Directive 2004/10/EC of the European Parliament and of the Council
of 11 February 2004
on the 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)
(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),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
Whereas:
(1) Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substances(3) has been significantly amended. In the interests of clarity and rationality the said Directive should be codified.
(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(4) requires tests to be carried out on chemical substances in order to enable their potential risk to man and the environment to be determined.
(3) When the active substances in pesticides undergo tests they should do so in accordance with Directive 67/548/EEC.
(4) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(5) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(6) lay down that non-clinical tests on pharmaceutical products are to be carried out in accordance with the principles of good laboratory practice (GLP) in force in the Community for chemical substances, compliance with which is also required by other Community legislation.
(5) The methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC.
(6) It is necessary to comply with the principles of GLP in carrying out the tests laid down by Directive 67/548/EEC so as to ensure that the results are comparable and of high quality.
(7) The resources devoted to the tests should not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another.
(8) The Council of the Organisation for Economic Cooperation and Development (OECD) took a Decision on 12 May 1981 on the mutual acceptance of data for the evaluation of chemical products. It issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with GLP. The principles of GLP have been modified by OECD Council Decision (C(97) 186 (final)).
(9) Animal protection requires that the number of experiments conducted on animals be restricted. Mutual recognition of the results of tests obtained using standard and recognised methods is an essential condition for reducing the number of experiments in this area.
(10) It is necessary to set up a procedure allowing rapid adaptation of the principles of GLP.
(11) This Directive should be 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,
HAVE ADOPTED THIS DIRECTIVE:
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.
Done at Strasbourg, 11 February 2004.