Product Safety [EU]

Regulation (EC) No 764/2008

of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC.

Summary

The objective of this Regulation is to improve the free movement of goods in the Community. It establishes rules and procedures which should be followed by the authorities of Member States when they take or intend to take a decision which could hinder the free movement of a product lawfully marketed in another Member State and not covered by harmonised rules at Community level. It shall apply from 13 May 2009.

Scope

This Regulation shall apply to administrative decisions based on a technical rule which has the direct or indirect effect of:

• the prohibition of the placing on the market of a product;
• the modification or additional testing of that product before it can be placed on the market;
• the withdrawal of that product.

This Regulation does not apply to:

• judicial decisions;
• systems covered by Directives 96/48/ECand 2001/16/EC;
• the procedure for authorisation of the placing in service of rolling stock provided for in Directive 2004/49/EC;
• certain measures related to products posing a serious risk detailed in Directive 2001/95/EC;
• certain measures related to food posing a risk taken under Regulations 178/2002and 882/2004.

Procedures

This Regulation frames the assessment of product conformity with national technical rules. Competent authorities in the Member States must comply with the rules and procedures on:

• gathering information on the product concerned;
• the recognition of certificates or test reports issued by an accredited conformity-assessment body in accordance with Regulation No 765/2008: Member States cannot reject certificates or test reports on grounds related to the competency of that body;
• an evaluation of the need to apply a technical rule: the decision should be based on technical or scientific elements proving the proportionality of the envisaged measure, should be notified to the enterprise concerned and can be legally challenged;
• the temporary suspension of the marketing of a product: this is forbidden during the evaluation procedure, except in cases where the product poses a serious risk or is prohibited in a Member State on grounds of public morality or public security.

Product Contact Points

Each Member State shall designate one or more Product Contact Points in their territories and shall communicate their contact details to the Commission and to the other Member States. The task of the Product Contact Points is to provide information on the technical rules applicable in the territory in which they are established, on the contact details of the competent authorities and on the remedies available.

Reports

Each Member State shall send the Commission on a yearly basis a report on the application of this Regulation. The Commission shall review the application of this Regulation every five years and shall publish a list of products which are not subject to Community harmonisation legislation.

Context

This Regulation repeals and replaces Decision 3052/95/EC establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community, effective from 13 May 2009. This Act forms part of the strategy framework for a single market in the 21st century.