.de
Website: https://www.baua.de
Detergents
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin - BAuA (Federal Institute for Occupational Safety and Health)Fachbereich 4 Gefahrstoffe und Biostoffe (Department 4 Hazardous Substances and Biochemicals)
Friedrich-Henkel-Weg 1-25
44149 Dortmund
Postfach 17 02 02
44061 Dortmund
Tel: (+49) 231 9071 2509
Contact: info-zentrum@baua.bund.de / sekfb4@baua.bund.de
Website: https://www.baua.de
Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz (Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection)
Abteilung C Chemikaliensicherheit, Immissionsschutz und Verkehr (Division C Chemical Safety, Pollution Control and Traffic)
Unterabteilung C II Chemikaliensicherheit, Umwelt und Gesundheit (Subdivision C II Chemical Safety, Environment and Health)
Referat C II 1 Grundsatzfragen der Chemikaliensicherheit, Chemikalienrecht (Unit C II 1 Fundamental Aspects of Chemical Safety, Chemicals Legislation)
Robert-Schuman-Platz 3
53175 Bonn
Postfach 12 06 29
53048 Bonn
Tel: (+49) 228 99 305 2705 / (+49) 228 99 305 2732
Contact: poststelle@bmuv.bund.de
Website: https://www.bmuv.de
Umweltbundesamt (Federal Environment Agency)
Fachbereich IV Chemikaliensicherheit (Department IV Chemical Safety)
Abteilung IV 2 Arzneimittel, Chemikalien und Stoffuntersuchungen (Division IV 2 Pharmaceuticals, Chemicals and Materials Research)
Fachgebiet IV 2.2 Arzneimittel (Section IV 2.2 Pharmaceuticals)
Wörlitzer Platz 1
06844 Dessau-Roßlau
Tel: (+49) 340 2103 3255
Contact: detergenzien@uba.de / info@umweltbundesamt.de
Website: https://www.umweltbundesamt.de/themen/chemikalien/wasch-reinigungsmittel
Fertilisers
Bundesministerium für Ernährung und Landwirtschaft - BMEL (Federal Ministry of Food and Agriculture)Abteilung 7 Landwirtschaftliche Erzeugung, Gartenbau, Agrarsozialpolitik, Steuern, Agrarstatistik (Division 7 Agricultural Production, Horticulture, Agricultural Social Policy, Taxes, Agricultural Statistics)
Unterabteilung 71 Ökologische Lebensmittelwirtschaft, Pflanzliche Erzeugung, Gartenbau (Subdivision 71 Organic Food Economy, Plant Production, Horticulture)
Referat 711 Pfanzenbau, Grünland, Agroforst, Regenerative Landwirtschaft (Unit 711 Crop Production, Grassland, Agroforestry, Regenerative Agriculture)
Rochusstraße 1
53123 Bonn
Postfach 14 02 70
53107 Bonn
Tel: (+49) 228 99 529 3747
Contact: 711@bmel.bund.de
Website: https://www.bmel.de
Persistent organic pollutants
Umweltbundesamt (Federal Environment Agency)Fachbereich IV Chemikaliensicherheit (Department IV Chemical Safety)
Abteilung IV 2 Arzneimittel, Chemikalien und Stoffuntersuchungen (Division IV 2 Pharmaceuticals, Chemicals and Materials Research)
Wörlitzer Platz 1
06844 Dessau-Roßlau
Tel: (+49) 308 903 2026
Contact: info@umweltbundesamt.de / chemicals@uba.de
Website: https://www.umweltbundesamt.de
D. Control and management of waste
General surveillance
Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz (Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection)Abteilung T Transformation - Digitalisierung, Circular Economy, Klimaanpassung (Division T Transformation - Digitalisation, Circular Economy, Climate Adaptation)
Unterabteilung T II Kreislaufwirtschaft (Subdivision T II Resource Protection, Circular Economy)
Robert-Schuman-Platz 3
53175 Bonn
Postfach 12 06 29
53048 Bonn
Tel: (+49) 228 99 305 2300 / (+49) 228 99 305 2550
Contact: poststelle@bmuv.bund.de
Website: https://www.bmuv.de
Umweltbundesamt (Federal Environment Agency)
Anlaufstelle Basler Übereinkommen (Basel Convention Focal Point)
Wörlitzer Platz 1
06844 Dessau-Roßlau
Tel: (+49) 340 2103 3296
Contact: focal.point.basel@uba.de
Website: https://www.umweltbundesamt.de
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Deutsches Institut für Normung - DIN (German Standardisation Institute)Burggrafenstraße 6
10787 Berlin
Tel: (+49) 30 26 010
Contact: info@din.de
Website: https://www.din.de
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Bundesinstitut für Risikobewertung - BfR (Federal Institute for Risk Analysis)Abteilung 5 Lebensmittelsicherheit (Division 5 Food Safety)
Max-Dohrn-Straße 8-10
10589 Berlin
Postfach 12 69 42
10609 Berlin
Tel: (+49) 301 84 122 5000
Contact: 5@bfr.bund.de
Website: https://www.bfr.bund.de
Bundesministerium für Ernährung und Landwirtschaft - BMEL (Federal Ministry of Food and Agriculture)
Abteilung 3 Lebensmittelsicherheit, Tiergesundheit (Division 3 Food Safety, Animal Health)
Unterabteilung 31 Gesundheitlicher Verbraucherschutz - Sicherheit der Lebensmittelkette (Subdivision 31 Health-related Consumer Protection - Safety of the Food Chain)
Referat 313 Rückstände und Kontaminanten in Lebensmitteln, Lebensmittelbedarfsgegenstände (Unit 313 Residues and Contaminants in Food and Food Articles)
Rochusstraße 1
53123 Bonn
Postfach 14 02 70
53107 Bonn
Tel: (+49) 228 99 529 3677
Contact: 313@bmel.bund.de
Website: https://www.bmel.de
Packaging sizing
Physikalisch-Technische Bundesanstalt - PTB (National Metrology Institute)Bundesallee 100
38116 Braunschweig
Tel: (+49) 531 592 3006 / (+49) 531 592 0
Contact: info@ptb.de.de
Website: https://www.ptb.de
12. Labelling
The contents of the labelling must be at least in German. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
13. Special territories
The island of Heligoland and the territory of Büsingen form part of the Federal Republic of Germany, but are excluded from the European Customs territory.
Ελλάδα
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Hellenic Republic is a member of the European Union (EU) since 01/01/1981.
2. Currency
The Euro (EUR) is the official currency in Greece since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Aneksartiti Archi Dimosion Esodon (Independent Authority for Public Revenue)Geniki Diefthynsi Teloneion kai Eidikon Foron Katanalosis (E.F.K.) (Directorate-General for Customs and Excise Duty (SCT))
Pireos 180
17778 Tauros Athens
Tel: (+30) 213 132 0085
Contact: gdcustoms@aade.gr
Website: https://www.aade.gr/
Aneksartiti Archi Dimosion Esodon (Independent Authority for Public Revenue)
Geniki Diefthynsi Teloneion kai Eidikon Foron Katanalosis (E.F.K.) (Directorate-General for Customs and Excise Duty (SCT))
Diefthynsi Eidikon Foron Katanalosis kai Forou Prostithemenis Aksias (Directorate of Excise Duties and Value Added Tax)
Pireos 180
17778 Tauros Athens
Tel: (+30) 213 141 0640 / (+30) 213 141 0677
Contact: finexcis@aade.gr / finexcis@2001.syzefxis.gov.gr
Website: https://www.aade.gr/
4. Import Procedure
The Single Administrative Document - SAD (Eniaío Dioikitikó Éngrafo - EDE) must be submitted electronically using the Ilektronikés Synallagés - e-Customs - (e-Services of Independent Authority for Public Revenue). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Heraclion
- Piraeus
- Platigiali, Astakos Etoloakarnanias
- Thessaloniki
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Aneksartiti Archi Dimosion Esodon (Independent Authority for Public Revenue)Geniki diefthinsi forologias (Directorate General of Taxation)
Diefthynsi Diethnon Forologikon Sxesewn (Department of International Tax Relations)
Pireos 180
17778 Tauros Athens
Tel: (+30) 213 141 0160 / (+30) 213 141 0167 / (+30) 213 141 0247
Contact: dos@aade.gr
Website: https://www.aade.gr/
Import licences for agricultural products
Organismos Pliromon kai Elenchou Koinotikon Enischyseon Prosanatolismou kai Engyiseon - O.P.E.K.E.P.E (Payment and Control Agency for Guidance and Guarantee Community Aid)Domokou 5
10445 Athens
Tel: (+30) 210 880 2000
Contact: protokolo@opekepe.gr
Website: https://www.opekepe.gr/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Geniki Diefthynsi Ktiniatrikis (Directorate-General for Veterinary Services)
Dieythynsi Prostasias ton Zoon, Farmakon kai Ktiniatrikon Efarmogon (Directorate of Animal Welfare, Medicine and Veterinary Applications)
Tmima Katagrafis kai Epitirisis Zoikou Kefalaiou kai Technitis Spermateghysis (Department of Register and Supervision of Animal Capital and Artificial Insemination)
Veranzerou 46, Office 203
10438 Athens
Tel: (+30) 210 212 5735 / (+30) 210 212 5784
Contact: ekaranasiou@minagric.gr / thvitalis@minagric.gr
Website: https://www.minagric.gr/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Geniki Diefthynsi Georgias (Directorate-General for Agriculture)
Diefthynsi Prostasias Fytikis Paragogis (Directorate of Plant Production Protection)
Leoforos Syngrou 150, Office 305
17671 Athens
Tel: (+30) 210 928 7216 / (+30) 210 928 7221 / (+30) 210 212 5033
Contact: seni@minagric.gr / opapaioannou@minagric.gr / amavridou@minagric.gr
Website: https://www.minagric.gr/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Eniaios Foreas Elenchou Trofimon - EFET (Hellenic Food Authority - EFET)
124 Kifisias & Iatridou 2
11526 Athens
Tel: (+30) 213 214 5800 / (+30) 213 214 5860
Contact: info@efet.gr
Website: https://www.efet.gr/
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)
Geniki Diefthynsi Trofimon (Directorate-General for Food)
Diefthynsi Piotitas kai Asfalias Trofimon (Directorate of Food Quality and Safety)
Acharnon 2, Office 311
10176 Athens
Tel: (+30) 210 212 4352
Contact: ax2u090@minagric.gr / dgrammatikos@minagric.gr
Website: https://www.minagric.gr/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Geniki Diefthynsi Georgias (Directorate-General for Agriculture)
Diefthynsi Zootrofon kai Voskisimon Geon (Directorate of Animal Feed and Pasturelands)
Veranzerou 46
10438 Athens
Tel: (+30) 210 527 1646 / (+30) 210 212 5765
Contact: gkostop@minagric.gr / chgoulas@minagric.gr
Website: https://www.minagric.gr/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Eniaios Foreas Elenchou Trofimon - EFET (Hellenic Food Authority - EFET)
124 Kifisias & Iatridou 2
11526 Athens
Tel: (+30) 213 214 5800 / (+30) 213 214 5860
Contact: info@efet.gr
Website: https://www.efet.gr/
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)
Geniki Diefthynsi Georgias (Directorate-General for Agriculture)
Diefthynsi Prostasias Fytikis Paragogis (Directorate of Plant Production Protection)
Tmima Fytoygeionomikou Elenchou (Department of Plant Health Control)
Leoforos Syngrou 150
17671 Athens
Tel: (+30) 210 928 7246 / (+30) 210 928 7235 / (+30) 210 928 7232
Contact: chgkilpathi@minagric.gr / charampatzis@minagric.gr
Website: https://www.minagric.gr/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ypourgeio Perivallontos kai Energeias (Ministry of Environment and Energy)Geniki Diefthynsi Perivallontikis Politikis (General Secretariat for Environment)
Dieythinsi Klimatikis Allagis kai Poiotitas tis Atmosfairas (Directorate of Climate Change and Quality of the Atmosphere)
Tmima Poiotitas Atmosfairas (Department of Atmosphere Quality)
Patision 147
11251 Athens
Tel: (+30) 210 865 0076 / (+30) 210 864 6939
Contact: e.tsilibari@prv.ypeka.gr / a.adamopoulos@prv.ypeka.gr / c.viliardouprv.ypeka.gr
Website: https://ypen.gov.gr/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ypourgeio Perivallontos kai Energeias (Ministry of Environment and Energy)Geniki Diefthynsi Dason kai Dasikou Perivallontos (Directorate-General for Forests and Forestry Environment)
Dieythinisi Programmatismou kai Dasikis Politikis (Directorate of Planning and Foresters Policy)
Tmima Elenchou tis Emporias kai Diakinisis Agrias Zois kai Edon CITES (Department for control of the Trade and Distribution of Wildlife and CITES Species)
Terma Alkmanos
11528 Athens
Tel: (+30) 213 151 2296 / (+30) 213 151 2182 / (+30) 213 151 2130
Contact: ch.karakosta@prv.ypeka.gr / e.alexiou@prv.ypeka.gr / g.konstantakopoulou@prv.ypeka.gr / grggper@ypen.gr
Website: https://ypen.gov.gr/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Persistent organic pollutants
Aneksartiti Archi Dimosion Esodon (Independent Authority for Public Revenue)Geniki Diefthynsi Geniko Chimeio tou Kratous (General Chemical State Laboratory)
Diefthynsi Alkoolis kai Trofimon (Directorate of Alcohol and Foods)
Tmima B' Trofimon, Neron kai Perivallontos (Section B - Foods, Water and Environment)
A. Tsocha 16
11521 Athens
Tel: (+30) 213 211 7251 / (+30) 210 647 9000
Contact: dat.gcsl@aade.gr
Website: https://www.aade.gr/gcsl
Ypourgeio Perivallontos kai Energeias (Ministry of Environment and Energy)
Geniki Diefthynsi Perivallontikis Politikis (General Secretariat for Environment)
Dieythinsi Klimatikis Allagis kai Poiotitas tis Atmosfairas (Directorate of Climate Change and Quality of the Atmosphere)
Tmima Poiotitas Atmosfairas (Department of Atmosphere Quality)
Patision 147
11251 Athens
Tel: (+30) 210 865 0076 / (+30) 210 864 6939
Contact: e.tsilibari@prv.ypeka.gr / a.adamopoulos@prv.ypeka.gr / c.viliardouprv.ypeka.gr
Website: https://ypen.gov.gr/
Dangerous chemicals, detergents and fertilisers
Aneksartiti Archi Dimosion Esodon (Independent Authority for Public Revenue)Geniki Diefthynsi Geniko Chimeio tou Kratous (General Chemical State Laboratory)
Diefthynsi Energiakon, Biomihanikon kai Chimikon Proionton (Directorate of Energy, Industrial and Chemical Products)
Tmima B' Chimikon, Biomihanikon kai Proionton Kapnou (Section B - Chemical, Industrial and Tobacco Products)
A. Tsocha 16
11521 Athens
Tel: (+30) 213 211 7265 / (+30) 210 647 9000
Contact: environment.gcsl@aade.gr / devxp.gcsl@aade.gr
Website: https://www.aade.gr/gcsl
Fertilisers
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Geniki Diefthynsi Agrotikis Anaptyksis (Directorate-General for Sustainable Rural Development)
Diefthynsi Perivallontos, Xhorotaksias kai Klimatikis Allagis (Directorate of Environment, Land Planning and Climate Change)
Tmima Lipasmaton kai Edafologias (Section of Fertilizers and Soil Science)
Patision 207 kai Skalistiri 19
11253 Athens
Tel: (+30) 210 212 8223 / (+30) 210 212 8202
Contact: chvlachou@minagric.gr / ggiannop@minagric.gr
Website: https://www.minagric.gr/
Dangerous chemicals
Ypourgeio Agrotikis Anaptyxis kai Trofimon (Ministry of Rural Development and Food)Geniki Diefthynsi Georgias (Directorate-General for Agriculture)
Diefthynsi Prostasias Fytikis Paragogis (Directorate of Plant Production Protection)
Tmima Fytoprostateftikon Proionton (Department of Plant Protection Products)
Leoforos Syngrou 150
17671 Athens
Tel: (+30) 210 928 7254 / (+30) 210 928 7216 / (+30) 210 928 7224
Contact: navramidis@minagric.gr / dpitarokili@minagric.gr
Website: https://www.minagric.gr/
D. Control and management of waste
Ypourgeio Perivallontos kai Energeias (Ministry of Environment and Energy)Mesogion Avenue 119
11526 Athens
Tel: (+30) 213 151 3000
Contact: info@ypen.gov.gr
Website: https://ypen.gov.gr/
Packaging waste
Ypourgeio Perivallontos kai Energeias (Ministry of Environment and Energy)Geniki Grammateia Sintonismou kai Diaxirisis Apobliton (General Secretariat for Coordination and Management of Waste)
Diefthynsi Diachirisis Apovliton (Department of Waste Management)
Mesogion 119
10192 Athens
Tel: (+30) 210 151 3198
Contact: a.arfanakou@prv.ypeka.gr / s.mani@prv.ypeka.gr
Website: https://ypen.gov.gr/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Ypourgeio Anaptyxis kai Ependyseon (Ministry of Development and Investments)Geniki Grammateia Viomichanias (General Secretariat for Industry)
Ethniko Systima Ypodomon Poiotitas (National Quality Infrastructure System)
Ellinikos Organismos Typopoiisis - ELOT (Hellenic Organization for Standardization)
Kifisou Avenue 50 & Sperchiados 4
12133 Athens
Tel: (+30) 210 212 0100
Contact: dt_info@elot.gr / info@esyp.eu / info@elot.gr
Website: https://elot.gr/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Aneksartiti Archi Dimosion Esodon (Independent Authority for Public Revenue)Geniki Diefthynsi Geniko Chimeio tou Kratous (General Chemical State Laboratory)
Diefthynsi Alkoolis kai Trofimon (Directorate of Alcohol and Foods)
Tmima B' Trofimon, Neron kai Perivallontos (Section B - Foods, Water and Environment)
A. Tsocha 16
11521 Athens
Tel: (+30) 213 211 7251 / (+30) 210 647 9000
Contact: dat.gcsl@aade.gr
Website: https://www.aade.gr/gcsl
Packaging sizing
Ypourgeio Anaptyxis kai Ependyseon (Ministry of Development and Investments)Geniki Grammateia Viomichanias (General Secretariat for Industry)
Ethniko Systima Ypodomon Poiotitas (National Quality Infrastructure System)
Elliniko Institouto Metrologias - EIM (Hellenic Institute of Metrology)
Intersection: NB6 and DA10 Industrial Area of Thessalonki, Block 45TK
57022 Sindos (Thessaloniki)
Tel: (+30) 231 056 9989 / (+30) 231 056 9999
Contact: info@eim.gr / mdk@elot.gr
Website: https://eim.gr/
12. Labelling
The contents of the labelling must be at least in Greek. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Ουγγαρία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
Hungary is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Hungarian Forint (HUF) is the official currency in Hungary.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Nemzeti Adó- és Vámhivatal - NAV (National Tax and Customs Administration)Széchenyi u. 2.
1054 Budapest
Tel: (+36) 1 428 5100
Contact: vam.info@nav.gov.hu / nav_kozpont@nav.gov.hu / ki.ajf@nav.gov.hu
Website: https://nav.gov.hu/
4. Import Procedure
The Single Administrative Document - SAD (Egységes Vámokmány - SAD) must be submitted electronically via Electronic Data Interchange (EDI). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Customs free zone Záhony
5. Trade Regime and Import Licenses
The bodies in charge of issuing import licenses for products subject to trade regimes are:
Budapest Főváros Kormányhivatala - BFKH (Government Office of the Capital City Budapest)Kereskedelmi, Haditechnikai, Exportellenőrzési és Nemesfémhitelesítési Főosztály (Department of Trade, Defence Industry, Export Control and Precious Metal Assay)
Metrológiai és Műszaki Felügyeleti Főosztály (Metrology and Technical Supervisory Department)
Kereskedelmi Osztály (Trade Unit)
Németvölgyi út 37-39.
1124 Budapest
Tel: (+36) 1 458 5529 / (+36) 1 458 5800 / (+36) 1 458 5519
Contact: keo@bfkh.gov.hu
Website: https://mkeh.gov.hu/kereskedelmi/kereskedelmi_osztaly
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Agrárminisztérium (Ministry of Agriculture)Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Állategészségügyi és Állatvédelmi Igazgatóság (Directorate for Animal Health and Protection)
Keleti Károly u. 24.
1024 Budapest
Tel: (+36) 1 336 9302
Contact: aai@nebih.gov.hu
Website: https://portal.nebih.gov.hu/allat-egeszsegugy-es-allatvedelem
7. Plant Health
The competent authorities for phytosanitary inspections are:
Agrárminisztérium (Ministry of Agriculture)Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Növényvédelmi és Borászati Igazgatóság (Directorate for Plant Protection and Wine)
Dayka Gábor u. 3.
1118 Budapest
Tel: (+36) 30 216 6303
Contact: novenyegeszsegugy@nebih.gov.hu; nbi@nebih.gov.hu
Website: https://portal.nebih.gov.hu/novenyegeszsegugy
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Agrárminisztérium (Ministry of Agriculture)Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Élelmiszer- és Takarmánybiztonsági Igazgatóság (Directorate for Food and Feed Safety)
Keleti Károly u. 24.
1024 Budapest
Tel: (+36) 1 336 9474
Contact: etbi@nebih.gov.hu
Website: https://portal.nebih.gov.hu/elelmiszer-es-takarmanybiztonsag
Nemzetgazdasági Minisztérium (Ministry for National Economy)
Vám utca 5-7
1011 Budapest
Contact: fogyasztovedelem@ngm.gov.hu
Website: https://magyarefk.hu
Nemzeti Népegészségügyi és Gyógyszerészeti Központ - NNGYK (National Center for Public Health and Pharmacy - NCPHP)
Albert Flórián út 2-6.
1097 Budapest
Tel: (+36) 1 476 1100
Contact: tisztifoorvos@nngyk.gov.hu
Website: https://nnk.gov.hu/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Agrárminisztérium (Ministry of Agriculture)Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Élelmiszer- és Takarmánybiztonsági Igazgatóság (Directorate for Food and Feed Safety)
Keleti Károly u. 24.
1024 Budapest
Tel: (+36) 1 336 9474
Contact: etbi@nebih.gov.hu
Website: https://portal.nebih.gov.hu/elelmiszer-es-takarmanybiztonsag
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Agrárminisztérium (Ministry of Agriculture)Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Növényvédelmi és Borászati Igazgatóság (Directorate for Plant Protection and Wine)
Dayka Gábor u. 3.
1118 Budapest
Tel: (+36) 30 216 6303
Contact: novenyegeszsegugy@nebih.gov.hu; nbi@nebih.gov.hu
Website: https://portal.nebih.gov.hu/novenyegeszsegugy
Agrárminisztérium (Ministry of Agriculture)
Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Élelmiszer- és Takarmánybiztonsági Igazgatóság (Directorate for Food and Feed Safety)
Keleti Károly u. 24.
1024 Budapest
Tel: (+36) 1 336 9474
Contact: etbi@nebih.gov.hu
Website: https://portal.nebih.gov.hu/elelmiszer-es-takarmanybiztonsag
Budapest Főváros Kormányhivatala - BFKH (Government Office of the Capital City Budapest)
Kereskedelmi, Haditechnikai, Exportellenőrzési és Nemesfémhitelesítési Főosztály (Department of Trade, Defence Industry, Export Control and Precious Metal Assay)
Metrológiai és Műszaki Felügyeleti Főosztály (Metrology and Technical Supervisory Department)
Kereskedelmi Osztály (Trade Unit)
Németvölgyi út 37-39.
1124 Budapest
Tel: (+36) 1 458 5800 / (+36) 1 458 5519
Contact: keo@bfkh.gov.hu
Website: https://mkeh.gov.hu
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Energiaügyi Minisztérium (Ministry of Energy)Nemzeti Klímavédelmi Hatóság (National Climate Defense Authority)
Október huszonharmadika u. 18.
1117 Budapest
Tel: (+36) 1 896 3907
Contact: nkvh@em.gov.hu / euetshatosag@em.gov.hu
Website: http://nkvh.kormany.hu/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Agrárminisztérium (Ministry of Agriculture)Biodiverzitás és Génmegőrzési Főosztály (Department for Biodiversity and Gene Conservation)
Apáczai Csere János u. 9.
1052 Budapest
Tel: (+36) 1 795 3686
Contact: gmo@am.gov.hu / bgmf@am.gov.hu
Website: https://gmo.kormany.hu/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Detergents and persistent organic pollutants
Agrárminisztérium (Ministry of Agriculture)Természetvédelemért Felelős Államtitkárság (State Secretariat for Nature Conservation)
Kossuth Lajos tér 11.
1055 Budapest
Tel: (+36) 1 795 2000
Contact: tvhat@am.gov.hu / https://termeszetvedelem.hu/category/intezmenyrendszer/termeszetvedelemert-felelos-helyettes-allamtitkarsag/
Website: https://kormany.hu/agrarminiszterium/
Dangerous chemicals and fertilisers
Agrárminisztérium (Ministry of Agriculture)Nemzeti Élelmiszerlánc-biztonsági Hivatal - NÉBIH (National Food Chain Safety Office)
Növényvédelmi és Borászati Igazgatóság (Directorate for Plant Protection and Wine)
Dayka Gábor u. 3.
1118 Budapest
Tel: (+36) 30 216 6303
Contact: novenyegeszsegugy@nebih.gov.hu; nbi@nebih.gov.hu
Website: https://portal.nebih.gov.hu/novenyegeszsegugy
Detergents
Nemzetgazdasági Minisztérium (Ministry for National Economy)Vám utca 5-7
1011 Budapest
Contact: fogyasztovedelem@ngm.gov.hu
Website: https://fogyasztovedelem.kormany.hu
Pest Vármegyei Kormányhivatal (Government Office of Pest County)
Környezetvédelmi, Természetvédelmi és Hulladékgazdálkodási Főosztály (Department for Environment, Nature Protection and Waste Management)
Mészáros u. 58/B
1016 Budapest
Tel: (+36) 1 7766 280
Contact: zoldhatosag@pest.gov.hu
Website: https://kormanyhivatalok.hu/kormanyhivatalok/pest/megye/szervezet/kornyezetvedelmi-termeszetvedelmi-es-hulladekgazdalkodasi
Dangerous chemicals
Nemzeti Népegészségügyi és Gyógyszerészeti Központ - NNGYK (National Center for Public Health and Pharmacy - NCPHP)Kémiai Biztonsági és Kompetens Hatósági Főodsztály (Department of Chemical Safety and Competent Authorities)
Albert Flórián út 2-6.
1097 Budapest
Tel: (+36) 1 476 1195 / (+36) 1 476 1184 / (+36) 1 476 1195
Contact: kembizt@nnk.gov.hu
Website: https://www.nnk.gov.hu/index.php/kemiai-biztonsagi-es-kompetens-hatosagi-fo/kbkhf-kezdolapja
D. Control and management of waste
General surveillance
Agrárminisztérium (Ministry of Agriculture)Természetvédelemért Felelős Államtitkárság (State Secretariat for Nature Conservation)
Kossuth Lajos tér 11.
1055 Budapest
Tel: (+36) 1 795 2000
Contact: tvhat@am.gov.hu / https://termeszetvedelem.hu/category/intezmenyrendszer/termeszetvedelemert-felelos-helyettes-allamtitkarsag/
Website: https://kormany.hu/agrarminiszterium/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Magyar Szabványügyi Testület - MSZT (Hungarian Standards Institution)Horváth Mihály tér 1.
1082 Budapest
Tel: (+36) 1 456 6800
Contact: cert@mszt.hu
Website: https://mszt.hu
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Budapest Főváros Kormányhivatala - BFKH (Government Office of the Capital City Budapest)Kereskedelmi, Haditechnikai, Exportellenőrzési és Nemesfémhitelesítési Főosztály (Department of Trade, Defence Industry, Export Control and Precious Metal Assay)
Metrológiai és Műszaki Felügyeleti Főosztály (Metrology and Technical Supervisory Department)
Kereskedelmi Osztály (Trade Unit)
Németvölgyi út 37-39.
1124 Budapest
Tel: (+36) 1 458 5800 / (+36) 1 458 5519
Contact: keo@bfkh.gov.hu
Website: https://mkeh.gov.hu/kereskedelmi/kereskedelmi_osztaly
Materials and articles intended to come into contact with foodstuffs
Nemzeti Népegészségügyi és Gyógyszerészeti Központ - NNGYK (National Center for Public Health and Pharmacy - NCPHP)Élelmezés- és Táplálkozástudományi Főigazgatóság (Directorate-General for Food and Nutrition Science)
Szabolcs utca 33.
1135 Budapest
Tel: (+36) 1 886 9300 / (+36) 1 886 9204 / (+36) 3 071 45746
Contact: etf.titkarsag@ogyei.gov.hu
Website: https://ogyei.gov.hu/
12. Labelling
The contents of the labelling must be at least in Hungarian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Ιρλανδία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
Ireland is a member of the European Union (EU) since 01/01/1973.
2. Currency
The Euro (EUR) is the official currency in Ireland since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Irish Tax and CustomsGovernment Offices
St. Conlon's Road
Nenagh
Co. Tipperary, E45 T611
Tel: (+353) 67 631 39 / (+353) 1 890 204 304
Contact: https://www.revenue.ie/en/contact-us/index.aspx
Website: https://www.revenue.ie/en/Home.aspx
4. Import Procedure
The Single Administrative Document - SAD must be submitted electronically using Automated Entry Processing (AEP) system. Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Ireland.
5. Trade Regime and Import Licenses
Import licences for agricultural products
Department of Agriculture, Food and the MarineImport and Export Licensing Section
Agriculture Structures and Market Supports Division
Johnstown Castle Estate
Co. Wexford, Y35 PN52
Tel: (+353) 53 91 63 415 / (+353) 53 91 63 448 / (+353) 53 91 63 406 / (+353) 53 91 65 558 / (+353) 53 91 65 567
Contact: licences@agriculture.gov.ie
Website: https://www.gov.ie/en/organisation/department-of-agriculture-food-and-the-marine/
Licences for iron, steel and aluminium products
Department of Enterprise, Trade and EmploymentImport Licensing Unit
23 Kildare Street
Dublin 2, D02 TD30
Tel: (+353) 1 631 21 21 / (+353) 1 631 22 56
Contact: info@enterprise.gov.ie / imports@enterprise.gov.ie
Website: https://www.enterprise.gov.ie/en/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Department of Agriculture, Food and the MarineAnimal Health and Welfare Division
Agriculture House
4C Kildare Street
Dublin 2, D02 WK12
Tel: (+353) 1 607 23 79
Contact: animalwelfare@agriculture.gov.ie / info@agriculture.gov.ie
Website: https://www.gov.ie/en/organisation/department-of-agriculture-food-and-the-marine/
Control of fishery and aquaculture products
Sea Fisheries Protection Authority - SFPAHeadquarters
Park Road, Clogheen
Clonakilty
Co. Cork P85 TX47
Tel: (+353) 23 885 93 00
Contact: sfpa_info@sfpa.ie
Website: https://www.sfpa.ie/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Department of Agriculture, Food and the MarineHorticulture and Plant Health Division
2nd Floor Backweston Administration Building
Backwestown Campus
Celbridge
Co. Kildare W23 X3PH
Tel: (+353) 1 505 88 85
Contact: plantandpests@agriculture.gov.ie
Website: https://www.gov.ie/en/organisation/department-of-agriculture-food-and-the-marine/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Food Safety Authority of IrelandThe Exchange, George's Dock, IFSC
Dublin 1, D01 P2V6
Tel: (+353) 1 817 13 00
Contact: info@fsai.ie
Website: https://www.fsai.ie/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Department of Agriculture, Food and the MarineAgriculture House
4C Kildare Street
Dublin 2, D02 WK12
Tel: (+353) 1 607 20 00
Contact: info@agriculture.gov.ie
Website: https://www.gov.ie/en/organisation/department-of-agriculture-food-and-the-marine/
Sea Fisheries Protection Authority - SFPA
Headquarters
Park Road, Clogheen
Clonakilty
Co. Cork P85 TX47
Tel: (+353) 23 885 93 00
Contact: sfpa_info@sfpa.ie
Website: https://www.sfpa.ie/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Sea Fisheries Protection Authority - SFPAHeadquarters
Park Road, Clogheen
Clonakilty
Co. Cork P85 TX47
Tel: (+353) 23 885 93 00
Contact: sfpa_info@sfpa.ie
Website: https://www.sfpa.ie/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Environmental Protection AgencyOzone Depleting Substances (ODS)
P.O. Box 3000
Johnstown Castle Estate
Co. Wexford, Y35 W821
Tel: (+353) 53 916 06 00
Contact: ods@epa.ie / https://www.epa.ie/who-we-are/contact-us/contact-us-form/
Website: https://www.epa.ie/our-services/compliance--enforcement/air/ozone-depleting-substances-ods/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Department of Housing, Local Government and HeritageNational Parks and Wildlife Service - NPWS
CITES Management Authority
90 North King Street
Dublin 7, D07 N7CV
Tel: (+353) 1 888 39 33
Contact: CITES@npws.gov.ie
Website: https://www.npws.ie/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Department of Agriculture, Food and the MarineCrop Policy, Production and Safety Division
Administration Building,
Backweston Campus ,
Co. Kildare, Celbridge
Tel: (+353) 1 607 20 00
Contact: info@agriculture.gov.ie / beekeeping@agriculture.gov.ie
Website: https://www.gov.ie/en/organisation/department-of-agriculture-food-and-the-marine/
Pesticides
Department of Agriculture, Food and the MarinePesticide Registration and Control Division
Backweston Campus
Celbridge
Co. Kildare W23 X3PH
Tel: (+353) 1 615 75 52
Contact: pcs@agriculture.gov.ie
Website: https://www.pcs.agriculture.gov.ie/
Detergents
Department of Enterprise, Trade and EmploymentSafety, Health and Chemicals Policy Unit
23 Kildare Street
Dublin 2, D02 TD30
Tel: (+353) 1 631 21 21
Contact: info@enterprise.gov.ie / chemicals@enterprise.gov.ie
Website: https://www.enterprise.gov.ie/en/
Environmental Protection Agency
P.O. Box 3000
Johnstown Castle Estate
Co. Wexford, Y35 W821
Tel: (+353) 53 916 06 00
Contact: info@epa.ie / https://www.epa.ie/who-we-are/contact-us/contact-us-form/
Website: https://www.epa.ie/our-services/licensing/waste/
Persistent organic pollutants
Environmental Protection AgencyOffice of Environmental Sustainability - OES
P.O. Box 3000
Johnstown Castle Estate
Co. Wexford, Y35 W821
Tel: (+353) 53 916 06 00
Contact: info@epa.ie / https://www.epa.ie/who-we-are/contact-us/contact-us-form/
Website: https://www.epa.ie/our-services/monitoring--assessment/waste/chemicals/pops/
Dangerous chemicals and detergents
Health and Safety AuthorityChemical Policy and Services Head Office
3rd Floor, Hebron House
Hebron Road
Co. Kilkenny, R95 T91Y
Tel: (+353) 1 614 70 00
Contact: chemicals@enterprise.gov.ie / https://www.hsa.ie/eng/contact_us/
Website: https://www.hsa.ie/eng/
D. Control and management of waste
Environmental Protection AgencyOffice of Environmental Sustainability - OES
P.O. Box 3000
Johnstown Castle Estate
Co. Wexford, Y35 W821
Tel: (+353) 53 916 06 00
Contact: info@epa.ie / https://www.epa.ie/who-we-are/contact-us/contact-us-form/
Website: https://www.epa.ie/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
National Standards Authority of Ireland1 Swift Square
Northwood
Santry
Dublin 9, D09 A0E4
Tel: (+353) 1 807 38 00
Contact: https://www.nsai.ie/about/contact-us/
Website: https://www.nsai.ie/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Department of Agriculture, Food and the MarineFood Safety Liaison Division
Agriculture House
4C Kildare Street
Dublin 2, D02 WK12
Tel: (+353) 1 607 24 55
Contact: info@agriculture.gov.ie / https://www.fsai.ie/contact
Website: https://www.gov.ie/en/organisation/department-of-agriculture-food-and-the-marine/
Food Safety Authority of Ireland
The Exchange, George's Dock, IFSC
Dublin 1, D01 P2V6
Tel: (+353) 1 817 13 00
Contact: info@fsai.ie
Website: https://www.fsai.ie/
Packaging sizing
National Standards Authority of Ireland1 Swift Square
Northwood
Santry
Dublin 9, D09 A0E4
Tel: (+353) 1 807 38 00
Contact: https://www.nsai.ie/about/contact-us/
Website: https://www.nsai.ie/
12. Labelling
The contents of the labelling must be at least in English. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Ιταλία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Italian Republic is one of the six founding Member States of the European Union (EU) as it took part in the ratification of the Treaties of Rome, which established the European Communities and became effective in 1958.
The Italian continental territory, plus Sicily and Sardinia form part of the European Customs Territory.
2. Currency
The Euro (EUR) is the official currency in Italy since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Agenzia delle Dogane e dei Monopoli (Customs and Monopolies Agency)Piazza Mastai, 12
00153 Roma
Tel: (+39) 06 5024 6028
Contact: dir.dogane@adm.gov.it
Website: https://www.adm.gov.it
4. Import Procedure
The Single Administrative Document - SAD (Documento amministrativo unico - DAU) must be submitted electronically using the Servizio Telematico Doganale - (Telematic Customs Service). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in Italian.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Punto franco di Trieste
- Punto franco di Venezia
- Zona Franca doganale di Portovesme
5. Trade Regime and Import Licenses
Import licences for agricultural products
Ministero degli Affari Esteri e della Cooperazione Internazionale (Ministry of Foreign Affairs and International Cooperation)Direzione Generale per l'Europa e la politica commerciale internazionale (Directorate-General for Europe and International Trade Policy)
Viale Boston, 25
00144 Roma
Tel: (+39) 06 3691 8775
Contact: dgue.segreteria@esteri.it
Website: https://www.esteri.it
Licences for iron, steel and aluminium products
Ministero delle Imprese e del Made in Italy (Ministry of Enterprise and Made in Italy)Via Molise, 2
00187 Roma
Tel: (+39) 06 4705 1
Contact: urp@mise.gov.it
Website: https://www.mimit.gov.it
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministero della Salute (Ministry of Health)Dipartimento della Salute Umana, della Salute Animale e dell'Ecosistema (One Health) e dei Rapporti Internazionali (Human Health, Animal Health and Ecosystem (One Health) and International Relations Department)
Direzione Generale della Salute Animale (Directorate-General for Animal Health)
Viale Giorgio Ribotta, 5
00144 Roma
Tel: (+39) 06 5994 6584
Contact: sanita.animale@sanita.it
Website: https://www.salute.gov.it
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (Ministry of Agriculture, Food Sovereignty and Forestry)Dipartimento dell'Ispettorato Centrale della Tutela della Qualità e della Repressione Frodi dei Prodotti Agroalimentari (Department of Central Inspectorate of the Protection of the Quality and Fraud Repression of Food Products)
Via Quintino Sella, 42
00187 Roma
Tel: (+39) 06 4665 6610
Contact: icqrf.segreteria@masaf.gov.it
Website: https://www.politicheagricole.it
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Ministero della Salute (Ministry of Health)Dipartimento della Salute Umana, della Salute Animale e dell'Ecosistema (One Health) e dei Rapporti Internazionali (Human Health, Animal Health and Ecosystem (One Health) and International Relations Department)
Direzione Generale dell'Hgiene e della Sicurezza Alimentare (Directorate-General for Hygiene and Food Safety)
Viale Giorgio Ribotta, 5
00144 Roma
Tel: (+39) 06 5994 6616
Contact: segreteriadgsan@sanita.it
Website: https://www.salute.gov.it
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Control of plants, fruits and vegetables
Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (Ministry of Agriculture, Food Sovereignty and Forestry)Dipartimento della Politica Agricola Comune e dello Sviluppo Rurale (Department of Common Agricultural Policy and Rural Development)
Direzione Generale delle Politiche Internazionali e dell'Unione Europea (Directorate-General for the European Union and International Policies)
PIUE IV - Olio d'oliva e OCM unica (PIUE IV - Olive Oil and WTO unique)
Via XX Settembre, 20
00187 Roma
Tel: (+39) 06 4665 4026
Contact: piue4@masaf.gov.it
Website: https://www.politicheagricole.it
Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (Ministry of Agriculture, Food Sovereignty and Forestry)
Dipartimento della Politica Agricola Comune e dello Sviluppo Rurale (Department of Common Agricultural Policy and Rural Development)
Direzione Generale delle Politiche Internazionali e dell'Unione Europea (Directorate-General for the European Union and International Policies)
PIUE V - Ortofrutta (PIUE V - Fruit and Vegetable)
Via XX Settembre, 20
00187 Roma
Tel: (+39) 06 4665 4027
Contact: piue5@masaf.gov.it
Website: https://www.politicheagricole.it
Control of food of animal origin
Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (Ministry of Agriculture, Food Sovereignty and Forestry)Dipartimento della Politica Agricola Comune e dello Sviluppo Rurale (Department of Common Agricultural Policy and Rural Development)
Direzione Generale delle Politiche Internazionali e dell'Unione Europea (Directorate-General for the European Union and International Policies)
PIUE VI - Settore Produzioni Animali (PIUE VI - Animal Production Sector)
Via XX Settembre, 20
00187 Roma
Tel: (+39) 06 4665 4044
Contact: piue6@masaf.gov.it
Website: https://www.politicheagricole.it
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministero dell'Ambiente e della Sicurezza Energetica (Ministry of the Environment and Energy Security)Dipartimento Sviluppo Sostenibile (DISS) (Department for Sustainable Development)
Direzione Generale Valutazioni Ambientali (VA) (Directorate-General for Environmental Assessments)
Via Cristoforo Colombo, 44
00147 Roma
Tel: (+39) 06 5722 5000 / (+39) 06 5722 5104
Contact: va-udg@mase.gov.it
Website: https://www.mase.gov.it/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministero dell'Ambiente e della Sicurezza Energetica (Ministry of the Environment and Energy Security)Dipartimento Amministrazione Generale, Pianificazione e Patrimonio Naturale (DIAG) (Department for General Administration, Planning and Natural Heritage)
Direzione Generale Tutela della Biodiversità e del Mare (TBM) (Directorate-General for Natural Heritage and the Sea)
Via Cristoforo Colombo, 44
00147 Roma
Tel: (+39) 06 5722 3401 / (+39) 06 5722 8368 / (+39) 06 5722 8104
Contact: tbm-udg@mase.gov.it
Website: https://www.mase.gov.it/
Arma dei Carabinieri (Carabinieri Arm)
Organizzazione per la Tutela Forestale, Ambientale e Agroalimentare (Unit Command for Forest, Environmental and Agricultural Protection)
Comando Carabinieri per la Tutela della Biodiversità (Carabinieri Command for the Protection of Biodiversity)
Raggruppamento Carabinieri CITES (CITES Carabinieri Grouping)
Via Giosuè Carducci, 5
00187 Roma
Tel: (+39) 06 4665 7221 / (+39) 06 4665 7878
Contact: cites@carabinieri.it
Website: https://www.carabinieri.it/
Ministero degli Affari Esteri e della Cooperazione Internazionale (Ministry of Foreign Affairs and International Cooperation)
Direzione Generale per l'Europa e la politica commerciale internazionale (Directorate-General for Europe and International Trade Policy)
Viale Boston, 25
00144 Roma
Tel: (+39) 06 3691 8775
Contact: dgue.segreteria@esteri.it
Website: https://www.esteri.it
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals and persistant organic pollutants
Instituto Superiore di Sanità (Higher Institute for Health)Centro Nazionale delle Sostanze Chimiche, Prodotti Cosmetici e Protezione del Consumatore (National Centre for Chemical Substances, Cosmetic Products and Consumer Protection)
Viale Regina Elena, 299
00161 Roma
Tel: (+39) 06 4990 2333
Contact: lucilla.baldassarri@iss.it
Website: https://www.iss.it/it/cnsc-copertina
Dangerous chemicals, detergents and persistent organic pollutants
Ministero della Salute (Ministry of Health)Dipartimento della Salute Umana, della Salute Animale e dell'Ecosistema (One Health) e dei Rapporti Internazionali (Human Health, Animal Health and Ecosystem (One Health) and International Relations Department)
Direzione Generale dei corretti stili di vita e dei rapporti con l'Ecosistema (Directorate-General for Healthy Lifestyles and Ecosystem Relations)
Viale Giorgio Ribotta, 5
00144 Roma
Tel: (+39) 06 5994 6945
Contact: dip.onehealth@sanita.it
Website: https://www.salute.gov.it
Fertilisers
Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (Ministry of Agriculture, Food Sovereignty and Forestry)Dipartimento dell'Ispettorato Centrale della Tutela della Qualità e della Repressione Frodi dei Prodotti Agroalimentari (Department of Central Inspectorate of the Protection of the Quality and Fraud Repression of Food Products)
Via Quintino Sella, 42
00187 Roma
Tel: (+39) 06 4665 6610
Contact: icqrf.segreteria@masaf.gov.it
Website: https://www.politicheagricole.it
Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (Ministry of Agriculture, Food Sovereignty and Forestry)
Dipartimento della Politica Agricola Comune e dello Sviluppo Rurale (Department of Common Agricultural Policy and Rural Development)
Direzione Generale dello Sviluppo Rurale (Directorate-General for Rural Development)
DISR V - Servizio Fitosanitario Centrale, Produzioni Vegetali (DISR V - Central Plant Protection Service, Crop Production)
Via XX Settembre, 20
00187 Roma
Tel: (+39) 06 4665 6090
Contact: disr5@masaf.gov.it
Website: https://www.politicheagricole.it
D. Control and management of waste
General surveillance
Ministero dell'Ambiente e della Sicurezza Energetica (Ministry of the Environment and Energy Security)Dipartimento Sviluppo Sostenibile (DISS) (Department for Sustainable Development)
Direzione Generale Economia Circolare e Bonifiche (ECB) (Directorate-General for Circular Economy and Recovery)
Via Cristoforo Colombo, 44
00147 Roma
Tel: (+39) 06 5722 5168 / (+39) 06 5722 8605
Contact: diss@pec.mase.gov.it
Website: https://www.mase.gov.it/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Comitato Elettrotecnico Italiano - CEI (Italian Electro-Technical Committee)Via Saccardo, 9
20134 Milano
Tel: (+39) 02 210 061
Contact: info@ceinorme.it
Website: https://www.ceinorme.it
Ente Nazionale Italiano di Normazione - UNI (Italian National Standardisation Body)
Via Sannio, 2
20137 Milano
Tel: (+39) 02 7002 41 / (+39) 02 7002 4200
Contact: uni@uni.com / normazione@uni.com
Website: https://www.uni.com
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Instituto Superiore di Sanità (Higher Institute for Health)Dipartimento di Sicurezza Alimentare, Nutrizione e Sanità Pubblica Veterinaria (Department of Food Safety, Nutrition and Veterinary Public Health)
Viale Regina Elena, 299
00161 Roma
Tel: (+39) 06 4990 3420
Contact: dipspvsa@iss.it
Website: https://www.iss.it/
Ministero della Salute (Ministry of Health)
Dipartimento della Salute Umana, della Salute Animale e dell'Ecosistema (One Health) e dei Rapporti Internazionali (Human Health, Animal Health and Ecosystem (One Health) and International Relations Department)
Direzione Generale dell'Hgiene e della Sicurezza Alimentare (Directorate-General for Hygiene and Food Safety)
Viale Giorgio Ribotta, 5
00144 Roma
Tel: (+39) 06 5994 6616
Contact: segreteriadgsan@sanita.it
Website: https://www.salute.gov.it
Packaging sizing
Ministero delle Imprese e del Made in Italy (Ministry of Enterprise and Made in Italy)Dipartimento Mercato e Tutela (Directorate-General for Market and Consumer Protection)
Via Molise, 2
00187 Roma
Tel: (+39) 06 4705 3616
Contact: Dip.mercato@mimit.gov.it
Website: https://www.mimit.gov.it
12. Labelling
The contents of the labelling must be at least in Italian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
13. Special territories
The municipality of Livigno is not part of the European Customs Union. The municipality Campione d'Italia and the territorial waters of Lake Lugano located between the bank and the political frontier of the area between Ponte Tresa and Porto Ceresio are part of the customs territory of the Union and under the scope of application of Directive 2008/118/EC, for the purposes of excises, since February 2020. However, they are outside the territorial scope of VAT.
Λετονία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Latvia is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Latvia since 01/01/2014.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Latvijas Republikas Finanšu ministrija (Ministry of Finance of the Republic of Latvia)Smilšu iela 1
1919 Riga
Tel: (+371) 670 954 05
Contact: pasts@fm.gov.lv
Website: https://www.fm.gov.lv/lv
Valsts ieņēmumu dienests (State Revenue Service)
Talejasiela 1
1978 Riga
Tel: (+371) 671 200 00
Contact: vid@vid.gov.lv
Website: https://www.vid.gov.lv
4. Import Procedure
The Single Administrative Document - SAD (vienotā administratīvā dokumenta - VAD) must be submitted electronically using EMDAS - Elektroniskā muitas datu apstrādes sistēma - (Electronic data processing system). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Rīgas brīvosta
- Liepājas speciālā ekonomiskā zona
- Ventspils brīvosta
- Rēzeknes speciālā ekonomiskā zona
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Latvijas Republikas Ekonomikas Ministrija (Ministry of Economics of the Republic of Latvia)Brīvības iela 55
1519 Riga
Tel: (+371) 670 131 00
Contact: pasts@em.gov.lv
Website: https://www.em.gov.lv/lv
Import licences for agricultural products
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Lauku atbalsta dienests - LAD (Rural Support Service)
Republikas laukums 2
1981 Riga
Tel: (+371) 670 950 00
Contact: pasts@lad.gov.lv
Website: https://www.lad.gov.lv/lv
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Pārtikas un veterinārais dienests - PVD (Food and Veterinary Service)
Peldu iela 30
1050 Riga
Tel: (+371) 670 952 30
Contact: pasts@pvd.gov.lv
Website: https://www.pvd.gov.lv/lv
7. Plant Health
The competent authorities for phytosanitary inspections are:
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Valsts augu aizsardzības dienests - VAAD (State Plant Protection Service)
Lielvārdes iela 36
1006 Riga
Tel: (+371) 670 270 98 / (+371) 670 274 06
Contact: pasts@vaad.gov.lv
Website: https://www.vaad.gov.lv/lv
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Pārtikas un veterinārais dienests - PVD (Food and Veterinary Service)
Peldu iela 30
1050 Riga
Tel: (+371) 670 952 30
Contact: pasts@pvd.gov.lv
Website: https://www.pvd.gov.lv/lv
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Pārtikas un veterinārais dienests - PVD (Food and Veterinary Service)
Peldu iela 30
1050 Riga
Tel: (+371) 670 952 30
Contact: pasts@pvd.gov.lv
Website: https://www.pvd.gov.lv/lv
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Valsts vides dienests (State Environmental Service)Attistibas un uzraudzibas departaments (Development and Supervisory Division)
Rūpniecības iela 23
1045 Riga
Tel: (+371) 670 842 00 / (+371) 670 842 30
Contact: pasts@vvd.gov.lv
Website: https://www.vvd.gov.lv/lv
Klimata un enerģētikas Ministrija (Ministry of Climate and Energy)
Vides kvalitātes nodaļa (Environmental Quality Department)
Latgales iela 165
1019 Riga
Tel: (+371) 630 073 00 / (+371) 630 073 78
Contact: pasts@kem.gov.lv
Website: https://www.kem.gov.lv
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Dabas aizsardzības pārvalde (Nature Protection Board)Baznicas iela 7
2150 Sigulda
Tel: (+371) 675 095 45
Contact: pasts@daba.gov.lv
Website: https://www.daba.gov.lv/lv
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Valsts augu aizsardzības dienests - VAAD (State Plant Protection Service)
Agrokimijas departaments (Agrochemical Department)
Lielvārdes iela 36
1006 Riga
Tel: (+371) 670 270 98 / (+371) 675 512 72
Contact: pasts@vaad.gov.lv
Website: https://www.vaad.gov.lv/lv
Dangerous chemicals and detergents
Latvijas Vides, ģeoloģijas un meteoroloģijas centrs - LVĢMC (Latvian Environment, Geology and Meteorology Centre)Ķīmisko vielu un bīstamo atkritumu nodaļa (Chemicals and Hazardous Waste Department)
Latgales iela 165
1019 Riga
Tel: (+371) 67 032 600 / (+371) 67 032 620 / (+371) 67 032 665
Contact: lvgmc@lvgmc.lv
Website: https://videscentrs.lvgmc.lv/
Detergents
Veselības Ministrija (Ministry of Health)Veselības inspekcija (Health Inspectorate)
Klijanu iela 7
1012 Riga
Tel: (+371) 670 816 00
Contact: vi@vi.gov.lv
Website: https://www.vi.gov.lv/lv
Persistent organic pollutants
Klimata un enerģētikas Ministrija (Ministry of Climate and Energy)Vides kvalitātes nodaļa (Environmental Quality Department)
Latgales iela 165
1019 Riga
Tel: (+371) 630 073 00 / (+371) 630 073 78
Contact: pasts@kem.gov.lv
Website: https://www.kem.gov.lv
D. Control and management of waste
Valsts vides dienests (State Environmental Service)Vides resursu pārvaldības departaments (Environmental Resource Management Department)
Atkritumu aprites departaments (Waste Circulation Department)
Rūpniecības iela 23
1045 Riga
Tel: (+371) 670 842 00 / (+371) 670 84 205
Contact: pasts@vvd.gov.lv
Website: https://www.vvd.gov.lv/lv
Packaging waste
Klimata un enerģētikas Ministrija (Ministry of Climate and Energy)Vides kvalitātes nodaļa (Environmental Quality Department)
Latgales iela 165
1019 Riga
Tel: (+371) 630 073 00 / (+371) 630 073 78
Contact: pasts@kem.gov.lv
Website: https://www.kem.gov.lv
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Latvijas standarts - LVS (Latvian Standard Ltd)K. Valdemāra iela 157
1013 Riga
Tel: (+371) 27 334 460
Contact: lvs@lvs.lv / standard@lvs.lv
Website: https://www.lvs.lv/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Latvijas Nacionālais Metroloģijas Centrs - LNMC (Latvian National Metrology Centre)Kr. Valdemāra iela 157
1013 Riga
Tel: (+371) 264 831 10
Contact: info@lnmc.lv
Website: http://lnmc.lv/lv/
Materials and articles intended to come into contact with foodstuffs
Latvijas Republikas Zemkopības ministrija (Ministry of Agriculture of the Republic of Latvia)Pārtikas un veterinārais dienests - PVD (Food and Veterinary Service)
Peldu iela 30
1050 Riga
Tel: (+371) 670 952 30
Contact: pasts@pvd.gov.lv
Website: https://www.pvd.gov.lv/lv
12. Labelling
The contents of the labelling must be at least in Latvian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Λιθουανία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Lithuania is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Lithuania since 01/01/2015.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Muitinės departamentas (Customs Department)A. Jakšto g. 1
01105 Vilnius
Tel: (+370) 5 266 5000
Contact: muitine@lrmuitine.lt
Website: https://lrmuitine.lt/
4. Import Procedure
The Single Administrative Document - SAD (Bendrasis administracinis dokumentas - BAD) must be submitted electronically using Elektroninės sistemos - (Electronic Systems of Customs Department). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- UAB Vingės logistika (Klaipėda)
- UAB Ad rem lez (Klaipėda)
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Lietuvos Respublikos ekonomikos ir inovacijų ministerija (Ministry of the Economy and Innovation of the Republic of Lithuania)Geresnio reglamentavimo ir verslo priežiūros politikos grupė (Better Regulation and Business Supervision Policy Group)
Gedimino pr. 38
01104 Vilnius
Tel: (+370) 706 64 845 / (+370) 687 38 390
Contact: kanc@eimin.lt
Website: https://eimin.lrv.lt/
Import licences for agricultural products
Nacionalinė mokėjimo agentūra (National Paying Agency)Blindžių g. 17
08111 Vilnius
Tel: (+370) 5 252 69 99
Contact: info@nma.lt
Website: https://www.nma.lt/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Valstybinė maisto ir veterinarijos tarnyba (State Food and Veterinary Service)Siesikų g. 19
07170 Vilnius
Tel: (+370) 5 240 4361
Contact: info@vmvt.lt
Website: https://www.vmvt.lt/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Valstybinė augalininkystės tarnyba (State Plant Service)Ozo g. 4A
08200 Vilnius
Tel: (+370) 5 237 5631
Contact: info@vatzum.lt
Website: http://www.vatzum.lt/
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Valstybinė maisto ir veterinarijos tarnyba (State Food and Veterinary Service)Siesikų g. 19
07170 Vilnius
Tel: (+370) 5 240 4361
Contact: info@vmvt.lt
Website: https://www.vmvt.lt/
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Lietuvos Respublikos žemės ūkio ministerija (Ministry of Agriculture of the Republic of Lithuania)Maisto pramonės ir kokybės skyrius (Food Industry and Quality Division)
Gedimino pr. 19
01103 Vilnius
Tel: (+370) 5 239 11 63 / (+370) 5 239 11 43
Contact: zum@zum.lt
Website: https://zum.lrv.lt/
Control of plants, fruits and vegetables
Valstybinė augalininkystės tarnyba (State Plant Service)Ozo g. 4A
08200 Vilnius
Tel: (+370) 5 237 5631
Contact: info@vatzum.lt
Website: http://www.vatzum.lt/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Lietuvos Respublikos aplinkos ministerija (Ministry of Environment of the Republic of Lithuania)Taršos prevencijos politikos grupė (Pollution Prevention Policy Group)
A. Jakšto g. 4
01105 Vilnius
Tel: (+370) 626 22 252 / (+370) 686 46 087
Contact: info@am.lt
Website: https://am.lrv.lt/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Wildlife licences
Aplinkos apsaugos agentūra (Environmental Protection Agency)Gyvosios gamtos licencijavimo skyrius (Wildlife Licensing Division)
A. Juozapavičiaus g. 9
09311 Vilnius
Tel: (+370) 612 88 923
Contact: aaa@aaa.am.lt
Website: https://aaa.lrv.lt/lt/veiklos-sritys/gyvoji-gamta
Flora licences
Lietuvos Respublikos aplinkos ministerija (Ministry of Environment of the Republic of Lithuania)Miškų politikos grupė (Forest Policy Group)
A. Jakšto g. 4
01105 Vilnius
Tel: (+370) 626 22 252 / (+370) 696 59 321
Contact: info@am.lt
Website: https://am.lrv.lt/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals
Aplinkos apsaugos agentūra (Environmental Protection Agency)Cheminių medžiagų skyrius (Chemical Substances Division)
A. Juozapavičiaus g. 9
09311 Vilnius
Tel: (+370) 687 08 146
Contact: chemija@aaa.am.lt
Website: https://aaa.lrv.lt/lt/veiklos-sritys/chemines-medziagos-ir-misiniai
Dangerous chemicals and persistant organic pollutants
Lietuvos Respublikos aplinkos ministerija (Ministry of Environment of the Republic of Lithuania)Taršos prevencijos politikos grupė (Pollution Prevention Policy Group)
A. Jakšto g. 4
01105 Vilnius
Tel: (+370) 626 22 252 / (+370) 686 46 087
Contact: info@am.lt
Website: https://am.lrv.lt/
Fertilisers
Lietuvos Respublikos ekonomikos ir inovacijų ministerija (Ministry of the Economy and Innovation of the Republic of Lithuania)Geresnio reglamentavimo ir verslo priežiūros politikos grupė (Better Regulation and Business Supervision Policy Group)
Gedimino pr. 38
01104 Vilnius
Tel: (+370) 706 64 845 / (+370) 687 38 390
Contact: kanc@eimin.lt
Website: https://eimin.lrv.lt/
Detergents
Valstybinė vartotojų teisių apsaugos tarnyba (State Consumer Rights Protection Authority)Rinkos priežiūros koordinavimo skyrius (Market Surveillance Coordination Division)
Vilniaus g. 25
01402 Vilnius
Tel: (+370) 5 262 67 51 / (+370) 659 91 756
Contact: tarnyba@vvtat.lt
Website: https://www.vvtat.lt/
D. Control and management of waste
Aplinkos apsaugos agentūra (Environmental Protection Agency)Atliekų licencijavimo skyrius (Waste licensing division)
A. Juozapavičiaus g. 9
09311 Vilnius
Tel: (+370) 618 40 427
Contact: aaa@aaa.am.lt
Website: https://aaa.lrv.lt/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Lietuvos standartizacijos departamentas (Lithuanian Standards Board)Algirdo g. 31
03219 Vilnius
Tel: (+370) 5 270 93 60
Contact: lstboard@lsd.lt
Website: https://www.lsd.lt/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Lietuvos metrologijos inspekcija (Lithuanian Metrology Inspectorate)Goštauto g. 9
01108 Vilnius
Tel: (+370) 7066 8011
Contact: metrinsp@metrinsp.lt
Website: https://metrinsp.lrv.lt/
Materials and articles intended to come into contact with foodstuffs
Nacionalinis visuomenės sveikatos centras (National Public Health Centre)Kalvarijų g. 153
08352 Vilnius
Tel: (+370) 5 264 9676
Contact: info@nvsc.lt
Website: https://nvsc.lrv.lt/
12. Labelling
The contents of the labelling must be at least in Lithuanian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Λουξεμβούργο
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Grand Duchy of Luxembourg is one of the six founding Member States of the European Union (EU) as it took part in the ratification of the Treaties of Rome, which established the European Communities and became effective in 1958.
