CELEX: 32015R0661
Language: en
Date: 2015-04-28 00:00:00
Title: Commission Implementing Regulation (EU) 2015/661 of 28 April 2015 concerning the authorisation of the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying (holder of the authorisation Adisseo France S.A.S.) (Text with EEA relevance)

29.4.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 110/1
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2015/661
   of 28 April 2015
   concerning the authorisation of the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying (holder of the authorisation Adisseo France S.A.S.)
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   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-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis sp. nov. (formerly named Penicillium funiculosum) IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               That application concerns the authorisation of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis (formerly named Penicillium funiculosum) IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 July 2014 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis (formerly named Penicillium funiculosum) IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 does not have an adverse effect on animal health, human health or the environment, and that it has a potential to improve the body weight gain in chickens for fattening. This conclusion can be extended to chickens reared for laying. Since the mode of action can be considered to be similar in all poultry species, this conclusion can be extrapolated to minor poultry species for fattening or reared for laying. 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.
            
         
               (5)
            
            
               The assessment of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Talaromyces versatilis (formerly named Penicillium funiculosum) IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that 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 Plants, Animals, Food and Feed,
            
         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 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, 28 April 2015.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2014; 12(7):3793.
   
      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.
                  
               
            
                  4a22
               
               
                  Adisseo France S.A.S.
               
               
                  Endo-1,4-beta-xylanase EC 3.2.1.8
                  and
                  Endo-1,3(4)-beta-glucanase EC 3.2.1.6
               
               
                  
                     Additive composition
                  
                  Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 having a minimum activity of:
                  
                              —
                           
                           
                              solid form: endo-1,4-beta-xylanase 22 000  VU/g and endo-1,3(4)-beta-glucanase 15 200  VU (1)/g,
                           
                        
                              —
                           
                           
                              liquid form: endo-1,4-beta-xylanase activity of 5 500  VU/ml and endo-1,3(4)-beta-glucanase 3 800  VU/ml.
                           
                        
                     Characterisation of the active substance
                  
                  Endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702.
                  
                     Analytical method
                      (2)
                  
                  For the quantification of endo-1,4-beta-xylanase activity:
                  
                              —
                           
                           
                              viscosimetric method based on decrease in viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate (wheat arabinoxylan).
                           
                        For the quantification of endo-1,3(4)-beta-glucanase activity:
                  
                              —
                           
                           
                              viscosimetric method based on decrease in viscosity produced by action of endo-1,3(4)-beta-glucanase on the glucan substrate barley betaglucan at pH = 5,5 and 30 °C.
                           
                        
               
                  Chickens for fattening
                  Chickens reared for laying
                  Minor poultry species for fattening and reared for laying
               
               
                  —
               
               
                  endo-1,4-beta-xylanase 1 100  VU
                  endo-1,3(4)-beta-glucanase 760 VU
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
               
                  19 May 2025
               
            
         (1)  1 VU (viscosimetry unit) is the amount of enzyme which hydrolyses the substrate (barley betaglucan and wheat arabinoxylan, respectively), reducing the viscosity of the solution, to give a change in relative fluidity of 1 (dimensionless unit)/min at 30 °C and pH 5,5.
      
         (2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports