Chemische producten
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Gelieve er rekening mee te houden dat op deze pagina een algemene beschrijving van elke rubriek in alle EU-talen wordt gegeven. De gegevens zijn echter alleen in het Engels beschikbaar.
Controle op de handel in gevaarlijke chemische stoffen
De invoer van bepaalde gevaarlijke chemische stoffen (pesticiden en industriële chemische stoffen) is verboden of aan strenge beperkingen onderworpen en onderworpen aan controlemaatregelen die zijn gebaseerd op het Verdrag van Rotterdam inzake de procedure met betrekking tot voorafgaande geïnformeerde toestemming (PIC).
Latest revision date of the information: 01 March 2025
Imports of certain dangerous chemicals into the European Union (EU) are banned or severely restricted and subject to control measures laid down in Regulation (EU) 649/2012 (CELEX 32012R0649), which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade, with a view to protecting human health and the environment from potential harm and contributing to the environmentally sound use of such chemicals.
These control measures are based on a standardised system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclude chemicals they cannot manage safely.
Product scope
In Annex I to the Regulation are listed:
- Products included in a category of the Rotterdam Convention (i.e. pesticides or industrial chemicals) or in one of the European Union's subcategories (i.e. pesticide used as a plant protection product, biocidal product, industrial chemical for use by professionals, industrial chemical for use by the public).
- Chemicals or chemical groups that are subject to the PIC procedure according to the Rotterdam Convention.
Import procedures
There are two basic import procedures:
- Prior Informed Consent (PIC) procedure
- Notification procedure
Prior Informed Consent (PIC) procedure
Exports of certain pesticides and industrial chemicals that have been banned or severely restricted for health or environmental reasons can only take place with the explicit prior informed consent (PIC) of the importing country.
The importing country may decide whether it accepts future shipments or not, or if it consents to import these products only subject to specified conditions.
Notification procedure
Until the chemical becomes subject to the PIC procedure, the designated national authority (DNA) of the country that plans to export a chemical that is banned or severely restricted for use within its territory, must inform the designated national authority of the importing country that such export will take place (notification procedure) before the first shipment and annually thereafter.
The European Chemicals Agency (ECHA) is the common national designated authority for the EU for all the administrative functions of the Convention: it sends and receives the export notifications from third countries, it establishes EU import decisions and submits PIC notifications.
Legislation
- Regulation (EU) 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L-201 27/07/2012) (CELEX 32012R0649)
- Commission Implementing Decision (EU) 2016/770 of 14 April 2016 establishing a common format for the submission of information concerning the operation of the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L-127 18/05/2016) (CELEX 32016D0770)
- Commission Implementing Decision (EU) 2016/1115 of 7 July 2016 establishing a format for the submission by the European Chemicals Agency of information concerning the operation of the procedures pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L-186 09/07/2016) (CELEX 32016D1115)
Other information sources
- Rotterdam Convention: https://www.pic.int/
- European Chemicals Agency (ECHA): https://echa.europa.eu/
- Trade of Dangerous Chemicals: https://environment.ec.europa.eu/topics/chemicals/international-agreements_en
- Understanding PIC: https://echa.europa.eu/regulations/prior-informed-consent/understanding-pic
- Chemicals subject to PIC: https://echa.europa.eu/information-on-chemicals/pic/chemicals
- PIC Legislation: https://echa.europa.eu/regulations/prior-informed-consent/legislation
- Guidance documents on PIC: https://echa.europa.eu/guidance-documents/guidance-on-pic
- Guidance document on export and import of hazardous chemicals: https://echa.europa.eu/documents/10162/2324906/guidance_pic_en.pdf/813e3826-5b6d-4a31-9088-6bb9ceae34b4
- ePIC - Prior Informed Consent IT system: https://echa.europa.eu/web/guest/support/dossier-submission-tools/epic
- Commission Expert Group on implementation of the Rotterdam Convention: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=483
Controle op de handel in kwik
De invoer van metallisch kwik en bepaalde kwikmengsels is verboden of aan strenge beperkingen onderworpen om een hoog niveau van bescherming van de menselijke gezondheid en het milieu te waarborgen.
Latest revision date of the information: 01 March 2025
Imports into the European Union (EU) of metallic mercury (Hg CAS RN 7439-97-6) and mixtures of mercury listed in Annex I and Annex II to Regulation (EU) 2017/852 (CELEX 32017R0852) are prohibited or severally restricted, in order to ensure a high level of protection of human health and of the environment.
These measures are aimed at ensuring the fulfilment of the obligations of United Nations Minamata Convention on Mercury.
