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Marketing of products - CE conformity marking
This Decision establishes common principles intended to be applicable across sectoral legislation during its revision or recast. Furthermore, it constitutes a framework for future legislation which will harmonise the conditions for the marketing of products. It contributes to increasing consumer confidence and improving the free movement of goods within the European Union.
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.
This common framework for the marketing of products sets out:
- common definitions;
- common conformity assessment procedures;
- obligations for economic operators (manufacturers, importers and distributors);
- rules for the use of the EC marking, thereby making it possible to increase trust in the products marketed in the EU;
- notification criteria for the conformity assessment bodies;
- safeguard procedures.
The common framework will be a toolbox for future sectoral regulations on the approximation of legislation (harmonisation). It draws on the new approach, according to which legislation shall be restricted to the setting of essential requirements and use of harmonised standards. As far as possible, future sectoral legislation must therefore draw on the provisions of this Decision and define essential requirements for the marketing of products. Where necessary, specific legislation may nevertheless offer other solutions.
This decision establishes clear definitions of fundamental concepts such as "manufacturer", "distributor", "importer", "harmonised standard", "placing on the market" and "conformity assessment". The establishment of explicit, single definitions will make it easier to interpret and correctly apply future laws in this field.
Obligations of manufacturers, importers and distributors
In order to be placed on the market, a product must comply with certain essential requirements. The manufacturer must ensure that his products comply with the applicable requirements by carrying out or commissioning a product conformity assessment procedure. If the product complies with the essential requirements, the manufacturer affixes the CE marking on the product and draws up an EC declaration of conformity. The manufacturer indicates his name, registered trade name or registered trade mark, as well as his address on the product. They shall ensure that series production remains in conformity. The product must be accompanied by instructions and safety information in a language which can be easily understood. In the case where an external conformity assessment body intervenes, the manufacturer shall affix the body's identification number.
The importer and the distributor must ensure that the manufacturer has fulfilled his obligations, i.e. check that the product has a conformity marking and that the required documents have been supplied.
Manufacturers (or their authorised representative), distributors and importers must provide the competent authorities with all necessary information on the product concerned in order to ensure product traceability.
This Decision sets a clearer framework for conformity assessment. It establishes a number of conformity assessment procedures (specified in the Annex), from which the legislator can choose the most appropriate.
Furthermore, it lays down the rules and conditions for affixing the "CE" marking, which is subject to the general principles defined by Regulation No 765/2008. Member States shall ensure correct application of the regime governing the "CE" marking and provide sanctions for infringements.
In certain conformity assessment procedures, the conformity assessment is carried out by the conformity assessment bodies which are notified, i.e. declared, to the Commission by the Member States.
This decision sets out common criteria for the notification of the conformity assessment bodies. The conformity assessment bodies must offer all guarantees of independence, objectivity, impartiality, confidentiality and professional integrity. In addition, they must possess the necessary technical competencies and means in order to correctly carry out the tasks entrusted to them.
The Commission ensures appropriate coordination and cooperation between the notified bodies.
A Community safeguard procedure applicable to all products which present a risk at national level is also provided for. In particular, it provides for the Commission and the other Member States to be informed. It can be initiated in the event of disagreement between Member States over measures taken by one of them.
This Decision repeals Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the "CE" conformity marking, applicable to technical harmonisation Directives.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Decision No 768/2008/EC||
OJ L 218 of 13.8.2008