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 (1)

Extract


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 (1)

DECISIONS ADOPTED JOINTLY BY THE EUROPEAN PARLIAMENT AND THE COUNCIL 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 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1 ),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2 ),

Whereas:

(1) On 7 May 2003 the Commission issued a Communication to the Council and the European Parliament entitled `Enhancing the Implementation of the New Approach Directives'. In its Resolution of 10 November 2003 (3 ), the Council acknowledged the importance of the New Approach as an appropriate and efficient regulatory model allowing technological innovation and enhancing the competitiveness of European industry, and confirmed the necessity of extending the application of its principles to new areas, while recognising the need for a clearer framework for conformity assessment, accreditation and market surveillance.

(2) This Decision lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. This Decision therefore constitutes a general framework of a horizontal nature for future legislation harmonising the conditions for the marketing of products and a reference text for existing legislation.

(3) This Decision provides, in the form of reference provisions, definitions and general obligations for economic operators and a range of conformity assessment procedures from which the legislator can select as appropriate. It also lays down rules for CE marking. Furthermore, reference provisions are provided as regards the requirements for conformity assessment bodies to be notified to the Commission as competent to carry out the relevant conformity assessment procedures and as regards the notification procedures. In addition, this Decision includes reference provisions concerning procedures for dealing with products presenting a risk in order to ensure the safety of the market place.

(4) Whenever legislation is drawn up which concerns a product already subject to other Community acts, those acts must be taken into account to ensure the consistency of all legislation concerning the same product.

(5) However, the specificities of sectoral needs may provide grounds for recourse to other regulatory solutions. In particular, that is the case where there are specific, comprehensive legal systems already in place in a sector, as for example in the fields of feed and food, cosmetic and tobacco products, common market organisations for agricultural products, plant health and plant protection, human blood and tissues, medicinal products for human and veterinary use and chemicals, or where sectoral needs require specific adaptation of the common principles and reference provisions, as for example in the fields of medical devices, construction products and marine equipment. Such adaptations may also be related to the modules set out in Annex II.

L 218/82 EN Official Journal of the European Union 13.8.2008 (1) OJ C 120, 16.5.2008, p. 1.

(2) Opinion of the European Parliament of 21 February 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008.

(3 ) OJ C 282, 25.11.2003, p. 3.

(6) Whenever legislation is drawn up, the legislator may depart, totally or partially, from the common principles and reference provisions laid down in this Decision on account of the specificities of the sector concerned. Any such departure should be justified.

(7) Although the incorporation of the provisions of this Decision in future legislative acts cannot be required by law, the co-legislators adopting this Decision have entered into a clear political commitment which they should respect in any legislative act falling within the scope of this Decision.

(8) Specific product legislation should, wherever possible, avoid going into technical detail but should limit itself to the expression of essential requirements. Such legislation should, where appropriate, have recourse to harmonised standards adopted in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (1 ) for the purpose of expressing detailed technical specifications. This Decision builds on and complements the standardisation system provided for by that Directive.

However, where health and safety, the protection of consumers or of ...

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