CELEX: 32012R1196
Language: en
Date: 2012-12-13 00:00:00
Title: Commission Implementing Regulation (EU) No 1196/2012 of 13 December 2012 amending Regulation (EU) No 9/2010 as regards the minimum content of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive in feed for laying hens (holder of authorisation Danisco Animal Nutrition) Text with EEA relevance

14.12.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 342/25
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 1196/2012
   of 13 December 2012
   amending Regulation (EU) No 9/2010 as regards the minimum content of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive in feed for laying hens (holder of authorisation Danisco Animal Nutrition)
   (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 use of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for use on chickens for fattening, laying hens, ducks and turkeys for fattening by Commission Regulation (EU) No 9/2010 (2), for weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 528/2011 (3) and for minor poultry species other than ducks by Commission Implementing Regulation (EU) No 1021/2012 (4).
            
         
               (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 preparation concerned by reducing its minimum content from 2 500 U/kg to 625 U/kg as regards the use on laying hens. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter ‘the Authority’).
            
         
               (3)
            
            
               The Authority concluded in its opinion of 22 May 2012 (5) that, under the new proposed conditions of use, the preparation concerned is efficacious at the requested minimum dose of 625 U/kg. 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.
            
         
               (4)
            
            
               The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.
            
         
               (5)
            
            
               Regulation (EU) No 9/2010 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
   The Annex to Regulation (EU) No 9/2010 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, 13 December 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 3, 7.1.2010, p. 10.
   
      (3)  OJ L 143, 31.5.2011, p. 10.
   
      (4)  OJ L 307, 7.11.2012, p. 68.
   
      (5)  EFSA Journal 2012; 10(6):2739.
   
      ANNEX
      The Annex to Regulation (EU) No 9/2010 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
                        
                     
                  
                        4a11
                     
                     
                        Danisco Animal Nutrition
                        (legal entity: Danisco (UK) Limited)
                     
                     
                        Endo-1,4-beta-xylanase
                        EC 3.2.1.8
                     
                     
                        
                                     
                                 
                                 
                                    
                                       Additive composition
                                    
                                    Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei
                                    
                                    (ATCC PTA 5588) with a minimum activity of 40 000 U (1)/g
                                 
                              
                                     
                                 
                                 
                                    
                                       Characterisation of the active substance
                                    
                                    endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588)
                                 
                              
                                     
                                 
                                 
                                    
                                       Analytical method
                                        (2)
                                    
                                    For quantification of endo-1,4-beta-xylanase activity:
                                    colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-beta-xylanase on azurine cross-linked wheat arabinoxylan at pH 4,25 and 50 °C.
                                 
                              
                     
                        Chickens for fattening
                     
                     
                         
                     
                     
                        625 U
                     
                     
                         
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
                                 
                              
                                    2.
                                 
                                 
                                    For use in feed rich in non-starch polysaccharides (mainly beta- arabinoxylans).
                                 
                              
                     
                        13 January 2020
                     
                  
                        Laying hens
                     
                     
                        625 U
                     
                  
                        Ducks
                     
                     
                        625 U
                     
                  
                        Turkeys for fattening
                     
                     
                        1 250 U
                     
                  
      
      
         (1)  1 U is the amount of enzyme which liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt arabinoxylan substrate at pH 5,3 and 50 °C in one minute.
      
         (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’