CELEX: 32011R0527
Language: en
Date: 2011-05-30 00:00:00
Title: Commission Implementing Regulation (EU) No 527/2011 of 30 May 2011 concerning the authorisation of a preparation of endo-1,4-β-xylanase produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) as feed additive for weaned piglets (holder of the authorisation Aveve NV)  Text with EEA relevance

31.5.2011   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 143/6
            
         COMMISSION IMPLEMENTING REGULATION (EU) No 527/2011
   of 30 May 2011
   concerning the authorisation of a preparation of endo-1,4-β-xylanase produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) as feed additive for weaned piglets (holder of the authorisation Aveve NV)
   (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 endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase (EC 3.2.1.6) produced by Trichoderma reesei (MUCL 49754) and polygalacturonase (EC 3.2.1.15) produced by Aspergillus aculeatus (CBS 589.94), as set out in the Annex. 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 the preparation set out in the Annex as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinions of 8 July 2009 (2) and 2 February 2011 (3) that the preparation set out in the Annex, under the proposed conditions of use, does not have an adverse effect on animal health, consumer health or the environment, and that this additive has the potential to increase the body weight and feed to gain ratio in the target 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 Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003.
            
         
               (5)
            
            
               The assessment of the preparation set out in the Annex 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.
            
         
               (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 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, 30 May 2011.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  The EFSA Journal (2009) 1186, 1-17.
   
      (3)  EFSA Journal (2011); 9(2):2010.
   
      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
                  
               
            
                  4a 14
               
               
                  Aveve NV
               
               
                  
                               
                           
                           
                              Endo-1,4-β-xylanase
                              EC 3.2.1.8
                           
                        
                               
                           
                           
                              Endo-1,3(4)-β-glucanase
                              EC 3.2.1.6
                           
                        
                               
                           
                           
                              Polygalacturonase
                              EC 3.2.1.15
                           
                        
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase (EC 3.2.1.6) produced by Trichoderma reesei (MUCL 49754) and polygalacturonase (EC 3.2.1.15) produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of:
                              
                                           
                                       
                                       
                                          solid form:
                                          
                                                       
                                                   
                                                   
                                                      Endo-1,4-β-xylanase: 21 400 XU (1)/g
                                                   
                                                
                                                       
                                                   
                                                   
                                                      Endo-1,3(4)-β-glucanase: 12 300 BGU (2)/g
                                                   
                                                
                                                       
                                                   
                                                   
                                                      Polygalacturonase: 460 PGLU (3)/g.
                                                   
                                                
                                    
                                           
                                       
                                       
                                          liquid form:
                                          
                                                       
                                                   
                                                   
                                                      Endo-1,4-β-xylanase: 10 700 XU/g
                                                   
                                                
                                                       
                                                   
                                                   
                                                      Endo-1,3(4)-β-glucanase: 6 150 BGU/g
                                                   
                                                
                                                       
                                                   
                                                   
                                                      Polygalacturonase: 230 PGLU/g.
                                                   
                                                
                                    
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              Endo-1,4-β-xylanase (EC 3.2.1.8)
                              produced by Trichoderma reesei, endo-1,3(4)-β-glucanase (EC 3.2.1.6) produced by Trichoderma reesei and polygalacturonase (EC 3.2.1.15) produced by Aspergillus aculeatus
                              
                           
                        
                               
                           
                           
                              
                                 Method of Analysis
                                  (4)
                              
                              Characterisation of the active substances in the additive and feedingstuffs:
                              
                                          —
                                       
                                       
                                          colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from dye cross-linked wheat arabinoxylan substrate,
                                       
                                    
                                          —
                                       
                                       
                                          colorimetric method measuring water soluble dye released by action of endo-1,3(4)-β-glucanase from dye cross-linked barley betaglucan substrate,
                                       
                                    
                                          —
                                       
                                       
                                          viscosimetric method based on a decrease of viscosity produced by action of polygalacturonase on the pectin-containing substrate, polymethylgalacturonic acid.
                                       
                                    
                        
               
                  Piglets (weaned)
               
               
                   
               
               
                  
                               
                           
                           
                              Endo-1,4-β-xylanase: 2 140 XU
                           
                        
                               
                           
                           
                              Endo-1,3(4)-β-glucanase: 1 230 BGU
                           
                        
                               
                           
                           
                              Polygalacturonase: 46 PGLU
                           
                        
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For piglets (weaned) up to 35 kg.
                           
                        
                              3.
                           
                           
                              For use in compound feed rich in non-starch polysaccharides.
                           
                        
               
                  20 June 2021
               
            
         (1)  1 XU is the amount of enzyme which releases 1 μmol of reducing sugar (xylose equivalent) per minute from xylan of oat spelt at 50 °C and pH 4,8.
      
         (2)  1 BGU is the amount of enzyme which releases 1 μmol of reducing sugar (cellobiose equivalent) per minute from β-glucan of barley at 50 °C and pH 5,0.
      
         (3)  1 PGLU is the amount of enzyme which releases 1 μmol of reducing sugar (glucose equivalent) per minute from polymethylgalacturonic acid (pectin containing substrate) at 35 °C and pH 4,8.
      
         (4)  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