CELEX: 32004R1646
Language: en
Date: 2004-09-20 00:00:00
Title: Commission Regulation (EC) No 1646/2004 of 20 September 2004 amending Annex I 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)

21.9.2004   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 296/5
            
         
      COMMISSION REGULATION (EC) No 1646/2004
   of 20 September 2004
   amending Annex I 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 establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1), and in particular Articles 6, 7 and 8 thereof;
   Whereas:
   
               (1)
            
            
               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.
            
         
               (2)
            
            
               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.
            
         
               (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 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).
            
         
               (4)
            
            
               In view of the reduced availability of veterinary medicinal products for certain food-producing species (2), maximum residue limits may be established by methods of extrapolation from maximum residue limits set for other species on a strictly scientific basis.
            
         
               (5)
            
            
               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, the 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.
            
         
               (6)
            
            
               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.
            
         
               (7)
            
            
               Albendazole, Febantel, Fenbendazole, Oxfendazole, Thiabendazole, Oxyclozanide, Amitraz, Cypermethrin, Deltamethrin and Dexamethasone should be inserted into Annex I to Regulation (EEC) No 2377/90;
            
         
               (8)
            
            
               An adequate period 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 authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC (3) of the European Parliament and of the Council to take account of the provisions of this Regulation.
            
         
               (9)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products.
            
         HAS ADOPTED THE FOLLOWING REGULATION:
   Article 1
   Annex I to Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex hereto.
   Article 2
   This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.
   It shall apply from the sixtieth day following its publication.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 September 2004.
      
         
            For the Commission
         
         Olli REHN
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1101/2004 (OJ L 211, 12.6.2004, p. 3).
   
      (2)  Availability of veterinary medicinal products Communication from the Commission to the Council and the European Parliament COM(2000) 806 final.
   
      (3)  OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).
   
      ANNEX
      The following substance(s) is(are) inserted in Annex I:
      
                  2.
               
               
                  Antiparasitic agents
               
            
                  2.1.
               
               
                  Agents acting against endoparasites
               
            
                  2.1.3.
               
               
                  Benzimidazoles and pro-benzimidazoles
               
            
         
                     Pharmacologically active substance(s)
                  
                  
                     Marker residue
                  
                  
                     Animal species
                  
                  
                     MRLs
                  
                  
                     Target tissues
                  
               
                     
                        ‘Albendazole
                     
                  
                  
                     Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole
                  
                  
                     All ruminants
                  
                  
                     100 μg/kg
                  
                  
                     Muscle
                  
               
                     100 μg/kg
                  
                  
                     Fat
                  
               
                     1 000 μg/kg
                  
                  
                     Liver
                  
               
                     500 μg/kg
                  
                  
                     Kidney
                  
               
                     100 μg/kg
                  
                  
                     Milk
                  
               
                     
                        Febantel
                     
                  
                  
                     Sum of extractable residues which may be oxidised to oxfendazole sulphone
                  
                  
                     All ruminants
                  
                  
                     50 μg/kg
                  
                  
                     Muscle
                  
               
                     50 μg/kg
                  
                  
                     Fat
                  
               
                     500 μg/kg
                  
                  
                     Liver
                  
               
                     50 μg/kg
                  
                  
                     Kidney
                  
               
                     10 μg/kg
                  
                  
                     Milk
                  
               
                     
                        Fenbendazole
                     
                  
                  
                     Sum of extractable residues which may be oxidised to oxfendazole sulphone
                  
                  
                     All ruminants
                  
                  
                     50 μg/kg
                  
                  
                     Muscle
                  
               
                     50 μg/kg
                  
                  
                     Fat
                  
               
                     500 μg/kg
                  
                  
                     Liver
                  
               
                     50 μg/kg
                  
                  
                     Kidney
                  
               
                     10 μg/kg
                  
                  
                     Milk
                  
               
                     
                        Oxfendazole
                     
                  
                  
                     Sum of extractable residues which may be oxidised to oxfendazole sulphone
                  
                  
                     All ruminants
                  
                  
                     50 μg/kg
                  
                  
                     Muscle
                  
               
                     50 μg/kg
                  
                  
                     Fat
                  
               
                     500 μg/kg
                  
                  
                     Liver
                  
               
                     50 μg/kg
                  
                  
                     Kidney
                  
               
                     10 μg/kg
                  
                  
                     Milk
                  
               
                     
                        Thiabendazole
                     
                  
                  
                     Sum of thiabendazole and 5-hydroxythiabendazole
                  
                  
                     Caprine
                  
                  
                     100 μg/kg
                  
                  
                     Muscle
                  
               
                     100 μg/kg
                  
                  
                     Fat
                  
               
                     100 μg/kg
                  
                  
                     Liver
                  
               
                     100 μg/kg
                  
                  
                     Kidney
                  
               
                     100 μg/kg
                  
                  
                     Milk’
                  
               
      
                  2.1.4.
               
               
                  Phenol derivatives including salicylanides
               
            
         
                     Pharmacologically active substance(s)
                  
                  
                     Marker residue
                  
                  
                     Animal species
                  
                  
                     MRLs
                  
                  
                     Target tissues
                  
               
                     
                        ‘Oxyclozanide
                     
                  
                  
                     Oxyclozanide
                  
                  
                     All ruminants
                  
                  
                     20 μg/kg
                  
                  
                     Muscle
                  
               
                     20 μg/kg
                  
                  
                     Fat
                  
               
                     500 μg/kg
                  
                  
                     Liver
                  
               
                     100 μg/kg
                  
                  
                     Kidney
                  
               
                     10 μg/kg
                  
                  
                     Milk’
                  
               
      
                  2.2.
               
               
                  Agents acting against ectoparasites
               
            
                  2.2.2.
               
               
                  Formamidines
               
            
         
                     Pharmacologically active substance(s)
                  
                  
                     Marker residue
                  
                  
                     Animal species
                  
                  
                     MRLs
                  
                  
                     Target tissues
                  
               
                     
                        ‘Amitraz
                     
                  
                  
                     Sum of amitraz and all metabolites containing the 2,4-dimethylaniline moiety, expressed as amitraz
                  
                  
                     Caprine
                  
                  
                     200 μg/kg
                  
                  
                     Fat
                  
               
                     100 μg/kg
                  
                  
                     Liver
                  
               
                     200 μg/kg
                  
                  
                     Kidney
                  
               
                     10 μg/kg
                  
                  
                     Milk’
                  
               
      
                  2.2.3.
               
               
                  Pyrethroids
               
            
         
                     Pharmacologically active substance(s)
                  
                  
                     Marker residue
                  
                  
                     Animal species
                  
                  
                     MRLs
                  
                  
                     Target tissues
                  
               
                     
                        ‘Cypermethrin
                     
                  
                  
                     Cypermethrin (sum of isomers)
                  
                  
                     All ruminants
                  
                  
                     20 μg/kg
                  
                  
                     Muscle
                  
               
                     200 μg/kg
                  
                  
                     Fat
                  
               
                     20 μg/kg
                  
                  
                     Liver
                  
               
                     20 μg/kg
                  
                  
                     Kidney
                  
               
                     20 μg/kg
                  
                  
                     Milk (1)
                     
                  
               
                     
                        Deltamethrin
                     
                  
                  
                     Deltamethrin
                  
                  
                     All ruminants
                  
                  
                     10 μg/kg
                  
                  
                     Muscle
                  
               
                     50 μg/kg
                  
                  
                     Fat
                  
               
                     10 μg/kg
                  
                  
                     Liver
                  
               
                     10 μg/kg
                  
                  
                     Kidney
                  
               
                     20 μg/kg
                  
                  
                     Milk
                  
               
      
                  5.
               
               
                  Corticoids
               
            
                  5.1.
               
               
                  Glucocorticoids
               
            
         
                     Pharmacologically active substance(s)
                  
                  
                     Marker residue
                  
                  
                     Animal species
                  
                  
                     MRLs
                  
                  
                     Target tissues
                  
               
                     
                        ‘Dexamethasone
                     
                  
                  
                     Dexamethasone
                  
                  
                     Caprine
                  
                  
                     0,75 μg/kg
                  
                  
                     Muscle
                  
               
                     2 μg/kg
                  
                  
                     Liver
                  
               
                     0,75 μg/kg
                  
                  
                     Kidney
                  
               
                     0,3 μg/kg
                  
                  
                     Milk’
                  
               
      
         (1)  Further provisions in Commission Directive 98/82/EC are to be observed (OJ L290, 29.10.1998, p. 25).’