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 the environment, other aspects of public interest, or clarity and practicability so require, detailed technical specifications may be set out in the legislation concerned. (9) The presumption of conformity to a legal provision conferred by conformity to a harmonised standard should enhance recourse to compliance with harmonised standards. (10) It should be possible for Member States or the Commission to object in cases in which a harmonised standard does not entirely satisfy the requirements of Community harmonisation legislation. The Commission should be able to decide not to publish such a standard. To that end, the Commission should, in such manner as appropriate, consult sectoral representatives and Member States before the Committee set up by Article 5 of Directive 98/34/EC delivers its opinion. (11) The essential requirements should be worded precisely enough to create legally binding obligations. They should be formulated so as to make it possible to assess conformity with them even in the absence of harmonised standards or where the manufacturer chooses not to apply a harmonised standard. The degree of detail of the wording will depend on the characteristics of each sector. (12) The successful accomplishment of the required conformity assessment procedure enables economic operators to demonstrate and the competent authorities to ensure that products made available on the market conform to the requirements applicable. (13) The modules for the conformity assessment procedures to be used in the Community harmonisation legislation were initially set out in 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, which are intended to be used in the technical harmonisation directives (2). This Decision replaces that Decision. (14) It is necessary to offer a choice of clear, transparent and coherent conformity assessment procedures, restricting the possible variants. This Decision provides for a menu of modules, enabling the legislator to choose a procedure from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. (15) For the purposes of ensuring inter-sectoral coherence and avoiding ad-hoc variants, it is desirable that the procedures which are to be used in sectoral legislation be chosen from among the modules, in accordance with the general criteria set out. (16) In the past, legislation on the free movement of goods has used a set of terms partly without defining them and guidelines for explanation and interpretation have consequently been necessary. Where legal definitions have been introduced they differ to some extent in their wording and sometimes in their meaning, which gives rise to difficulties in their interpretation and correct implementation. This Decision therefore introduces clear definitions of certain fundamental concepts. (17) Products that are placed on the Community market should comply with the relevant applicable Community legislation, and economic operators should be responsible for the compliance of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of consumers and of the environment, and to guarantee fair competition on the Community market. (18) All economic operators are expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market. (19) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only products which are in conformity with the applicable legislation. This Decision provides a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution process. 13.8.2008 EN Official Journal of the European Union L 218/83 (1 ) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). (2 ) OJ L 220, 30.8.1993, p. 23. (20) As certain tasks can be executed only by the manufacturer, it is necessary to distinguish clearly between the manufacturer and operators further down the distribution chain. It is also necessary to distinguish clearly between the importer and the distributor, as the importer introduces products from third countries to the Community market. The importer has thus to make sure that those products comply with the applicable Community requirements. (21) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. Conformity assessment should therefore remain the obligation of the manufacturer alone. (22) It is necessary to ensure that products from third countries entering the Community market comply with...
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