CELEX: 32012R1019
Language: en
Date: 2012-11-06 00:00:00
Title: Commission Implementing Regulation (EU) No 1019/2012 of 6 November 2012 amending Commission Regulation (EC) No 1096/2009 as regards the minimum content of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) as a feed additive in feed for chickens for fattening and for ducks (holder of authorisation BASF SE)  Text with EEA relevance

7.11.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 307/60
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 1019/2012
   of 6 November 2012
   amending Commission Regulation (EC) No 1096/2009 as regards the minimum content of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) as a feed additive in feed for chickens for fattening and for ducks (holder of authorisation BASF SE)
   (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)
            
            
               The enzyme endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713), belonging to the additive category of ‘zootechnical additives’ was authorised for 10 years as a feed additive for use on chickens for fattening and for ducks by Commission Regulation (EC) No 1096/2009 (2) and for use on turkeys for fattening by Commission Regulation (EC) No 1380/2007 (3).
            
         
               (2)
            
            
               In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of the enzyme concerned by reducing its minimum content from 560 TXU/kg to 280 TXU/kg as regards use on chickens for fattening and ducks. The application was accompanied by the relevant supporting data.
            
         
               (3)
            
            
               The European Food Safety Authority (hereinafter ‘the Authority’) concluded in its opinion of 2 February 2012 (4) that, under the new proposed conditions of use, the enzyme concerned is efficacious at the requested minimum dose of 280 TXU/kg. The Authority does not consider that there is a need for specific requirements of post-market monitoring.
            
         
               (4)
            
            
               The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.
            
         
               (5)
            
            
               Commission Regulation (EC) No 1096/2009 should therefore be amended accordingly.
            
         
               (6)
            
            
               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
   Regulation (EC) No 1096/2009 is amended in accordance with the Annex to this Regulation.
   Article 2
   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, 6 November 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 301, 17.11.2009, p. 3.
   
      (3)  OJ L 309, 27.11.2007, p. 21.
   
      (4)  EFSA Journal 2012; 10(2):2575.
   
      ANNEX
      The Annex to Regulation (EC) No 1096/2009 is replaced by the following:
      
         
            ‘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
                     
                  
                        Units of activity/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        
                           Category of zootechnical additives. Functional group: digestibility enhancers.
                        
                     
                  
                        4a62
                     
                     
                        BASF SE
                     
                     
                        Endo-1,4-beta-xylanase
                        EC 3.2.1.8
                     
                     
                        
                                     
                                 
                                 
                                    
                                       Additive composition
                                    
                                    Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) having a minimum activity of:
                                    
                                                 
                                             
                                             
                                                solid form: 5 600 TXU (1)/g
                                             
                                          
                                                 
                                             
                                             
                                                liquid form: 5 600 TXU/ml
                                             
                                          
                              
                                     
                                 
                                 
                                    
                                       Characterisation of the active substance
                                    
                                    Endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713)
                                 
                              
                                     
                                 
                                 
                                    
                                       Analytical method
                                        (2)
                                    
                                    Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-xylanase on the xylan-containing substrate (wheat arabinoxylan) at pH 3,5 and 55 °C
                                 
                              
                     
                        Chickens for fattening
                     
                     
                        —
                     
                     
                        280 TXU
                     
                     
                        —
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                                 
                              
                                    2.
                                 
                                 
                                    Recommended maximum dose per kilogram of complete feedingstuff for chickens for fattening and ducks: 800 TXU.
                                 
                              
                                    3.
                                 
                                 
                                    For use in feed rich in starch and non-starch polysaccharides (mainly beta-glucans and arabinoxylans).
                                 
                              
                     
                        7.12.2019
                     
                  
                        Ducks
                     
                     
                        280 TXU
                     
                  
      
      
         (1)  1 TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.
      
         (2)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx’