CELEX: 32021R2096
Language: en
Date: 2021-11-29 00:00:00
Title: Commission Implementing Regulation (EU) 2021/2096 of 29 November 2021 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 as a feed additive for all poultry species, pigs for fattening, piglets and all minor porcine species (holder of the authorisation: Danisco (UK) Ltd, represented in the Union by Genencor International B.V.) (Text with EEA relevance)

30.11.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 427/187
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/2096
         of 29 November 2021
         concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 as a feed additive for all poultry species, pigs for fattening, piglets and all minor porcine species (holder of the authorisation: Danisco (UK) Ltd, represented in the Union by Genencor International B.V.)
         (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 an authorisation.
                  
               
                     (2)
                  
                  
                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953. The 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) produced by Trichoderma reesei CBS 143953 as a feed additive for all poultry species, pigs for fattening, piglets and all minor porcine species to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 March 2021 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 as a feed additive for all poultry species, pigs for fattening, piglets and all minor porcine species does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that that additive should be considered a respiratory sensitiser and a potential eye irritant. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period. 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 produced by Trichoderma reesei CBS 143953 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, 29 November 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2021;19(5):6539.
      
      
         
            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 feed with a moisture content of 12 %
                     
                  
                        
                           Category of zootechnical additives. Functional group: digestibility enhancers.
                        
                     
                  
                        4a11
                     
                     
                        Danisco (UK) Ltd, represented in the Union by Genencor International B.V.
                     
                     
                        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 CBS 143953 with a minimum activity of 40 000  U/g (1)
                        
                        
                           
                              Characterisation of active substance
                           
                        
                        Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei CBS 143953
                        
                           
                              Analytical method
                           
                            (2)
                        
                        For quantification of endo-1,4-beta-xylanase activity:
                        colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabinoxylan substrates
                     
                     
                        All poultry species
                     
                     
                        -
                     
                     
                        625  U
                     
                     
                        -
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes and breathing protection.
                                 
                              
                     
                        20.12.2031
                     
                  
                        Pigs for fattening Piglets (weaned and suckling)
                        All minor porcine species
                     
                     
                        2 000  U
                     
                  
               (1)  1 U is the amount of enzyme which releases 0,48 μmol of reducing sugar (xylose equivalent) per minute from wheat arabino xylan at pH 4,2 and 50 °C.
            
               (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