CELEX: 32011R0532
Language: en
Date: 2011-05-31 00:00:00
Title: Commission Implementing Regulation (EU) No 532/2011 of 31 May 2011 concerning the authorisation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening (holder of authorisation Alpharma Belgium BVBA) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004  Text with EEA relevance

1.6.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 146/7
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 532/2011
   of 31 May 2011
   concerning the authorisation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening (holder of authorisation Alpharma Belgium BVBA) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004
   (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 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 9(2) thereof,
   Whereas:
   
               (1)
            
            
               Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
            
         
               (2)
            
            
               Robenidine hydrochloride, CAS number 25875-50-7, was authorised for 10 years in accordance with Directive 70/524/EEC as a coccidiostat for use on rabbits for breeding by Commission Regulation (EC) No 2430/1999 (3) and for use on turkeys, chickens for fattening and rabbits for fattening by Commission Regulation (EC) No 1800/2004 (4). The additive was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening, requesting that additive to be classified in the additive category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               The European Food Safety Authority (the Authority) concluded in its opinion of 7 March 2011 that, under the proposed conditions of use, robenidine hydrochloride does not have an adverse effect on animal health, human health or the environment, and that the additive is effective in controlling coccidiosis in rabbits for fattening and for breeding (5). It also verified the report on the method of analysis of the feed additive in feed submitted by the European Union Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of robenidine hydrochloride shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.
            
         
               (6)
            
            
               As a consequence of a new authorisation being granted by this Regulation, the entry in Regulation (EC) No 2430/1999 concerning robenidine hydrochloride for rabbits for breeding purposes is deleted.
            
         
               (7)
            
            
               As a further consequence of this new authorisation, the entry for robenidine hydrochloride in the Annex to Regulation (EC) No 1800/2004 should be amended.
            
         
               (8)
            
            
               Since the modifications to the conditions of authorisation are not related to safety reasons, it is appropriate to allow a transitional period for the disposal of existing stocks of pre-mixtures and compound feed containing this preparation, as authorised by Regulation (EC) No 2430/1999 for use on rabbits for breeding purposes and by Regulation (EC) No 1800/2004 for use on rabbits for fattening.
            
         
               (9)
            
            
               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
   The preparation specified in the Annex I, belonging to the additive category ‘coccidiostats and histomonostats’ is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
   Article 2
   In Annex I to Regulation (EC) No 2430/1999, the entry under registration number of additive E 758 concerning robenidine hydrochloride for rabbits for breeding purposes is deleted.
   Article 3
   The Annex to Regulation (EC) No 1800/2004 is amended in accordance with Annex II to this Regulation.
   Article 4
   Premixtures and compound feed labelled in accordance with Directive 70/524/EEC and containing robenidine hydrochloride, as authorised by Regulation (EC) No 2430/1999 for use on rabbits for breeding purposes and by Regulation (EC) No 1800/2004 for use on rabbits for fattening, may continue to be placed on the market and used until the existing stocks are exhausted.
   Article 5
   This Regulation shall enter into force on the 20th day following 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, 31 May 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (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 317, 16.10.2004, p. 37.
   
      (5)  EFSA Journal 2011;9(3):2102.
   
      ANNEX I
      
                  Identification number of the additive
               
               
                  Name of the holder of authorisation
               
               
                  Additive
                  (Trade name)
               
               
                  Composition, chemical formula, description, analytical method
               
               
                  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 with a moisture content of 12 %
               
            
                  
                     Coccidiostats and histomonostats
                  
               
            
                  5 1 758
               
               
                  Alpharma Belgium BVBA
               
               
                  Robenidine hydrochloride 66g/kg
                  (Cycostat 66G)
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              
                                           
                                       
                                       
                                          Robenidine hydrochloride: 66 g/kg
                                       
                                    
                                           
                                       
                                       
                                          Lignosulfonate: 40 g/kg
                                       
                                    
                                           
                                       
                                       
                                          Calcium sulphate dihydrate: 894 g/kg
                                       
                                    
                        
