L 323/6 Official Journal of the European Union 26.10.2004 COMMISSION REGULATION (EC) No 1851/2004 of 25 October 2004 amending Annex I to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits for 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 ('), and in particular Articles 7 and 8 thereof, Whereas: 1 ©) In accordance with 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. Maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products (CVMP) of all the relevant infor- mation 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. 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 relevant food obtained from the treated animal (target tissue) as well as the nature of the residue that is relevant for the monitoring of residues (‘marker residue’). For the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney. However, liver and kidney are frequently removed from carcasses moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues. In the case of veterinary medicinal products intended for use in laying birds, lactating animals or honey bees, () OJL 224,18.8.1990, p. 1. Regulation as last modified by Commission Regulation (EC) No 16462004 (O] L 296, 21.9.2004, p. 5). maximum residue limits must also be established for eggs, milk or honey. 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. Based on an opinion of the CVMP, Annex IIl of Regu- lation (EEC) No 2377/90 was amended by Commission Regulation (EC) No 997/1999 (3 to include provisional maximum residue limits for morantel, in order to allow for the completion of scientific studies, notably concerning the marker residue and the analytical method for the determination of residues of morantel in the target tissues. These maximum residue limits were subsequently extended by Commission Regulation (EC) No 1322/2001 (}) to allow the applicant further time for completion of the requested studies. The requested data on the marker residue and the analytical method was evaluated by the CVMP and found to be not completely in accordance with the requirements laid down in Volume 8 of the Rules Governing Medicinal Products in the European Union. The method was nevertheless considered fully validated for muscle and milk and either kidney or liver for the species cattle and sheep. The CVMP subsequently proposed to insert morantel in Annex II of Regulation (EEC) No 2377/90, with the motivation that residues of morantel depleted rapidly and therefore the establishment of maximum residue limits was not necessary for the protection of public health. As residues of morantel in foodstuff from treated animals may supersede the acceptable daily intake 24 hours after administration, it is considered necessary, for reasons of consumer safety and to allow adequate withdrawal periods to be established for veterinary medicinal products containing morantel, to establish maximum residues limits, taking account of the maximum residue limits previously established. Morantel is a pharmacologically active anthelmintic substance which has been in wuse in veterinary medicinal products for food-producing animal species for a considerable time for treatment against roundworms and tapeworms. In view of the possible development of resistance, it is considered that access to multiple choices for treatment should remain possible. () O] L 122, 12.5.1999, p. 24. () O] L 177, 30.6.2001, p. 52.