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 use of veterinary medicinal products in food-producing animals may result in the presence of residues of foodstuffs obtained from treated animals;

Whereas as a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicines in foodstuffs at ever lower levels; whereas it is therefore necessary to establish maximum residue limits for pharmacologically active substances which are used in veterinary medicinal products in respect of all the various foodstuffs of animal origin, including meat, fish, milk, eggs and honey;

Whereas in order to protect public health, maximum residue limits must be established in accordance with generally recognized principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned which may have been undertaken by international organizations, in particular the Codex Alimentarius or, where such substances are used for other purposes, by other scientific committees established within the Community;

Whereas the use of veterinary medicinal products plays an important part in agricultural production; whereas the establishment of maximum residue levels will facilitate the marketing of foodstuffs of animal origin;

Whereas the establishment of different maximum residue levels by Member States may hinder the free movement of foodstuffs and of veterinary medicinal products themselves;

Whereas it is therefore necessary to lay down a procedure for the establishment of maximum residue levels of veterinary medicinal products by the Community, following a single scientific assessment of the highest possible quality;

Whereas the need for the establishment of maximum residue levels throughout the Community is recognized in the Community rules relating to trade in foodstuffs of animal origin;

Whereas provisions must be adopted with a view to the systematic establishment of maximum residue levels for new substances capable of pharmacological action intended for administration to food-producing animals;

Whereas arrangements must also be made for the establishment of maximum residue levels for substances which are currently used in veterinary medicines administered to food-producing animals; whereas, however, in view of the complexity of this matter and the large number of substances involved, long transitional arrangements are required;

Whereas, after scientific assessment by the Committee for Veterinary Medicinal Products, maximum residue levels must be adopted by a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(4), as last amended by Directive 87/20/EEC(5); whereas an urgent procedure is also required to ensure the swift review of any tolerance which might prove insufficient to protect public health;

Whereas medicinally induced immunological responses are usually indistinguishable from those which arise naturally, and do not affect consumers of food of animal origin;

Whereas the information necessary to assess the safety of residues should be presented in accordance with the principles laid down by Directive 81/852/EEC,

HAS ADOPTED THIS REGULATION: