Directive 2004/10 - 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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official title
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)Legal instrument | Directive |
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Number legal act | Directive 2004/10 |
Original proposal | COM(2002)530 ![]() |
CELEX number29 | 32004L0010 |
Document | 11-02-2004 |
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Publication in Official Journal | 20-02-2004; OJ L 50, 20.2.2004,Special edition in Slovak: Chapter 15 Volume 008,Special edition in Polish: Chapter 15 Volume 008,Special edition in Lithuanian: Chapter 15 Volume 008,Special edition in Bulgarian: Chapter 15 Volume 010,Special edition in Latvian: Chapter 15 Volume 008,Special edition in Czech: Chapter 15 Volume 008,Special edition in Romanian: Chapter 15 Volume 010,Special edition in Croatian: Chapter 15 Volume 007,Special edition in Maltese: Chapter 15 Volume 008,Special edition in Estonian: Chapter 15 Volume 008,Special edition in Hungarian: Chapter 15 Volume 008,Special edition in Slovenian: Chapter 15 Volume 008 |
Effect | 11-03-2004; Entry into force Date pub. + 20 See Art 7 |
End of validity | 31-12-9999 |
Transposition | 30-06-1988; At the latest See Art 6 |
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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)
Official Journal L 050 , 20/02/2004 P. 0044 - 0059
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:
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(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.
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(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.
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(3)When the active substances in pesticides undergo tests they should do so in accordance with Directive 67/548/EEC.
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(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.
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(5)The methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC.
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(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.
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(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.
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(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)).
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(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.
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(10)It is necessary to set up a procedure allowing rapid adaptation of the principles of...
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- 1.COM(1987) 868 PV.
- 2.See Annex 3 to Part A of such conclusions.
- 3.Carried out pursuant to the Communication from the Commission to the European Parliament and the Council - Codification of the Acquis communautaire, COM(2001) 645 final.
- 4.See Annex II, Part A of this proposal.
- 5.OJ C , , p. .
- 6.OJ C , , p. .
- 7.OJ L 15, 17. 1. 1987, p. 29. Directive amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999, p. 8).
- 8.See Annex II, Part A.
- 9.OJ 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21. 8. 2001, p.1).
- 10.Carried out pursuant to the Communication from the Commission to the European Parliament and the Council - Codification of the Acquis communautaire, COM(2001) 645 final.
- 11.See Annex 3 to Part A of such conclusions.
- 12.OJ L 311, 28. 11. 2001, p. 1.
- 13.OJ L 311, 28. 11. 2001, p. 67.
- 14.COM(1987) 868 PV.
- 15.COM(1987) 868 PV.
- 16.See Annex 3 to Part A of such conclusions.
- 17.Carried out pursuant to the Communication from the Commission to the European Parliament and the Council - Codification of the Acquis communautaire, COM(2001) 645 final.
- 18.See Annex II, Part A of this proposal.
- 19.OJ C , , p. .
- 20.OJ C , , p. .
- 21.OJ L 15, 17. 1. 1987, p. 29. Directive amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999, p.
8).
- 22.See Annex II, Part A.
- 23.OJ 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21. 8. 2001, p.1).
- 24.Carried out pursuant to the Communication from the Commission to the European Parliament and the Council - Codification of the Acquis communautaire, COM(2001) 645 final.
- 25.See Annex 3 to Part A of such conclusions.
- 26.OJ L 311, 28. 11. 2001, p. 1.
- 27.OJ L 311, 28. 11. 2001, p. 67.
- 28.COM(1987) 868 PV.
- 29.Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
- 30.EUR-lex provides an overview of the proposal, amendments, citations and legality.