30.12. 95 Official Journal of the European Communities No L 332/15 COUNCIL DIRECTIVE 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (!), Having regard to the opinion of the European Parliament (%), Having regard to the opinion of the Economic and Social Committee (3), 1. Whereas Council Directive 70/524/EEC of 23 November 1970 concerning  additives in feedingstuffs (*), lays down the minimum conditions to be met by manufacturers of certain additives, premixtures and compound feedingstuffs containing such additives; 2. Whereas these rules restrict the manufacture or use of certain categories of additives, premixtures and compound feedingstuffs containing such additives and premixtures to those manufacturers who are included on a national list; 3. Whereas individuals holding goods covered by this Directive for the sole purposes of their trade promotion or their transport are not regarded as being intermediaries as defined in this Directive; 4, Whereas with the operation of the internal market in mind, some optional provisions which still allow the Member States to derogate from the Community provisions applying to the sector in question should be abolished and the criteria for approving or registering manufacturers or intermediaries should be specified so as to avoid distortions of competition caused by the Member ) O] No C 348, 28. 12. 1983, p. 18. 2) O] No C 91, 28. 3. 1994, p. 296. ) OJ No C 148, 30. 5. 1994, p. 21. ) O] No L 270, 14, 12. 1970, p. 1. Directive as last amended by Commission Directive 95/37/EC (O] No L 172 an 22. 7. 1995, p. 21). States’ different ways of applying and interpreting pre-existing approval conditions and to forestall any potentially adverse effects on animals, humans or the environment, given the risks inherent in using certain additives; 5. Whereas, to forestall certain particularly undesirable substances occurring in feedingstuffs, Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (), aims to limit their presence in raw materials to an acceptable level; whereas these rules also restrict the use of those raw materials to those persons who have the necessary qualifications, facilities and equipment for the dilution operations which ensure that the maximum levels laid down in the Directive as regards the various types of compound feedingstuffs are complied with; 6. Whereas  establishments  producing  certain substances listed in Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (¢), should also be subject to approval, as should intermediaries; 7.  Whereas, with a view to ensuring the quality.of the product and preventing the occurrence of residues of certain additives in animal products or of high levels of certain undesirable substances which might result from defective manufacture, all manufacturers  of  additives,  premixtures, compound feedingstuffs and certain products covered by  Directive  82/471/EEC, and intermediaries should be approved or registered on the basis of standard, specific criteria; 8. Whereas the level of requirements for the exercise of activities laid down in this Directive must be in proportion to the risks involved in the manufacture or use by establishments of additives and premixtures listed in Directive 70/524/EEC, (°) O] No L 38, 11. 2. 1974, p. 31. Directive as last amended by Commission Directive 94/16/EC (O] No L 104, 23. 4. 1994, p. 32). (¢) O] No L 213, 21. 7. 1982, p. 8. Directive as last amended by Commission Directive 95/33/EC (O] No L 167, 18. 7. 1995, p. 17).