The import of these products may be allowed, only if the importing Member State has granted written consent to such import in either of the following circumstances:
- the exporting country is a Party to Minamata Convention on Mercury and the exported mercury is not from primary mining that is prohibited under Article 3 (3) and (4) of the Convention; or
- the exporting country not being a Party to the Minamata Convention on Mercury has provided certification that the mercury is not from primary mercury mining; or
- the mercury or the mixtures are imported for disposal purposes as waste, where the exporting country has no access to available capacity within its own territory.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EU) 2017/852 (CELEX 32017R0852) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Legislation
- Regulation (EU) 2017/852 of the European Parliament and the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L-137 24/05/2017) (CELEX 32017R0852)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Commission Implementing Decision (EU) 2017/2287 of 8 December 2017 specifying the forms to be used in relation to the import of mercury and of certain mixtures of mercury pursuant to Regulation (EU) 2017/852 of the European Parliament and of the Council on mercury (OJ L-328 12/12/2017) (CELEX 32017D2287)
- Council Decision (EU) 2018/1730 of 12 November 2018 on the position to be taken on behalf of the European Union at the second meeting of the Conference of the Parties to the Minamata Convention on Mercury with regard to the adoption of guidelines on the environmentally sound interim storage of mercury, other than waste mercury, referred to in Article 10(2) and (3) of the Convention (OJ L-288 16/11/2018) (CELEX 32018D1730)
- Council Decision (EU) 2019/2135 of 21 November 2019 on the position to be taken, on behalf of the European Union, at the third meeting of the Conference of the Parties to the Minamata Convention on Mercury, as regards the adoption of a Decision on the phasing-out of dental amalgam and amending Annex A to that Convention (OJ L-324 13/12/2019) (CELEX 32019D2135)
- Council Decision (EU) 2019/2119 of 21 November 2019 on the position to be taken, on behalf of the European Union, at the third meeting of the Conference of the Parties to the Minamata Convention on Mercury, as regards the adoption of a Decision establishing thresholds for mercury waste, as referred to in Article 11(2) of that Convention (OJ L-320 11/12/2019) (CELEX 32019D2119)
Other information sources
- Minamata Convention on Mercury: https://www.mercuryconvention.org/
- Mercury overview: https://ec.europa.eu/environment/chemicals/mercury/index_en.htm
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
- Group of Experts on Mercury: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3535
Beheersing van persistente organische verontreinigende stoffen
Om de bepalingen van het Verdrag van Stockholm inzake persistente organische verontreinigende stoffen (POP’s) en het Protocol bij het regionale VN/ECE-Verdrag betreffende grensoverschrijdende luchtverontreiniging over lange afstand ten uitvoer te leggen, is de invoer van POP’s verboden of hoofdelijk beperkt.
Latest revision date of the information: 01 March 2025
Imports of persistent organic pollutants (POPs) into the European Union (EU) are prohibited or severally restricted, so as to eliminate or minimise the use of these products to protect human health and the environment.
These measures implement 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.
Persistent organic pollutants are toxic chemical substances which resist degradation. They remain in the environment for decades, become widely distributed geographically and accumulate in living organisms, where they can damage human health and wildlife. This group of pollutants consists of pesticides (such as DDT), industrial chemicals (such as polychlorinated biphenyls - PCBs) and unintentional by-products of combustion and industrial processes (such as dioxins and furans).
Regulation (EU) 2019/1021 (CELEX 32019R1021) lays down the prohibition on imports of intentionally produced POP substances listed in its Annex I, whether on their own, in preparations or as constituents of articles.
POPs may only be imported under certain circumstances, if an exemption has been granted authorising production and use of the substances in question, e.g. for environmentally sound disposal of existing POPs (destruction of waste, etc.) or for laboratory scale-research.
These restrictions are in line with those laid down by Regulation (EC) 1907/2006 (CELEX 32006R1907) which can be imposed on the use of a substance in certain circumstances and products, on the use by consumers or even on all uses (complete ban of a substance).
According to this Regulation, any substance on its own, in a preparation or in an article, may be subject to restrictions if its use poses unacceptable risks to health or the environment. Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing on the market of this substance is listed in Annex XVII.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EU) 2019/1021 (CELEX 32019R1021) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Legislation
- Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L-169 25/06/2019) (CELEX 32019R1021)
- Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L-81 19/03/2004) (CELEX 32004D0259)
- Council Decision (EU) 2016/769 of 21 April 2016 on the acceptance of the Amendments to the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L-127 18/05/2016) (CELEX 32016D0769)
- Council Decision (EU) 2016/768 of 21 April 2016 on the acceptance of the Amendments to the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Heavy Metals (OJ L-127 18/05/2016) (CELEX 32016D0768)
- Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L-209 31/07/2006) (CELEX 32006D0507)
- Commission Decision 2009/63/EC of 20 November 2008 defining a format for the submission of the information by Member States in accordance with Article 7(4)(b)(iii) of the Regulation (EC) No 850/2004 of the European Parliament and of the Council (OJ L-23 27/01/2009) (CELEX 32009D0063)
- Council Decision (EU) 2015/627 of 20 April 2015 on the position to be taken, on behalf of the European Union, at the seventh meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants as regards the proposals for amendments to Annexes A, B and C (OJ L-103 22/04/2015) (CELEX 32015D0627)
- Council Decision (EU) 2019/448 of 18 March 2019 on the submission, on behalf of the European Union, of a proposal for the listing of methoxychlor in Annex A to the Stockholm Convention on Persistent Organic Pollutants (OJ L-77 20/03/2019) (CELEX 32019D0448)
- Council Decision (EU) 2019/639 of 15 April 2019 on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants (OJ L-109 24/04/2019) (CELEX 32019D0639)
- Council Decision (EU) 2021/592 of 7 April 2021 on the submission, on behalf of the European Union, of a proposal for the listing of chlorpyrifos in Annex A to the Stockholm Convention on Persistent Organic Pollutants (OJ C-125 13/04/2021) (CELEX 32021D0592)
Other information sources
- Stockholm Convention on Persistent Organic Pollutants: http://www.pops.int/
- Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution: https://unece.org/environment-policyair/protocol-persistent-organic-pollutants-pops
- Persistant Organic Pollutants (POPs): https://ec.europa.eu/environment/chemicals/international_conventions/index_en.htm
- General information about REACH: https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
- Commission Expert Group on Persistent Organic Pollutants: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=1656
Voorschriften voor het in de handel brengen van meststoffen
Bepaalde minerale meststoffen moeten voldoen aan de technische voorschriften met betrekking tot benaming, indeling en samenstelling; etikettering en verpakking; conformiteitsbeoordeling en traceerbaarheid.
Latest revision date of the information: 01 March 2025
The placing on the European Union (EU) market of fertilising products and other products relevant as inputs for agriculture, such as soil improvers and growing media, must comply with the provisions laid down by the new EU Fertilising Products Regulation (EU) 2019/1009 (CELEX 32019R1009) in order to ensure that they do not present a risk to human, animal or plant health, to safety or to the environment.
Designation and CE Marking
An EU fertilising product is a fertilising product which is CE marked when made available on the market.
A manufacturer is allowed to CE mark a fertilising product only if, in accordance with the Fertilising Products Regulation (FPR), it:
- meets the requirements for the relevant product function category (Annex I)
- meets the requirements for the relevant component material category or categories (Annex II)
- is labelled in accordance with the labelling requirements (Annex III), and
- has successfully passed the relevant conformity assessment procedure (Annex IV).
Regulation (EU) 2019/1009 (CELEX 32019R1009) does not replace national legislations and does not prevent non-harmonised fertilising products from being available on the EU market in accordance with national legislations.
Compliance with the harmonised rules as laid down in the FPR remains optional. Manufacturers may decide if:
- to apply the FPR and affix the CE-mark to their products;
- to follow the rules laid down at national level in an EU country and use the mutual recognition rules;
- or to market the product both under the FPR and the national legislations, provided that the requirements under both sets of rules are met.
Classification and composition
According to the FPR, EU fertilising products are divided into different product function categories (PFCs), which will be subject to specific safety and quality requirements adapted to their different intended uses.
Component materials for EU fertilising products are also divided into different categories, subject to specific process requirements and control mechanisms. This means that it should be possible to find on the market an EU fertilising product composed of several component materials from various component material categories, where each material complies with the requirements of the category to which the material belongs.
If a fertilising product, which complies with all requirements set in Regulation (EU) 2019/1009 (CELEX 32019R1009), happens to contain a substance or microorganism known to have a pesticidal or other plant protection effect, it could still be covered by this Regulation, as long as this fertilising product does not have a pesticidal or other plant protection function within the meaning of the FPR.
Moreover, the new Regulation includes new limit values for contaminants in fertilisers.
All substances, if they are to be incorporated into a fertilizer product in the EU, must be registered by REACH in a dossier and meet minimum requirements:
- the information requirements described by REACH for the tonnage band greather than 10T/year
- a Chemical Safety Report (CSR) assessing the use of the substance as a fertilizer.
By-products belonging to Component Material Category (CMC) 11 referred to in Part II of Annex II to Regulation (EU) 2019/1009 (CELEX 32019R1009), which provide nutrients to plants or mushrooms or improve their nutrition efficiency, shall meet the criteria for agronomic efficiency and safety established in Regulation (EU) 2022/973 (CELEX 32022R0973).
Packaging and labelling obligations
Manufacturers, importers and distributors shall ensure that:
- EU fertilising products are accompanied by the information required under Annex III
- the packaging of the EU fertilising products bears a type number, batch number or other element allowing their identification or, the information is provided in an accompanying document (leaflet) where the EU fertilising products are supplied without packaging
- they indicate their name, registered trade name or registered trademark and the postal address on the packaging of the product or in the leaflet, where the product is supplied without packaging.
Such information shall be in a language easily understood by end-users and market surveillance authorities and shall be clear, understandable and legible.
Regulation (EU) 2022/973 (CELEX 32022R0973) establishes additional labeling criteria for certain EU fertilizers containing selenium (Se) or chloride (Cl-).
Conformity assessment and traceability
Conformity assessment of an EU fertilising product with the requirements laid down in this Regulation shall be carried out under the applicable conformity assessment procedure in accordance with Annex IV. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for this commitment.
Records and correspondence relating to conformity assessment procedures shall be drawn up in the official language(s) of the Member State in which the notified body carrying out these procedures is established, or in a language accepted by that body.
Before placing an EU fertilising product on the market, importers and distributors shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer and that he has complied with the obligations regarding the products' packaging and labelling.
Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep a copy of the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities.
Tests for verifying the conformity of EU fertilising products with the requirements set out in Annex I, Annex II and Annex III shall be performed in a reliable and reproducible manner.
Regulation (EU) 2022/973 (CELEX 32022R0973) establishes that compliance may be presumed in the conformity assessment procedure without verification (such as testing), at the responsibility of the manufacturer, for by-products complying with agronomic efficiency and safety criteria.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EU) 2019/1009 (CELEX 32019R1009) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
To facilitate market access, the European Union (EU) has signed Mutual Recognition Agreements (MRAs) with Australia, Canada, Japan, New Zealand, the USA, Israel or Switzerland concerning the conformity assessment of certain products, negotiated in each agreement. These MRAs lay down the conditions for reciprocal acceptance of conformity assessment results such as reports, certificates and marks to be delivered between partner countries.