2. Currency
The Euro (EUR) is the official currency in Luxembourg since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Administration des Douanes et Accises (Customs and Excise Duties Administration)Inspection Douanes et Accises (Customs and Excise Inspection)
22, rue de Bitbourg
1273 Luxembourg
Tel: (+352) 281 828 18
Contact: douanes@do.etat.lu
Website: https://douanes.public.lu/fr.html
4. Import Procedure
The Single Administrative Document - SAD (Document Administratif Unique - DAU) must be submitted electronically using eDouane - (e-Services of Luxembourg Customs). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Luxembourg Free Port
5. Trade Regime and Import Licenses
Import licences for agricultural products
Administration des Douanes et Accises (Customs and Excise Duties Administration)Inspection Douanes et Accises (Customs and Excise Inspection)
22, rue de Bitbourg
1273 Luxembourg
Tel: (+352) 281 828 18
Contact: douanes@do.etat.lu
Website: https://douanes.public.lu/fr.html
Licences for iron, steel and aluminium products
Ministère de l'Économie (Ministry of Economy)Direction Générale de la Promotion du Commerce Extérieur et des Investissements (Directorate-General for the Promotion of Foreign Trade and Investments)
Office du contrôle des exportations, importations et du transit (Office for Export, Import and Transit Controls)
19-21, boulevard Royal
2449 Luxembourg
Tel: (+352) 247 841 37 / (+352) 22 61 62
Contact: oceit@eco.etat.lu
Website: https://guichet.public.lu/fr/entreprises/import-export/licences.html
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration luxembourgeoise vétérinaire et alimentaire (ALVA) (Luxembourg Veterinary and Food Administration (ALVA))
7, rue Thomas Edison
1445 Strassen
Tel: (+352) 45 71 72 248 / (+352) 24 78 25 39
Contact: info@alva.etat.lu
Website: https://ma.gouvernement.lu/fr/administrations/alva.html
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration des Services Techniques de l'Agriculture - ASTA (Administration of Agricultural Technical Services)
16, Route d'Esch
1470 Luxembourg
Tel: (+352) 45 71 72 200
Contact: info@asta.etat.lu / directeur@asta.etat.lu
Website: https://agriculture.public.lu/de.html
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministère de la Santé (Ministry of Health)Direction de la Santé (National Health Directorate)
Division de la Sécurité Alimentaire (Food Safety Unit)
7A rue Thomas Edison
1445 Strassen
Tel: (+352) 247 756 20
Contact: secualim@ms.etat.lu / import.secualim@ms.etat.lu
Website: https://dirsante.gouvernement.lu/fr.html
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration des Services Techniques de l'Agriculture - ASTA (Administration of Agricultural Technical Services)
Service de la Production Animale (Animal Production Services)
Contrôle des aliments pour animaux (Official Control of Feedingstuffs)
72, Avenue Salentiny
9080 Ettelbruck
Tel: (+352) 81 00 81 310
Contact: info@asta.etat.lu / aliments.animaux@asta.etat.lu
Website: https://agriculture.public.lu/de.html
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration des Services Techniques de l'Agriculture - ASTA (Administration of Agricultural Technical Services)
Division des Laboratoires (Testing Laboratories Division)
72, Avenue Salentiny
9080 Ettelbruck
Tel: (+352) 45 71 72 400
Contact: info@asta.etat.lu / danielle.ruckert@asta.etat.lu
Website: https://agriculture.public.lu/de.html
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministère de l'Environnement, du Climat et du Développement durable (Ministry of the Environment, Climate and Sustainable Development)Administration de l'Environnement (Environment Agency)
1, avenue du Rock'n'Roll
4361 Esch-sur-Alzette
Tel: (+352) 40 56 56 1
Contact: infos@aev.etat.lu
Website: https://environnement.public.lu/fr.html
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministère de l'Environnement, du Climat et du Développement durable (Ministry of the Environment, Climate and Sustainable Development)Direction des Ressources Naturelles, de l’Eau et des Forêts (Directorate of Natural Resources, Water and Forests)
4, Place de l'Europe
1499 Luxembourg
Tel: (+352) 247 86 824 / (+352) 247 86 853
Contact: eric.schauls@mev.etat.lu
Website: https://environnement.public.lu/fr.html
Flora licences
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration des Services Techniques de l'Agriculture - ASTA (Administration of Agricultural Technical Services)
16, Route d'Esch
1470 Luxembourg
Tel: (+352) 45 71 72 200
Contact: info@asta.etat.lu / directeur@asta.etat.lu
Website: https://agriculture.public.lu/de.html
Wildlife licences
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration luxembourgeoise vétérinaire et alimentaire (ALVA) (Luxembourg Veterinary and Food Administration (ALVA))
7, rue Thomas Edison
1445 Strassen
Tel: (+352) 45 71 72 248 / (+352) 24 78 25 39
Contact: info@alva.etat.lu / cites@alva.etat.lu / info@alva.etat.lu
Website: https://ma.gouvernement.lu/fr/administrations/alva.html
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Ministère de l'Agriculture, de la Viticulture et du Développement rural (Ministry of Agriculture, Viticulture and Rural Development)Administration des Services Techniques de l'Agriculture - ASTA (Administration of Agricultural Technical Services)
Division des Laboratoires (Testing Laboratories Division)
72, Avenue Salentiny
9080 Ettelbruck
Tel: (+352) 45 71 72 400
Contact: info@asta.etat.lu / danielle.ruckert@asta.etat.lu
Website: https://agriculture.public.lu/de.html
Detergents
Ministère de l'Environnement, du Climat et du Développement durable (Ministry of the Environment, Climate and Sustainable Development)Administration de la Gestion de l'Eau (Water Management Agency)
1, avenue du Rock'n'Roll
4361 Esch-sur-Alzette
Tel: (+352) 245 56 1
Contact: info@eau.public.lu / direction@eau.etat.lu
Website: https://eau.gouvernement.lu/fr.html
Dangerous chemicals and persistant organic pollutants
Ministère de l'Environnement, du Climat et du Développement durable (Ministry of the Environment, Climate and Sustainable Development)Administration de l'Environnement (Environment Agency)
1, avenue du Rock'n'Roll
4361 Esch-sur-Alzette
Tel: (+352) 40 56 56 1
Contact: infos@aev.etat.lu
Website: https://environnement.public.lu/fr/loft/air/Polluants_atmospheriques/POP.html
D. Control and management of waste
Ministère de l'Environnement, du Climat et du Développement durable (Ministry of the Environment, Climate and Sustainable Development)Administration de l'Environnement (Environment Agency)
1, avenue du Rock'n'Roll
4361 Esch-sur-Alzette
Tel: (+352) 40 56 56 1
Contact: infos@aev.etat.lu
Website: https://environnement.public.lu/fr.html
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Ministère de l'Économie (Ministry of Economy)Institut luxembourgeois de la normalisation, de l'accréditation, de la sécurité et qualité des produits et services - ILNAS (Luxembourg Institute of Standardisation, Accreditation, Safety and Quality of Products and Services)
Département de la Surveillance du Marché (Department of Market Surveillance)
Southlane Tower I
1, avenue du Swing
4367 Belvaux (Esch/Belval)
Tel: (+352) 247 743 20
Contact: info@ilnas.etat.lu / surveillance@ilnas.etat.lu
Website: https://portail-qualite.public.lu/fr.html
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Ministère de l'Économie (Ministry of Economy)Institut luxembourgeois de la normalisation, de l'accréditation, de la sécurité et qualité des produits et services - ILNAS (Luxembourg Institute of Standardisation, Accreditation, Safety and Quality of Products and Services)
Service de la Métrologie légale (Legal Metrology Service)
35 Rue J.F. Kennedy
7327 Steinsel
Tel: (+352) 247 643 10
Contact: metrologie@ilnas.etat.lu
Website: https://portail-qualite.public.lu/fr.html
Materials and articles intended to come into contact with foodstuffs
Ministère de la Santé (Ministry of Health)Direction de la Santé (National Health Directorate)
Division de la Sécurité Alimentaire (Food Safety Unit)
7A rue Thomas Edison
1445 Strassen
Tel: (+352) 247 756 20
Contact: secualim@ms.etat.lu / import.secualim@ms.etat.lu
Website: https://dirsante.gouvernement.lu/fr.html
12. Labelling
The contents of the labelling must be at least in French or German. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Μάλτα
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Malta is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Malta since 01/01/2008.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Ministry for FinanceCustoms Department
Custom House, Lascaris Wharf
Valleta VLT 1920
Tel: (+356) 23 783 310
Contact: malta.customs@gov.mt
Website: https://customs.gov.mt/
4. Import Procedure
The Single Administrative Document - SAD must be submitted electronically using the Customs Electronic System (CES). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Malta Freeport Terminals Ltd
5. Trade Regime and Import Licenses
Import licences for agricultural products
Ministry for Agriculture, Fisheries and Animal RightsAgriculture and Rural Payments Agency
Luqa Road
QORMI QRM 9075 Malta
Tel: (+356) 22 926 148
Contact: arpa.mafa@gov.mt
Website: https://arpa.gov.mt/
Licences for iron, steel and aluminium products
Ministry for the Economy, European Funds and LandsCommerce Department
Trade-related Services and Projects Directorate
Daħlet Gnien is-Sultan
Lascaris Bastions
Valletta VLT 1933
Tel: (+356) 21 226 688 / (+356) 25 690 315
Contact: commerce@gov.mt / import-export@gov.mt
Website: https://commerce.gov.mt/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministry for Agriculture, Fisheries and Animal RightsVeterinary Regulation Directorate
Pinto Business Centre, Level 3
Mill Street, Qormi
Tel: (+356) 22 925 197 / (+356) 22 925 301
Contact: veterinaryregulation.mafa@gov.mt
Website: https://ahwd.gov.mt/en/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministry for Agriculture, Fisheries and Animal RightsPlant Protection Directorate
110, Annibale Preca Street
Lija LJA 1915
Tel: (+356) 22 926 535 / (+356) 80 072 310
Contact: plantprotection@gov.mt / plantquarantine@gov.mt
Website: https://plantprotection.gov.mt/en/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministry for HealthEnvironmental Health Directorate
Health Inspectorate Services
Continental Business Centre
Level 1
Old Railway Road
Santa Venera, SVR 9018
Tel: (+356) 21 337 333
Contact: mhi@gov.mt / admin.ehd@gov.mt
Website: https://environmentalhealth.gov.mt/en/services/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministry for Agriculture, Fisheries and Animal RightsAgriculture and Rural Payments Agency
Luqa Road
QORMI QRM 9075 Malta
Tel: (+356) 22 926 148
Contact: arpa.mafa@gov.mt
Website: https://arpa.gov.mt/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministry for Agriculture, Fisheries and Animal RightsRural Affairs Department
Agriculture Research and Innovation Hub
Marsa, Malta
Tel: (+356) 22 924 194
Contact: ruralaffairs.mafa@gov.mt
Website: https://ruralaffairs.gov.mt/en/
Ministry for Health
Environmental Health Directorate
Health Inspectorate Services
Continental Business Centre
Level 1
Old Railway Road
Santa Venera, SVR 9018
Tel: (+356) 21 337 333
Contact: mhi@gov.mt / admin.ehd@gov.mt
Website: https://environmentalhealth.gov.mt/en/services/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Environment and Resources AuthorityHexagon House
Spencer Hill
Marsa MRS 1441
Tel: (+356) 22 923 517 / (+356) 22 923 500
Contact: info@era.org.mt / mcu.cites.malta@era.org.mt / https://cc-eris.eraportal.org.mt/submit-case
Website: https://era.org.mt/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Environment and Resources AuthorityHexagon House
Spencer Hill
Marsa MRS 1441
Tel: (+356) 22 923 517 / (+356) 22 923 500
Contact: cites.permitting@era.org.mt / info@era.org.mt / mcu.cites.malta@era.org.mt / https://cc-eris.eraportal.org.mt/submit-case
Website: https://era.org.mt/topic/trade-protected-species/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Persistent organic pollutants
Environment and Resources AuthorityHexagon House
Spencer Hill
Marsa MRS 1441
Tel: (+356) 22 923 517 / (+356) 22 923 500
Contact: info@era.org.mt / mcu.cites.malta@era.org.mt / https://cc-eris.eraportal.org.mt/submit-case
Website: https://era.org.mt/
Dangerous chemicals, detergents and fertilisers
Malta Competition and Consumer Affairs AuthorityTechnical Regulations Division
Mizzi House, National Road
Blata I - Bajda
Hamrun, HMR 9010
Tel: (+356) 23 952 000
Contact: rad@mccaa.org.mt / marketsurveillance@mccaa.org.mt
Website: https://www.mccaa.org.mt/
D. Control and management of waste
Environment and Resources AuthorityHexagon House
Spencer Hill
Marsa MRS 1441
Tel: (+356) 22 923 517 / (+356) 22 923 500
Contact: info@era.org.mt / mcu.cites.malta@era.org.mt / https://cc-eris.eraportal.org.mt/submit-case
Website: https://era.org.mt/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Malta Competition and Consumer Affairs AuthorityStandards and Metrology Institute
Mizzi House
National Road, Blata I - Bajda
Hamrum HMR 9010
Tel: (+356) 23 952 000
Contact: standards@mccaa.org.mt / certification@mccaa.org.mt / marketsurveillance@mccaa.org.mt
Website: https://www.mccaa.org.mt/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Malta Competition and Consumer Affairs AuthorityStandards and Metrology Institute
Mizzi House
National Road, Blata I - Bajda
Hamrum HMR 9010
Tel: (+356) 23 952 000
Contact: standards@mccaa.org.mt / certification@mccaa.org.mt / marketsurveillance@mccaa.org.mt
Website: https://www.mccaa.org.mt/
Materials and articles intended to come into contact with foodstuffs
Ministry for HealthEnvironmental Health Directorate
Health Inspectorate Services
Continental Business Centre
Level 1
Old Railway Road
Santa Venera, SVR 9018
Tel: (+356) 21 337 333
Contact: mhi@gov.mt / admin.ehd@gov.mt
Website: https://environmentalhealth.gov.mt/en/services/
12. Labelling
The contents of the labelling must be at least in Maltese or in English. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Κάτω Χώρες
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Kingdom of the Netherlands is one of the six founding Member States of the European Union (EU) as it took part in the ratification of the Treaties of Rome, which established the European Communities and became effective in 1958.
2. Currency
The Euro (EUR) is the official currency in the Netherlands since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Belastingdienst (Tax and Customs Administration)Douane (Customs)
Postbus 3070
6401 DN Heerlen
Tel: (+31) 55 538 53 89
Website: https://www.belastingdienst.nl/wps/wcm/connect/en/customs/customs
4. Import Procedure
The Single Administrative Document - SAD (Enig document - SAD) must be submitted electronically using DMS - Douaneaangiften Management Systeem - (Customs Declarations Management System). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in the Netherlands.
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Belastingdienst (Tax and Customs Administration)Douane (Customs)
Centrale Dienst voor In- en uitvoer - Cdiu (Central import and export service)
Postbus 3070
6401 DN Heerlen
Tel: (+31) (088) 151 21 22
Contact: drn-cdiu.groningen@belastingdienst.nl
Website: https://www.belastingdienst.nl/wps/wcm/connect/en/customs/customs
Import licences for agricultural products
Ministerie van Economische Zaken (Ministry of Economic Affairs)Rijksdienst voor Ondernemend Nederland - RVO (Netherlands Enterprise Agency)
Postbus 93144
2509 AC Den Haag
Tel: (+31) 70 379 80 00 / (+31) 088 042 42 42
Contact: https://english.rvo.nl/en/topics/contact/form
Website: https://english.rvo.nl/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)Nederlandse Voedsel en Waren Autoriteit - NVWA (Netherlands Food and Consumer Product Safety Authority)
Postbus 43006
3540 AA Utrecht
Tel: (+31) 88 223 33 33
Contact: https://formulieren.nvwa.nl/formulier/en-GB/Extern/sc1123_VraagStellen.aspx/CB_Authenticatie/CB_Inleiding
Website: https://english.nvwa.nl/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)Nederlandse Voedsel en Waren Autoriteit - NVWA (Netherlands Food and Consumer Product Safety Authority)
Postbus 43006
3540 AA Utrecht
Tel: (+31) 88 223 33 33
Contact: https://formulieren.nvwa.nl/formulier/en-GB/Extern/sc1123_VraagStellen.aspx/CB_Authenticatie/CB_Inleiding
Website: https://english.nvwa.nl/
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)Nederlandse Voedsel en Waren Autoriteit - NVWA (Netherlands Food and Consumer Product Safety Authority)
Postbus 43006
3540 AA Utrecht
Tel: (+31) 88 223 33 33
Contact: https://formulieren.nvwa.nl/formulier/en-GB/Extern/sc1123_VraagStellen.aspx/CB_Authenticatie/CB_Inleiding
Website: https://english.nvwa.nl/
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)Postbus 20401
2500 EK Den Haag
Tel: (+31) 070 379 8911
Contact: https://www.government.nl/contact/public-information-service/email
Website: https://www.government.nl/ministries/ministry-of-agriculture-fisheries-food-security-and-nature
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)
Nederlandse Voedsel en Waren Autoriteit - NVWA (Netherlands Food and Consumer Product Safety Authority)
Postbus 43006
3540 AA Utrecht
Tel: (+31) 88 223 33 33
Contact: https://formulieren.nvwa.nl/formulier/en-GB/Extern/sc1123_VraagStellen.aspx/CB_Authenticatie/CB_Inleiding
Website: https://english.nvwa.nl/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministerie van Infrastructuur en Waterstaat (Ministry of Infrastructure and Water Management)Planbureau voor leeformgeving - PBL (Environmental design agency)
Postbus 30314
2500 GH Den Haag
Tel: (+31) 070 328 8700
Contact: info@pbl.nl
Website: https://www.pbl.nl/en
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerie van Economische Zaken (Ministry of Economic Affairs)Rijksdienst voor Ondernemend Nederland - RVO (Netherlands Enterprise Agency)
Postbus 93144
2509 AC Den Haag
Tel: (+31) 70 379 80 00 / (+31) 088 042 42 42
Contact: cites@rvo.nl / https://english.rvo.nl/en/topics/contact/form
Website: https://www.rvo.nl/onderwerpen/cites/dit-cites
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals, detergents and persistent organic pollutants
Ministerie van Infrastructuur en Waterstaat (Ministry of Infrastructure and Water Management)Inspectie Leefomgeving en Transport - ILT (Environmental and Transport Inspectorate)
Postbus 16191
2500 BD Den Haag
Tel: (+31) 088 489 00 00
Contact: https://e-loket.ilent.nl/formulier/en-GB/defaultEnvironment/VraagAanDeILT.aspx/VraagAanDeILT
Website: https://english.ilent.nl/
Fertilisers
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)Postbus 20401
2500 EK Den Haag
Tel: (+31) 070 379 8911
Contact: https://www.government.nl/contact/public-information-service/email
Website: https://www.government.nl/ministries/ministry-of-agriculture-fisheries-food-security-and-nature
Wageningen Voedselveiligheid Onderzoek (Wageningen Food Safety Research Institute)
Postbus 230
6700 AE Wageningen
Tel: (+31) 0 317 48 02 56
Contact: studievoorlichting@wur.nl / https://www.wur.nl/nl/Contact-Wageningen-University-Research/contactformulier-studievoorlichting.htm
Website: https://www.wur.nl/en/Research-Results/Research-Institutes/food-safety-research.htm
Detergents
Ministerie van Volksgezondheid, Welzijn en Sport (Ministry of Health, Welfare and Sport)Rijksinstituut voor Volksgezondheid en Milieu - RIVM (National Institute for Public Health and the Environment)
Postbus 1
3720 BA Bilthoven
Tel: (+31) 030 274 91 11
Contact: info@rivm.nl
Website: https://www.rivm.nl/en
D. Control and management of waste
Ministerie van Infrastructuur en Waterstaat (Ministry of Infrastructure and Water Management)Inspectie Leefomgeving en Transport - ILT (Environmental and Transport Inspectorate)
Postbus 16191
2500 BD Den Haag
Tel: (+31) 088 489 00 00
Contact: https://e-loket.ilent.nl/formulier/en-GB/defaultEnvironment/VraagAanDeILT.aspx/VraagAanDeILT
Website: https://english.ilent.nl/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Nederlands Normalisatie-instituut - NEN (Netherlands' Standardisation Institute)Postbus 5059
2600 GB Delft
Tel: (+31) 015 2 690 391
Contact: klantenservice@nen.nl
Website: https://www.nen.nl/en/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Ministerie van Landbouw, Visserij, Voedselzekerheid en Natuur (Ministry of Agriculture, Fisherie, Food Security and Nature)Nederlandse Voedsel en Waren Autoriteit - NVWA (Netherlands Food and Consumer Product Safety Authority)
Postbus 43006
3540 AA Utrecht
Tel: (+31) 88 223 33 33
Contact: https://formulieren.nvwa.nl/formulier/en-GB/Extern/sc1123_VraagStellen.aspx/CB_Authenticatie/CB_Inleiding
Website: https://english.nvwa.nl/
Ministerie van Volksgezondheid, Welzijn en Sport (Ministry of Health, Welfare and Sport)
Directie Voeding, Gezondheidsbescherming en Preventie - VGP (Food, Health Protection and Prevention Directorate)
Postbus 20350
2500 EJ Den Haag
Tel: (+31) 070 3406880
Contact: https://www.government.nl/contact/public-information-service/email
Website: https://www.government.nl/ministries/ministry-of-health-welfare-and-sport
Packaging sizing
NMI (Measuring Institute of the Netherlands)Postbus 463
2600 AL Delft
Tel: (+31) 88 636 2332
Contact: nmi@nmi.nl
Website: https://www.nmi.nl/
12. Labelling
The contents of the labelling must be at least in Dutch. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Πολωνία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Poland is a member of the European Union (EU) since 01/05/2004.
Poland is organised in 16 regional provinces (Województwa).
2. Currency
The Zloty (PLN) is the official currency in Poland.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Krajowa Administracja Skarbowa (National Revenue Administration)ul. Świętokrzyska 12
00-916 Warszawa
Tel: (+48) 22 330 03 30
Contact: kancelaria@mf.gov.pl
Website: https://www.gov.pl/web/kas
4. Import Procedure
The Single Administrative Document - SAD (Jednolity Dokument Administracyjny - JDA) must be submitted electronically using System Informacyjny Skarbowo-Celny (SISC) - (Tax and Customs Information System). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in Polish.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Wolny Obszar Celny na terenie Portu Lotniczego im. Fryderyka Chopina w Warszawie
- Wolny Obszar Celny w Gliwicach
- Wolny Obszar Celny w gminie
- Wolny Obszar Celny w Szczecinie
- Wolny Obszar Celny w Świnoujściu
- Wolny Obszar Celny w Gdańsku
- Wolny Obszar Celny w Mszczonowie w województwie mazowieckim
5. Trade Regime and Import Licenses
Import licences for agricultural products
Krajowy Ośrodek Wsparcia Rolnictwa (National Agricultural Support Center)ul. Karolkowa 30
01-207 Warszawa
Tel: (+48) 22 376 76 76
Contact: warszawa@kowr.gov.pl
Website: https://www.kowr.gov.pl
Licences for iron, steel and aluminium products
Ministerstwo Rozwoju i Technologii (Ministry of Development and Technology)Departament Małych i Średnich Przedsiębiorstw (Department of Small and Medium-Sized Enterprises)
Pl. Trzech Krzyzy 3/5
00-507 Warszawa
Tel: (+48) 22 411 94 47
Contact: SekretariatDMP@mrit.gov.pl
Website: https://www.gov.pl/web/rozwoj
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministerstwo Rolnictwa i Rozwoju Wsi (Ministry of Agriculture and Rural Development)Główny Inspektorat Weterynarii (General Veterinary Inspectorate)
ul. Wspólna 30
00-930 Warszawa
Tel: (+48) 22 623 17 17 / (+48) 22 623 20 89
Contact: wet@wetgiw.gov.pl
Website: https://www.wetgiw.gov.pl
7. Plant Health
The competent authorities for phytosanitary inspections are:
Panstwowa Inspekcja Ochrony Roslin i Nasiennictwa - PIORiN (State Plant Health and Seed Inspection Service)al. Jana Pawła II 11
00-828 Warszawa
Tel: (+48) 22 652 92 90
Contact: gi@piorin.gov.pl
Website: https://www.gov.pl/web/piorin
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Główny Inspektorat Sanitarny (Chief Sanitary Inspectorate)ul. Targowa 65
03-729 Warszawa
Tel: (+48) 22 345 33 00
Contact: inspektorat@sanepid.gov.pl
Website: https://www.gov.pl/web/gis
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministerstwo Rolnictwa i Rozwoju Wsi (Ministry of Agriculture and Rural Development)Główny Inspektorat Weterynarii (General Veterinary Inspectorate)
ul. Wspólna 30
00-930 Warszawa
Tel: (+48) 22 623 17 17 / (+48) 22 623 20 89
Contact: wet@wetgiw.gov.pl
Website: https://www.wetgiw.gov.pl
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Główny Inspektorat Jakości Handlowej Artykułów Rolno-Spożywczych (Chief Inspectorate of Commercial Quality of Agricultural and Food Products)Aleje Jerozolimskie 98
00-807 Warszawa
Tel: (+48) 22 255 78 00
Contact: sekretariat@ijhars.gov.pl
Website: https://www.gov.pl/web/ijhars
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Instytut Chemii Przemyslowej (Industrial Chemistry Research Institute)Biuro Ochrony Warstwy Ozonowej i Klimatu (Ozone Layer And Climate Protection Unit)
ul. Rydygiera 8
01-793 Warszawa
Tel: (+48) 22 568 23 93
Contact: ichp@ichp.pl / bowoik@ichp.lukasiewicz.gov.pl
Website: https://ichp.lukasiewicz.gov.pl/en/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerstwo Klimatu i Środowiska (Ministry of Climate and Enviroment)Departament Ochrony Przyrody (Department of Nature Conservation)
ul. Wawelska 52/54
00-922 Warszawa
Tel: (+48) 22 369 24 79
Contact: Departament.Ochrony.Przyrody@klimat.gov.pl
Website: https://www.gov.pl/web/klimat
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals and detergents
Biuro do Spraw Substancji Chemicznych (Bureau for Chemical Substances)Inspektor do Spraw Substancji Chemicznych (Inspector for Chemical Substances)
ul. Dowborczyków 30/34
90-019 Lódz
Tel: (+48) 42 253 84 00 / (+48) 42 253 84 01
Contact: biuro@chemikalia.gov.pl
Website: https://www.gov.pl/web/chemikalia/biuro-do-spraw-substancji-chemicznych/
Persistent organic pollutants
Instytut Ochrony Środowiska (Institute of Environmental Protection)ul.Słowicza 32
02-170 Warszawa
Tel: (+48) 22 375 05 25 / (+48) 22 621 36 70
Contact: sekretariat@ios.edu.pl
Website: https://ios.edu.pl/
Ministerstwo Klimatu i Środowiska (Ministry of Climate and Enviroment)
Departament Gospodarki Odpadami (Department of Waste Management)
ul. Wawelska 52/54
00-922 Warszawa
Tel: (+48) 22 369 22 62
Contact: Departament.Gospodarki.Odpadami@klimat.gov.pl
Website: https://www.gov.pl/web/klimat
Fertilisers
Ministerstwo Rolnictwa i Rozwoju Wsi (Ministry of Agriculture and Rural Development)Departament Hodowli i Ochrony Roślin (Department of Plant Breeding and Protection)
Wydział Nawozów i Środków Wspomagających Uprawę Roślin (Division of Fertilisers and Aids Supporting Cultivation of Plants)
ul. Wspólna 30
00-930 Warszawa
Tel: (+48) 22 623 21 51
Contact: sekretariat.dhr@minrol.gov.pl
Website: https://www.gov.pl/web/rolnictwo
D. Control and management of waste
Główny Inspektorat Ochrony Środowiska - GIOS (Chief Inspectorate of Environmental Protection)Ul. Bitwy Warszawskiej 1920 r. 3
02-362 Warszawa
Tel: (+48) 22 369 22 26
Contact: gios@gios.gov.pl
Website: https://www.gov.pl/web/gios
General surveillance
Instytut Ochrony Środowiska (Institute of Environmental Protection)ul.Słowicza 32
02-170 Warszawa
Tel: (+48) 22 375 05 25 / (+48) 22 621 36 70
Contact: sekretariat@ios.edu.pl
Website: https://ios.edu.pl/
Ministerstwo Klimatu i Środowiska (Ministry of Climate and Enviroment)
ul. Wawelska 52/54
00-922 Warszawa
Tel: (+48) 22 369 29 00
Contact: info@klimat.gov.pl
Website: https://www.gov.pl/web/klimat
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Polski Komitet Normalizacyjny (Polish Committee for Standardization)ul. Świętokrzyska 14
00-050 Warszawa
Tel: (+48) 22 556 77 55 / (+48) 22 556 77 77
Contact: info@pkn.pl
Website: https://www.pkn.pl
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Glówny Urzad Miar - GUM (Central Office of Measures)ul. Elektoralna 2
00-139 Warszawa
Tel: (+48) 22 581 93 99 / (+48) 22 620 02 41
Contact: gum@gum.gov.pl
Website: https://www.gum.gov.pl/
Materials and articles intended to come into contact with foodstuffs
Główny Inspektorat Sanitarny (Chief Sanitary Inspectorate)ul. Targowa 65
03-729 Warszawa
Tel: (+48) 22 345 33 00
Contact: inspektorat@sanepid.gov.pl
Website: https://www.gov.pl/web/gis
Narodowy Instytut Zdrowia Publicznego - Państwowy Instytut Badawczy (National Institute of Public Health - National Research Institute)
ul. Chocimska 24
00-791 Warszawa
Tel: (+48) 22 542 14 00 / (+48) 22 542 12 00
Contact: pzh@pzh.gov.pl
Website: https://www.pzh.gov.pl/
12. Labelling
The contents of the labelling must be at least in Polish. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Πορτογαλία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Portuguese Republic is a member of the European Union (EU) since 01/01/1986.
After a transitional period, it fully integrated into the EU in 1993. Portugal comprises the territory on the Continent of Europe as is historically defined and the archipelagos of the Azores and Madeira.
2. Currency
The Euro (EUR) is the official currency in Portugal since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Ministério das Finanças (Ministry of Finance)Autoridade Tributária e Aduaneira (Revenue and Customs Authority)
Rua da Alfândega, 5 r/c
1149-006 Lisboa
Tel: (+351) 21 881 38 18 / (+351) 21 720 67 07
Contact: dsta@at.gov.pt
Website: https://www.portaldasfinancas.gov.pt
4. Import Procedure
The Single Administrative Document - SAD (Documento Administrativo Único - DAU) must be submitted electronically using STADA - Servicios Aduaneiros Portal Aduaneiro - (Customs Services - Customs Portal). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in Portuguese.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Zona Franca da Madeira (Caniçal)
5. Trade Regime and Import Licenses
The bodies in charge of issuing import licenses for products subject to trade regimes are:
Ministério das Finanças (Ministry of Finance)Autoridade Tributária e Aduaneira (Revenue and Customs Authority)
Direcção de Serviços de Licenciamento - DSL (Directorate of Trade Licenses)
Rua da Alfândega, 5 r/c
1149-006 Lisboa
Tel: (+351) 21 881 38 43
Contact: dsl@at.gov.pt
Website: https://www.portaldasfinancas.gov.pt
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministério da Agricultura e da Alimentação (Ministry of Agriculture and Food)Direção-Geral de Alimentação e Veterinária - DGAV (Directorate-General for Food and Veterinary Services)
Campo Grande, 50
1700-093 Lisboa
Tel: (+351) 21 323 95 00
Contact: geral@dgav.pt
Website: https://www.dgav.pt
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministério da Agricultura e da Alimentação (Ministry of Agriculture and Food)Direção-Geral de Alimentação e Veterinária - DGAV (Directorate-General for Food and Veterinary Services)
Campo Grande, 50
1700-093 Lisboa
Tel: (+351) 21 323 95 00
Contact: geral@dgav.pt
Website: https://www.dgav.pt
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Ministério da Agricultura e da Alimentação (Ministry of Agriculture and Food)Direção-Geral de Alimentação e Veterinária - DGAV (Directorate-General for Food and Veterinary Services)
Campo Grande, 50
1700-093 Lisboa
Tel: (+351) 21 323 95 00
Contact: geral@dgav.pt
Website: https://www.dgav.pt
The responsibility for the implementation of the control is also devolved to the Direcções Regionais de Agricultura e Pescas (Regional Agricultural and Fishery Directorates).
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministério da Agricultura e da Alimentação (Ministry of Agriculture and Food)Direção-Geral de Alimentação e Veterinária - DGAV (Directorate-General for Food and Veterinary Services)
Campo Grande, 50
1700-093 Lisboa
Tel: (+351) 21 323 95 00
Contact: geral@dgav.pt
Website: https://www.dgav.pt
Imports of certain agricultural and fishery products shall obtain a quality certificate. This certificate guarantees that the goods conform to the respective quality standards. Inspections are carried out either at their own premises or at the designated Border control posts.
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Agência Portuguesa do Ambiente - APA (Portuguese Environment Agency)Rua da Murgueira 9
Zambujal - Alfragide
2610-124 Amadora
Tel: (+351) 21 472 82 00
Contact: geral@apambiente.pt
Website: https://www.apambiente.pt
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Instituto de Conservação da Natureza e das Florestas (Institute for Nature Conservation and Forests)Av. Dr. Alfredo Magalhães Ramalho 1
1495-165 Algés
Tel: (+351) 21 350 79 84 / (+351) 21 350 79 00
Contact: cites@icnf.pt
Website: https://www.icnf.pt/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Detergents and fertilisers
Ministério da Economia e do Mar (Ministry of Economy and Maritime Affairs)Direção-Geral das Atividades Económicas - DGAE (Directorate-General for Economic Affairs)
Avenida Visconde de Valmor, 72
1069-041 Lisboa
Tel: (+351) 21 791 91 00
Contact: dgae@dgae.gov.pt
Website: https://www.dgae.gov.pt
Dangerous chemicals and persistant organic pollutants
Agência Portuguesa do Ambiente - APA (Portuguese Environment Agency)Rua da Murgueira 9
Zambujal - Alfragide
2610-124 Amadora
Tel: (+351) 21 472 82 00
Contact: geral@apambiente.pt
Website: https://www.apambiente.pt
D. Control and management of waste
Agência Portuguesa do Ambiente - APA (Portuguese Environment Agency)Rua da Murgueira 9
Zambujal - Alfragide
2610-124 Amadora
Tel: (+351) 21 472 82 00
Contact: geral@apambiente.pt
Website: https://www.apambiente.pt
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Instituto Português da Qualidade - IPQ (Portuguese Institute of Quality)Departamento de Metrologia (Metrology Department)
Rua António Gião, 2
2829-513 Caparica
Tel: (+351) 21 294 81 00
Contact: ipq@ipq.pt
Website: https://www.ipq.pt/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Ministério da Agricultura e da Alimentação (Ministry of Agriculture and Food)Gabinete de Planeamento, Políticas e Administração Geral - GPP (Planning, Policy and General Administration Office)
Praça do Comércio
1149-010 Lisboa
Tel: (+351) 21 323 46 00
Contact: geral@gpp.pt
Website: https://www.gpp.pt
Packaging sizing
Instituto Português da Qualidade - IPQ (Portuguese Institute of Quality)Departamento de Metrologia (Metrology Department)
Rua António Gião, 2
2829-513 Caparica
Tel: (+351) 21 294 81 00
Contact: ipq@ipq.pt
Website: https://www.ipq.pt/
12. Labelling
The contents of the labelling must be at least in Portuguese. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Ρουμανία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
Romania is a member of the European Union (EU) since 01/01/2007.
