CELEX: 32015R1043
Language: en
Date: 2015-06-30 00:00:00
Title: Commission Implementing Regulation (EU) 2015/1043 of 30 June 2015 concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 (holder of authorisation Huvepharma NV) (Text with EEA relevance)

1.7.2015   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 167/63
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1043
   of 30 June 2015
   concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 (holder of authorisation Huvepharma 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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
            
         
               (2)
            
            
               The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) (formerly Trichoderma longibrachiatum) was authorised in accordance with Directive 70/524/EEC without a time limit as a feed additive for chickens for fattening by Commission Regulation (EC) No 2148/2004 (3), for turkeys for fattening by Commission Regulation (EC) No 828/2007 (4) and for laying hens and weaned piglets by Commission Regulation (EC) No 322/2009 (5). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
            
         
               (3)
            
            
               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) (formerly Trichoderma longibrachiatum) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinions of 31 January 2013 (6) and 10 December 2014 (7) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) (formerly Trichoderma longibrachiatum) does not have an adverse effect on animal health, human health or the environment.
            
         
               (5)
            
            
               The Authority also concluded that the use of that preparation has the potential to be efficacious in turkeys for fattening, chickens for fattening, laying hens, weaned piglets and pigs for fattening. The Authority further considered that the conclusions on the efficacy can be extrapolated to minor poultry species for fattening and 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.
            
         
               (6)
            
            
               The assessment of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) (formerly Trichoderma longibrachiatum) 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.
            
         
               (7)
            
            
               Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 should therefore be amended accordingly.
            
         
               (8)
            
            
               Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
            
         
               (9)
            
            
               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
   Authorisation
   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
   Amendment to Regulation (EC) No 2148/2004
   In Annex IV to Regulation (EC) No 2148/2004 the entry on E 1617, endo-1,4-beta-xylanase EC 3.2.1.8, is deleted.
   Article 3
   Amendment to Regulation (EC) No 828/2007
   Regulation (EC) No 828/2007 is amended as follows:
   
               (1)
            
            
               Article 2 is deleted;
            
         
               (2)
            
            
               Annex II is deleted.
            
         Article 4
   Amendment to Regulation (EC) No 322/2009
   Regulation (EC) No 322/2009 is amended as follows:
   
               (1)
            
            
               Article 2 is deleted;
            
         
               (2)
            
            
               Annex II is deleted.
            
         Article 5
   Transitional measures
   The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 21 January 2016 in accordance with the rules applicable before 21 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
   Article 6
   Entry into force
   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, 30 June 2015.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
   
      (3)  Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).
   
      (4)  Commission Regulation (EC) No 828/2007 of 13 July 2007 concerning the permanent and provisional authorisation of certain additives in feedingstuffs (OJ L 184, 14.7.2007, p. 12).
   
      (5)  Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 101, 21.4.2009, p. 9).
   
      (6)  EFSA Journal 2013; 11(2):3105.
   
      (7)  EFSA Journal 2015; 13(1):3969.
   
      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
                  
               
            
                  4a1617
               
               
                  Huvepharma NV
               
               
                  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 citrinoviride Bisset (IM SD135) with a minimum activity of 6 000 EPU (1)/g
                  (solid and liquid form)
                  
                     Characterisation of the active substance
                  
                  endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135)
                  
                     Analytical method
                      (2)
                  
                  For characterisation of endo-1,4-beta-xylanase activity:
                  colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates.
               
               
                  Turkeys for fattening and minor poultry species for fattening
               
               
                  —
               
               
                  1 050 EPU
               
               
                  —
               
               
                  
                              1.
                           
                           
                              In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
                           
                        
                              2.
                           
                           
                              For use in feed rich in starch and non-starch polysaccharides (mainly beta- arabinoxylans).
                           
                        
                              3.
                           
                           
                              For safety: breathing protection, glasses and gloves shall be used during handling.
                           
                        
                              4.
                           
                           
                              For use in weaned piglets until approximately 35 kg.
                           
                        
               
                  21 July 2025
               
            
                  Chickens for fattening
                  Laying hens
                  Minor poultry species for laying
                  Weaned piglets
                  Pigs for fattening
               
               
                  1 500 EPU
               
            
         (1)  1 EPU is the amount of enzyme which releases 0,0083 μmol of reducing sugars (xylose equivalent) per minute from oat spelt xylan at pH 4,7 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