CELEX: 31996R2034
Language: en
Date: 1996-10-24 00:00:00
Title: 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

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31996R2034

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  

Official Journal L 272 , 25/10/1996 P. 0002 - 0005

 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 veterinary medicinal products in  foodstuffs of animal origin  (1), as last amended by Commission Regulation (EC) No 2010/96  (2),  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 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; Whereas, 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 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 residues (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 international trade,  and maximum residue limits should therefore 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 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 veterinary 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  Scientific 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 residues in  food of animal origin either significantly different 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 additives 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  (3), as last amended by Directive 93/40/EEC  (4) to  take account of the provisions of this Regulation; Whereas the measures provided for in this Regulation are in accordance with the opinion of the  Standing Committee on Veterinary Medicinal Products, HAS ADOPTED THIS REGULATION: Article 1 Annexes I, II and III of Regulation (EEC) No 2377/90 are hereby  amended as set out in the Annex hereto. Article 2 This Regulation shall enter into force on the 60th day following that of its  publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all  Member States. Done at Brussels, 24 October 1996. For the Commission Martin BANGEMANN Member of the Commission  ANNEX Regulation (EEC) No 2377/90 is amended as follows: A. Annex I is modified as follows: 1. Anti-infectious agents 1.2. Antibiotics 1.2.1. Penicillins >TABLE>  B. Annex II is modified as follows: 1. Inorganic chemicals >TABLE>  2. Organic compounds >TABLE>  5. Substances used as food additives in foodstuffs for human consumption >TABLE> C. Annex III is modified as follows: 1. Anti-infectious agents 1.2. Antibiotics 1.2.7. Naphtalene-ringed ansamycin >TABLE>