Legal provisions of COM(2002)530 - Harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)

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dossier COM(2002)530 - Harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good ...
document COM(2002)530 EN
date February 11, 2004


Contents

Article 1

1. Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice (GLP) as laid down in Annex I to this Directive.

2. Paragraph 1 shall apply also where other Community provisions provide for the application of the principles of GLP in respect of tests on chemical products to evaluate their safety for man and/or the environment.

Article 2

When submitting results, the laboratories referred to in Article 1 shall certify that the tests have been carried out in conformity with the principles of GLP referred to in that Article.

Article 3

1. Member States shall adopt the measures necessary for verification of compliance with the principles of GLP. These measures shall include, in particular, inspections and study checks in accordance with the recommendations of the OECD in this area.

2. Member States shall notify to the Commission the name or names of the authority or authorities responsible for verifying compliance with the principles of GLP, as referred to in paragraph 1. The Commission shall inform the other Member States thereof.

Article 4

Any adaptation to the principles of GLP mentioned in Article 1 shall be adopted in accordance with the procedure referred to in Article 29 of Directive 67/548/EEC.

Article 5

1. Where Community provisions require application of the principles of GLP following the entry into force of this Directive for tests on chemical products, Member States may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied by the laboratories concerned are in conformity with those mentioned in Article 1.

2. Should a Member State establish on the basis of detailed evidence that the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man and the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that substance on its territory. It shall immediately inform the Commission and the other Member States thereof and give the grounds for its decision.

The Commission shall, within six weeks, consult the Member States concerned and then give its opinion and take suitable measures without delay.

Should the Commission consider that technical adaptations to this Directive are necessary, those adaptations shall be adopted either by the Commission or by the Council in accordance with the procedure referred to in Article 4. In that case, the Member State which adopted the safeguard measures may maintain them until the entry into force of those adaptations.

Article 6

Directive 87/18/EEC is hereby repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition of the Directives set out in Annex II, part B.

References made to the repealed Directive shall be construed as being made to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 7

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Article 8

This Directive is addressed to the Member States.