                               
                           
                           
                              
                                 Active substance
                              
                              Robenidine hydrochloride,
                              C15H13Cl2N5 . HCl,
                              CAS number: 25875-50-7,
                              1,3-bis [(p-chlorobenzylidene) amino]-guanidine hydrochloride: > 97 %
                              Related impurities:
                              
                                           
                                       
                                       
                                          N,N',N''-Tris[(p-Cl-benzylidene)amino]guanidine (TRIS): ≤ 0,5 %
                                       
                                    
                                           
                                       
                                       
                                          Bis-4[4-Cl-benzylidene]hydrazine (AZIN): ≤ 0,5 %
                                       
                                    
                        
                               
                           
                           
                              
                                 Analytical methods
                                  (1)
                              
                              Determination of robenidine hydrochloride in feed: reverse phase high performance liquid chromatography coupled to ultraviolet spectrometry (HPLC/UV) in accordance with Method E in Annex IV to Commission Regulation (EC) No 152/2009 (2).
                           
                        
               
                  Rabbits for breeding
               
               
                  —
               
               
                  50
               
               
                  66
               
               
                  
                              1.
                           
                           
                              The additive shall be incorporated in compound feed in the form of a pre-mixture.
                           
                        
                              2.
                           
                           
                              Robenidine hydrochloride shall not be mixed with other coccidiostats.
                           
                        
                              3.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
                              4.
                           
                           
                              A post-market monitoring program on the resistance to Eimeria spp. shall be planned and executed by the holder of authorisation.
                           
                        
                              5.
                           
                           
                              Use is prohibited at least 5 days before slaughter.
                           
                        
               
                  21 June 2021
               
               
                  200 μg/kg wet weight for liver and kidney
                  100 μg /kg wet weight for all other tissues
               
            
                  Rabbits for fattening
               
               
                  50
               
               
                  66
               
            
         (1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
      
         (2)  OJ L 54, 26.2.2009, p. 1.
   
   
      ANNEX II
      The Annex to Regulation (EC) No 1800/2004 is replaced by the following:
      
         
            ‘ANNEX
            
                        Registration number of the additive
                     
                     
                        Name and the registration number of the 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
                     
                  
                        mg of active substance/kg of complete feedingstuff
                     
                  
                        
                           Coccidiostats and other medicinal substances
                        
                     
                  
                        E 758
                     
                     
                        Alpharma Belgium BVBA
                     
                     
                        Robenidine hydrochloride 66 g/kg
                        (Cycostat 66G)
                     
                     
                        
                                     
                                 
                                 
                                    
                                       Additive composition
                                    
                                    
                                                 
                                             
                                             
                                                Robenidine hydrochloride: 66 g/kg
                                             
                                          
                                                 
                                             
                                             
                                                Lignosulfonate: 40 g/kg
                                             
                                          
                                                 
                                             
                                             
                                                Calcium sulphate dihydrate: 894 g/kg
                                             
                                          
                              
                                     
                                 
                                 
                                    
                                       Active substance
                                    
                                    Robenidine hydrochloride,
                                    C15H13Cl2N5. HCl,
                                    1,3-bis [(p-chlorobenzylidene) amino]-guanidine hydrochloride CAS number: 25875-50-7,
                                    Related impurities:
                                    
                                                 
                                             
                                             
                                                N,N',N''-Tris[(p-Cl-benzylidene)amino]guanidine (TRIS): ≤ 0,5 %
                                             
                                          
                                                 
                                             
                                             
                                                Bis-4[4-Cl-benzylidene]hydrazine (AZIN): ≤ 0,5 %
                                             
                                          
                              
                     
                        Chickens for fattening
                     
                     
                        —
                     
                     
                        30
                     
                     
                        36
                     
                     
                        Use is prohibited at least 5 days before slaughter.
                     
                     
                        29 October 2014
                     
                  
                        Turkeys
                     
                     
                        30
                     
                     
                        36
                     
                     
                        Use is prohibited at least 5 days before slaughter.
                     
                     
                        29 October 2014’