2. Currency
The Romanian Leu (RON) is the official currency in Romania.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Autoritatea Vamala Româna (Romanian Customs Authority)Str. Alexandru Ivasiuc nr 34-40, bl.5, sector 6
60305 Bucuresti
Tel: (+40) 21 315 58 58 / (+40) 21 315 58 59
Contact: relatiipublice@customs.ro / vama@customs.ro
Website: https://www.customs.ro/
4. Import Procedure
The Single Administrative Document - SAD (Documentul administrativ unic - DAU) must be submitted electronically using Sistemului Informatic Integrat Vamal - SIIV - (Customs Integrated Information System). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Free zone Curtici Arad
- Free zone Galati
- Free zone Giurgiu
- Free zone Braila
- Free zone Sulina
- Free zone Constanta Sud si Basarabi
5. Trade Regime and Import Licenses
Import licences for agricultural products
Agentia de Plati si Interventie pentru Agricultura (Paying and Intervention Agency for Agriculture)Directia Comert Exterior si Promovare Produse Agricole (External Trade and Agricultural Products Promotion Directorate)
Bulevardul Carol I nr. 17, sector 2
010096 Bucureşti
Tel: (+40) 21 305 48 00
Contact: relatii.cu.publicul@apia.org.ro
Website: https://apia.org.ro/
Licences for iron, steel and aluminium products
Ministerul Economiei (Ministry of Economy)Direcţia Politici Comerciale și Afaceri Europene (Directorate for Trade Policies and European Affairs)
Calea Victoriei, nr. 152, sector 1
010096, Bucureşti
Tel: (+40) 372 492 630
Contact: dezbateri_publice@economie.gov.ro
Website: https://economie.gov.ro/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Autoritatea Naţională Sanitară Veterinară şi pentru Siguranta Alimentelor (National Sanitary Veterinary and Food Safety Authority)Direcţia posturi de inspectie la frontiera si TRACES (Directorate for Border Inspection Posts and TRACES)
Piata Presei Libere nr. 1, Corp D1, Sector 1
013701 Bucuresti
Tel: (+40) 3 721 18 49 77
Contact: office@ansvsa.ro
Website: http://www.ansvsa.ro/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministerul Agriculturii şi Dezvoltării Rurale (Ministry of Agriculture and Rural Development)Autoritatea Naţională Fitosanitară (National Authority for Plant Health)
Bldv. Voluntari nr. 11
077190 Voluntari, Ilfov
Tel: (+40) 21 270 32 56 / (+40) 21 270 57 96 / (+40) 21 270 32 60
Contact: fitosanitar@anfdf.ro / anf@anfdf.ro / fitosanitar@anfdf.ro
Website: https://www.anfdf.ro/
8. Food and feed safety and marketing standards
A. Food and feed safety
The competent authorities for the official inspections in the field of animal nutrition and food safety are:
Autoritatea Naţională Sanitară Veterinară şi pentru Siguranta Alimentelor (National Sanitary Veterinary and Food Safety Authority)Direcţia posturi de inspectie la frontiera si TRACES (Directorate for Border Inspection Posts and TRACES)
Piata Presei Libere nr. 1, Corp D1, Sector 1
013701 Bucuresti
Tel: (+40) 3 721 18 49 77
Contact: office@ansvsa.ro
Website: http://www.ansvsa.ro/
B. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministerul Agriculturii şi Dezvoltării Rurale (Ministry of Agriculture and Rural Development)Direcţia Generală Politici Agricole (Directorate-General for Agricultural Policy)
B-dul Carol I, nr. 2-4, sector 3
030163, Bucureşti
Tel: (+40) 21 307 24 35
Contact: politici.agricole@madr.ro
Website: https://www.madr.ro/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministerul Mediului (Ministry of Environment)B-dul Libertătii nr. 12, sector 5
040129 Bucureşti
Tel: (+40) 21 408 95 00
Contact: relatii.public@mmediu.ro / registraturap@mmediu.ro
Website: http://www.mmediu.ro/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerul Mediului (Ministry of Environment)Direcţia Dezvoltare Durabila şi Protectia Naturii (Directorate for Sustainable Development and Nature Protection)
B-dul Libertăţii nr. 12, sector 5
040129 Bucureşti
Tel: (+40) 21 408 95 00
Contact: srp@mmediu.ro / registratura@mmediu.ro
Website: http://www.mmediu.ro/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Detergents
Autoritatea Naţională Pentru Protecţia Consumatorilor (National Authority for Consumer Protection)Bulevardul Aviatorilor, nr. 72, sector 1
011865 Bucureşti
Tel: (+40) 21 377 755 100
Contact: secretariat@anpc.ro
Website: https://anpc.ro/
Ministerul Mediului (Ministry of Environment)
Agenţia Naţională pentru Protecţia Mediului (National Agency for Environment Protection)
Splaiul Independentei, nr. 294, Sector 6
060031 Bucureşti
Tel: (+40) 21 207 11 01 / (+40) 21 207 11 02
Contact: office@anpm.ro
Website: https://www.anpm.ro/
Fertilisers
Ministerul Agriculturii şi Dezvoltării Rurale (Ministry of Agriculture and Rural Development)Inspecţia de Stat pentru controlul fertilizanţilor (State Inspectorate for the control of fertilisers)
B-dul Carol I, nr.2-4, Sector 3
030163 Bucureşti
Tel: (+40) 21 307 23 58
Contact: omg@maa.ro / fertilizanti@madr.ro
Website: https://www.madr.ro//inspectia-in-domeniul-fertilizantilor.html
Persistent organic pollutants
Ministerul Mediului (Ministry of Environment)Direcţia Controlul Poluării şi Evaluare Impact (Directorate for the Control of Pollution and Impact Evaluation)
Bd. Libertăţii nr. 12, sector 5
040129 Bucureşti
Tel: (+40) 21 408 95 00
Contact: registratura@mmediu.ro
Website: http://www.mmediu.ro//
Dangerous chemicals
Ministerul Mediului (Ministry of Environment)Direcţia Gestiune Deşeuri şi Substanţe Periculoase (Directorate for Waste Control and Dangerous Substances)
B-dul Libertăţii, nr.12, Sector 5
040129 Bucureşti
Tel: (+40) 21 408 95 00
Contact: registratura@mmediu.ro
Website: http://www.mmediu.ro//
D. Control and management of waste
Garda Naţională de Mediu (National Environmental Guard)B-dul Unirii 78, bloc J2, Sector 3
Bucureşti
Tel: (+40) 21 326 89 70
Contact: gardamediu@gnm.ro
Website: https://www.gnm.ro/
General surveillance
Ministerul Mediului (Ministry of Environment)Agenţia Naţională pentru Protecţia Mediului (National Agency for Environment Protection)
Splaiul Independentei, nr. 294, Sector 6
060031 Bucureşti
Tel: (+40) 21 207 11 08 / (+40) 21 207 11 01 / (+40) 21 207 11 02
Contact: office@anpm.ro
Website: https://www.anpm.ro/
Ministerul Mediului (Ministry of Environment)
Direcţia Gestiune Deşeuri şi Substanţe Periculoase (Directorate for Waste Control and Dangerous Substances)
B-dul Libertăţii, nr.12, Sector 5
040129 Bucureşti
Tel: (+40) 21 408 95 00
Contact: registratura@mmediu.ro
Website: http://www.mmediu.ro//
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Asociaţia de Standardizare din România (Romanian Standards Association)Str. Mihai Eminescu nr. 238
20085, Bucureşti
Tel: (+40) 21 316 32 96
Contact: asro@asro.ro
Website: https://www.asro.ro/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Ministerul Economiei (Ministry of Economy)Biroul Român de Metrologie Legală (Romanian Bureau of Legal Metrology)
Sos. Vitan Bârzesti 11, sector 4
042122, Bucureşti
Tel: (+40) 21 332 09 54
Contact: office@brml.ro
Website: https://www.brml.ro/index.php
Materials and articles intended to come into contact with foodstuffs
Ministerul Sănătăţii (Ministry of Health)Intr. Cristian Popişteanu 1-3, sector 1
010024, Bucureşti
Tel: (+40) 21 307 25 35 / (+40) 21 307 25 00 / (+40) 21 307 25 24 / (+40) 21 307 25 35
Contact: relatii.publice@ms.ro
Website: https://www.ms.ro/
12. Labelling
The contents of the labelling must be at least in Romanian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Σλοβακική Δημοκρατία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Slovak Republic is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Slovakia since 01/01/2009.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Finančného Riaditeľstvo Slovenskej Republiky (Financial Directorate of Slovak Republic)Lazovná č. 63
974 01 Banská Bystrica
Tel: (+421) 48 4393 111 / (+421) 48 4317 222
Contact: podatelna@mfsr.sk
Website: https://www.financnasprava.sk/
4. Import Procedure
The Single Administrative Document - SAD (Jednotného colného dokladu - JCD) must be submitted electronically using Elektronické služby - (Electronic Services of Finance Administration). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Slovakia.
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Ministerstvo hospodárstva Slovenskej Republiky (Ministry of Economy of the Slovak Republic)Mlynské nivy 44/a
82715 Bratislava 212
Tel: (+421) 2 4854 2167 / (+421) 2 4854 1111
Contact: licencie@mhsr.sk / info@economy.gov.sk
Website: https://www.economy.gov.sk/
Import licences for agricultural products
Pôdohospodárska platobná agentúra - PPA (Agricultural Paying Agency)Hraničná 12
815 26 Bratislava
Tel: (+421) 918 612 429
Contact: info@apa.sk
Website: http://www.apa.sk/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Štátna veterinárna a potravinová správa Slovenskej republiky (State Veterinary and Food Administration of the Slovak Republic)Odbor zdravia a ochrany zvierat (Department of Health and Protection of Animals)
Botanická 17
84213 Bratislava
Tel: (+421) 2 6025 7227
Contact: sekretariat-UR@svps.sk
Website: https://www.svps.sk/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ústredný kontrolný a skúšobný ústav poľnohospodársky - ÚKSÚP (Central Control and Testing Institute in Agriculture)Obdor ochrany rastlin (Department of Plant Protection)
Matúskova 21
83316 Bratislava
Tel: (+421) 2 5988 0348
Contact: ochrana@uksup.sk
Website: https://www.uksup.sk/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Štátna veterinárna a potravinová správa Slovenskej republiky (State Veterinary and Food Administration of the Slovak Republic)Botanická 17
84213 Bratislava
Tel: (+421) 2 6025 7211
Contact: sekretariat-UR@svps.sk
Website: https://www.svps.sk/
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ústredný kontrolný a skúšobný ústav poľnohospodársky - ÚKSÚP (Central Control and Testing Institute in Agriculture)Odbor krmív a výživy zvierat (Department of Feeds and Animal Nutrition)
Matúskova 21
83316 Bratislava
Tel: (+421) 0917 745 456 / (+421) 2 5988 0263 / (+421) 2 5988 0267
Contact: krmiva@uksup.sk
Website: https://www.uksup.sk/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Control of food of animal origin
Ministerstvo pôdohospodárstva a rozvoja vidieka Slovenskej Republiky (Ministry of Agriculture and Rural Development of the Slovak Republic)Odbor živocíšnej výroby (Department of Animal Products)
Dobrovicova 12
81266 Bratislava
Tel: (+421) 2 5926 6549
Contact: info@land.gov.sk
Website: https://www.mpsr.sk/
Štátna veterinárna a potravinová správa Slovenskej republiky (State Veterinary and Food Administration of the Slovak Republic)
Odbor zahranicných vztahov, dovozov a vývozov (Department of Foreign Affairs, Imports and Exports)
Botanická 17
84213 Bratislava
Tel: (+421) 2 6025 7124
Contact: sekretariat-UR@svps.sk
Website: https://www.svps.sk/
Control of plants, fruits and vegetables
Ministerstvo pôdohospodárstva a rozvoja vidieka Slovenskej Republiky (Ministry of Agriculture and Rural Development of the Slovak Republic)Odbor rastlinnej výroby (Department of Plant Products)
Dobrovicova 12
81266 Bratislava
Tel: (+421) 2 5926 6360
Contact: info@land.gov.sk
Website: https://www.mpsr.sk/
Štátna veterinárna a potravinová správa Slovenskej republiky (State Veterinary and Food Administration of the Slovak Republic)
Odbor kontroly potravín rastlinného pôvodu (Department of Foodstuffs of Plant Origin)
Botanická 17
84213 Bratislava
Tel: (+421) 2 6025 7429
Contact: cvo.svfa@svps.sk / sekretariat-UR@svps.sk
Website: https://www.svps.sk/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministerstvo životného prostredia (Ministry of Environment)Sekcia zmeny klímy a ochrany ovzdušia (Climate Change and Air Protection Section)
Námestie Ľudovíta Štúra 1
81235 Bratislava
Tel: (+421) 2 5956 2246 / (+421) 2 5956 2271
Contact: info@enviro.gov.sk
Website: https://www.minzp.sk/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerstvo životného prostredia (Ministry of Environment)Odbor regulácie obchodu s ohrozenými druhmi (Department of Regulation of Trade in Endangered Species)
Námestie Ľudovíta Štúra 1
81235 Bratislava
Tel: (+421) 2 5956 2422
Contact: cites@sopsr.sk
Website: https://www.cites.sk/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Detergents
Centrum pre chemické látky a prípravky (Centre for Chemical Substances and Preparations)Mlynské nivy 44
82715 Bratislava
Tel: (+421) 2 4854 4504 / (+421) 2 4854 4511
Contact: detergents@ccsp.sk / chemicals@ccsp.sk
Website: https://www.ccsp.sk/
Dangerous chemicals
Ministerstvo hospodárstva Slovenskej Republiky (Ministry of Economy of the Slovak Republic)Odbor pre zákaz chemických zbraní a riadenie obchodovania s vybranými chemickými látkami (Prohibition of Chemical Weapons and Management of Trade in Selected Chemical Substances Department)
Mlynské nivy 44/a
82715 Bratislava 212
Tel: (+421) 2 4854 1111 / (+421) 2 4854 2164
Contact: info@economy.gov.sk / licencie@mhsr.sk
Website: https://www.economy.gov.sk/
Ústredný kontrolný a skúšobný ústav poľnohospodársky - ÚKSÚP (Central Control and Testing Institute in Agriculture)
Odbor registrácie pesticídov (Department of Pesticides Registration)
Matúškova 21
83116 Bratislava
Tel: (+421) 55 7901220
Contact: pesticidy@uksup.sk
Website: https://www.uksup.sk/
Persistent organic pollutants
Slovenská agentúra životného prostredia (Slovak Environmental Agency)Odbor environmentálneho manažérstva (Department of the Environmental Management)
Tajovského 28
97590 Banská Bystrica
Tel: (+421) 850 221 715 / (+421) 222 117 715
Contact: sazp@sazp.sk
Website: https://www.sazp.sk/
Fertilisers
Ústredný kontrolný a skúšobný ústav poľnohospodársky - ÚKSÚP (Central Control and Testing Institute in Agriculture)Odbor pôdy a hnojív (Department of Soil and Fertilizers)
Matúškova 21
83116 Bratislava
Tel: (+421) 2 5988 0339
Contact: hnojiva@uksup.sk
Website: https://www.uksup.sk/
D. Control and management of waste
Ministerstvo životného prostredia (Ministry of Environment)Odbor odpadového a obehového hospodárstva (Waste Management Department and Circular Economy)
Námestie Ľudovíta Štúra 1
81235 Bratislava
Tel: (+421) 2 5956 4335
Contact: info@enviro.gov.sk
Website: https://www.minzp.sk/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky (Slovak Office of Standards, Metrology and Testing)Odbor technickej normalizácie (Department of technical standardisation)
Štefanovičova 3
P.O. Box 76
81005 Bratislava 15
Tel: (+421) 2 2090 7200 / (+421) 2 2090 7300
Contact: info@normoff.gov.sk
Website: https://www.unms.sk/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Slovenský metrologický ústav (Slovak Institute of Metrology)Karloveská 63
84255 Bratislava
Tel: (+421) 2 6029 4412
Contact: info@smu.gov.sk / sluzby@smu.gov.sk
Website: https://www.smu.sk/
Materials and articles intended to come into contact with foodstuffs
Úrad verejného zdravotníctva Slovenskej Republiky (Public Health Office of the Slovak Republic)Regionálny úrad verejného zdravotníctva so sídlom v Poprade (Regional public health authority in Poprad)
Zdravotnícka 3
05897 Poprad
Tel: (+421) 5 2418 0712
Contact: pp.sekr@uvzsr.sk
Website: https://uvzsr.sk/web/ruvzpp
12. Labelling
The contents of the labelling must be at least in Slovak. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Σλοβενία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Republic of Slovenia is a member of the European Union (EU) since 01/05/2004.
2. Currency
The Euro (EUR) is the official currency in Slovenia since 01/01/2007.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Ministrstvo za Finance (Ministry of Finance)Finančna uprava Republike Slovenije (Financial Administration of the Republic of Slovenia)
Šmartinska cesta 55
1000 Ljubljana
Tel: (+386) 1 478 38 00
Contact: gfu.fu@gov.si
Website: https://www.fu.gov.si/
4. Import Procedure
The Single Administrative Document - SAD (Enotna upravna listina - SAD) must be submitted electronically using e-Carina - (e-Services of Slovenian Customs Administration) or via computer data exchange (IBM MQ). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Luka Koper - Prosta cona Koper
5. Trade Regime and Import Licenses
Licences for iron, steel and aluminium products
Ministrstvo za gospodarstvo, turizem in šport (Ministry of Economy, Tourism and Sport)Kotnikova ulica 5
1000 Ljubljana
Tel: (+386) 1 400 33 11
Contact: taric.fu@gov.si / gp.mgrt@gov.si
Website: https://www.gov.si/drzavni-organi/ministrstva/ministrstvo-za-gospodarstvo-turizem-in-sport/
Import licences for agricultural products
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Agencija Republike Slovenije za kmetijske trge in razvoj podeželja (Agency for Agricultural Markets and Rural Development)
Dunajska cesta 160
1000 Ljubljana
Tel: (+386) 1 580 77 92
Contact: aktrp@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/agencija-za-kmetijske-trge-in-razvoj-podezelja/
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out by the authorities at the designated Border control posts. The authorities in charge of these inspections are:
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Inšpektorat Republike Slovenije za kmetijstvo, gozdarstvo, lovstvo in ribištvo (Inspectorate of the Republic of Slovenia for Agriculture, Forestry, Hunting and Fisheries)
Dunajska cesta 58
1000 Ljubljana
Tel: (+386) 1 434 57 00
Contact: irskglr.mkgp@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/inspektorat-za-kmetijstvo-gozdarstvo-lovstvo-in-ribistvo/
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)
Uprava Republike Slovenije za varno hrano, veterinarstvo in varstvo rastlin (Administration of the Republic of Slovenia for Food Safety, Veterinary and Plant Protection)
Dunajska cesta 22
1000 Ljubljana
Tel: (+386) 1 300 13 00
Contact: gp.uvhvvr@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/uprava-za-varno-hrano-veterinarstvo-in-varstvo-rastlin/
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Inšpektorat Republike Slovenije za kmetijstvo, gozdarstvo, lovstvo in ribištvo (Inspectorate of the Republic of Slovenia for Agriculture, Forestry, Hunting and Fisheries)
Dunajska cesta 58
1000 Ljubljana
Tel: (+386) 1 434 57 00
Contact: irskglr.mkgp@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/inspektorat-za-kmetijstvo-gozdarstvo-lovstvo-in-ribistvo/
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)
Uprava Republike Slovenije za varno hrano, veterinarstvo in varstvo rastlin (Administration of the Republic of Slovenia for Food Safety, Veterinary and Plant Protection)
Dunajska cesta 22
1000 Ljubljana
Tel: (+386) 1 300 13 00
Contact: gp.uvhvvr@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/uprava-za-varno-hrano-veterinarstvo-in-varstvo-rastlin/
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Inšpektorat Republike Slovenije za kmetijstvo, gozdarstvo, lovstvo in ribištvo (Inspectorate of the Republic of Slovenia for Agriculture, Forestry, Hunting and Fisheries)
Dunajska cesta 58
1000 Ljubljana
Tel: (+386) 1 434 57 00
Contact: irskglr.mkgp@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/inspektorat-za-kmetijstvo-gozdarstvo-lovstvo-in-ribistvo/
Ministrstvo za zdravje (Ministry of Health)
Zdravstveni inšpektorat Republike Slovenije (Health Inspectorate of the Republic of Slovenia)
Vožarski pot 12
1000 Ljubljana
Tel: (+386) 1 280 38 02
Contact: gp.zirs@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/zdravstveni-inspektorat
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Inšpektorat Republike Slovenije za kmetijstvo, gozdarstvo, lovstvo in ribištvo (Inspectorate of the Republic of Slovenia for Agriculture, Forestry, Hunting and Fisheries)
Dunajska cesta 58
1000 Ljubljana
Tel: (+386) 1 434 57 00
Contact: irskglr.mkgp@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/inspektorat-za-kmetijstvo-gozdarstvo-lovstvo-in-ribistvo/
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)
Uprava Republike Slovenije za varno hrano, veterinarstvo in varstvo rastlin (Administration of the Republic of Slovenia for Food Safety, Veterinary and Plant Protection)
Dunajska cesta 22
1000 Ljubljana
Tel: (+386) 1 300 13 00
Contact: gp.uvhvvr@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/uprava-za-varno-hrano-veterinarstvo-in-varstvo-rastlin/
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Inšpektorat Republike Slovenije za kmetijstvo, gozdarstvo, lovstvo in ribištvo (Inspectorate of the Republic of Slovenia for Agriculture, Forestry, Hunting and Fisheries)
Dunajska cesta 58
1000 Ljubljana
Tel: (+386) 1 434 57 00
Contact: irskglr.mkgp@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/inspektorat-za-kmetijstvo-gozdarstvo-lovstvo-in-ribistvo/
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministrstvo za okolje, podnebje in energijo (Ministry of the Environment, Climate and Energy)Agencija Republike Slovenije za okolje (Slovenian Environment Agency)
Vojkova cesta 1b
1000 Ljubljana
Tel: (+386) 1 478 40 00
Contact: stik@arso.gov.si / gp.arso@gov.si
Website: https://www.arso.gov.si/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministrstvo za okolje, podnebje in energijo (Ministry of the Environment, Climate and Energy)Agencija Republike Slovenije za okolje (Slovenian Environment Agency)
Vojkova cesta 1b
1000 Ljubljana
Tel: (+386) 1 478 40 00
Contact: stik@arso.gov.si / gp.arso@gov.si
Website: https://www.arso.gov.si/
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Ministrstvo za kmetijstvo, gozdarstvo in prehrano (Ministry of Agriculture, Forestry and Food)Uprava Republike Slovenije za varno hrano, veterinarstvo in varstvo rastlin (Administration of the Republic of Slovenia for Food Safety, Veterinary and Plant Protection)
Sektor za fitofarmacevtska sredstva (Plant Protection Products Division)
Dunajska cesta 22
1000 Ljubljana
Tel: (+386) 1 300 13 00
Contact: gp.uvhvvr@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/uprava-za-varno-hrano-veterinarstvo-in-varstvo-rastlin/o-upravi/sektor-za-fitofarmacevtska-sredstva/
Dangerous chemicals, detergents and persistent organic pollutants
Ministrstvo za zdravje (Ministry of Health)Urad Republike Slovenije za kemikalije (Chemicals Office of the Republic of Slovenia)
Ajdovščina 4
1000 Ljubljana
Tel: (+386) 1 400 60 51
Contact: gp-ursk.mz@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/urad-za-kemikalije/
D. Control and management of waste
Ministrstvo za okolje, podnebje in energijo (Ministry of the Environment, Climate and Energy)Agencija Republike Slovenije za okolje (Slovenian Environment Agency)
Vojkova cesta 1b
1000 Ljubljana
Tel: (+386) 1 478 74 00 / (+386) 1 478 40 00
Contact: stik@arso.gov.si / gp.arso@gov.si
Website: https://www.arso.gov.si/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Slovenski inštitut za standardizacijo - SIST (Slovenian Institute for Standardization)Ulica gledališča BTC 2
1000 Ljubljana
Tel: (+386) 1 478 30 13
Contact: sist@sist.si
Website: https://www.sist.si/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Packaging sizing
Ministrstvo za gospodarstvo, turizem in šport (Ministry of Economy, Tourism and Sport)Urad Republike Slovenije za meroslovje (Metrology Institute of the Republic of Slovenia)
Tkalska ulica 15
3000 Celje
Tel: (+386) 3 428 07 50
Contact: gp.mirs@gov.si
Website: https://www.gov.si/drzavni-organi/organi-v-sestavi/urad-za-meroslovje/
Materials and articles intended to come into contact with foodstuffs
Ministrstvo za zdravje (Ministry of Health)Direktorat za javno zdravje (Directorate of Public Health)
Štefanova ulica 5
1000 Ljubljana
Tel: (+386) 1 478 60 07
Contact: gp.mz@gov.si
Website: https://www.gov.si/drzavni-organi/ministrstva/ministrstvo-za-zdravje/o-ministrstvu/direktorat-za-javno-zdravje/
12. Labelling
The contents of the labelling must be at least in Slovenian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
Ισπανία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The Kingdom of Spain is a member of the European Union (EU) since 01/01/1986.
