CELEX: 32017R0961
Language: en
Date: 2017-06-07 00:00:00
Title: Commission Implementing Regulation (EU) 2017/961 of 7 June 2017 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No 887/2011 (holder of authorisation Evonik Nutrition &amp; Care GmbH) (Text with EEA relevance. )

8.6.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 145/7
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/961
      of 7 June 2017
      concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No 887/2011 (holder of authorisation Evonik Nutrition & Care GmbH)
      (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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
               
            
                  (2)
               
               
                  The preparation of Enterococcus faecium CECT 4515 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for weaned piglets by Commission Regulation (EC) No 2036/2005 (3). That preparation was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. That preparation has been authorised for chickens for fattening by Commission Implementing Regulation (EU) No 887/2011 (4).
               
            
                  (3)
               
               
                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, applications were submitted for the re-evaluation of the preparation of Enterococcus faecium CECT 4515 as a feed additive in feed for weaned piglets and for a new use in water for drinking for weaned piglets and chickens for fattening. The applicant requested the additive to be classified in the additive category ‘zootechnical additives’. The applications were 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 opinions of 9 April 2014 (5), 29 April 2015 (6) and 8 September 2015 (7) that, under the proposed conditions of use, the preparation of Enterococcus faecium CECT 4515 does not have an adverse effect on animal health, human health or the environment. In its opinion of 29 April 2015, the Authority also concluded that the additive has the potential to improve the zootechnical performance of weaned piglets when used in feed. In its opinion of 8 September 2015, the Authority further concluded that the use of the preparation of Enterococcus faecium CECT 4515 in water for drinking for weaned piglets and chickens for fattening has the same efficacy as when it is used in 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)
               
               
                  The assessment of the preparation of Enterococcus faecium CECT 4515 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 Annexes to this Regulation.
               
            
                  (6)
               
               
                  As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 2036/2005 should be amended accordingly. Furthermore, the existing authorisation of the preparation of Enterococcus faecium CECT 4515 for chickens for fattening in Implementing Regulation (EU) No 887/2011 should be supplemented by a new use in water for drinking by way of an amendment to that Implementing Regulation.
               
            
                  (7)
               
               
                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
               
            
                  (8)
               
               
                  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 ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
      Article 2
      Amendment to Regulation (EC) No 2036/2005
      In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
      Article 3
      Amendment to Regulation (EU) No 887/2011
      The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
      Article 4
      Transitional measures
      The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 28 December 2017 in accordance with the rules applicable before 28 June 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
      Article 5
      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, 7 June 2017.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (1)  OJ L 268, 18.10.2003, p. 29.
      
         (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).
      
         (3)  Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (OJ L 328, 15.12.2005, p. 13).
      
         (4)  Commission Implementing Regulation (EU) No 887/2011 of 5 September 2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Evonik Nutrition & Care GmbH) (OJ L 229, 6.9.2011, p. 7).
      
         (5)  EFSA Journal 2014;12(5):3672.
      
         (6)  EFSA Journal 2015;13(5):4111.
      
         (7)  EFSA Journal 2015; 13(9):4232.
      
         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
                  
                  
                     Minimum content
                  
                  
                     Maximum content
                  
                  
                     Other provisions
                  
                  
                     End of period of authorisation
                  
               
                     CFU/kg of complete feedingstuff with a moisture content of 12 %
                  
                  
                     CFU/l of water for drinking
                  
               
                     
                        Category of zootechnical additives. Functional group: gut flora stabilisers
                     
                  
               
                     4b1713
                  
                  
                     Evonik Nutrition & Care GmbH)
                  
                  
                     
                        Enterococcus faecium
                     
                     CECT 4515
                  
                  
                     
                        Additive composition
                     
                     Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid form
                     
                        Characterisation of the active substance
                     
                     Viable cells of Enterococcus faecium CECT 4515
                     
                        Analytical method
                         (1)
                     
                     Enumeration: spread plate method using bile esculin azide agar (EN 15788)
                     Identification: Pulsed-Field Gel Electrophoresis (PFGE)
                  
                  
                     Weaned piglets
                  
                  
                      
                  
                  
                     1 × 109
                     
                  
                  
                     —
                  
                  
                     5 × 108
                     
                  
                  
                     —
                  
                  
                     
                                 1.
                              
                              
                                 The additive may be used in water for drinking.
                              
                           
                                 2.
                              
                              
                                 In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
                              
                           
                                 3.
                              
                              
                                 In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                              
                           
                                 4.
                              
                              
                                 For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.
                              
                           
                                 5.
                              
                              
                                 For use in weaned piglets up to 35 kg of body weight.
                              
                           
                                 6.
                              
                              
                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin protection.
                              
                           
                  
                     28 June 2027
                  
               
            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: 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 zootechnical additives. Functional group: gut flora stabilisers
                           
                        
                     
                           4b1713
                        
                        
                           Evonik Nutrition & Care GmbH)
                        
                        
                           
                              Enterococcus faecium
                           
                           CECT 4515
                        
                        
                           
                              Additive composition
                           
                           Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive
                           Solid forms
                           
                              Characterisation of the active substance
                           
                           Viable cells of Enterococcus faecium CECT 4515
                           
                              Analytical method
                               (1)
                           
                           Enumeration: spread plate method using bile esculin azide agar (EN 15788)
                           Identification: Pulsed-Field Gel Electrophoresis (PFGE)
                        
                        
                           Chickens for fattening
                        
                        
                           —
                        
                        
                           1 × 109
                           
                        
                        
                           —
                        
                        
                           
                                       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 is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.
                                    
                                 
                                       3.
                                    
                                    
                                       For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin protection.
                                    
                                 
                        
                           26 September 2021
                        
                     
                  
               
                           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
                           
                        
                     
                           4b1713
                        
                        
                           Evonik Nutrition & Care GmbH)
                        
                        
                           
                              Enterococcus faecium
                           
                           CECT 4515
                        
                        
                           
                              Additive composition
                           
                           Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive
                           Solid forms.
                           
                              Characterisation of the active substance
                           
                           Viable cells of Enterococcus faecium CECT 4515
                           
                              Analytical method
                               (2)
                           
                           Enumeration: spread plate method using bile esculin azide agar (EN 15788)
                           Identification: Pulsed- Field Gel Electrophoresis (PFGE)
                        
                        
                           Chickens for fattening
                        
                        
                           —
                        
                        
                           5 × 108
                           
                        
                        
                           —
                        
                        
                           
                                       1.
                                    
                                    
                                       The additive may be used in water for drinking.
                                    
                                 
                                       2.
                                    
                                    
                                       In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
                                    
                                 
                                       3.
                                    
                                    
                                       For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.
                                    
                                 
                                       4.
                                    
                                    
                                       The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.
                                    
                                 
                                       5.
                                    
                                    
                                       For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin protection.
                                    
                                 
                        
                           28 June 2027
                        
                     ’
         
            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
         
            (2)  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