CELEX: 32017R0930
Language: en
Date: 2017-05-31 00:00:00
Title: Commission Implementing Regulation (EU) 2017/930 of 31 May 2017 concerning the authorisation of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species and amending Implementing Regulation (EU) No 1016/2013 (Text with EEA relevance. )

1.6.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 141/6
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/930
      of 31 May 2017
      concerning the authorisation of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species and amending Implementing Regulation (EU) No 1016/2013
      (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) and Article 13(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 a new use of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family and for an amendment of the terms of the current authorisation for pigs granted by Commission Implementing Regulation (EU) No 1016/2013 (2). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support the amendment request.
               
            
                  (3)
               
               
                  The application concerns the authorisation of a new use of the preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species, to be classified in the additive category ‘technological additives’ and the modification of the terms of the current authorisation for pigs to extend the use to all trichothecene mycotoxins.
               
            
                  (4)
               
               
                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 December 2016 (3) that, under the proposed conditions of use, the preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family does not have an adverse effect on animal health, human health or the environment. The Authority recognised that the preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family has the capacity to reduce deoxynivalenol (DON) from contaminated feed. It concluded that the preparation has the capacity to reduce the 12,13-epoxide group in a number of representative trichothecenes and in other mycotoxins of the same structural type regardless of the animal species or category receiving contaminated feed. 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)
               
               
                  In order to allow for the use of the additive with other trichothecenes, it is appropriate to amend Implementing Regulation (EU) No 1016/2013.
               
            
                  (6)
               
               
                  The assessment of the preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family 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.
               
            
                  (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
      Authorisation
      The preparation specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Amendments to Implementing Regulation (EU) No 1016/2013
      The Annex to Implementing Regulation (EU) No 1016/2013 is replaced by Annex II to this Regulation.
      Article 3
      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, 31 May 2017.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (1)  OJ L 268, 18.10.2003, p. 29.
      
         (2)  Commission Implementing Regulation (EU) No 1016/2013 of 23 October 2013 concerning the authorisation of a preparation of micro-organism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for pigs (OJ L 282, 24.10.2013, p. 36).
      
         (3)  EFSA Journal 2017;15(1):4676.
      
         ANNEX I
         
                     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/kg of complete feedingstuff with a moisture content of 12 %
                  
               
                     
                        Category of technological additives. Functional group: substances for the reduction of the contamination of feed by mycotoxins: trichothecenes
                     
                  
               
                     1m01
                  
                  
                     —
                  
                  
                     Microorganism strain DSM 11798 of the Coriobacteriaceae family
                  
                  
                     
                        Additive composition
                     
                     Preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family containing a minimum of 5 × 109 CFU/g of additive.
                     Solid form
                     
                        Characterisation of the active substance
                     
                     Viable cells of: microorganism strain DSM 11798 of the Coriobacteriaceae family
                     
                        Analytical method
                         (1)
                     
                     Enumeration of microorganism strain DSM 11798 of the Coriobacteriaceae family: pour plate method using VM agar supplemented with Oxyrase.
                     Identification of microorganism strain DSM 11798 of the Coriobacteriaceae family: Pulsed Field Gel Electrophoresis (PFGE).
                  
                  
                     All avian species
                  
                  
                     —
                  
                  
                     1,7 × 108
                     
                  
                  
                     —
                  
                  
                     
                                 1.
                              
                              
                                 In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                              
                           
                                 2.
                              
                              
                                 The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.
                              
                           
                                 3.
                              
                              
                                 The use is permitted in feed containing the following authorised coccidiostats: narasin/nicarbazin, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, narasin, or nicarbazin.
                              
                           
                                 4.
                              
                              
                                 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 breath protections.
                              
                           
                  
                     21 June 2027
                  
               
            (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
      
      
         ANNEX II
         ‘
               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/kg of complete feedingstuff with a moisture content of 12 %
                        
                     
                           
                              Category of technological additives. Functional group: substances for the reduction of the contamination of feed by mycotoxins: trichothecenes
                           
                        
                     
                           1m01
                        
                        
                           —
                        
                        
                           Microorganism strain DSM 11798 of the Coriobacteriaceae family
                        
                        
                           
                              Additive composition
                           
                           Preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family containing a minimum of 5 × 109 CFU/g of additive.
                           Solid form
                           
                              Characterisation of the active substance
                           
                           Viable cells of: microorganism strain DSM 11798 of the Coriobacteriaceae family
                           
                              Analytical method
                               (1)
                           
                           Enumeration of microorganism strain DSM 11798 of the Coriobacteriaceae family: pour plate method using VM agar supplemented with Oxyrase.
                           Identification of microorganism strain DSM 11798 of the Coriobacteriaceae family: Pulsed Field Gel Electrophoresis (PFGE).
                        
                        
                           Pigs
                        
                        
                           —
                        
                        
                           1,7 × 108
                           
                        
                        
                           —
                        
                        
                           
                                       1.
                                    
                                    
                                       In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                                    
                                 
                                       2.
                                    
                                    
                                       The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.
                                    
                                 
                                       3.
                                    
                                    
                                       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 breath protections.
                                    
                                 
                        
                           13 November 2023
                        
                     ’
         
            (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