Document ID: 31987L0153

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COUNCIL DIRECTIVE
of 16 February 1987
fixing guidelines for the assessment of additives in animal nutrition
(87/153/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 86/525/EEC (2), and in particular Article 9 thereof,
Having regard to the proposal from the Commission,
Whereas Directive 70/524/EEC provides that the examination of additives must be performed on the basis of a dossier forwarded officially to the Member States and to the Commission;
Whereas such dossiers must make it possible to verify that additives comply, in respect of their proposed use, with the general principles laid down in the Directive for their inclusion in the Annexes thereto;
Whereas it has been found necessary to provide for the dossiers to be compiled in accordance with common guidelines defining the scientific data which make it possible to identify and characterize the products concerned and the studies necessary in order to evaluate, in particular, their efficacy and their safety for man, animals and the environment;
Whereas the guidelines are intended primarily as a general guide; whereas, depending on the nature of the additive or its conditions of use, the extent of the studies necessary in order to evaluate its properties or its effects may vary;
Whereas it is indispensable to apply the principles of good laboratory practice when developing additives intended for use in feedingstuffs to ensure that the results of laboratory tests are not disputed; whereas recourse to procedures involving the use of laboratory animals for experimental or other scientific purposes should be kept to a minimum;
Whereas the guidelines have been drawn up on the basis of present scientific and technical knowledge and they may be adapted if necessary to any developments in this sphere,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Member States shall prescribe that the dossiers which must accompany every request for the inclusion of an additive or a new use of an additive in the Annexes to Directive 70/524/EEC are to be compiled in accordance with the guidelines set out in the Annex to this Directive.
Article 2
This Directive shall apply without prejudice to provisions on:
(a) good laboratory practice for the purposes of mutual acceptance of data for the evaluation of chemical products; and
(b) the protection of animals used for experimental or other scientific purposes.
Article 3
Member States shall bring into force the laws, regulations or administrative provisions necessary in order to comply with this Directive by 31 December 1987 at the latest. They shall forthwith inform the Commission thereof.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 16 February 1987.

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