CELEX: 32013R1235
Language: en
Date: 2013-12-02 00:00:00
Title: Commission Implementing Regulation (EU) No 1235/2013 of 2 December 2013 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance diclazuril  Text with EEA relevance

3.12.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 322/21
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 1235/2013
   of 2 December 2013
   amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance diclazuril
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,
   Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,
   Whereas:
   
               (1)
            
            
               The maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry are established in accordance with Regulation (EC) No 470/2009.
            
         
               (2)
            
            
               Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).
            
         
               (3)
            
            
               Diclazuril is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for all ruminants and porcine species, for oral use only, and for poultry, applicable to muscle, skin and fat, liver and kidney, excluding animals from which eggs are produced for human consumption.
            
         
               (4)
            
            
               An application for the extension of the existing entry for diclazuril applicable to rabbits has been submitted to the European Medicines Agency.
            
         
               (5)
            
            
               The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for diclazuril for rabbits, applicable to muscle, fat, liver and kidney.
            
         
               (6)
            
            
               Regulation (EU) No 37/2010 should therefore be amended to include the MRL for diclazuril in respect of rabbits.
            
         
               (7)
            
            
               It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.
            
         
               (8)
            
            
               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
   The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 3 February 2014.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 2 December 2013.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 152, 16.6.2009, p. 11.
   
      (2)  OJ L 15, 20.1.2010, p. 1.
   
      ANNEX
      In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for diclazuril is replaced by the following:
      
         
                     Pharmacologically active Substance
                  
                  
                     Marker residue
                  
                  
                     Animal Species
                  
                  
                     MRL
                  
                  
                     Target Tissues
                  
                  
                     Other Provisions
                     (according to Article 14(7) of Regulation (EC) No 470/2009)
                  
                  
                     Therapeutic Classification
                  
               
                     ‘Diclazuril
                  
                  
                     NOT APPLICABLE
                  
                  
                     All ruminants, porcine
                  
                  
                     No MRL required
                  
                  
                     NOT APPLICABLE
                  
                  
                     For oral use only
                  
                  
                     NO ENTRY
                  
               
                     Diclazuril
                  
                  
                     Poultry
                  
                  
                     500 μg/kg
                  
                  
                     Muscle
                  
                  
                     Not for use in animals from which eggs are produced for human consumption
                  
                  
                     Antiparasitic agents/Agents acting againsts protozoa’
                  
               
                     500 μg/kg
                  
                  
                     Skin and fat in natural proportions
                  
               
                     1 500 μg/kg
                  
                  
                     Liver
                  
               
                     1 000 μg/kg
                  
                  
                     Kidney
                  
               
                     Rabbit
                  
                  
                     150 μg/kg
                  
                  
                     Muscle
                  
                  
                      
                  
               
                     300 μg/kg
                  
                  
                     Fat
                  
               
                     2 500 μg/kg
                  
                  
                     Liver
                  
               
                     1 000 μg/kg
                  
                  
                     Kidney