Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP)

COUNCIL  DIRECTIVE
of 9 June 1988
on the inspection and verification of Good Laboratory Practice (GLP)
(88/320/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100A thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the application of standardized organizational processes and conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing of chemicals for the protection of man, animals and the environment, hereinafter referred to as 'Good Laboratory Practice' (GLP), contributes to the reassurance of Member States as to the quality of the test data generated;
Whereas, in Annex 2 to its Decision on 12 May 1981 on the mutual acceptance of data in the assessment of chemicals, the council of the Organization for Economic Cooperation and Development (OECD) adopted principles of good laboratory practice which are accepted within the Community and are specified in 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 (4);
Whereas, in the conduct of tests on chemicals, it is desirable that specialist manpower and testing laboratory resources should not be wasted owing to the need to duplicate tests because of differences in laboratory practices from one Member State to another; whereas this applies especially for animal protection which requires that the number of experiments on animals be restricted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (5); 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, however, in order to ensure that test data generated by laboratories in one Member State are also recognized by other Member States, it is necessary to provide for a harmonized system for study audit and inspection of laboratories to ensure that they are working under GLP conditions;
Whereas Member States designate the authorities responsible for carrying out monitoring on compliance with GLP;
Whereas a committee, the members of which will be appointed by the Member States, would be of assistance to the Commission in the technical application of this Directive and would cooperate in its efforts to encourage the free movement of goods by the mutual recognition by Member States of procedures for monitoring compliance
with GLP; whereas the committee set up by 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 (1), as last amended by Directive 87/432/EEC (2), may be used for this purpose;
Whereas this committee may assist the Commission not only in the application of this Directive but also in contributing to the exchange of information and experience in this field,