Uniform conditions for the marketing of safe products in the EU (conformity marking)

SUMMARY OF:

Decision No 768/2008/EC — a common framework for the marketing of products in the EU

SUMMARY

WHAT DOES THE DECISION DO?

• It sets out common principles and procedures which EU legislation must follow when harmonising conditions for marketing products in the EU and the European Economic Area (EEA).
• It includes reference requirements to be incorporated whenever product legislation is revised. As such, it is a template for future product harmonisation legislation.
• It lays down rules for CE marking*.

KEY POINTS

• It provides clear definitions for relevant terms, such as ‘manufacturer’, ‘placing on the market’, ‘recall’ or ‘withdrawal’ of products.
• Clear divisions of responsibility are set for manufacturers, importers and distributors along the product chain.
• Manufacturers must ensure their products comply with the relevant legislation and follow the appropriate conformity assessment* procedure. They must place the CE marking on the product once compliance is demonstrated.
• Importers must make sure the manufacturer has complied with the appropriate conformity assessment procedure and the product is accompanied by the necessary documentation and CE marking.
• Distributors must act with due care and verify the product has the necessary documentation and CE marking.
• A common set of different conformity assessment procedures, known as modules, is provided. Legislators must choose which one is the most appropriate depending on the risk a product might present.
• Uniform rules are laid down for designating and supervising notified bodies which carry out the conformity assessments on the basis of EU legislation. The rules lay down their responsibilities when third-party product conformity assessments (i.e. certification of conformity by an independent body) are required.
• Market surveillance rules deal with products which present a health or safety risk or do not comply with the relevant legislation.

KEY TERMS

* CE marking: this indicates that a product meets the applicable health, safety and environmental requirements and has undergone the relevant conformity assessment procedure.

* Conformity assessment: the process confirming that a product satisfies the necessary process, service, system, person or body requirements.

BACKGROUND

For businesses, CE marking means their product can move freely throughout the European Economic Area (EU countries, Iceland, Liechtenstein and Norway). For consumers, it indicates that the item they buy conforms to European product legislation.

• CE marking
• Check conformity

ACT

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

last update 22.10.2015