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

Member States shall prescribe that the dossiers which must accompany every request for including 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. These provisions shall apply without any prejudice to other provisions in force relating to: (a) good laboratory practices 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. The guidelines are structured as follows: (1) General aspects; (2) Contents (summary of the data in the dossier; identity, characterization and conditions of the use of the additives; methods of control; studies concerning the effectiveness of the additive; studies concerning the safety of use of the additive; form of monograph).