Decision No 768/2008/EC of the European Parliament and of the CouncilShow full title

Article 1 U.K. General principles

1. Products placed on the Community market shall comply with all applicable legislation.

2. When placing products on the Community market, economic operators shall, in relation to their respective roles in the supply chain, be responsible for the compliance of their products with all applicable legislation.

3. Economic operators shall be responsible for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with Community rules applicable.

Article 2 U.K. Subject matter and scope

This Decision sets out the common framework of general principles and reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products (Community harmonisation legislation).

Community harmonisation legislation shall have recourse to the general principles set out in this Decision and to the relevant reference provisions of Annexes I, II and III. However, Community legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place.

Article 3 U.K. Level of protection of public interests

1. As regards the protection of public interests, Community harmonisation legislation shall restrict itself to setting out the essential requirements determining the level of such protection and shall express those requirements in terms of the results to be achieved.

Where recourse to essential requirements is not possible or not appropriate, in view of the objective of ensuring the adequate protection of consumers, public health and the environment or other aspects of public interest protection, detailed specifications may be set out in the Community harmonisation legislation concerned.

2. Where Community harmonisation legislation sets out essential requirements, it shall provide for recourse to be had to harmonised standards, adopted in accordance with Directive 98/34/EC, which shall express those requirements in technical terms and which shall, alone or in conjunction with other harmonised standards, provide for the presumption of conformity with those requirements, while maintaining the possibility of setting the level of protection by other means.

Article 4 U.K. Conformity assessment procedures

1. Where Community harmonisation legislation requires conformity assessment to be performed in respect of a particular product, the procedures which are to be used shall be chosen from among the modules set out and specified in Annex II, in accordance with the following criteria:

(a) whether the module concerned is appropriate to the type of product;

(b) the nature of the risks entailed by the product and the extent to which conformity assessment corresponds to the type and degree of risk;

(c) where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules set out in Annex II;

(d) the need to avoid imposing modules which would be too burdensome in relation to the risks covered by the legislation concerned.

2. Where a product is subject to several Community acts within the scope of this Decision, consistency among conformity assessment procedures shall be ensured by the legislator.

3. The modules referred to in paragraph 1 shall be applied as appropriate to the product concerned and in accordance with the instructions set out in those modules.

4. For custom-made products and small series production, the technical and administrative conditions relating to conformity assessment procedures shall be alleviated.

5. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument may:

(a) regarding technical documentation, require information additional to that which is already stipulated in the modules;

(b) regarding the time for which the manufacturer and/or notified body are obliged to keep any kind of documentation, alter the period stipulated in the modules;

(c) specify the manufacturer's choice as to whether the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer;

(d) where product verification is performed, specify the manufacturer's choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, by examination and testing of every product, or by examination and testing of the products on a statistical basis;

(e) provide for the EC-type examination certificate to have a period of validity;

(f) regarding the EC-type examination certificate, specify relevant information relating to conformity assessment and in-service control to be included in it or its annexes;

(g) provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;

(h) if the notified body carries out periodic audits, specify their frequency.

6. When applying the modules referred to in paragraph 1, and wherever applicable and relevant, the legislative instrument shall:

(a) where product checks and/or verification are performed, determine the products concerned, the appropriate tests, the adequate sampling schemes, the operational characteristics of the statistical method to be applied and the corresponding action to be taken by the notified body and/or the manufacturer;

(b) where EC-type examination is performed, determine the appropriate manner (design type, production type, design and production type) and the specimens required.

7. An appeal procedure against decisions of the notified body shall be available.

Article 5 U.K. EC declaration of conformity

Where Community harmonisation legislation requires a statement by the manufacturer that fulfilment of the requirements relating to a product has been demonstrated (EC declaration of conformity), the legislation shall provide that a single declaration shall be drawn up in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates, and giving the publication references of the acts concerned.

Article 6 U.K. Conformity assessment

1. Where Community harmonisation legislation requires conformity assessment, it may provide for that assessment to be carried out by public authorities, manufacturers or notified bodies.

2. Where Community harmonisation legislation provides for conformity assessment to be carried out by public authorities, the legislation shall provide that the conformity assessment bodies on which those authorities rely for technical assessments must comply with the same criteria as those set out in this Decision for notified bodies.

Article 7 U.K. Reference provisions

The reference provisions for Community harmonisation legislation for products shall be as set out in Annex I.

Article 8 U.K. Repeal

Decision 93/465/EEC is hereby repealed.

References to the repealed Decision shall be construed as references to this Decision.

Done at Strasbourg, 9 July 2008.

For the European Parliament

The President

H.-G. Pöttering

For the Council

The President

J.P. Jouyet