(fra kommisjonsforodningen)

(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 and renewing such an authorisation. 

(2) A preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 143953 (formerly deposited at the American Type Culture Collection (ATCC) PTA 5588), subtilisin produced with Bacillus subtilis CBS 143946 (formerly ATCC 2107) and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 (formerly ATCC 3978) was authorised for a period of 10 years as a feed additive for chickens for fattening, for ducks and for turkeys for fattening by Commission Regulation (EC) No 1087/2009 and for laying hens by Commission Implementing Regulation (EU) No 389/2011. 

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of endo-1,4-betaxylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 as a feed additive for chickens for fattening, turkeys for fattening, ducks and laying hens, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. The application included a proposal for amending the conditions of the original authorisation of the preparation consisting in the reduction of the minimum recommended level in turkeys for fattening (from 300 U endo-1,4-betaxylanase, 4,000 U subtilisin and 400 U alpha-amylase/kg feed to 187.5 U endo-1,4-beta-xylanase, 2,500 U subtilisin and 250 U alpha-amylase/kg feed). The application was accompanied by the particulars and documents required under Article 14(2) and by the relevant data supporting the request for the change. 

(4) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of new uses of the preparation of endo-1,4-betaxylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954. The application concerns the authorisation of that preparation as a feed additive for all poultry species (except ducks) for laying other than laying hens, for fattening other than chickens and turkeys, reared for breeding and reared for laying requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 April 2024 that, under the proposed conditions of use, the preparation of endo-1,4- beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 is safe for chickens for fattening, ducks, turkeys for fattening and laying hens. The conclusion can be extended to all poultry species for fattening, reared for breeding, reared for laying and all poultry species for laying. It further stated that the preparation is safe for consumers and the environment. The Authority also concluded that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 is a mild irritant to skin and eyes, it is not a dermal sensitiser but should be considered a respiratory sensitiser. The Authority further concluded that the preparation of endo1,4-beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 has the potential to be efficacious in ducks at 75 U xylanase, 1000 U subtilisin and 100 U amylase/kg of complete feed, in turkeys for fattening, all poultry species for fattening, reared for breeding and reared for laying (except for ducks) at 187.5 U xylanase, 2500 U subtilisin and 250 U amylase per kg of complete feed and at 300 U xylanase, 4000 U subtilisin and 400 U amylase per kg of complete feed for all poultry species for laying (except for ducks). It did not consider that there is a need for specific requirements of post-market monitoring. The Authority 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) In view of the above, the Commission considers that the preparation of endo-1,4-betaxylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for chickens for fattening, turkeys for fattening, ducks and laying hens, and the use of that preparation should be authorised for all poultry species (except ducks) for laying other than laying hens, for fattening other than chickens and turkeys, reared for breeding and reared for laying. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law. 

(7) As a consequence of the renewal of the authorisation of the preparation of endo-1,4- beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 as a feed additive for chickens for fattening, turkeys for fattening, ducks and laying hens, Regulation (EC) No 1087/2009 and Implementing Regulation (EU) No 389/2011 should be repealed. 

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 as a feed additive for chickens for fattening, turkeys for fattening, ducks and laying hens, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of 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,