CELEX: 32016R0576
Language: en
Date: 2016-04-14 00:00:00
Title: Commission Implementing Regulation (EU) 2016/576 of 14 April 2016 amending Regulation (EU) No 37/2010 as regards the substance ‘rafoxanide’ (Text with EEA relevance)

15.4.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 99/1
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2016/576
   of 14 April 2016
   amending Regulation (EU) No 37/2010 as regards the substance ‘rafoxanide’
   (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)
            
            
               Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘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 is established in a Regulation.
            
         
               (2)
            
            
               Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
            
         
               (3)
            
            
               Rafoxanide is currently included in that table as an allowed substance, for bovine and ovine species, applicable to muscle, fat, liver, kidney and milk. The provisional maximum residue limits for that substance set out for bovine and ovine milk expired on 31 December 2015.
            
         
               (4)
            
            
               An application for the extension of the time period applying to the provisional MRL for rafoxanide in bovine and ovine milk has been submitted to the European Medicines Agency (hereinafter ‘EMA’).
            
         
               (5)
            
            
               The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use has considered that an extension of the existing provisional MRL for rafoxanide in bovine and ovine milk would allow completion of scientific studies in progress and has therefore recommended the extension of the provisional MRL until 31 December 2017.
            
         
               (6)
            
            
               Regulation (EU) No 37/2010 should therefore be amended accordingly.
            
         
               (7)
            
            
               Since the provisional MRL for rafoxanide in bovine and ovine milk expired on 31 December 2015 and in order to protect the legitimate expectations of market operators regarding the use of that substance, the extension of the provisional MRL should enter into force as a matter of urgency and should apply with effect from 1 January 2016.
            
         
               (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 day of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2016.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 April 2016.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 152, 16.6.2009, p. 11.
   
      (2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
   
      ANNEX
      In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘rafoxanide’ 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
                  
               
                     ‘Rafoxanide
                  
                  
                     Rafoxanide
                  
                  
                     Bovine
                  
                  
                     30 μg/kg
                     30 μg/kg
                     10 μg/kg
                     40 μg/kg
                  
                  
                     Muscle
                     Fat
                     Liver
                     Kidney
                  
                  
                     NO ENTRY
                  
                  
                     Antiparasitic agents/Agents against endoparasites’
                  
               
                     Ovine
                  
                  
                     100 μg/kg
                     250 μg/kg
                     150 μg/kg
                     150 μg/kg
                  
                  
                     Muscle
                     Fat
                     Liver
                     Kidney
                  
               
                     Bovine, ovine
                  
                  
                     10 μg/kg
                  
                  
                     Milk
                  
                  
                     Provisional MRL shall expire on 31 December 2017