CELEX: 32020R0377
Language: en
Date: 2020-03-05 00:00:00
Title: Commission Implementing Regulation (EU) 2020/377 of 5 March 2020 concerning the authorisation of sodium selenate as a feed additive for ruminants (Text with EEA relevance)

6.3.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 69/6
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/377
         of 5 March 2020
         concerning the authorisation of sodium selenate as a feed additive for ruminants
         (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 sodium selenate as a feed additive for ruminants.
                  
               
                     (3)
                  
                  
                     The applicant requested sodium selenate to be classified in the additive category ‘nutritional additives’. The 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 3 July 2019 (2) that, under the proposed conditions of use, sodium selenate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the additive is considered a skin and eye irritant and a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of selenium for ruminants. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Article 21 of Regulation (EC) No 1831/2003.
                  
               
                     (5)
                  
                  
                     The assessment of sodium selenate 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 additive 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 Plants, Animals, Food and Feed,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            The substance 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, 5 March 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2019;17(7):5788.
      
      
         
            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
                     
                  
                        Selenium in mg/kg of complete feed with a moisture content of 12 %
                     
                  
                        
                           Category of nutritional additives. Functional group: compounds of trace elements
                        
                     
                  
                        3b803
                     
                     
                         
                     
                     
                        Sodium selenate
                     
                     
                        
                           Characterisation of the additive
                        
                        Sodium selenate, as a powder, with a minimum content of 41 % selenium
                        
                           Characterisation of the active substance
                        
                        Disodium selenate
                        Chemical formula: Na2SeO4
                        
                        CAS number 13410-01-0
                        
                           Analytical method
                            (1)
                        
                        For the quantification of total selenium in the feed additive:
                        
                                    —
                                 
                                 
                                    Titration
                                 
                              For the quantification of total sodium in sodium selenate:
                        
                                    —
                                 
                                 
                                    Atomic Absorption Spectrometry (AAS) – EN ISO 6869:2000; or
                                 
                              
                                    —
                                 
                                 
                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) – EN 15510:2007
                                 
                              For the quantification of total selenium in premixtures, feed materials and compound feed:
                        
                                    —
                                 
                                 
                                    Hydride Generation Atomic Absorption Spectrometry (HGAAS) after microwave digestion – EN 16159:2012
                                 
                              
                     
                        Ruminants
                     
                     
                        —
                     
                     
                         
                     
                     
                        0,50 (total)
                     
                     
                        
                                    1.
                                 
                                 
                                    Sodium selenate may be placed on the market and used as an additive consisting of a preparation.
                                 
                              
                                    2.
                                 
                                 
                                    The additive shall be incorporated into feed in the form of a premixture.
                                 
                              
                                    3.
                                 
                                 
                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.
                                 
                              
                     
                        26 March 2030
                     
                  
               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports