(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 6-phytase produced with Komagataella phaffii CGMCC 7.370. 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 6-phytase produced with Komagataella phaffii CGMCC 7.370 as a feed additive for all avian species and ornamental, exotic and game birds and all pigs, 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 23 November 2022 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced with Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species, as well as for the consumers and the environment. The Authority also concluded that the additive in both formulations, powder and liquid, is considered to be non-irritant to skin or eyes but should be considered a skin and respiratory sensitiser. Furthermore, it concluded that the additive has the potential to be efficacious in laying hens at 1 000 U phytase/kg complete feed and this conclusion can be extrapolated to other birds for egg production or breeding. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 26 June 2025 (3) that the additive has a potential to be efficacious as a zootechnical additive for all poultry for fattening and reared for laying/breeding and for reproductive porcine species at 500 U phytase/kg complete feed and for all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete 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 methods 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 6-phytase produced with Komagataella phaffii CGMCC 7.370 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for porcine species, poultry and ornamental birds. 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,