Legislation
- Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L-170 25/06/2022) (CELEX 32019R1009)
- Commission Delegated Regulation (EU) 2022/973 of 14 March 2022 supplementing Regulation (EU) 2019/1009 of the European Parliament and of the Council by laying down criteria on agronomic efficiency and safety for the use of by-products in EU fertilising products (OJ L-167 24/06/2022) (CELEX 32022R0973)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Communication from the Commission concerning the visual appearance of the label on EU fertilising products referred to in Annex III to Regulation (EU) 2019/1009 of the European Parliament and of the Council (OJ C-119 07/04/2021) (CELEX 52021XC0407(04))
Other information sources
- Mutual Recognition Agreements (MRAs): https://single-market-economy.ec.europa.eu/single-market/goods/international-aspects-single-market/mutual-recognition-agreements_en
- EU chemical industry: https://single-market-economy.ec.europa.eu/sectors/chemicals_en
- Specific chemicals: https://single-market-economy.ec.europa.eu/sectors/chemicals/chemicals-legislation_en
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
- National competent authorities responsible for the Fertilising Products Regulation: https://ec.europa.eu/docsroom/documents/51354?locale=en
- FAQs related to Regulation (EU) 2019/1009 on fertilising products (the 'Fertilising Products Regulation'): https://ec.europa.eu/docsroom/documents/50874
- The Blue Guide on the implementation of EU product rules 2022: https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en
- Commission Expert Group on Fertilising Products: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=1320
- Standards and conformity assessment: https://trade.ec.europa.eu/access-to-markets/en/content/standards-and-conformity-assessment
Voorschriften voor het in de handel brengen van detergentia
Detergentia moeten voldoen aan specifieke bepalingen om een hoog niveau van milieubescherming en menselijke gezondheid te waarborgen (beperkingen op het in de handel brengen op basis van biologische afbreekbaarheid, etikettering en verplichte productinformatie, controle- en vrijwaringsmaatregelen)
Latest revision date of the information: 01 March 2025
The placing on the European Union (EU) market of detergents and surfactants for detergents must comply with specific provisions laid down in Regulation (EC) 648/2004 (CELEX 32004R0648) designed to ensure a high level of environmental protection, especially of the aquatic environment, and human health.
Detergent means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. They may be in any form (liquid, powder, paste, cake, etc.) and marketed for used in household, or institutional or industrial purposes.
Hence, these products are affected by provisions concerning more particularly:
- Marketing limitations based on the biodegradability of surfactants
- Labelling and mandatory product information
- Control and safeguard measures
In addition, certain surfactants used as disinfectants may be subject to the provisions laid down in Regulation (EU) 528/2012 (CELEX 32012R0528) concerning the placing of biocidal products on the EU market.
Marketing limitations based on the biodegradability of surfactants
Only the surfactants and detergents containing surfactants that meet the criteria for biodegradation as laid down in Annex III of Regulation (EC) 648/2004 (CELEX 32004R0648) may be placed on the EU market without further limitations relating to biodegradability.
However, if an industrial or institutional detergent contains surfactants for which the level of biodegradation is lower than the stipulated in Annex III but meet the biodegradability criteria of Annex II the person responsible for the placing of the product on the market may ask for derogation in accordance with a uniform procedure set out in the Regulation.
The list of surfactants that have obtained derogation, with the corresponding conditions or limitations of use, is included in Annex V.
Labelling and mandatory product information
Those responsible for the placing of a detergent on the market must, upon request, make available without delay and free of charge, to healthcare professionals (medical personnel and/or specific public body) in the Member State an ingredient datasheet. This information will be kept confidential and will be used only for medical purposes.
The following information must appear in legible, visible and indelible characters on the packaging in which the detergents are put up for sale to the consumer:
- the name and trade name of the product;
- the name or trade name and full address and telephone number of the party esponsible for placing the product on the market;
- the address, email, where available, and telephone number of the specific public body from which the ingredient datasheet can be obtained.
Specifications on the content, instructions for use, special precautions and dosage instructions must be also indicated on the packaging of detergents and cleaning products and laundry detergents.
The same information must appear on all documents accompanying detergents transported in bulk.
Besides this information, the provisions relating to the classification, labelling and packaging (CLP) of substances and mixtures laid down by with Regulation (EC) 1272/2008 (CELEX 32008R1272) are also applicable to detergents and surfactants classified as hazardous.
Control and safeguard measures
Member States' competent authorities may apply, as appropriate, all necessary control measures to detergents placed on the market which ensure the compliance of the product with the provisions of this Regulation.
If a Member State has justifiable grounds for believing that a specific detergent constitutes a risk to safety or health of humans or of animals or a risk to the environment, it may temporarily prohibit the placing on the market of that detergent in its territory or make it temporarily subject to special conditions.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EC) 648/2004 (CELEX 32004R0648) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Legislation
- Regulation (EC) 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L-104 08/04/2004) (CELEX 32004R0648)
- Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L-167 27/06/2012) (CELEX 32012R0528)
- Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging (CLP) of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 1907/2006 (OJ L-353 31/12/2008) (CELEX 32008R1272)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Updated list of approved laboratories that according to Article 8(2) of Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents are competent to carry out the tests required by the Regulation (OJ C-39 18/02/2009) (CELEX 52009XC0218(01))
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
Other information sources
- EU chemical industry: https://single-market-economy.ec.europa.eu/sectors/chemicals_en
- Specific chemicals: https://single-market-economy.ec.europa.eu/sectors/chemicals/chemicals-legislation_en
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
- Summaries of the legislation and guidance documents on detergents: https://www.aise.eu
- Commission Working Group on Detergents: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=1321
Voorschriften voor het in de handel brengen van chemische stoffen
Chemische producten moeten voldoen aan de voorschriften voor het in de handel brengen die een hoog niveau van bescherming van de menselijke gezondheid en het milieu moeten waarborgen.
