29.12.2001 Official Journal of the European Communities L 3457 COUNCIL REGULATION (EC) No 2584/2001 of 19 December 2001 amending Annexes I and III of Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EEC) No 237790 of 26 June 1990 laying down a Community procedure for the estab- lishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin ('), and in particular Article 7 thereof, Having regard to the proposal from the Commission, Whereas: 1) In accordance with Regulation (EEC) No 2377/90, maximum residue limits are to be established progres- sively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals. Maximum residue limits should be established only after examination within the Committee for Veterinary Medi- cinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs and taking into account all publicly available relevant scientific information concerning the safety of residues of the substance concerned for the consumer of food- stuffs of animal origin, including for example opinions of the Scientific Committee on Veterinary Measures Relating to Public Health, reports from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) or reports from internationally renowned research organisations. In establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels at which they may be present in each of the relevant tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue). In the case of veterinary medi- cinal products intended for use in lactating animals maximum residue limits shall be established for milk. () OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commis- sion Regulation (EC) No 2162/2001 (O] L 291, 8.11.2001, p. 9). (4) Regulation (EEC) No 2377/90 provides that the estab- lishment of maximum residue limits shall in no way prejudice the application of other relevant Community legislation. For the purpose of monitoring residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney. However, as the liver and kidney are frequently removed from carcasses moving in inter- national trade, maximum residue limits should conse- quently be established always for muscle or fat tissues. The substances chlormadinone, flugestone acetate and altrenogest are hormones and are therefore subject to restrictions and control of use as provided for in Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of p-agonists (3. Under certain conditions, these hormones may be administered to farm animals for therapeutic or zootechnical purposes only. In particular, these conditions require the administration of these substances by a veterinarian or under his direct responsi- bility. In addition, the type of treatment, the types of products authorised, the date of treatment and the iden- tity of the animals treated must be officially recorded by the veterinarian. Furthermore, the conditions laid down in Directive 96/ 22[EC prohibit the administration of hormones for ther- apeutic or zootechnical purposes to breeding animals during the fattening period at the end of their reproduc- tive life. Moreover, they provide that meat or products from animals to which hormones have been adminis- tered for therapeutic or zootechnical treatment should not be placed on the market for human consumption unless they have been treated in accordance with Directive 96/22/EC and insofar as the withdrawal period laid down was observed before the animals were slaugh- tered. The overall evaluation of the available risk assessments of these substances and of the entire body of available scientific information and data indicate that, as concerns the excess intake of hormone residues and their metabo- lites, and in view of the intrinsic properties of hormones and epidemiological findings, a risk to the consumer has been identified. () O] L 125, 23.5.1996, p. 3.