CELEX: 32012R0269
Language: en
Date: 2012-03-26 00:00:00
Title: Commission Implementing Regulation (EU) No 269/2012 of 26 March 2012 concerning the authorisation of dicopper chloride trihydroxide as feed additive for all animal species  Text with EEA relevance

27.3.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 89/3
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 269/2012
   of 26 March 2012
   concerning the authorisation of dicopper chloride trihydroxide as feed additive for all animal species
   (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.
            
         
               (2)
            
            
               In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of dicopper chloride trihydroxide. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               The application concerns the authorisation of dicopper chloride trihydroxide as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 September 2011 (2) that, under the proposed conditions of use, dicopper chloride trihydroxide does not have an adverse effect on animal health, human health or the environment and that its use may be considered as an effective source of copper for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of dicopper chloride trihydroxide 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)
            
            
               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, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
   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.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 26 March 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2011; 9(9):2355.
   
      ANNEX
      
                  Identification number of the additive
               
               
                  Name of the holder of authorisation
               
               
                  Additive
               
               
                  Composition, chemical formula, description, analytical method
               
               
                  Species or category of animal
               
               
                  Maximum age
               
               
                  Minimum content
               
               
                  Maximum content
               
               
                  Other provisions
               
               
                  End of period of authorisation
               
            
                  Content of element (Cu) in mg/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Category of nutritional additives. Functional group: compounds of trace elements
                  
               
            
                  3b409
               
               
                  —
               
               
                  Dicopper chloride trihydroxide
               
               
                  
                               
                           
                           
                              
                                 Characterisation of the additive:
                              
                                           
                                       
                                       
                                          Chemical formula: Cu2(OH)3Cl
                                       
                                    
                                           
                                       
                                       
                                          CAS Number: 1332-65-6
                                       
                                    
                                           
                                       
                                       
                                          crystal form atacamite/paratacamite in a 1:1 to 1:1,5 ratio
                                       
                                    
                                           
                                       
                                       
                                          Purity: min. 90 %
                                       
                                    
                                           
                                       
                                       
                                          alpha-crystal: min. 95 % in the crystalline product
                                       
                                    
                                           
                                       
                                       
                                          Cu content: min. 53 %
                                       
                                    
                                           
                                       
                                       
                                          Particles < 50 μm: below 1 %
                                       
                                    
                        
                               
                           
                           
                              
                                 Analytical method
                                  (1):
                              
                                           
                                       
                                       
                                          For the identification of dicopper chloride trihydroxide atacamite/paratacamite crystal forms in the additive: X-ray diffraction (XRD).
                                       
                                    
                                           
                                       
                                       
                                          For the determination of total copper in the additive and premixtures:
                                          
                                                      —
                                                   
                                                   
                                                      EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), or
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      CEN/TS 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion.
                                                   
                                                
                                    
                                           
                                       
                                       
                                          For the determination of total copper in feed materials and compound feed:
                                          
                                                      —
                                                   
                                                   
                                                      Atomic Absorption Spectrometry (AAS), or
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      EN 15510, or
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      CEN/TS 15621.
                                                   
                                                
                                    
                        
               
                  All animal species
               
               
                  —
               
               
                  —
               
               
                  Bovine
                  
                              —
                           
                           
                              Bovine before the start of rumination: 15 (total)
                           
                        
                              —
                           
                           
                              Other bovine: 35 (total)
                           
                        Ovine: 15 (total)
                  Piglets up to 12 weeks: 170 (total)
                  Crustaceans: 50 (total)
                  Other animals: 25 (total)
               
               
                  
                              1.
                           
                           
                              The additive shall be incorporated into feed in the form of a premixture.
                           
                        
                              2.
                           
                           
                              For user safety: breathing protection, safety glasses and gloves should be worn during handling.
                           
                        
                              3.
                           
                           
                              The following words shall be included in the labelling:
                              
                                          —
                                       
                                       
                                          For feed for sheep if the level of copper in the feed exceeds 10 mg/kg:
                                          
                                             ‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’
                                          
                                       
                                    
                                          —
                                       
                                       
                                          For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:
                                          
                                             ‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’
                                          
                                       
                                    
                        
               
                  16 April 2022
               
            
         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx