CELEX: 32011R0389
Language: en
Date: 2011-04-19 00:00:00
Title: Commission Implementing Regulation (EU) No 389/2011 of 19 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive for laying hens (holder of authorisation Danisco Animal Nutrition)  Text with EEA relevance

20.4.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 104/7
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 389/2011
   of 19 April 2011
   concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive 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 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 an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA 5588, subtilisin produced by Bacillus subtilis ATCC 2107 and alpha-amylase produced by Bacillus amyloliquefaciens ATCC 3978. That 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 an enzyme preparation of endo-1,4-beta-xylanase subtilisin and alpha-amylase as a feed additive for laying hens, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The use of the preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase has been authorised for 10 years for chickens for fattening, for ducks, and for turkeys for fattening by Commission Regulation (EC) No 1087/2009 (2).
            
         
               (5)
            
            
               The European Food Safety Authority (the Authority) concluded in its opinion of 7 December 2010 (3) that the enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase, under the proposed conditions of use, does not have an adverse effect on animal health, human health or the environment, and that that additive has the potential to improve egg parameter production in laying hens. 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.
            
         
               (6)
            
            
               The assessment of the enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase 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 ‘digestibility enhancers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
   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, 19 April 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  OJ L 297, 13.11.2009, p. 4.
   
      (3)  EFSA Journal (2011); 9(1):1949.
   
      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
                  
               
            
                  4a10
               
               
                  Danisco Animal Nutrition
               
               
                  Endo-1,4-beta-xylanase
                  EC 3.2.1.8
                  Subtilisin
                  EC 3.4.21.62
                  Alpha-amylase
                  EC 3.2.1.1
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107), solid form having a minimum activity of:
                              
                                          —
                                       
                                       
                                          endo-1,4-beta-xylanase 1 500 U (1)/g,
                                       
                                    
                                          —
                                       
                                       
                                          subtilisin 20 000 U (2)/g,
                                       
                                    
                                          —
                                       
                                       
                                          alpha-amylase 2 000 U (3)/g.
                                       
                                    
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              Endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107).
                           
                        
                               
                           
                           
                              
                                 Analytical methods
                                  (4)
                              
                              Determination of the active substance in the additive, premixtures and feedingstuffs.
                              
                                           
                                       
                                       
                                          Endo-1,4-beta-xylanase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-beta-xylanase on commercially available azurine cross-linked wheat arabinoxylan substances.
                                       
                                    
                                           
                                       
                                       
                                          Alpha-amylase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of alpha-amylase on commercially available azurine cross-linked starch polymer substances.
                                       
                                    
                                           
                                       
                                       
                                          Subtilisin: colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of subtilisin on commercially available cross-linked casein substances.
                                       
                                    
                        
               
                  Laying hens
               
               
                  —
               
               
                  
                               
                           
                           
                              endo-1,4-beta-xylanase
                              300 U
                           
                        
                               
                           
                           
                              subtilisin
                              4 000 U
                           
                        
                               
                           
                           
                              alpha-amylase
                              400 U
                           
                        
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive, indicate the storage temperature, storage life, and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize.
                           
                        
                              3.
                           
                           
                              For safety reasons: breathing protection, glasses and gloves shall be used during handling.
                           
                        
               
                  10 May 2021
               
            
         (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 xylan substrate per minute at pH 5,3 and 50 °C.
      
         (2)  1 U is the amount of enzyme which liberates 1 μmol of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.
      
         (3)  1 U is the amount of enzyme which liberates 1 μmol of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.
      
         (4)  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