CELEX: 32011R0361
Language: en
Date: 2011-04-13 00:00:00
Title: Commission Implementing Regulation (EU) No 361/2011 of 13 April 2011 concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005  Text with EEA relevance

14.4.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 100/22
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 361/2011
   of 13 April 2011
   concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005
   (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 NCIMB 10415 was authorised in accordance with Directive 70/524/EEC as a feed additive without a time limit for use on calves up to 6 months by Commission Regulation (EC) No 1288/2004 (3), for use on chickens for fattening and pigs for fattening by Commission Regulation (EC) No 943/2005 (4), for use on sows by Commission Regulation (EC) No 1200/2005 (5), for use on piglets by Commission Regulation (EC) No 252/2006 (6) and for use on cats and dogs by Commission Regulation (EC) No 102/2009 (7). That additive was subsequently entered in the Community Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening, requesting that additive be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required pursuant to Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 22 June 2010 (8) that, under the proposed conditions of use, Enterococcus faecium NCIMB 10415 does not have an adverse effect on animal health, human health or on the environment, and that that additive has the potential to increase the final body weight of chickens for fattening. 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 European Union Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of Enterococcus faecium NCIMB 10415 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 Annex I to this Regulation.
            
         
               (6)
            
            
               As a consequence of a new authorisation being granted by this Regulation, the entry concerning Enterococcus faecium NCIMB 10415 for chickens for fattening in Regulation (EC) No 943/2005 should be deleted.
            
         
               (7)
            
            
               Since the modifications to the conditions of the authorisation are not related to safety reasons, it is appropriate to allow a transitional period for the disposal of existing stocks of premixtures and compound feed.
            
         
               (8)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   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
   Annex I to Regulation (EC) No 943/2005 is replaced by the text in Annex II to this Regulation.
   Article 3
   Premixtures and compound feed containing Enterococcus faecium NCIMB 10415 labelled in accordance with Directive 70/524/EEC may continue to be placed on the market and used until stocks are exhausted.
   Article 4
   This Regulation shall enter into force on the 20th day following 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, 13 April 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 270, 14.12.1970, p. 1.
   
      (3)  OJ L 243, 15.7.2004, p. 10.
   
      (4)  OJ L 159, 22.6.2005, p. 6.
   
      (5)  OJ L 195, 27.7.2005, p. 6.
   
      (6)  OJ L 44, 15.2.2006, p. 3.
   
      (7)  OJ L 34, 4.2.2009, p. 8.
   
      (8)  EFSA Journal 2010; 8(7):1661.
   
      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 zootechnical additives. Functional group: gut flora stabilisers
                  
               
            
                  4b1705
               
               
                  DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o
               
               
                  
                     Enterococcus faecium
                  
                  NCIMB 10415
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of Enterococcus faecium
                              
                              NCIMB 10415 containing a minimum of:
                              
                                           
                                       
                                       
                                          coated form (with shellac):
                                          2 × 1010 CFU/g of additive;
                                       
                                    
                                           
                                       
                                       
                                          Other microencapsulated forms:
                                          1 × 1010 CFU/g additive
                                       
                                    
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              
                                 Enterococcus faecium
                              
                              NCIMB 10415
                           
                        
                               
                           
                           
                              
                                 Analytical method
                                  (1)
                              
                              Enumeration: spread plate method using bile esculin azide agar
                              Identification: Pulsed- Field Gel Electrophoresis (PFGE)
                           
                        
               
                  Chickens for fattening
               
               
                   
               
               
                  3 × 108
                  
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                           
                        
                              2.
                           
                           
                              The use is permitted in feed containing the authorised coccidiostats: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, or semduramycin.
                           
                        
               
                  4 May 2021
               
            
         (1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives
   
   
      ANNEX II
      Annex I to Regulation (EC) No 943/2005 is replaced by the following:
      
         
            ‘ANNEX I
            
                        EC No
                     
                     
                         
                     
                     
                        Additive
                     
                     
                        Chemical formula, description
                     
                     
                        Species or category of animal
                     
                     
                        Maximum age
                     
                     
                        Minimum content
                     
                     
                        Maximum content
                     
                     
                        Other provisions
                     
                     
                        End of period of authorisation
                     
                  
                        CFU/kg of complete feedingstuff
                     
                  
                        
                           Micro-organisms
                        
                     
                  
                        E 1705
                     
                     
                         
                     
                     
                        
                           Enterococcus faecium
                        
                        NCIMB 10415
                     
                     
                        Preparation of Enterococcus faecium containing a minimum of:
                        
                                     
                                 
                                 
                                    Microencapsulated form:
                                    1,0 × 1010 CFU/g of additive;
                                 
                              
                                     
                                 
                                 
                                    Granulated form:
                                    3,5 × 1010 CFU/g additive
                                 
                              
                     
                        Pigs for fattening
                     
                     
                        —
                     
                     
                        0,35 × 109
                        
                     
                     
                        1,0 × 109
                        
                     
                     
                        In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                     
                     
                        Without a time limit’