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 6-phytase produced by Komagataella phaffii CGMCC 7.19 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 6-phytase produced by Komagataella phaffii CGMCC 7.19 as a feed additive for chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds, 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 30 September 2020 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in the thermostable granulate formulation and in the granulate formulation is safe for consumers and the environment. The Authority also concluded that the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in all its formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance, it should be considered a respiratory sensitiser. The Authority concluded in its opinion of 4 May 2022 (3) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in the powder formulation and in the liquid formulation is safe for consumers and the environment. It also stated that the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in all its formulations is safe for chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds. The Authority further concluded in its opinion of 27 September 2023 (4) that the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 has the potential to be efficacious for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds, at the minimum recommended level of 500 FTU/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 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 6-phytase produced by Komagataella phaffii CGMCC 7.19 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 or reared for laying 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,