Decision 2008/768 - Decision 768/2008/EC on a common framework for the marketing of products - Main contents
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official title
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| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2008/768 |
| Original proposal | COM(2007)53  |
| CELEX number i | 32008D0768 |
| Document | 09-07-2008 |
|---|---|
| Publication in Official Journal | 13-08-2008; OJ L 218, 13.8.2008,Special edition in Croatian: Chapter 15 Volume 012 |
| Effect | 09-07-2008; Entry into force Date of document |
| End of validity | 31-12-9999 |
13.8.2008 |
EN |
Official Journal of the European Union |
L 218/82 |
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. |
(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... |
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