Voorschriften voor het in de handel brengen van pesticiden en biociden
Gewasbeschermingsmiddelen, biociden en de werkzame stoffen daarvan moeten voldoen aan de voorschriften voor het in de handel brengen om een hoog niveau van bescherming van de menselijke gezondheid te waarborgen.
Latest revision date of the information: 01 March 2025
The placing on the European Union (EU) market of plant protection products, biocidal products and their active substances must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health.
Plant protection products
Regulation (EC) 1107/2009 (CELEX 32009R1107) lays down the rules for the authorisation of plant protection products in commercial form, the approval of their active substances as well as the rules for their placing on the market, use and control within the EU.
Plant protection products are preparations consisting of or containing active substances (chemical elements or micro-organisms, including viruses), safeners or synergists, and intended for one of the following uses:
- protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
- influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
- preserving plant products;
- destroying undesired plants or parts of plants;
- checking or preventing undesired growth of plants.
Marketing requirements and control
These products are subject to the following requirements:
Procedure and criteria for the approval of active substances
An active substance will be approved if it fulfils the procedure and criteria detailed in Annex II to the Regulation. These criteria relate to the efficacy of the substance, the relevance of metabolites, its composition, the methods of analysis, the impact on human health and the environment, ecotoxicology and residues.
Initially, the first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user.
Active substances which have been approved may be consulted on the EU Pesticides Database
Authorisation for the placing on the market of plant protection products
A plant protection product will be authorised if its active substances have been approved and the specific conditions established in the Regulation (EC) 1107/2009 (CELEX 32009R1107) and the uniform principles for evaluation laid down in Regulation (EU) 546/2011 (CELEX 32011R0546) are fulfilled.
Applications are submitted to the Member State where the product is intended to be placed on the market and will be accompanied by two dossiers containing all the information available to enable the potential effects of product on human and animal health, and the possible impact on the environment, to be assessed. Certain information provided by the applicant may be kept confidential if provide verifiable evidence that undermine his commercial interests.
A provisional authorisation for a period not exceeding three years may be granted for plant protection products containing an active substance not yet approved, is also foreseen by Regulation (EC) 1107/2009 (CELEX 32009R1107).
In addition, the provisions of mutual recognition establish that the holder of an authorisation granted in a Member State may apply for an authorisation for the same plant protection products, the same use and under comparable agriculture practices in another Member State.
Applications for authorisation of plant protection products, including for their amendment or renewal, submitted on or after 3 April 2023, must take into account the criteria set out in Annex to Regulation (EU) 2023/574 (CELEX 32023R0574) for the determination of co-formulants whose inclusion in a plant protection product is considered unacceptable.
Packaging and labelling of plant protection products
The labelling of plant protection products must comply with the requirements set out in Annex I to Regulation (EU) 547/2011 (CELEX 32011R0547) and contain the standard phrases for special risks and safety precautions protect to human or animal health or to the environment.
The products that may be mistaken for food, drink or feed must be packaged in such a way as to minimise the likelihood to be mistaken and contain components to discourage or prevent their consumption.
Moreover, the provisions on classification, labelling and packaging (CLP) of substances and mixtures laid down by Regulation (EC) 1272/2008 (CELEX 32008R1272) are also applicable to plant protection products.
Official control and emergency measures
Member States will carry out official controls in order to enforce compliance with the conditions established in Regulation (EC) 1107/2009 (CELEX 32009R1107).
European Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of an approved active substance or a plant protection product if it is likely to constitute a serious risk to human or animal health or the environment and that such risk cannot be contained satisfactorily by the Member State(s) concerned.
EU legislation on plant protection products
Other information sources on Plant Protection Products and Biocidal Products
General information sources on chemicals
Biocidal products
The biocidal products Regulation BPR, Regulation (EU) 528/2012 (CELEX 32012R0528) concerns the placing on the market and use of biocidal products within the EU.
Biocidal product is any active substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
The scope of BPR covers 22 different product types listed in Annex V (including disinfectants, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels) and articles treated with biocidal products (e.g. furniture treated with wood preservatives, textiles, etc.).
Other products that are sufficiently covered by existing EU legislation (medicinal products, medical devices, food and feed, additives, flavourings, cosmetic products, toys, plant protection products) are excluded from the scope of BPR.
Marketing requirements
These products are subject to the following requirements:
Authorisation of biocides
The following conditions must be met for the authorisation of biocidal products:
- the active substances are approved for the relevant product-type;
- the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
- the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
- where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
- where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.
All biocidal products must get an authorisation before they can be made available on the market. Companies can choose between several alternative procedures, depending on their product and the number of countries where they wish to sell it:
- National authorisation and mutual recognition: Once first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries;
- Union authorisation: This procedure allows companies to place certain biocidal products directly on the entire EU market;
- Simplified authorisation: To be eligible for this procedure the biocide must comply with the following conditions:
- All the active substances contained in the product appear in Annex I of the BPR and satisfy the specific restrictions;
- It does not contain any substance of concern or any nanomaterials;
- It is sufficiently effective;
- Its handling and intended use do not require personal protective equipment.
Beside, BPR provides for a simplified procedure for granting authorisation to very similar products which only vary in terms of relatively minor differences in composition and have the same use and user type (Product family).
Approval of active substances
Companies have to apply for approval of an active substance by submitting a dossier (complying with the requirements of Annex II to BPR) to European Chemicals Agency (ECHA). After the validation check has been performed, the evaluating competent authority carries out a completeness check and an evaluation within one year. The approval of an active substance is granted for a defined number of years, not exceeding ten years.
BPR also provides that substances included in Annex I to Directive 98/8/EC (CELEX 31998L0008) (previous legislation) will be included in the list of arpproved substances to be kept up to date by the European Commission.
Labelling and packaging
Companies will ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications 'low-risk biocidal product', 'non-toxic', 'harmless', 'natural', 'environmentally friendly', 'animal friendly' or similar indications.
In addition, the label must show clearly and indelibly the following information:
- The type of formulation, the identity of every active substance and its concentration;
- The authorisation number, the identification (name and address) of the authorisation holder;
- Directions for use, frequency of application and dose rate in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;
- Particulars of likely direct or indirect adverse side effects and any directions for first aid;
- Directions for the safe disposal of the biocidal product and its packaging.
The provisions relating to the classification, labelling and packaging (CLP) of substances and mixtures laid down by Regulation (EC) 1272/2008 (CELEX 32008R1272) are also applicable.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EU) 528/2012 (CELEX 32012R0528) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
EU legislation on biocidal products
Other information sources on Plant Protection Products and Biocidal Products
General information sources on chemicals
Notification of arrival
According to Regulation (EU) 2024/2104 (CELEX 32024R2104), from 3 March 2025, Member States may request operators to notify the arrival of consignments of certain goods from third countries for which the Common Health Entry Document (CHED) is not required and to which articles 47 and 48 of Regulation (EU) 2017/625 (CELEX 32017R0625) do not apply.
The operator responsible for the consignment should notify the arrival of that consignment by completing and submitting the relevant data in the Trade Control and Expert System (TRACES) in the IMSOC, for transmission to the competent authorities at the border control posts of first arrival into the Union and for access to the data by customs authorities.
Using a standardised format, the notification of arrival should describe the consignment in sufficient detail to allow the competent authorities to immediately and completely identify the consignment, their destination and intended use, such as human consumption, feedstuff, sample, display exhibition item, food contact materials, plant protection products or other. In addition, the operator responsible for the consignment should certify that the information provided in the notification of arrival is true and complete.
Handelsnormen voor benzine, dieselbrandstof, gasolie en zware stookolie
Loodvrije benzine en dieselbrandstof die in de EU in de handel worden gebracht, moeten voldoen aan bepaalde kwaliteits- en milieuspecificaties om de uitstoot van verontreinigende stoffen door motorvoertuigen te verminderen. Voor gasolie en zware stookolie gelden beperkingen ten aanzien van het zwavelgehalte.
Latest revision date of the information: 01 March 2025
In order to reduce air pollutant emissions, Directive 98/70/EC (CELEX 31998L0070) sets fuel quality specifications and binding targets to reduce fuels greenhouse gas emissions during their life cycle.
Environmental specifications for petrol and diesel fuels
The technical specifications concern fuel for positive-ignition engines and compression-ignition engines used in road vehicles and non-road mobile machinery, tractors and recreational craft.
Petrol
Unleaded petrol can be marketed within the European Union (EU) only if it complies with the environmental specifications set out in Annex I to the Directive concerning octane level, vapour pressure, distillation by evaporation, aromatics, benzene, olefins, oxygen, oxygenates, sulphur and lead content.
In accordance with Directive 98/70/EC (CELEX 31998L0070), the marketing of leaded petrol is banned within the EU.
Diesel fuel
The environmental requirements for diesel fuel are set out in Annex II and cover cetane level, density, distillation, polycyclic aromatic hydrocarbons, sulphur content and FAME (fatty acid methyl ester) content.
Metallic additives
The presence of the metallic additive MMT (methylcyclopentadienyl manganese tricarbonyl) in fuels is limited to 2 mg of manganese per litre.
Fuels containing MMT must display a label with the text 'Contains metallic additives'. This label must be clearly visible and easily legible.
Greenhouse gas emission reduction
Fuel suppliers are responsible for gradually reducing fuel's greenhouse gas emissions according to the targets set by the Directive. In addition, they must report annually to the Member States competent authorities on the greenhouse gas intensity of the fuel supplied.
Sulphur content of gas oil and heavy fuel oil
In order to reduce the emissions of sulphur dioxide, Directive (EU) 2016/802 (CELEX 32016L0802) imposes limits on the sulphur content of certain liquid fuels: heavy fuel oil, gas oil and marine gas oil as well as marine diesel oil. These fuels can only be marketed within the EU if they do not exceed the established limits.
These requirements do not apply to fuels intended for processing prior to final combustion, for the lex.refining industry, for research and testing, etc.
In case of a sudden change of supply, Member States may be authorised by the Commission to apply higher limits for a maximum period of 6 months.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Directive 98/70/EC (CELEX 31998L0070) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Legislation
- Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L-350 28/12/1998) (CELEX 31998L0070)
- Directive (EU) 2016/802 of the European Parliament and of the Council of 11 May 2016 relating to a reduction in the sulphur content of certain liquid fuels (codification) (OJ L-107 25/04/2015) (CELEX 32016L0802)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999 and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652 (OJ L 2023/2413 31/10/2023) (CELEX 32023L2413)
- Notice 2020/C 127/02 on the application of Article 3 of Directive 98/70/EC with regard to the maximum vapour pressure for petrol (OJ C-127 20/04/2020) (CELEX 52020XC0420(01))
- Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L-328 21/12/2018) (CELEX 32018L2001)
Other information sources
- Climate Action Policies: https://ec.europa.eu/clima/index_en
- Fuel Quality: https://climate.ec.europa.eu/eu-action/transport/fuel-quality_en
- Biofuels: https://energy.ec.europa.eu/topics/renewable-energy/bioenergy/biofuels_en
- EU energy policy: https://energy.ec.europa.eu/index_en
- Summaries of EU Legislation - Quality of petrol and diesel fuels: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM:l28077
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
Beperking van het gebruik van bepaalde chemische stoffen in juwelen
Latest revision date of the information: 01 March 2025
The placing on the EU market of jewellery articles containing certain chemical substances, group of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment, according to provisions listed on Annex XVII to Regulation (EC) 1907/2006 (CELEX 32006R1907).
According to this Regulation, the main chemical substances, group of substances or mixtures which are not allowed in jewellery articles are:
- Cadmium and its compounds in bracelets, necklaces, rings, piercing jewellery, wrist watches, wrist-wear, brooches and cufflinks.
- Nickel in earrings, necklaces, bracelets, chains, anklets, finger rings, wrist-watch cases, watch straps and tighteners.
- Lead and its compounds in bracelets, necklaces, rings, piercing jewellery, wrist watches, wrist-wear, brooches, cufflinks and any individual part or component.
- Polycyclic aromatic hydrocarbons compounds in watch-straps if any of their rubber or plastic components come into direct as well as prolonged or short-term repetitive contact with the skin or the oral cavity.
- Formaldehyde and formaldehyde-releasing substances in articles other than furniture and wood-based articles when the concentration of formaldehyde released from those articles exceeds 0,080 mg/m3.
- Synthetic polymer microparticles where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.
The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EC) 1907/2006 (CELEX 32006R1907) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Legislation
- Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
Other information sources
- European Chemicals Agency (ECHA): https://echa.europa.eu/
- REACH Restrictions: https://echa.europa.eu/regulations/reach/restriction
- Substances restricted under REACH: https://echa.europa.eu/substances-restricted-under-reach
- Guideline on lead and its compunds restrictions: https://echa.europa.eu/documents/10162/13563/lead_guideline_information_en.pdf/43269f58-7035-42ea-a396-268a17abb5ab
- REACH Restrictions: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en
- General information about REACH: https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
Beperking van het gebruik van bepaalde chemische stoffen in textiel- en lederproducten
Latest revision date of the information: 01 March 2025
The placing on the EU market of textile and leather articles containing certain chemical substances, group of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment.
Dangerous chemical substances
Acording to provisions listed on Annex XVII to Regulation (EC) 1907/2006 (CELEX 32006R1907) (REACH), the main chemical substances, group of substances or mixtures which are not allowed in textile and leather articles are:
- Tris (2,3 dibromopropyl) phosphate in textile articles intended to come into contact with the skin.
- Tris (aziridinyl) phosphinoxide in textile articles intended to come into contact with the skin.
- Polybrominated biphenyls (PBB) in textile articles intended to come into contact with the skin.
- Mercury compounds / certain new measuring devices containing mercury in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture.
- Dioctyltin (DOT) compounds in textile articles, footwear or part of footwear intended to come into contact with the skin.
- Nickel in articles intended to come into direct and prolonged contact with the skin, such as rivets buttons, tighteners, rivets, zippers and metal marks, when these are used in garments.
- Azodyes which may release one or more of the aromatic amines listed in Appendix 8, in textile and leather articles which may come into direct and prolonged contact with the skin or oral cavity.
- Nonylphenol and nonylphenol ethoxylates in textile and leather processing.
- Chromium VI compounds in leather articles intended to come into contact with the skin.
- Polycyclic aromatic hydrocarbons compounds in clothing, footwear, gloves and sporstwear if any of their rubber or plastic components come into direct as well as prolonged or short-term repetitive contact with the skin or the oral cavity.
- The substances listed in column 1 of the Table in Appendix 12 in clothing or relating accessories, footwear and other textiles intended to come into contact with human skin in a concentration, measured in homogeneous material, equal to or greater than that specified for that substance in Appendix 12.
- Formaldehyde and formaldehyde-releasing substances in articles other than furniture and wood-based articles when the concentration of formaldehyde released from those articles exceeds 0,080 mg/m3.
- Synthetic polymer microparticles where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.
- Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances in textiles, leather, furs and hides in clothing and related accessories for the general public.
The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU.
Persistent organic pollutants
Persistent organic pollutants are toxic chemical substances which resist degradation.
Regulation (EU) 2019/1021 (CELEX 32019R1021) on persistent organic pollutants lays down the prohibition on imports of POP substances listed in its Annex I, whether on their own, in preparations or as constituents of articles. Therefore, POP substances listed in Annex I to this Regulation are not allowed in textile and leather articles.
Biocidal products
Biocidal product is any active substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. All types of biocidal products are listed and described in a Annex V to Regulation (EU) 528/2012 (CELEX 32012R0528).
Biocidal products are not allowed in textile and leather articles unless authorised in accordance with this Regulation.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EC) 1907/2006 (CELEX 32006R1907) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Legislation
- Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
- Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L-169 25/06/2019) (CELEX 32019R1021)
- Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L-167 27/06/2012) (CELEX 32012R0528)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
Other information sources
- European Chemicals Agency (ECHA): https://echa.europa.eu/
- REACH Restrictions: https://echa.europa.eu/regulations/reach/restriction
- Substances restricted under REACH: https://echa.europa.eu/substances-restricted-under-reach
- Biocidal Products Regulations - ECHA: https://echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr
- REACH Restrictions: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en
- General information about REACH: https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
Beperking van het gebruik van bepaalde chemische stoffen in speelgoed
Latest revision date of the information: 01 March 2025
The placing on the EU market of toys containing certain chemical substances, groups of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment.
Directive 2009/48/EC (CELEX 32009L0048) on safety of toys restricts a number of chemical substances in toys. Annex II, part III, point 3 of the Directive provides that chemicals classified as carcinogenic, mutagenic or toxic for reproduction (CMRs) shall not be used in toys or their parts, unless certain controlled derogations listed under points 4 to 7 apply.
Toys shall not contain 55 allergenic fragances listed under point 11, while a further 11 allergenic fragances shall be labelled if they exceed a certain limit. Furthermore, point 13 sets limits for 19 metallic elements in toy materials.
Finally, Appendix C provides for specific limit values for chemicals in toys for children under 36 months, and in toys for children of any age if such toys are intended to be placed in the mouth, such as toy flutes.
According to provisions listed on Annex XVII to Regulation (EC) 1907/2006 (CELEX 32006R1907) (REACH), the main chemical substances, groups of substances or mixtures which are not allowed in toys are:
- Benzene in toys or parts of toys.
- Creosote in toys.
- Azodyes which may release one or more of the aromatic amines listed in Appendix 8, in textile or leather toys and toys which include textile or leather garments.
- Phthalates:
- Bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP)s in toys.
- Di-'isononyl' phthalate (DINP), di-'isodecyl' phthalate (DIDP) and di-n-octyl phthalate (DNOP) in toys which can be placed in the mouth by children.
- Liquid substances or mixtures which are regarded as dangerous in accordance with Regulation (EC) 1272/2008 (CELEX 32008R1272) in games or any article intended to be used as such, even with ornamental aspects.
- Polycyclic aromatic hydrocarbons compounds in toys, including activity toys, and childcare articles if any of their rubber or plastic components come into direct as well as prolonged or short-term repetitive contact with the skin or the oral cavity.
- Formaldehyde and formaldehyde-releasing substances in articles other than furniture and wood-based articles when the concentration of formaldehyde released from those articles exceeds 0,080 mg/m3.
- Synthetic polymer microparticles where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight.
The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorisation and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU.
Cosmetic toys, such as play cosmetic for dolls, have to comply with Regulation (EC) 1223/2009 (CELEX 32009R1223) on cosmetic products.
Market Surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any other authority in their territory as the authorities in charge of controlling that the products entering the Union market meet the requirements of the applicable rules and that the affixing and use of the CE marking, where applicable, is correct in accordance with the EU market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities.
Products complying with Regulation (EC) 1907/2006 (CELEX 32006R1907) enjoy free circulation within the EU. However, in case a Member State ascertains that a product does not comply with the requirements of the Regulation, the competent authority of the Member State shall forbid its placing on the market, restrict the free movement, or even withdraw the product from the market where other corrective measures have failed.
The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.
Notification of arrival
According to Regulation (EU) 2024/2104 (CELEX 32024R2104), from 3 March 2025, Member States may request operators to notify the arrival of consignments of certain goods from third countries for which the Common Health Entry Document (CHED) is not required and to which articles 47 and 48 of Regulation (EU) 2017/625 (CELEX 32017R0625) do not apply.
The operator responsible for the consignment should notify the arrival of that consignment by completing and submitting the relevant data in the Trade Control and Expert System (TRACES) in the IMSOC, for transmission to the competent authorities at the border control posts of first arrival into the Union and for access to the data by customs authorities.
Using a standardised format, the notification of arrival should describe the consignment in sufficient detail to allow the competent authorities to immediately and completely identify the consignment, their destination and intended use, such as human consumption, feedstuff, sample, display exhibition item, food contact materials, plant protection products or other. In addition, the operator responsible for the consignment should certify that the information provided in the notification of arrival is true and complete.
Legislation
- Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L-170 30/06/2009) (CELEX 32009L0048)
- Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 793/93 and Commission Regulation (EC) 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006) (CELEX 32006R1907)
- Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging (CLP) of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 1907/2006 (OJ L-353 31/12/2008) (CELEX 32008R1272)
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L-342 22/12/2009) (CELEX 32009R1223)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
- Commission Delegated Regulation (EU) 2024/2104 of 27 June 2024 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union (OJ L 2024/2104 25/09/2024) (CELEX 32024R2104)
- Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L-95 07/04/2017) (CELEX 32017R0625)
- Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L-169 25/06/2019) (CELEX 32019R1020)
Other information sources
- European Chemicals Agency (ECHA): https://echa.europa.eu/
- REACH Restrictions: https://echa.europa.eu/regulations/reach/restriction
- Substances restricted under REACH: https://echa.europa.eu/substances-restricted-under-reach
- Guideline on phthalates restrictions: https://echa.europa.eu/documents/10162/13645/guideline_interpretation_concept_mouth_en.pdf/6f0869f4-1ff1-45ad-ac13-f623d9717718
- REACH Restrictions: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/restrictions_en
- Toys safety - DG Growth: https://ec.europa.eu/growth/sectors/toys/safety_en
- General information about REACH: https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en
- Market surveillance for products: https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/market-surveillance_en
Controle op drugsprecursoren
De invoer van bepaalde chemische stoffen die illegaal bij de vervaardiging van drugs kunnen worden gebruikt, is onderworpen aan controlevereisten, namelijk vergunningverlening en/of registratie van marktdeelnemers, aanwijzing van een verantwoordelijke functionaris, verstrekking van informatie over de invoer en invoervergunningen.