12.4.2003 Official Journal of the European Union L 96/7 COMMISSION REGULATION (EC) No 665/2003 of 11 April 2003 amending Annex III to Council 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 COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EEC) No 2377/90 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 (!), as last amended by Commission Regulation (EC) No 61/2003 (*) and in particular Articles 7 and 8 thereof; Having regard to the decision of the 2404th Council of the European Union (agriculture) not to adopt draft measures proposed by the Commission concerning the establishment of maximum residue limits for norgestomet (COM(2001) 627 final); Whereas: (1) In accordance with Council Regulation (EEC) No 2377/ 90, maximum residue limits should be established for all pharmacologically active substances that are used within the Community in veterinary medicinal products intended for administration to food-producing animals. (2)  Maximum residue limits should be established after examination, within the Committee for Veterinary Medicinal Products (CVMP), of all the relevant informa- tion provided by applicants in accordance with the provisions of Regulation (EEC) 2377/90 and taking into account all publicly available relevant scientific informa- tion concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin, including for example opinions of the Scientific Committee on Veterinary Measures related to Public Health, Joint FAO/WHO Expert Committee on Food Additives reports, or reports form internationally renowned research organisations. (3)  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 the 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) as well as the nature of the residue that is relevant for the moni- toring of residues (marker residue). In the case of veter- inary medicinal products intended for use in lactating animals maximum residue limits must be established for milk. () OJ L 224, 18.8.1990, p. 1. () OJL 11, 16.1.2003, p. 12. (4)  Council Regulation (EEC) No 2377/90 provides that the establishment of maximum residue limits shall in no way prejudice the application of other relevant Commu- nity legislation. (5)  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 interna- tional trade, maximum residue limits should conse- quently be established always for muscle or fat tissues. (6)  The substances norgestomet and flugestone acetate are progestagen hormones, and therefore are subject to restrictions and control of use as provided for in Council Directive 96/22/EC of 29 April 1996 (). Under certain conditions, these hormones may be administered to farm animals for therapeutic or zootechnical purposes only. In particular, these conditions require, inter alia, the administration of these substances by a veterinarian or under his direct responsibility. In addition, the type of treatment, the type of products authorised, the date of treatment and the identity of the animals treated must be officially recorded by the veterinarian. (7)  Furthermore, the conditions laid down in Directive 96/ 22[EC prohibit the administration of hormones for therapeutic or zootechnical purposes to breeding animals during the fattening period at the end of their reproductive life. Moreover, they provide that meat or products from animals to which hormones have been administered for therapeutic or zootechnical treatment should not be placed on the market for human consumption unless they have been treated in accor- dance with the provisions of Council Directive 96/22/EC and in so far as the withdrawal period laid down was observed before the animals were slaughtered. (8)  After its initial evaluation, the CVMP considered that it was not necessary, for the protection of public health, to establish maximum residues limits norgestomet when used in veterinary medicinal products authorised in accordance with Community legislation. The substance was therefore proposed to be included in the list in Annex II of Council Regulation (EEC) No 2377/90. Furthermore, the CVMP considered for the same reasons that it was not necessary to establish maximum residue limits for flugestone acetate for other target tissues than milk. () OJ L 125, 23.5.1996, p. 3.