CELEX: 32019R1315
Language: en
Date: 2019-08-02 00:00:00
Title: Commission Implementing Regulation (EU) 2019/1315 of 2 August 2019 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive (in water for drinking) for sows (holder of authorisation Lactosan GmbH &amp; Co) (Text with EEA relevance.)

5.8.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 205/7
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1315
         of 2 August 2019
         concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive (in water for drinking) for sows (holder of authorisation Lactosan GmbH & Co)
         (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 a preparation of Enterococcus faecium DSM 7134 as a feed additive for sows. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
                  
               
                     (3)
                  
                  
                     That application concerns the authorisation of a preparation of Enterococcus faecium DSM 7134 to be used in water for drinking, to be classified in the additive category ‘zootechnical additives’.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 January 2019 (2) that, under the proposed conditions of use, the preparation of Enterococcus faecium DSM 7134 does not have an adverse effect on animal health or the environment. However, it also concluded that the additive is considered as 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 has a potential to be efficacious to improve zootechnical parameters in water for drinking, for sows. 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 the preparation of Enterococcus faecium DSM 7134 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that 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 Plants, Animals, Food and Feed,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            Authorisation
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition as set out in that Annex.
         
         
            Article 2
            Entry into force
            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, 2 August 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2019;17(2):5612.
      
      
         
            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
                     
                  
                        CFU/l of water for drinking
                     
                  
                        
                           Category of zootechnical additives. Functional group: gut flora stabilisers.
                        
                     
                  
                        4b1841
                     
                     
                        Lactosan Starterkulturen GmbH & Co
                     
                     
                        
                           Enterococcus faecium DSM 7134
                     
                     
                        
                           Additive composition
                        
                        Preparation of Enterococcus faecium DSM 7134 containing a minimum of:
                        Powder: 1 × 1010 CFU/g of additive
                        
                           Characterisation of the active substance
                        
                        Viable cells of Enterococcus faecium DSM 7134
                        
                           Analytical method
                            (1)
                        
                        For enumeration: spread plate method using bile esculin azide agar (EN 15788)
                        For identification: pulsed field gel electrophoresis (PFGE)
                     
                     
                        Sows
                     
                     
                        —
                     
                     
                        2,5 × 108
                        
                     
                     
                        —
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment including breathing protection and gloves.
                                 
                              
                                    3.
                                 
                                 
                                    For use of the additive in water for drinking the homogeneous dispersion of the additive shall be ensured.
                                 
                              
                     
                        25 August 2029
                     
                  
               (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