THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas the conditions with which medicated feeding-stuffs should comply, in particular as concerns their preparation, supply, use and administration to animals, have no small influence on the rational development of the keeping and on the rearing of animals and the production of products of animal origin;
Whereas the keeping and rearing of animals constitutes a major portion of the common agricultural policy;
Whereas, to safeguard public health from any dangers arising from the use of medicated feedingstuffs for animals intended for food production, and to prevent distortions in competition in the keeping and rearing of farm animals, conditions should be laid down regarding the preparation, placing on the market and use of medicated feedingstuffs and regarding intra-Community trade in those products;
Whereas Community rules regarding veterinary medicinal products, and in particular Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products(4), and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(5), as amended by Directive 87/20/EEC(6), should be taken into account;
Whereas medicated feedingstuffs must, with regard to the medicinal components, comply with the rules applicable to veterinary medicinal products; whereas, however, in the manufacture of medicated feedingstuffs simple mixing is the main process; whereas only authorized medicated pre-mixes may be used and precise instructions must be given for the use of these medicated feedingstuffs; whereas, in addition, the person responsible for manufacture must have at his disposal sufficient staff and premises so that can meet the requirements of this Directive;
Whereas it is the manufacturer's responsibility to carry out a quality control on the products placed on the market; whereas, however, the manufacturing unit should be placed under satisfactory official control;
Whereas, for the purposes of this Directive, the rules concerning checks and the safeguard measures laid down by Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(7) should be used;
Whereas the supply of medicated feedingstuffs to stock-farmers may only be on prescription of a veterinarian, who must himself comply with particular conditions when issuing the prescription;
Whereas, in order for there be to effective control, the persons concerned must be required to keep a register or, where appropriate, to retain the documents for a specified period of time;
Whereas, pending the complete harmonization of the rules authorizing the placing of veterinary medicinal products on the market, the possibility of making national derogations, in particular with respect to the manufacture of intermediate products or certain medicated pre-mixes, should be kept,
HAS ADOPTED THIS DIRECTIVE: