CELEX: 32020R0159
Language: en
Date: 2020-02-05 00:00:00
Title: Commission Implementing Regulation (EU) 2020/159 of 5 February 2020 concerning the renewal of the authorisation of Enterococcus faecium DSM 7134 as a feed additive for weaned piglets and pigs for fattening and repealing Regulation (EC) No 538/2007 (holder of authorisation Lactosan Starterkulturen GmbH & Co) (Text with EEA relevance)

6.2.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 34/22
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/159
         of 5 February 2020
         concerning the renewal of the authorisation of Enterococcus faecium DSM 7134 as a feed additive for weaned piglets and pigs for fattening and repealing Regulation (EC) No 538/2007 (holder of authorisation Lactosan Starterkulturen 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 and renewing such authorisation.
                  
               
                     (2)
                  
                  
                     
                        Enterococcus faecium DSM 7134 was authorised for 10 years as a feed additive for weaned piglets and pigs for fattening by Commission Regulation (EC) No 538/2007 (2).
                  
               
                     (3)
                  
                  
                     In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Enterococcus faecium DSM 7134 as a feed additive for weaned piglets and pigs for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 February 2019 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority concluded that Enterococcus faecium DSM 7134 remains safe under the authorised conditions of use for the target animals, consumers, users and the environment. The Authority also concluded that the additive is considered a potential 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.
                  
               
                     (5)
                  
                  
                     The assessment 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 authorisation of that additive should be renewed as specified in the Annex to this Regulation.
                  
               
                     (6)
                  
                  
                     As a consequence of the renewal of the authorisation of Enterococcus faecium DSM 7134 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 538/2007 should be repealed.
                  
               
                     (7)
                  
                  
                     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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.
         
         
            Article 2
            Regulation (EC) No 538/2007 is repealed.
         
         
            Article 3
            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 February 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  Commission Regulation (EC) No 538/2007 of 15 May 2007 concerning the authorisation of a new use of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive (OJ L 128, 16.5.2007, p. 16).
         
            (3)  EFSA Journal 2019; 17(3):5650.
      
      
         
            ANNEX
            
                        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
                     
                  
                        CFU/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        
                           Category of zootechnical additives. Functional group: gut flora stabilisers.
                        
                     
                  
                        4b1841
                     
                     
                        Lactosan
                        Starterkulturen
                        GmbH & Co
                     
                     
                        
                           Enterococcus faecium DSM 7134
                     
                     
                        
                           Additive composition:
                        
                        Preparation of Enterococcus faeciumDSM 7134
                        containing a minimum of:
                        Powder: 1x1010 CFU/g of additive
                        Granules (microencapsulated): 1x1010 CFU/g of additive
                     
                     
                        Piglets (weaned)
                     
                     
                        —
                     
                     
                        0,5 x 109
                        
                     
                     
                        4 x 109
                        
                     
                     
                        
                                    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, skin and eye protections.
                                 
                              
                     
                        26 February 2030
                     
                  
                        
                           Characterisation of the active substance:
                        
                        Viable cells of Enterococcus faeciumDSM 7134
                     
                  
                        
                           Analytical method
                            (1)
                        
                        For enumeration: spread plate method using bile esculin azide agar (EN 15788)
                        For identification: pulsed field gel electrophoresis (PFGE)
                     
                  
                         
                     
                     
                         
                     
                     
                         
                     
                     
                         
                     
                     
                        Pigs for fattening
                     
                     
                        —
                     
                     
                        0,2 x 109
                        
                     
                     
                        1 x 109
                        
                     
                     
                        26 February 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