After a transitional period, it fully integrated into the EU in 1993. The Spanish peninsular territory, the Balearic Islands and the Canary Islands form part of the European Customs territory. Spain is organised in 17 regional governments (Comunidades Autónomas).
2. Currency
The Euro (EUR) is the official currency in Spain since 01/01/2002.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Agencia Estatal de Administración Tributaria - AEAT (Spanish State Tax Administration Agency)Departamento de Aduanas e Impuestos Especiales (Department of Customs and Excises)
Dirección Adjunta de Vigilancia Aduanera (Deputy Directorate of Customs Surveillance)
Avenida de Llano Castellano, 17
28034 Madrid
Tel: (+34) 91 728 94 50
Contact: gestionaduanera@correo.aeat.es
Website: https://sede.agenciatributaria.gob.es/
4. Import Procedure
The Single Administrative Document - SAD (Documento Único Administrativo - DUA) must be submitted electronically using *Servicio Web - Extensible Markup Language (XML) - (Web Service of the Customs Administration). Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in Spanish.
Further information may be found in:
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are free zones in the following places:
- Zona Franca de Barcelona
- Zona Franca de Cádiz
- Zona Franca de Vigo
- Zona Franca de Gran Canaria
- Zona Franca de Tenerife
- Zona Franca Santander
- Zona Franca de Sevilla
5. Trade Regime and Import Licenses
The bodies in charge of issuing import licenses for products subject to trade regimes are:
Ministerio de Economía, Comercio y Empresa (Ministry of Economy, Trade and Enterprise)Secretaría de Estado de Comercio (Secretariat of State for Trade)
Dirección General de Política Comercial (Directorate-General for Commercial Policy)
Paseo de la Castellana, 162
28046 Madrid
Tel: (+34) 91 258 28 52
Contact: sgagro.sscc@comercio.mineco.es / dgcominver.sscc@comercio.mineco.es
Website: https://comercio.gob.es/ImportacionExportacion/Regimenes/Paginas/index.aspx
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out at the designated Border control posts. The authorities in charge of these inspections depend on the kind of products:
Live animals and products of animal origin not intended for human consumption
Ministerio de Agricultura, Pesca y Alimentación (Ministry of Agriculture, Fishery and Food)Secretaría General de Recursos Agrarios y Seguridad Alimentaria (General Secretariat for Agricultural Resources and Food Safety)
Dirección General de Sanidad de la Producción Agroalimentaria y Bienestar Animal (Directorate-General for Agri-Food Production Health and Animal Welfare)
Subdirección General de Sanidad e Higiene Animal y Trazabilidad (Sub-Directorate-General for Animal Heath and Hygiene and Traceability)
C/ Almagro 33, 2a planta
28010 Madrid
Tel: (+34) 91 347 82 95
Contact: sganimal@mapa.es
Website: https://www.mapa.gob.es/es/ganaderia/temas/default.aspx
Products of animal origin intended for human consumption
Ministerio de Sanidad (Ministry of Health)Secretaría de Estado de Sanidad (Secretariat of State for Health)
Dirección General de Salud Pública (Directorate-General for Public Health)
Subdirección General de Sanidad Exterior - SGSE (Sub-Directorate-General for Foreign Health)
Paseo del Prado, 18-20
28071 Madrid
Tel: (+34) 91 596 10 00
Contact: saniext@mscbs.es / saniext@sanidad.gob.es
Website: https://www.sanidad.gob.es/areas/sanidadExterior/home.htm
7. Plant Health
The competent authorities for phytosanitary inspections are:
Ministerio de Agricultura, Pesca y Alimentación (Ministry of Agriculture, Fishery and Food)Secretaría General de Recursos Agrarios y Seguridad Alimentaria (General Secretariat for Agricultural Resources and Food Safety)
Dirección General de Sanidad de la Producción Agroalimentaria y Bienestar Animal (Directorate-General for Agri-Food Production Health and Animal Welfare)
Subdirección General de Acuerdos Sanitarios y Control en Frontera (Sub-Directorate-General for Health Agreements and Border Inspection)
C/ Almagro 33, 3a planta
28010 Madrid
Tel: (+34) 91 347 82 41
Contact: sgacuerdos@mapa.es
Website: https://www.mapa.gob.es/es/agricultura/temas/sanidad-vegetal/default.aspx
The Canary Islands have specific provisions according to Orden of 12/03/1987 (BOE 72 25/03/1987).
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Ministerio de Sanidad (Ministry of Health)Secretaría de Estado de Sanidad (Secretariat of State for Health)
Dirección General de Salud Pública (Directorate-General for Public Health)
Subdirección General de Sanidad Exterior - SGSE (Sub-Directorate-General for Foreign Health)
Paseo del Prado, 18-20
28071 Madrid
Tel: (+34) 91 596 10 00
Contact: saniext@mscbs.es / saniext@sanidad.gob.es
Website: https://www.sanidad.gob.es/areas/sanidadExterior/home.htm
Health controls on foodstuffs of non-animal origin are carried out at the designated Border control posts and other control points situated along the border. Customs authorities cannot release the goods unless they are accompanied by a Health Certificate issued by the competent authority with a favourable opinion.
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Ministerio de Agricultura, Pesca y Alimentación (Ministry of Agriculture, Fishery and Food)Secretaría General de Recursos Agrarios y Seguridad Alimentaria (General Secretariat for Agricultural Resources and Food Safety)
Dirección General de Sanidad de la Producción Agroalimentaria y Bienestar Animal (Directorate-General for Agri-Food Production Health and Animal Welfare)
Subdirección General de Acuerdos Sanitarios y Control en Frontera (Sub-Directorate-General for Health Agreements and Border Inspection)
C/ Almagro 33, 3a planta
28010 Madrid
Tel: (+34) 91 347 82 41
Contact: sgacuerdos@mapa.es
Website: https://www.mapa.gob.es/es/agricultura/temas/sanidad-vegetal/default.aspx
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Ministerio de Economía, Comercio y Empresa (Ministry of Economy, Trade and Enterprise)Secretaría de Estado de Comercio (Secretariat of State for Trade)
Dirección General de Política Comercial (Directorate-General for Commercial Policy)
Subdirección General de Inspección, Certificación y Asistencia Técnica del Comercio Exterior (Sub-Directorate-General for Inspection, Certification and Technical Assistance for International Trade)
Paseo de la Castellana, 162
28046 Madrid
Tel: (+34) 91 349 87 49
Contact: sgsoivre.sscc@mincotur.es
Website: https://comercio.gob.es/ImportacionExportacion/Controles/Paginas/default.aspx
Imports of certain agricultural and fishery products shall obtain a quality certificate. This certificate guarantees that the goods conform to the respective quality standards. Inspections are carried out either at their own premises or at the designated Border control posts.
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Ministerio para la Transición Ecológica y el Reto Demográfico (Ministry of Ecological Transition and Demographic Challenge)Secretaría de Estado de Medio Ambiente (Secretariat of State of Environment)
Dirección General de Calidad y Evaluación Ambiental (Directorate-General for Environmental Quality and Assessment)
Subdirección General de Prevención de la contaminación (Sub-Directorate General for Pollution Prevention)
Plaza de San Juan de la Cruz 10
28071 Madrid
Tel: (+34) 91 597 54 27 / (+34) 91 597 54 28
Contact: bzn-sgpc@miteco.es
Website: https://www.miteco.gob.es/es/calidad-y-evaluacion-ambiental/temas/atmosfera-y-calidad-del-aire/emisiones/prob-amb/SAO.aspx
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Ministerio para la Transición Ecológica y el Reto Demográfico (Ministry of Ecological Transition and Demographic Challenge)Secretaría de Estado de Medio Ambiente (Secretariat of State of Environment)
Dirección General de Biodiversidad, Bosques y Desertificación (Directorate-General for Biodiversity, Forests and Desertification)
Subdirección General de Biodiversidad Terrestre y Marina (Sub-Directorate-General for Land and Marine Biodiversity)
Plaza de San Juan de la Cruz 10
28071 Madrid
Tel: (+34) 91 597 60 56
Contact: bzn-cites@miteco.es / buzon-sgb@miteco.es
Website: https://www.miteco.gob.es/es/biodiversidad/temas/internacional-especies-madera/cites/default.aspx
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Dangerous chemicals, detergents, fertilisers and persistent organic pollutants
Ministerio para la Transición Ecológica y el Reto Demográfico (Ministry of Ecological Transition and Demographic Challenge)Secretaría de Estado de Medio Ambiente (Secretariat of State of Environment)
Dirección General de Calidad y Evaluación Ambiental (Directorate-General for Environmental Quality and Assessment)
Subdirección General de Prevención de la contaminación (Sub-Directorate General for Pollution Prevention)
Plaza de San Juan de la Cruz 10
28071 Madrid
Tel: (+34) 91 597 54 27 / (+34) 91 597 54 28
Contact: bzn-sgpc@miteco.es
Website: https://www.miteco.gob.es/es/calidad-y-evaluacion-ambiental/temas/productos-quimicos/
D. Control and management of waste
Ministerio para la Transición Ecológica y el Reto Demográfico (Ministry of Ecological Transition and Demographic Challenge)Secretaría de Estado de Medio Ambiente (Secretariat of State of Environment)
Dirección General de Calidad y Evaluación Ambiental (Directorate-General for Environmental Quality and Assessment)
Subdirección General de Residuos (Subdirectorate General for Waste)
Plaza de San Juan de la Cruz 10
28071 Madrid
Tel: (+34) 91 597 63 54
Contact: buzon-sgr@miteco.es
Website: https://www.miteco.gob.es/es/calidad-y-evaluacion-ambiental/temas/prevencion-y-gestion-residuos/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Asociación Española de Normalización - UNE (Spanish Standardisation Association)C/ Génova, 6
28004, Madrid
Tel: (+34) 91 529 49 00
Contact: info@une.org
Website: https://www.une.org/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Agencia Española de Seguridad Alimentaria y Nutrición - AESAN (Spanish Agency for Food Safety and Nutrition)C/ Alcalá, 56
28014 Madrid
Tel: (+34) 91 338 06 16
Contact: informacionaesan@aesan.gob.es
Website: https://www.aesan.gob.es/AECOSAN/web/home/aecosan_inicio.htm
Packaging sizing
Centro Español de Metrología - CEM (Spanish Metrology Centre)Calle Alfar, 2
28760 Tres Cantos, Madrid
Tel: (+34) 91 807 47 00
Contact: https://www.cem.es/es/form/contacto / cem@cem.es
Website: https://www.cem.es/es
12. Labelling
The contents of the labelling must be at least in Spanish. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.).
13. Special territories
Ceuta and Melilla are not part of the European Customs Union. At this respect, they are considered as third countries. The Canary Islands are part of the Customs territory of the EU since 1992 (with a transitional period up to 2000), however, some exceptions apply:
- specific provisions for indirect taxation;
- imports of certain essential agricultural products, certain end consumer products, raw materials, components for industrial transformation and fishery products are exempted from the applicable import duties under tariff quotas or subject to tariff suspensions or autonomous tariff quotas;
- the quantitative restrictions for textile and clothing products from certain origins are not applicable
Σουηδία
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The kingdom of Sweden is a member of the European Union (EU) since 01/01/1995.
2. Currency
The Swedish krona (SEK) is the official currency in Sweden.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Tullverket (Swedish Customs)Box 27311
102 54 Stockholm
Tel: (+46) 771 520 520
Contact: tullverket@tullverket.se
Website: https://tullverket.se
4. Import Procedure
The Single Administrative Document - SAD (Enhetsdokument - ED) must be submitted electronically using Tid - Tullverkets internetdeklaration - (Electronic Declaration System) or via EDI. Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in Swedish, Norwegian, Danish, English or German.
Further information may be found in:
- TID: https://www.tullverket.se/sv/foretag/tjansterforforetag/tullverketsinternetdeklarationtid.4.44a6a1ff14dad48234f15d0b.html
- EDI: https://www.tullverket.se/en/business/guidelinesforelectroniccustomstransactions/applicationprocedure.4.7df61c5915510cfe9e7657a.html
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Sweden.
5. Trade Regime and Import Licenses
Import licences for agricultural products
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Licences for iron, steel and aluminium products
Kommerskollegium (National Board of Trade)Box 6803
113 86 Stockholm
Tel: (+46) 86 90 48 00
Contact: registrator@kommerskollegium.se
Website: https://kommerskollegium.se
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out at the designated Border control posts. The authorities in charge of these inspections depend on the kind of products:
Live animals and products of animal origin not intended for human consumption
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Products of animal origin intended for human consumption
Livsmedelsverket (Swedish Food Agency)Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
7. Plant Health
The competent authorities for phytosanitary inspections are:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Livsmedelsverket (Swedish Food Agency)Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Livsmedelsverket (Swedish Food Agency)
Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Naturvårdsverket (Swedish Environmental Protection Agency)106 48 Stockholm
Tel: (+46) 10 698 10 00
Contact: kundtjanst@naturvardsverket.se
Website: https://www.naturvardsverket.se/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Dangerous chemicals, detergents, fertilisers and persistent organic pollutants
Kemikalieinspektionen - KEMI (Swedish Chemicals Agency)Box 2
172 13 Sundbyberg
Tel: (+46) 8 519 41 100
Contact: kemi@kemi.se
Website: https://kemi.se
Persistent organic pollutants
Naturvårdsverket (Swedish Environmental Protection Agency)106 48 Stockholm
Tel: (+46) 10 698 10 00
Contact: kundtjanst@naturvardsverket.se
Website: https://www.naturvardsverket.se/
D. Control and management of waste
Naturvårdsverket (Swedish Environmental Protection Agency)106 48 Stockholm
Tel: (+46) 10 698 10 00
Contact: kundtjanst@naturvardsverket.se
Website: https://www.naturvardsverket.se/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Svenka Institutet för Standarder - SIS (Swedish Institute for Standards)Box 45443
104 31 Stockholm
Tel: (+46) 8 555 520 00
Contact: info@sis.se
Website: https://sis.se
Svensk Elstandard - SEK (Swedish Electrotechnical Commission)
Box 1284
164 29 Kista
Tel: (+46) 8 444 14 00
Contact: sek@elstandard.se
Website: https://elstandard.se
Svenska Informations- och Telekommunikationsstandardisering - ITS (Swedish Organization for Telecommunication Standards)
Box 1284
164 29 Kista
Tel: (+46) 70 300 95 42
Contact: info@its.se
Website: https://its.se/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Livsmedelsverket (Swedish Food Agency)Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
Packaging sizing
SWEDAC (Swedish Board for Accreditation and Conformity Assessment)Box 878
501 15 Borås
Tel: (+46) 771 99 09 00
Contact: registrator@swedac.se
Website: https://swedac.se
12. Labelling
The contents of the labelling must be at least in one of the three Scandinavian languages, i.e. Swedish, Danish or Norwegian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.)
Latest revision date of the information: 01 March 2025
1. Introduction
This document intends to give a general overview of the European Union (EU or the Union) requirements to be met when importing goods from developing countries. These measures are adopted to protect public health, environment, consumers' demands, etc.
This overview is an outline of the most relevant policies of the European Union. It also supplies information sources of the European Commission as well as other European and international institutions where to find further details.
No provision of an exhaustive list of all import requirements is intended with this document.
More precise product information can be accessed in the Requirements and Taxes Section by introducing the specific Combined Nomenclature code, the country of origin and the Member State of destination in the input form.
2. Customs Union
The 27 Member States of the EU form a single territory for customs purposes. This implies that the EU is a Customs Union, meaning that its Member States have no customs duty barriers between themselves and they all have a common customs tariff for imported goods. Moreover, once customs duties have been duly paid and compliance with import conditions has been inspected, imported goods are free to circulate within the rest of the EU without any further customs controls.
The Customs Territory of the Union includes the territories of the following Member States:
- Belgium,
- Bulgaria,
- Croatia,
- the Czech Republic,
- Denmark, except the Faroe Islands and Greenland,
- Germany, except the Island of Heligoland and the territory of Büsingen,
- Estonia,
- Ireland,
- Greece,
- Spain, except Ceuta and Melilla,
- France, except New Caledonia, Saint-Pierre and Miquelon, Wallis and Futuna Islands, French Polynesia and French Southern and Antarctic Territories, but including the overseas departments of Guadeloupe, French Guiana, Martinique, Mayotte and Reunion Islands,
- Italy, except the municipality of Livigno,
- Cyprus (pending a settlement to the Cyprus problem, the application of the Union 'acquis' is suspended in those areas in which the Government of the Republic of Cyprus does not exercise effective control),
- Latvia,
- Lithuania,
- Luxembourg,
- Hungary,
- Malta,
- the Netherlands in Europe,
- Austria,
- Poland,
- Portugal,
- Romania,
- Slovenia,
- the Slovak Republic,
- Finland,
- Sweden,
The customs territory of the Union comprise territorial waters, internal waters and airspace of the Member States, except territorial waters, internal waters and airspace of the territories situated outside of the customs territory of the Union.
The territory of the principality of Monaco, including its territorial waters, inland maritime waters and airspace, although situated outside the territory of the Union, shall also be considered to be part of the customs territory of the Union.
Union Customs Code (UCC)
The bulk of the rules governing EU customs is contained in the Union Customs Code (UCC). This Code, adopted in Regulation (EU) 952/2013 (CELEX 32013R0952), as well as the following implementing legislation, cover all customs matters concerning trade with foreign countries:
- Regulation (EU) 2015/2446 (CELEX 32015R2446), which supplements certain non-essential elements of the UCC
- Regulation (EU) 2015/2447 (CELEX 32015R2447) laying down provisions for the uniform implementation of the UCC and the application of procedures by all Member States
- Regulation (EU) 2016/341 (CELEX 32016R0341) establishing transitional rules for operators and customs authorities until a fully electronic customs environment is applicable as stated in the provisions of the UCC
- Decision (EU) 2019/2151 (CELEX 32019D2151), establishing the work programme relating to the development and deployment of the electronic systems provided for in the UCC
These provisions ensure uniform and transparent customs practices in all the EU Member States.
The EORI Number
EORI stands for Economic Operator Registration and Identification. EORI commenced across the EU on 1 July 2009.
The EORI number is an identifier, unique throughout the EU, assigned by a customs authority in a Member State to Economic Operators (EOs), both companies (legal persons) or natural persons. By registering for customs purposes in one Member State, an EO is able to obtain an EORI number which is valid throughout the EU.
The operator will then use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.
Economic operators established outside the EU only have to be assigned an EORI number if they lodge a customs declaration, an Entry Summary declaration (ENS) or an Exit Summary declaration (EXS).
The implementation of EORI will ensure that the measures to enhance security introduced by the Security Amendment Regulation (EC) 648/2005 (CELEX 32005R0648) of the former Community Customs Code and the Union Customs Code at present, will be more effective, since EOs can be identified by reference to an unique number, common to all EU Member States.
More information can be found at the EORI Guidelines and at the page on National Customs Websites for information on Customs for specific Member States.
Entry Summary Declaration
Starting on 1 January 2011, the carrier of goods entering the customs territory of the EU needs to lodge advance cargo information in the first customs office of entry to the EU. This information is provided through the Entry Summary declaration (ENS) which needs to be lodged in advance by the carrier of the goods, although in some cases it can also be done by the importer-consignee, or a representative of the carrier or importer. The ENS declaration must be lodged even if the goods are not going to be imported to the EU.
The deadlines for the lodging of the ENS vary according to the mode of transport carrying the goods into the customs territory of the EU:
- Container maritime cargo: at least 24 hours before commencement of loading in the foreign load port.
- Bulk maritime cargo: at least 4 hours before arrival.
- Short sea shipping: at least 2 hours before arrival.
- Short haul flights (less than 4 hours duration): at least by the time of the actual take off of the aircraft.
- Long haul flights (duration of 4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the Union.
- Road traffic: at least 1 hour before arrival.
Part of the information that the carrier must include in the ENS comes from documents originated by the exporter: bill of lading, commercial invoices... so it is crucial that these reach the party responsible for the lodging of the ENS in a timely and accurate manner.
The ENS declaration falls within the scope of the Import Control System (ICS) which has become fully operational on 1 January 2011, as part of the Security Amendment laid down by Regulation (EC) 648/2005 (CELEX 32005R0648). The UCC has introduced several changes in this declaration in order to obtain more detailed information for risk analysis. The detailed specifications will be defined in 2017 and 2018.
Also a Guidance Document on Customs Formalities on Entry and Import into the European Union, including information about the ENS is available.
Import procedures
Goods imported into the EU customs territory must be accompanied by a summary declaration, which is presented to the customs authorities of the place where they are to be unloaded. Goods are then placed under the temporary storage situation (not exceeding 90 days in any case), which means that they are stored under customs supervision until they are placed under any of the following customs procedures or re-exported:
1. Release for free circulation
Goods are 'released for free circulation' when the conditions relating to importation into the EU have been duly fulfilled (payment of tariff duties and other charges, as appropriate, application of non-tariff commercial policy measures and completion of the other formalities related the import of the goods). Release for free circulation confers on non-Union goods the customs status of 'Union goods'.
Once the mentioned duties as well as the value added tax (VAT) and any applicable excise duties have been paid, goods are 'released for consumption', as they have satisfied the conditions for consumption in the Member State of destination.
2. Special procedures
Goods may be placed under any of the following categories of special procedures:
Transit, which comprises external and internal transit:
- External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy measures, thereby transferring customs clearance formalities to the customs office of destination.
- Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:
- Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges related to the import of the goods and commercial policy measures.
- Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported. Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
- Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any change. The maximum period during which goods may remain under this procedure is 2 years.
- End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use.
Processing, which comprises inward and outward processing:
- Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more processing operations, without being subject to import duties, taxes and commercial policy measures. The customs authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products are not finally exported, these shall be subject to the appropriate duties and measures.
- Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents
Customs declaration - SAD (Single Administrative Document)
The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD), which is a common form for all the EU Member States according to the Union Customs Code and the Transitional Delegated Act (Regulation (EU) 2016/341 (CELEX 32016R0341)) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
- electronic means directly linked to the customs authorities (each Member State may have its own system);
- or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, Customs declaration
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods. This principle determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination
This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of their origin, except for some permitted exceptions.
The mutual recognition principle
According to principle of free movement of goods any product lawfully produced and marketed under the regulations of a Member State must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are harmonised.
European Union, Summaries of Legislation, Summaries of EU Legislation
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
- the level of duty rates and other applicable levies on import and export;
- the possible application of certain measures such as anti-dumping;
- external trade statistics;
- import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code
The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the World Customs Organisation (WCO) which comprises about 5 000 commodity groups, organised by Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than 200 countries as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
| Code | Description | Level |
|---|---|---|
| 15 | - Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes | (HS Chapter) |
| 1516 | - - Animal or vegetable fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared: | (HS Heading) |
| 1516 10 | - - - Animal fats and oils and their fractions: | (HS Subheading) |
| 1516 10 10 | - - - - In immediate packings of a net content not exceeding 1 kg: | (CN Code) |
| 1516 10 10 10 | - - - - - Of fish and of marine mammals | (Taric code) |
| 1516 10 10 90 | - - - - - Other | (Taric code) |
European Commission, Taxation and Customs Union, Harmonised system
5. Import Trade Regime
The EU, as a member of the World Trade Organization (WTO), embraces the rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU are the following:
- Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and steel products.
- Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European producers against harmful mass importations at a very low price.
- Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these measures can be started either at the request of a Member State or at the European Commission's own initiative; however industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or safeguard measures.
European Commission, Trade, Agricultural Policy and Trade
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textiles, leather and fur industries
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
C. Iron, Steel and Aluminium Products
Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either in a prior European Union surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products
6. Food and Feed Safety
The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some extent to environmental protection.
Regulation (EC) 178/2002 (CELEX 32002R0178) lays down the general principles and requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the requirements for traceability.
The European Food Safety Authority (EFSA) provides the European Commission with independent scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
- General principles and requirements of Food Law established in Regulation (EC) 178/2002 (CELEX 32002R0178).
- General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulation (EC) 852/2004 (CELEX 32004R0852) and Regulation (EC) 853/2004 (CELEX 32004R0853) respectively.
- Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
- Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
- Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
- Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for particular nutritional purposes.
- General conditions regarding materials and articles intended to come into contact with foodstuff.
- Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety:
- Animal Feed
- General food law
- Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food controls
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
- The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of products or animals to the EU;
- Products of animal origin can only be imported into de EU if they come from approved processing establishments of the exporting third country;
- Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany imports of animals and animal products;
- Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare:
- Trade and Imports of live animals
- Trade and Imports of animal products
- Trade and Imports of Semen, Ova and Embryos
- General guidance on import and transit rules for live animals and animal products from third countries
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to plants or plant products across the EU. Regulation (EU) 2016/2031 (CELEX 32016R2031) establishes the basic legislation in this field which is based on the principles of the International Plant Protection Convention (IPPC) - FAO Organisation and the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
- be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
- undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
- be imported into the EU by a registered importer with a Member State's official Register; and
- be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member States or the EU itself might take temporary emergency measures.
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material must comply with specific marketing requirements designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety Office (CPVO) implements and applies this system.
European Commission, Health and Food Safety, Plant health and biosecurity
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at EU and Member State level, designed to confront major health threats in the territory of the EU, in particular:
- Surveillance and early warning of infectious diseases and other health threats in order to prevent their spread
- Policy action to end the epidemics of HIV/AIDS, hepatitis and tuberculosis
- Control policy of health problems related to unhealthy lifestyles, such as tobacco and/or drugs and substances
European Commission, Health and Food Safety, Public Health
In addition, Regulation (EC) 111/2005 (CELEX 32005R0111) sets up rules for the monitoring of trade in drug precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
European Commission, Taxation and Customs Union, Drug precursors control
10. Environment Protection
Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme, which covers the period from 2013 to 2020. It is mainly focused on four areas: climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals policy
Control of trade in Dangerous Chemicals
Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) 649/2012 (CELEX 32012R0649) which implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
All information regarding import requirements is contained in Chemicals subject to PIC in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals
Control of Persistent Organic Pollutants (POPs)
Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising the use of these products. Thus, Regulation (EU) 2019/1021 (CELEX 32019R1021) implements the provisions laid down by the Stockholm Convention on Persistent Organic Pollutants and the Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution.
European Commission, Environment, Persistant Organic Pollutants (POPs)
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Regulation (EC) 1907/2006 (CELEX 32006R1907) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency will manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures
Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance with the Regulation (EC) 1272/2008 (CELEX 32008R1272).
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS) which sets up the classification of chemicals according to their hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the ECHA's Understanding CLP website.
Plant protection products and biocidal products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the conditions for the authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists, which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Pesticides, plant products and active substances
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to the requirements established in Regulation (EU) 528/2012 (CELEX 32012R0528).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
Fertilisers
Regulation (EC) 2003/2003 (CELEX 32003R2003) includes the provisions relating to the placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Specific chemicals
B. Ozone-Depleting Substances (ODS)
Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the provisions of Regulation (EU) 2024/590 (CELEX 32024R0590): they must be subject to essential or critical uses, must be originated from a third country party to the 1987 Montreal Protocol on ODS, and must be accompanied by an import licence issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Protection of the ozone layer
C. Fluorinated Greenhouse Gases
The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol. Regulation (EU) 2024/573 (CELEX 32024R0573) provides for better containment and recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases
D. Endangered Species protection (CITES)
Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) which is meant to ensure that international trade in these animals and plants is not a threat to their conservation.
Regulation (EC) 338/97 (CELEX 31997R0338) establishes a system of permits and certificates that must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, The European Union and Trade in Wild Fauna and Flora
E. Control and management of Waste
The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for business operators in the Member States) are laid out in Directive 2008/98/EC (CELEX 32008L0098).
Further information is available at Waste and recycling
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) 1013/2006 (CELEX 32006R1013) on shipments of waste. This Regulation establishes a system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Waste shipments
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC (CELEX 31994L0062) lays down essential requirements as to the composition and the recoverable nature of all packaging placed on the EU market:
- Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for the product and for the consumer;
- Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
- Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste
Waste Electrical and Electronic Equipment (WEEE)
Directive 2011/65/EU (CELEX 32011L0065) on the restriction of the use of certain hazardous substances in electrical and electronic equipment and Directive 2012/19/EU (CELEX 32012L0019) on waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste.
European Commission, Environment, Waste from Electrical and Electronic Equipment (WEEE)
Batteries and Accumulators
Directive 2006/66/EC (CELEX 32006L0066) on batteries and accumulators and waste batteries and accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and recycling.
European Commission, Environment, Batteries
11. Marketing standards for agricultural and fishery products
Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Regulation (EU) 1308/2013 (CELEX 32013R1308) establishes a common marketing system for all the agricultural products concerned that may vary in order to take account of the particularities of each product related to different aspects: freshness, size, quality, presentation, tolerances, etc.
Regulation (EC) 2406/96 (CELEX 31996R2406) lays down common marketing standards for certain fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Food, Farming, Fisheries
Products from organic production
Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain production methods laid down by Regulation (EC) 834/2007 (CELEX 32007R0834) on Organic Farming. The aim of organic standards is the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that must be complied with.
European Commission, Agriculture and Rural Development, Organic farming
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Regulation (EU) 2023/988 (CELEX 32023R0988) on the General Product Safety.
The following obligations are imposed Economic Operators (EO):
- To establish internal product safety processes to comply with the regulation;
- To cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
- To provide specific product information, on request by authorities;
- To inform authorities about accidents caused by a product;
- To provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
- To inform directly to all affected consumers about product safety recalls and safety warnings;
- To offer consumers the choice of at least two of the following remedies when a product is recalled;
- To follow specific rules for distance sales.
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level. It specifically requires all businesses to report dangerous products through the Safety Gate, a tool provided by the European Commission for companies to report such products directly to the competent national authorities for product safety.
The General Product Safety Regulation (GPSR) applies in a complementary way to products covered by specific sector legislation such as:
- Cosmetics
- Pharmaceuticals
- Industrial products (chemicals, medical devices, electric equipment, machinery, vehicles, personal protective equipment, etc.)
- Liability of defective products
The GPSR applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the terms of this Regulation it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
13. Technical Standardisation
The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Resolution of 7 May 1985 (CELEX 31985Y0604(01)) laid down a new approach to technical harmonisation and standards, with three main objectives:
- the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
- the setting up of appropriate conformity assessment procedures
- the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for the Union policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical sectors.
New approach principles
- The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
- The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI)
- The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements
- Each Member State has designated Notified Bodies in charge of the conformity assessment procedures when a third party is required.
European Commission, Enterprise and Industry, New legislative framework
Global approach and Conformity assessment procedure
Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.
Resolution of 21 December 1989 (CELEX 31990Y0116(01)) sets up guiding principles for a reliable EU policy on conformity assessment, such as:
- Generalised use of the European standards relating to quality assurance
- Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure. The CE marking:
- has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production control phase when a third party is required
- is affixed to the product itself, to its packaging or to the accompanying document;
- enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.
New Internal Market Package for Goods
A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
- Regulation (EU) 2019/515 (CELEX 32019R0515)
- Regulation (EC) 765/2008 (CELEX 32008R0765) (applicable from 1 January 2010)
- Decision 768/2008/EC (CELEX 32008D0768)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, Market surveillance for products
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:
- Recycling materials, packaging waste prevention,
- Size, nominal quantities and capacities,
- Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
- General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (CELEX 31994L0062),
- Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC (CELEX 32007L0045),
- Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (CELEX 32004R1935)
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to phytosanitary measures established by Regulation (EU) 2016/2031 (CELEX 32016R2031).
In relation to wood packaging, the provisions introduced by Regulation (EU) 2016/2031 (CELEX 32016R2031) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material
15. Labelling
Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging
EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) 66/2010 (CELEX 32010R0066).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market.
European Commission, Environment, Eco-label
Latest revision date of the information: 01 March 2025
1. Integration into the EU
The kingdom of Sweden is a member of the European Union (EU) since 01/01/1995.
2. Currency
The Swedish krona (SEK) is the official currency in Sweden.
3. Customs Administration
Products imported from third countries are controlled by the following administrative authority:
Tullverket (Swedish Customs)Box 27311
102 54 Stockholm
Tel: (+46) 771 520 520
Contact: tullverket@tullverket.se
Website: https://tullverket.se
4. Import Procedure
The Single Administrative Document - SAD (Enhetsdokument - ED) must be submitted electronically using Tid - Tullverkets internetdeklaration - (Electronic Declaration System) or via EDI. Only in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators, the SAD may be submitted physically at the designated Customs offices.
The SAD must be drawn up in Swedish, Norwegian, Danish, English or German.
Further information may be found in:
- TID: https://www.tullverket.se/sv/foretag/tjansterforforetag/tullverketsinternetdeklarationtid.4.44a6a1ff14dad48234f15d0b.html
- EDI: https://www.tullverket.se/en/business/guidelinesforelectroniccustomstransactions/applicationprocedure.4.7df61c5915510cfe9e7657a.html
The SAD may be submitted to the customs authorities either by the importer or his representative. The representation may be:
- direct representation: representatives act in the name of, and on behalf of, another person;
- indirect representation: representatives act in their own name but on behalf of another person. Customs brokers, freight forwarders, and carriers can act as indirect representatives and they have joint responsibility.
A. Free Zones
There are no free zones in Sweden.
5. Trade Regime and Import Licenses
Import licences for agricultural products
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Licences for iron, steel and aluminium products
Kommerskollegium (National Board of Trade)Box 6803
113 86 Stockholm
Tel: (+46) 86 90 48 00
Contact: registrator@kommerskollegium.se
Website: https://kommerskollegium.se
6. Animal Health
Inspections of live animals and products of animal origin shall be carried out at the designated Border control posts. The authorities in charge of these inspections depend on the kind of products:
Live animals and products of animal origin not intended for human consumption
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Products of animal origin intended for human consumption
Livsmedelsverket (Swedish Food Agency)Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
7. Plant Health
The competent authorities for phytosanitary inspections are:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
8. Food and feed safety and marketing standards
A. Foodstuff of non-animal origin
The competent authorities for the control of foodstuffs of non animal origin are:
Livsmedelsverket (Swedish Food Agency)Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
B. Feedingstuff of non-animal origin
The competent authorities for the health control of feedingstuffs of non-animal origin are:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
C. Marketing standards for certain agricultural and fishery products
The compliance with agricultural and fishery marketing standards is controlled by:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Livsmedelsverket (Swedish Food Agency)
Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
9. Environment protection
A. Ozone-depleting substances and products
The authorities in charge of controlling imports of ozone-depleting substances (ODS) are:
Naturvårdsverket (Swedish Environmental Protection Agency)106 48 Stockholm
Tel: (+46) 10 698 10 00
Contact: kundtjanst@naturvardsverket.se
Website: https://www.naturvardsverket.se/
B. Imports of endangered species (CITES)
The competent bodies for the control of trade in endangered species of fauna and flora under the Washington Convention are:
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
C. Control of trade in chemical products
The competent authorities for controlling imports of chemical products are:
Fertilisers
Jordbruksverket (Swedish Board of Agriculture)551 82 Jönköping
Tel: (+46) 771 223 223
Contact: jordbruksverket@jordbruksverket.se
Website: https://jordbruksverket.se
Dangerous chemicals, detergents, fertilisers and persistent organic pollutants
Kemikalieinspektionen - KEMI (Swedish Chemicals Agency)Box 2
172 13 Sundbyberg
Tel: (+46) 8 519 41 100
Contact: kemi@kemi.se
Website: https://kemi.se
Persistent organic pollutants
Naturvårdsverket (Swedish Environmental Protection Agency)106 48 Stockholm
Tel: (+46) 10 698 10 00
Contact: kundtjanst@naturvardsverket.se
Website: https://www.naturvardsverket.se/
D. Control and management of waste
Naturvårdsverket (Swedish Environmental Protection Agency)106 48 Stockholm
Tel: (+46) 10 698 10 00
Contact: kundtjanst@naturvardsverket.se
Website: https://www.naturvardsverket.se/
10. Technical Standardisation
A. Competent authorities
There are several authorities responsible for checking that technical products (such as industrial products, medical devices, radio and telecommunications terminal equipment, vehicles, etc) placed on the market meet the standardisation requirements. Identification and contact details of these authorities are listed for the group of products analysed in the respective Specific Requirement.
B. Standardisation body
Svenka Institutet för Standarder - SIS (Swedish Institute for Standards)Box 45443
104 31 Stockholm
Tel: (+46) 8 555 520 00
Contact: info@sis.se
Website: https://sis.se
Svensk Elstandard - SEK (Swedish Electrotechnical Commission)
Box 1284
164 29 Kista
Tel: (+46) 8 444 14 00
Contact: sek@elstandard.se
Website: https://elstandard.se
Svenska Informations- och Telekommunikationsstandardisering - ITS (Swedish Organization for Telecommunication Standards)
Box 1284
164 29 Kista
Tel: (+46) 70 300 95 42
Contact: info@its.se
Website: https://its.se/
C. Notified bodies
There are several Notified Bodies in charge of the attestation of compliance of products with the technical standards (conformity assessment). Each body is responsible of certain groups of products under a specific directive.
11. Packaging
Materials and articles intended to come into contact with foodstuffs
Livsmedelsverket (Swedish Food Agency)Box 622
751 26 Uppsala
Tel: (+46) 18 17 55 00
Contact: livsmedelsverket@slv.se
Website: https://livsmedelsverket.se
Packaging sizing
SWEDAC (Swedish Board for Accreditation and Conformity Assessment)Box 878
501 15 Borås
Tel: (+46) 771 99 09 00
Contact: registrator@swedac.se
Website: https://swedac.se
12. Labelling
The contents of the labelling must be at least in one of the three Scandinavian languages, i.e. Swedish, Danish or Norwegian. In line with the EU legislation, there are specific provisions for the different types of products (foodstuffs, textiles, cosmetic products, medical devices, etc.)