Commission 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.) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/668of 22 March 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 laying poultry (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 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. 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 laying poultry, 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 29 June 2022EFSA Journal 2022;20(7):7439., that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 did not have an adverse effect on consumer safety or the environment. As regards the target species, the Authority concluded that the additive is safe and has the potential to be efficacious for laying hens when added to feed at 45000 U/kg and that the conclusions on laying hens can be extrapolated to all laying poultry species.(5)The Authority concluded that that additive was not irritant to eyes and skin but was considered a dermal and respiratory sensitiser.(6)The Authority considered that there was no 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.(7)The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 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. 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.(8)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: