Commission Implementing Regulation (EU) 2023/2802 of 18 December 2023 concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all poultry species for fattening, breeding, and reared for laying or breeding (holder of authorisation: Kemin Europa N.V.)
Commission Implementing Regulation (EU) 2023/2802of 18 December 2023concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all poultry species for fattening, breeding, and reared for laying or breeding (holder of authorisation: Kemin Europa N.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 nutritionOJ L 268, 18.10.2003, p. 29., 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 Komagataella phaffii ATCC PTA-127053 as a feed additive. 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 a preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all poultry species, requesting that additive to be classified in the category "zootechnical additives" and in the functional group "digestibility enhancers".(4)The use of that preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 has already been authorised for all laying poultry by Commission Implementing Regulation (EU) 2023/668Commission Implementing Regulation (EU) 2023/668 of 22 March 2023 concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.) (OJ L 84, 23.3.2023, p. 7). based on the conclusions of the opinion of 29 June 2022EFSA Journal 2022;20(7):7439. of the European Food Safety Authority ("the Authority").(5)The Authority concluded in its opinions of 29 June 2022 and 11 May 2023EFSA Journal 2023;21(6):8047. that, under the proposed conditions of use, the preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 is safe for all poultry species, consumers and the environment. It also concluded that the preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 is not irritant to the eyes and skin but should be considered a dermal and a respiratory sensitiser. The Authority further concluded that the preparation of endo–1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 has the potential to be efficacious for all poultry species under the proposed conditions of use. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods 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-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all poultry species for fattening, breeding, and reared for laying or breeding. 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.(7)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: