Legal act:
Regulation (EC) No 1221/2009
Decision No 768/2008/EC
Regulation (EC) No 765/2008

Consolidated act:
12/07/2023 of Regulation (EC) No 1221/2009
16/07/2021 of Regulation (EC) No 765/2008
09/07/2008 of Decision No 768/2008/EC (Languages available: CS and IT)

Regulation (EC) No 765/2008

Subject matter and scope

1. This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities.
2. This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security.
3. This Regulation provides a framework for controls on products from third countries.
4. This Regulation lays down the general principles of the CE marking.

Definitions

Making available on the market shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge.

Placing on the market shall mean the first making available of a product on the Community market.

Importer shall mean any natural or legal person established within the Community who places a product from a third country on the Community market

Distributor shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

Withdrawal shall mean any measure aimed at preventing a product in the supply chain from being made available on the market.

Market surveillance shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.

Market surveillance authority shall mean an authority of a Member State responsible for carrying out market surveillance on its territory.

CE marking shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing.

CHAPTER IV - CE MARKING

Article 30 - General principles of the CE marking

1. The CE marking shall be affixed only by the manufacturer or his authorised representative.
2. The CE marking as presented in Annex II shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
4. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.
5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
6. Without prejudice to Article 41, Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

For more informations see ANNEX II - CE marking p. 47.