No L 272/2 Official Journal of the European Communities 25. 10. 96 COMMISSION REGULATION (EC) No 2034/96 of 24 October 1996 amending Annexes I, II and III of 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 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 establishment of maximum residue limits of vet- erinary medicinal products in foodstuffs of animal origin ('), as last amended by Commission Regulation (EC) No 2010/96 (%), and in particular Articles 6, 7 and 8 thereof, Whereas, in accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food- producing animals; Whereas maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant informa- tion 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; Whereas, in establishing maximum residue limits for res- idues 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 which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of res- idues (marker residue); Whereas, 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; whereas, however, the liver and kidney are frequently removed from carcases moving in inter- national trade, and maximum residue limits should there- fore also always be established for muscle or fat tissues; Whereas, in the case of veterinary medicinal products intended for use in laying birds, lactating animals or () OJ No L 224, 18. 8. 1990, p. 1. @ OJ No L 269, 22. 10. 1996, p. 5. honey bees, maximum residue limits must also be established for eggs, milk or honey; Whereas, penethamate (applicable to bovine tissues) should be inserted in Annex I to Regulation (EEC) No 2377/90; Whereas, based on the currently authorized use in vet- erinary practice, boric acid and borates, polysulphated glycosaminoglycan, rifaximin and tau fluvalinate should be inserted into Annex II to Regulation (EEC) No 2377/90; Whereas, some substances were previously evaluated through European Union procedures, such as the Scien- tific Committee for Food; whereas, some of these substances were considered to be acceptable for addition to human foodstuffs and granted an E number; whereas, their administration to food producing animals as part of veterinary medicinal products is unlikely to result in res- idues in food of animal origin either significantly diffe- rent from the additive or in concentrations exceeding those of the additive where it has been added directly to the food; whereas, based on the currently authorized use in veterinary practice, those substances approved as addi- tives in foodstuffs for human consumption, with a valid E number, should be included in Annex II of Regulation (EEC) No 2377/90; Whereas, in order to allow for the completion of scientific studies, rifaximin (applicable to bovine milk) should be inserted in Annex III to Regulation (EEC) No 2377/90; Whereas a period of 60 days should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorizations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/EEC (®), as last amended by Directive 93/40/ EEC (* to take account of the provisions of this Regula- tion; Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, o L 317, 6. 11. 1981, p. 1. o L 214, 24. 8. 1993, p. 31. A zZ