BAKGRUNN (fra kommisjonsforordningen)

(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 CGMCC 7.371. 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 CGMCC 7.371 as a feed additive for all avian species, piglets (weaned and suckling) and minor growing porcine species, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 July 2023 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii CGMCC 7.371 is safe for all avian species, piglets (suckling and weaned) and minor growing porcine species, consumers and the environment. The Authority also concluded that the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii CGMCC 7.371 is considered to be non-irritant eyes, but that it should be considered a skin and respiratory sensitiser and that no conclusion could be drawn on the potential for the additive to be irritant to skin. The Authority further concluded that the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii CGMCC 7.371 has the potential to be efficacious in all laying birds and all Suidae (from suckling to weaning period) at 2 000 U/kg feed and in all other avian species/categories at 1 000 U/kg feed. 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.

(5) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii CGMCC 7.371 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 avian species and piglets of all Suidae (from suckling to weaning period). 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.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,