CELEX: 32011R0885
Language: en
Date: 2011-09-05 00:00:00
Title: Commission Implementing Regulation (EU) No 885/2011 of 5 September 2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of authorisation Kemin Europa N.V.)  Text with EEA relevance

6.9.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 229/3
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 885/2011
   of 5 September 2011
   concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of authorisation Kemin Europa N.V.)
   (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 the preparation of Bacillus subtilis (ATCC PTA-6737). The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               The application concerns the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The use of the preparation of Bacillus subtilis (ATCC PTA-6737) was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 107/2010 (2).
            
         
               (5)
            
            
               New data were submitted in support of the application for the authorisation of Bacillus subtilis (ATCC PTA-6737) for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches. The European Food Safety Authority (the Authority) concluded in its opinion of 15 March 2011 (3) that, under the proposed conditions of use, Bacillus subtilis (ATCC PTA-6737) does not have an adverse effect on animal health, consumer health or the environment, and that the use of this preparation can improve the zootechnical performance of the animal species. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (6)
            
            
               The assessment of Bacillus subtilis (ATCC PTA-6737) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this 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 the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   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, subject to the conditions laid down in that Annex.
   Article 2
   This Regulation enters into force on the 20th day following its publication in the Official Journal of the European Union.
   
      This Regulation is binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 5 September 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 36, 9.2.2010, p. 1.
   
      (3)  EFSA Journal 2011; 9(3):2114.
   
      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
                  
               
            
                  4b1823
               
               
                  Kemin Europa N.V.
               
               
                  
                     Bacillus subtilis (ATCC PTA-6737)
               
               
                  
                               
                           
                           
                              
                                 Additive composition:
                              
                              Preparation of Bacillus subtilis (ATCC PTA-6737) containing a minimum of 1 × 1010 CFU/g additive
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance:
                              
                              Spores of Bacillus subtilis (ATCC PTA-6737)
                           
                        
                               
                           
                           
                              
                                 Analytical method
                                  (1)
                                 :
                              
                              
                                           
                                       
                                       
                                          Enumeration: spread plate method using tryptone soya agar with pre-heat treatment of feed samples
                                       
                                    
                                           
                                       
                                       
                                          Identification: pulsed-field gel electrophoresis (PFGE) method
                                       
                                    
                        
               
                  Chickens reared for laying
                  Ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening
                  Ostriches
               
               
                  —
               
               
                  1 × 107
                  
               
               
                  —
               
               
                  
                              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 allowed in feed containing one of the authorised coccidiostats: diclazuril, decoquinate, salinomycin sodium, narasin/nicarbazin, lasalocid A sodium, maduramycin ammonium, monensin sodium, narasin or robenidine hydrochloride on condition that this coccidiostat is authorised for the relevant species
                           
                        
               
                  26 September 2021
               
            
         (1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx