CELEX: 32011R0168
Language: en
Date: 2011-02-23
Title: Commission Regulation (EU) No 168/2011 of 23 February 2011 amending Regulation (EU) No 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride  Text with EEA relevance

24.2.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 49/4
            
         COMMISSION REGULATION (EU) No 168/2011
   of 23 February 2011
   amending Regulation (EU) No 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride
   (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 13(3) 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)
            
            
               Regulation (EC) No 1831/2003 provides for the possibility to modify the authorisation of a feed additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority).
            
         
               (3)
            
            
               The use of the micro-organism preparation of Bacillus subtilis ATCC PTA-6737 was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 107/2010 (2).
            
         
               (4)
            
            
               The holder of the authorisation applied for a modification of the authorisation of Bacillus subtilis ATCC PTA-6737 to allow its use in feed containing the coccidiostats maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride for chickens for fattening. The holder of the authorisation submitted the relevant data to support this request.
            
         
               (5)
            
            
               The Authority concluded in its opinion of 7 October 2010 that the additive Bacillus subtilis ATCC PTA-6737 is compatible with maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride (3).
            
         
               (6)
            
            
               The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.
            
         
               (7)
            
            
               Regulation (EU) No 107/2010 should therefore be amended accordingly.
            
         
               (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 Annex to Regulation (EU) No 107/2010 is replaced by the text in the Annex to this Regulation.
   Article 2
   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, 23 February 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 2010; 8(10):1863.
   
      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 NV
               
               
                  
                     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 active substance:
                              
                              Spores of Bacillus subtilis ATCC PTA-6737
                           
                        
                               
                           
                           
                              
                                 Analytical methods
                                  (1)
                              
                              
                                           
                                       
                                       
                                          Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples
                                       
                                    
                                           
                                       
                                       
                                          Identification: pulsed-field gel electrophoresis (PFGE) method
                                       
                                    
                        
               
                  Chickens for fattening
               
               
                  —
               
               
                  1 × 107
                  
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                           
                        
                              2.
                           
                           
                              May be used in feed containing the permitted coccidiostats: diclazuril, decoquinate, salinomycin sodium, narasin/nicarbazin, lasalocid A sodium, maduramycin ammonium, monensin sodium, narasin or robenidine hydrochloride.
                           
                        
               
                  1.3.2020
               
            
         (1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives