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Manufacturers and distributors must:
- supply products that comply with the general safety requirements
- inform consumers of the risks that a product might pose and any precautions they should take
- notify the relevant national authorities if they discover that a product is dangerous and cooperate with them on the action taken to protect consumers.
The EU member countries carry out market surveillance and enforce the product safety rules. They are assisted by EU mechanisms like RAPEX - the rapid exchange of information between EU countries and the European Commission on dangerous products.
In addition to the general product safety rules, specific rules apply to certain categories of product, such as cosmetics and pharmaceutical products.
The EU encourages its member countries to adopt harmonised technical standards.
Over the years, the approach to harmonising technical standards has changed:
- from technical and detailed product-specific directives (the 'old approach') – which still covers foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and pharmaceutical products
- to the 'new approach':
- essential general health and safety requirements, applicable to sectors or families of products, that products must meet to be placed on the EU market (e.g. health, safety, consumer protection and environmental protection)
- technical specifications of specific products laid down in harmonised standards (voluntary) – products manufactured according to these standards are presumed to comply with the corresponding essential requirements
Harmonised standards can be drawn up by three independent standardisation bodies:
- European Committee for Standardisation (CEN)
- European Committee for Electrotechnical Standardisation (CENELEC)
- European Telecommunications Standards Institute (ETSI)
Procedures to assess the conformity of products to the essential requirements laid down in technical harmonisation directives are carried out by:
- the manufacturer, or
- a third party. 'Notified bodies' in each EU country are responsible for conformity assessment when a third party is required.
Conformity assessment procedures cover the design phase of products, their production phase or both, in a variety of ways: internal control of production, full quality assurance, etc.
Mutual recognition agreements exist between the EU and certain non-EU countries which are on a comparable level of technical development and have a compatible approach to conformity assessment.
- consists of the "CE" marking and the identification number of the notified body involved in the assessment (when required)
- is affixed to the product, its packaging or to the accompanying document
- enables the product to be placed on the EU market.
Check how to affix CE marking for 25 different product groups.
The national authorities in the EU countries are responsible for market surveillance to ensure that products meet the requirements to be placed on the EU market. Surveillance can consist of documentary checks and/or physical inspections.
See also: specific information for importers.
Manufacturers in non-EU countries who wish to sell their products in the EU must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing products that comply with all applicable requirements 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.
Since 2008, new rules have been in place to remove the remaining obstacles to free movement of goods anywhere in the EU.
- Procedures relating to the application of national technical rules to products lawfully marketed in another EU country
- Accreditation and market surveillance
- CE conformity marking and conformity assessment
Packaging marketed in the EU must meet both environmental and health requirements.
- general rules on packaging and packaging waste
- package sizing
- special rules for materials and articles intended to come into contact with foodstuffs
- Imports of packaging made of wood and other plant products may be subject to plant-health measures
In particular, wood packages (cases, boxes, crates, etc.) must go through one of the approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and bear the corresponding mark as specified in Annex II
Products marketed in the EU must comply with EU labelling requirements, intended to:
- protect consumers' health, safety and interests
- provide product information - content, composition, safe use and special precautions, etc.
See also the product specific factsheet summarising the EU import requirements on:
The EU Ecolabel or 'Flower logo' may be awarded to products that help improve the environment and provide consumer guidance on their environmental impact.
There are basic rules and specific Ecolabel criteria for different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products, etc).
Manufacturers, importers, service providers, traders and retailers may apply for the Ecolabel to the relevant authority in the EU country where the product has been placed on the market.