CELEX: 32013R0445
Language: en
Date: 2013-05-14 00:00:00
Title: Commission Implementing Regulation (EU) No 445/2013 of 14 May 2013 concerning the authorisation of hydroxy-analogue of selenomethionine as a feed additive for all animal species  Text with EEA relevance

15.5.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 130/21
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 445/2013
   of 14 May 2013
   concerning the authorisation of hydroxy-analogue of selenomethionine as a 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 hydroxy-analogue of selenomethionine. The 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 hydroxy-analogue of selenomethionine, an organic compound of selenium, 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 11 December 2012 (2) that, under the proposed conditions of use, hydroxy-analogue of selenomethionine 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 selenium 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 hydroxy-analogue of selenomethionine 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 Authority concluded that the limitation of the supplementation with organic selenium should apply to the already authorised organic selenium compounds, the selenised yeasts, and hydroxy-analogue of selenomethionine. Thus, in case inorganic compounds of selenium are also added to the feed, the supplementation with organic selenium should not exceed 0,2 mg per kg complete feed.
            
         
               (7)
            
            
               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, 14 May 2013.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2013; 11(1):3046.
   
      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 (Se) in mg/kg of complete feed with a moisture content of 12 %
               
            
                  
                     Category of nutritional additives. Functional group: compounds of trace elements
                  
               
            
                  3b814
               
               
                  —
               
               
                  Hydroxy-analogue of selenomethionine
               
               
                  
                               
                           
                           
                              
                                 Characterisation of the additive
                              
                              
                                           
                                       
                                       
                                          Solid and liquid preparation of Hydroxy-analogue of selenomethionine
                                       
                                    
                                           
                                       
                                       
                                          Content of selenium: 18 000 to 24 000 mg Se/kg
                                       
                                    
                                           
                                       
                                       
                                          Organic selenium > 99 % of total Se
                                       
                                    
                                           
                                       
                                       
                                          Hydroxy-analogue of selenomethionine > 98 % of total Se
                                       
                                    
                                           
                                       
                                       
                                          Solid preparation: 5 % Hydroxy-analogue of selenomethionine and 95 % carrier
                                       
                                    
                                           
                                       
                                       
                                          Liquid preparation: 5 % Hydroxy-analogue of selenomethionine and 95 % distilled water
                                       
                                    
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              
                                           
                                       
                                       
                                          Organic selenium from hydroxy-analogue of selenomethionine (R,S-2-hydroxy-4-methylselenobutanoic acid)
                                       
                                    
                                           
                                       
                                       
                                          Chemical formula: C5H10O3Se
                                       
                                    
                                           
                                       
                                       
                                          CAS number 873660-49-2
                                       
                                    
                        
                               
                           
                           
                              
                                 Analytical method
                                  (1)
                              
                              
                                           
                                       
                                       
                                          For the determination of hydroxy analogue of methionine in the feed additive:
                                          
                                                      —
                                                   
                                                   
                                                      High performance liquid chromatography coupled to UV detection at 220 nm (HPLC-UV)
                                                   
                                                
                                    
                                           
                                       
                                       
                                          For the determination of total selenium in the feed additive:
                                          
                                                      —
                                                   
                                                   
                                                      Inductively coupled plasma mass spectrometry (ICPMS) after microwave digestion with HNO3/H2O2, or
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Inductively coupled plasma atomic emission spectrometry (ICPAES) after digestion with HNO3/HCl
                                                   
                                                
                                    
                                           
                                       
                                       
                                          For the determination of total selenium in premixtures and feed:
                                          
                                                      —
                                                   
                                                   
                                                      Hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion with HNO3/H2O2 (EN 16159:2012)
                                                   
                                                
                                    
                        
               
                  All species
               
               
                  —
               
               
                   
               
               
                  0,50 (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.
                           
                           
                              Maximum supplementation with organic selenium:
                              0,20 mg Se/kg of complete feed with a moisture content of 12 %.
                           
                        
               
                  4 June 2023
               
            
         (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/authorisation/evaluation_reports/Pages/index.aspx