8. 12. 84 Official Journal of the European Communities No-L 319/13 ' (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE of 29 November 1984 amending Directive 70/524/EEC concerning additives in feedingstuffs (84/587/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commis- sion ('), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas the application of Council Directive 70/524/EEC of 23 November 1970 concerning addi- tives in feedingstuffs (*), as last amended by the 46th Commission Directive 84/547/EEC (%), has revealed a need to redefine certain fundamental concepts so as to take account of scientific and technical developments and satisfy the imperative need to ensure the best possible protection of animal health, human health and the environment ; Whereas experience has demonstrated, in particular, that the current rules on the use of additives in feedingstuffs have not afforded the required degree of safety ; whereas it.is therefore indispensable that addi- tional measures be taken in connection with the production, marketing and distribution of additives and premixtures of additives ; " () OJ No C 197, 18. 8. 1977, p. 3. () OJ No C 63, 13. 3. 1978, p. 53. () O] No C 84, 8. 4. 1978, p. 4. (9 OJ No L 270, 14. 12. 1970, p. 1. () OJ No L 297, 15. 11. 1984, p. 40. Whereas, to facilitate the application of the Directive, the list of definitions should be extended and certain definitions amended ; whereas the concept of an addi- tive should be more clearly defined in such a way that authorizations granted for the use of additives of certain categories refer to the specific preparations, ~which in future will be named in the Annexes; Whereas the interests of clarity call for a codification of the Annexes so that successive amendments made may be incorporated therein ; Whereas the prohibitions on the use of mixtures of additives of certain categories should be extended so as to prevent the unfavourable effects which may arise from certain associations ; Whereas, to ensure observance of the fundamental prmc1ples which must be obeyed if any new use of an additive is to be authorized, it is necessary — in the case of certain categories of additive — to require that a dossier be submitted officially by a Member State ; whereas, to facilitate examination of the additives in question, dossiers must be drawn up in accordance with common guidelines to be determined by the Council ; Whereas, for the purpose of identifying additives used in feedingstuffs, it is important that, in the case of antibiotics, coccidiostats and other medicinal substances, as also in that of growth promoters, a monograph be introduced indicating the criteria for the identification and characterization of each autho- rized additive ;