Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition

• Coming into Force: 19 February 1987
• End of Effective Date: 17 October 2004
• Celex Number: 31987L0153
• ELI: http://data.europa.eu/eli/dir/1987/153/oj
• Published date: 07 March 1987
• Date: 16 February 1987
• Official Gazette Publication: Official Journal of the European Communities, L 64, 7 March 1987

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31987L0153

Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition

Official Journal L 064 , 07/03/1987 P. 0019 - 0028
Finnish special edition: Chapter 3 Volume 22 P. 0226
Swedish special edition: Chapter 3 Volume 22 P. 0226

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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.

For the Council

The President

L. TINDEMANS

(1) OJ No L 270, 14. 12. 1970, p. 1.

(2) OJ No L 310, 5. 11. 1986, p. 19.

ANNEX

GUIDELINES FOR THE ASSESSMENT OF ADDITIVES IN FEEDINGSTUFFS

GENERAL ASPECTS

These guidelines are intended as a guide for establishing dossiers on substances and preparations being submitted for authorization as additives in feedingstuffs. These dossiers must enable an assessment to be made of the additives based on the present state of knowledge and make it possible to ensure their compliance with the fundamental principles laid down for their admission, which are the subject of the provisions of Article 7 (2) of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1).

All the studies outlined in these guidelines may be required and, if necessary, additional information will be requested. As a general rule, studies to establish the identity, conditions of use, physico-chemical properties, methods of determination and efficacy of the additive, and also its metabolism, biological and toxicological effects on target species must be provided. The studies necessary for the evaluation of risks to human health or the environment will depend essentially on the nature of the additive and the circumstances of its use. In this respect, no strict rule is applicable.

It will not always be necessary to subject additives intended exclusively for pet food to as exhaustive a programme of chronic toxicity, mutagenicity and carcinogenicity testing as that required for additives intended for feeding to livestock from which are derived produce for human consumption. To determine chronic toxicity, studies on two target species or on one target species and rats for a period of one year will generally suffice. Mutagenesis and carcinogenesis studies can generally be dispensed with if the chemical composition, practical experience, or other considerations do not indicate the likelihood of changes. It is possible to dispense with the analysis of residues in pet animals.

Knowledge of the metabolism of the additive in food producing stock, of the residues and their bioavailability is essential. In particular it must enable the extent of the toxicological studies to be performed on laboratory animals in order to assess the risks, if any, to the consumer to be determined. This evaluation cannot be based solely on data confined to determining the direct effects of the additives on laboratory animals. The latter do not provide specific information on the actual effects of residues resulting from the metabolism in the species for which the additive is intended.

Any application for authorization of an additive or a new usage for an additive shall be supported by a dossier which should include detailed reports presented in the order and with the numbering proposed in these guidelines. Reasons must be given for the omission from the dossier of any data prescribed in these guidelines. Publications to which reference is made must be attached to it. The reports of experiments must include the plan and reference number of the experiment, detailed description of the tests, results and their analysis, and also the name, address and signature of the person responsible for the study. A statement from the person responsible for good laboratory practice regarding observance of such practice is to be attached to the reports.

The determination of physico-chemical, toxicological and...