Directive 1987/18 - Harmonization 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 - Main contents

official title

Avis juridique important

|

Council Directive 87/18/EEC of 18 December 1986 on the harmonization 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

Official Journal L 015 , 17/01/1987 P. 0029 - 0030

Finnish special edition: Chapter 15 Volume 7 P. 0195

Swedish special edition: Chapter 15 Volume 7 P. 0195

*****

COUNCIL DIRECTIVE

of 18 December 1986

on the harmonization 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

(87/18/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the Economic and Social Committee (2),

Whereas 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 (3), as last amended by Directive 84/449/EEC (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;

Whereas Directive 75/318/EEC (5) as amended by Directive 87/19/EEC (6), and Directive 81/852/EEC (7) as amended by Directive 87/20/EEC (8) lay down that non-clinical tests on pharmaceutical products shall be carried out in accordance with the principles of good laboratory practice in force in the Community for chemical substances;

Whereas when the active substances in pesticides undergo tests they shall do so in accordance with the protocols provided for by Directive 67/548/EEC, and hence in accordance with good laboratory practice for chemical substances;

Whereas the methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC;

Whereas it is necessary to comply with the principles of good laboratory practice 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;

Whereas the Commission intends shortly to submit a proposal to the Council for a Directive aiming at verifying compliance with the principles of good laboratory practice;

Whereas the resources devoted to the tests must not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another;

Whereas the Council of the Organization 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; whereas it issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with good laboratory practice;

Whereas animal protection requires that the number of experiments conducted on animals be restricted; whereas mutual recognition of the results of tests obtained using standard and recognized methods is an essential condition for reducing the number of experiments in this area;

Whereas it is necessary to set up a procedure allowing rapid adaptation of the principles of good laboratory practice,

HAS 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 specified in Annex 2 to the Decision of 12 May 1981 of the Council of the OECD on the mutual acceptance of data for the evaluation of chemical products.

• 2. 

  Paragraph 1 shall apply also where other Community provisions provide for the application of the principles of...

This text has been adopted from EUR-Lex.

This page is also available in a full version containing de geconsolideerde versie, the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand and finally the related cases of the European Court of Justice.