CELEX: 32008R0976
Language: en
Date: 2008-10-06 00:00:00
Title: Commission Regulation (EC) No 976/2008 of 6 October 2008 amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive Clinacox , belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)

7.10.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 266/3
            
         
      COMMISSION REGULATION (EC) No 976/2008
   of 6 October 2008
   amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive ‘Clinacox’, belonging to the group of coccidiostats and other medicinal substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 13(3) thereof,
   Whereas:
   
               (1)
            
            
               The additive diclazuril (Clinacox 0,5 % Premix), belonging to the group of coccidiostats and other medicinal substances, was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). Commission Regulations (EC) No 2430/1999 (3), (EC) No 418/2001 (4) and (EC) No 162/2003 (5) authorised that additive for 10 years for use for chickens for fattening, turkeys for fattening and chickens reared for laying respectively, linking the authorisation to the person responsible for putting that additive into circulation. That additive was notified as an existing product in accordance with Article 10 of Regulation (EC) No 1831/2003. Since all the information required under that provision was submitted, that additive was entered into the Community Register of Feed Additives.
            
         
               (2)
            
            
               Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive diclazuril (Clinacox 0,5 % Premix) has submitted an application with which it proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority. At the same time it provided the necessary data to support that request.
            
         
               (3)
            
            
               In its opinion adopted on 16 April 2008 (6), the Authority concluded that no MRLs are required for chickens and turkeys for fattening. However, in case MRLs were considered necessary, it suggested values. Because it is possible that the chickens reared for laying enter in the food chain, not separately from the other chickens, it is necessary to consider the possibility to provide MRLs also for that animal category. It also considered that applying a withdrawal period of zero days would not compromise consumer safety.
            
         
               (4)
            
            
               To ensure a high level of safety for the consumers and to improve the controls of the correct use of diclazuril, it is appropriate to establish MRLs as proposed by the Authority. Because there are no relevant physiological differences between the chickens for fattening and chickens reared for laying it is appropriate to establish the same MRLs also for the latter category.
            
         
               (5)
            
            
               Commission Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 should therefore be amended accordingly.
            
         
               (6)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   In Annex I to Regulation (EC) No 2430/1999 the line for E 771 is replaced by the text in Annex I to this Regulation.
   Article 2
   Annex III to Regulation (EC) No 418/2001 is replaced by the text in Annex II to this Regulation.
   Article 3
   The Annex to Regulation (EC) No 162/2003 is replaced by the text in Annex III to this Regulation.
   Article 4
   This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 6 October 2008.
      
         
            For the Commission
         
         Androulla VASSILIOU
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 270, 14.12.1970, p. 1.
   
      (3)  OJ L 296, 17.11.1999, p. 3.
   
      (4)  OJ L 62, 2.3.2001, p. 3.
   
      (5)  OJ L 26, 31.1.2003, p. 3.
   
      (6)  Updated Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the Maximum Residue Limits for Clinacox 0,5 % (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying. The EFSA Journal (2008) 696, 1-12.
   
      ANNEX I
      
         
                     Registration number of additive
                  
                  
                     Name and registration number of person responsible for putting additive into circulation
                  
                  
                     Additive
                     (trade name)
                  
                  
                     Composition, chemical formula, description
                  
                  
                     Species or category of animal
                  
                  
                     Maximum age
                  
                  
                     Minimum content
                  
                  
                     Maximum content
                  
                  
                     Other provisions
                  
                  
                     End of period of authorisation
                  
                  
                     Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
                  
               
                     mg of active substance/kg of complete feedingstuff
                  
               
                     Coccidiostats and other medicinal substances
                  
               
                     ‘E 771
                  
                  
                     Janssen Pharmaceutica nv
                  
                  
                     Diclazuril
                     0,5 g/100 g
                     (Clinacox 0,5 % Premix)
                     Diclazuril
                     0,2 g/100 g
                     (Clinacox 0,2 % Premix)
                  
                  
                     
                                  
                              
                              
                                 
                                    Additive composition:
                                 
                                              
                                          
                                          
                                             Diclazuril: 0,5 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Soybean meal: 99,25 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Polyvidone K 30: 0,2 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Sodium hydroxide: 0,0538 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Diclazuril: 0,2 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Soybean meal: 39,7 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Polyvidone K 30: 0,08 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Sodium hydroxide: 0,0215 g/100 g
                                          
                                       
                                              
                                          
                                          
                                             Wheat middling: 60 g/100 g
                                          
                                       
                           
                                  
                              
                              
                                 
                                    Active substance:
                                 
                                              
                                          
                                          
                                             Diclazuril
                                             C17H9Cl3N4O2,
                                             (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,
                                          
                                       
                                              
                                          
                                          
                                             CAS number: 101831-37-2
                                          
                                       
                           
                                  
                              
                              
                                 
                                    Related impurities:
                                 
                                              
                                          
                                          
                                             Degradation compound (R064318): ≤ 0,2 %
                                          
                                       
                                              
                                          
                                          
                                             Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually
                                          
                                       
                                              
                                          
                                          
                                             Total impurities: ≤ 1,5 %
                                          
                                       
                           
                  
                     Chickens for fattening
                  
                  
                     —
                  
                  
                     1
                  
                  
                     1
                  
                  
                     —
                  
                  
                     30.9.2009
                  
                  
                     1 500 μg diclazuril/kg of wet liver
                     1 000 μg diclazuril/kg of wet kidney
                     500 μg diclazuril/kg of wet muscle
                     500 μg diclazuril/kg of wet skin/fat’
                  
               
   
   
      ANNEX II
      
         
            ‘ANNEX III
            
                        Registration number of additive
                     
                     
                        Name and registration number of person responsible for putting additive into circulation
                     
                     
                        Additive
                        (trade name)
                     
                     
                        Composition, chemical formula, description
                     
                     
                        Species or category of animal
                     
                     
                        Maximum age
                     
                     
                        Minimum content
                     
                     
                        Maximum content
                     
                     
                        Other provisions
                     
                     
                        End of period of authorisation
                     
                     
                        Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
                     
                  
                        mg of active substance/kg of complete feedingstuff
                     
                  
                        Coccidiostats and other medicinal substances
                     
                  
                        E 771
                     
                     
                        Janssen Pharmaceutica nv
                     
                     
                        Diclazuril
                        0,5 g/100 g
                        (Clinacox 0,5 % Premix)
                        Diclazuril
                        0,2 g/100 g
                        (Clinacox 0,2 % Premix)
                     
                     
                        
                                     
                                 
                                 
                                    
                                       Additive composition:
                                    
                                    
                                                 
                                             
                                             
                                                Diclazuril: 0,5 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Soybean meal: 99,25 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Polyvidone K 30: 0,2 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Sodium hydroxide: 0,0538 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Diclazuril: 0,2 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Soybean meal: 39,7 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Polyvidone K 30: 0,08 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Sodium hydroxide: 0,0215 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Wheat middling: 60 g/100 g
                                             
                                          
                              
                                     
                                 
                                 
                                    
                                       Active substance:
                                    
                                    
                                                 
                                             
                                             
                                                Diclazuril
                                             
                                          
                                                 
                                             
                                             
                                                C17H9Cl3N4O2,
                                             
                                          
                                                 
                                             
                                             
                                                (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,
                                             
                                          
                                                 
                                             
                                             
                                                CAS number: 101831-37-2
                                             
                                          
                              
                                     
                                 
                                 
                                    
                                       Related impurities:
                                    
                                    
                                                 
                                             
                                             
                                                Degradation compound (R064318): ≤ 0,2 %
                                             
                                          
                                                 
                                             
                                             
                                                Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually
                                             
                                          
                                                 
                                             
                                             
                                                Total impurities: ≤ 1,5 %
                                             
                                          
                              
                     
                        Turkeys for fattening
                     
                     
                        12 weeks
                     
                     
                        1
                     
                     
                        1
                     
                     
                        —
                     
                     
                        28.2.2011
                     
                     
                        1 500 μg diclazuril/kg of wet liver
                        1 000 μg diclazuril/kg of wet kidney
                        500 μg diclazuril/kg of wet muscle
                        500 μg diclazuril/kg of wet skin/fat’
                     
                  
      
   
   
      ANNEX III
      
         
            ‘ANNEX
            
                        Registration number of additive
                     
                     
                        Name and registration number of person responsible for putting additive into circulation
                     
                     
                        Additive
                        (trade name)
                     
                     
                        Composition, chemical formula, description
                     
                     
                        Species or category of animal
                     
                     
                        Maximum age
                     
                     
                        Minimum content
                     
                     
                        Maximum content
                     
                     
                        Other provisions
                     
                     
                        End of period of authorisation
                     
                     
                        Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
                     
                  
                        mg of active substance/kg of complete feedingstuff
                     
                  
                        Coccidiostats and other medicinal substances
                     
                  
                        E 771
                     
                     
                        Janssen Pharmaceutica nv
                     
                     
                        Diclazuril
                        0,5 g/100 g
                        (Clinacox 0,5 % Premix)
                        Diclazuril
                        0,2 g/100 g
                        (Clinacox 0,2 % Premix)
                     
                     
                        
                                     
                                 
                                 
                                    
                                       Additive composition:
                                    
                                    
                                                 
                                             
                                             
                                                Diclazuril: 0,5 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Soybean meal: 99,25 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Polyvidone K 30: 0,2 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Sodium hydroxide: 0,0538 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Diclazuril: 0,2 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Soybean meal: 39,7 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Polyvidone K 30: 0,08 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Sodium hydroxide: 0,0215 g/100 g
                                             
                                          
                                                 
                                             
                                             
                                                Wheat middling: 60 g/100 g
                                             
                                          
                              
                                     
                                 
                                 
                                    
                                       Active substance:
                                    
                                    
                                                 
                                             
                                             
                                                Diclazuril
                                             
                                          
                                                 
                                             
                                             
                                                C17H9Cl3N4O2,
                                             
                                          
                                                 
                                             
                                             
                                                (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,
                                             
                                          
                                                 
                                             
                                             
                                                CAS number: 101831-37-2
                                             
                                          
                              
                                     
                                 
                                 
                                    
                                       Related impurities:
                                    
                                    
                                                 
                                             
                                             
                                                Degradation compound (R064318): ≤ 0,2 %
                                             
                                          
                                                 
                                             
                                             
                                                Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually
                                             
                                          
                                                 
                                             
                                             
                                                Total impurities: ≤ 1,5 %
                                             
                                          
                              
                     
                        Chickens reared for laying
                     
                     
                        16 weeks
                     
                     
                        1
                     
                     
                        1
                     
                     
                        —
                     
                     
                        20.1.2013
                     
                     
                        1 500 μg diclazuril/kg of wet liver
                        1 000 μg diclazuril/kg of wet kidney
                        500 μg diclazuril/kg of wet muscle
                        500 μg diclazuril/kg of wet skin/fat’