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 with Aspergillus oryzae DSM 33737. 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 Aspergillus oryzae DSM 33737 as a feed additive for all poultry, all Suidae and all fin fish, 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 1 February 2024 that, under the proposed conditions of use, the preparation of 6- phytase produced with Aspergillus oryzae DSM 33737 is safe for all poultry, all Suidae and all fin fish. It further stated that the preparation is safe for consumers and the environment. The Authority also concluded that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737, in the final formulations of the additive, is not a skin irritant. The two liquid formulations of the additive are not eye irritants, while the two solid ones are to be considered eye irritants. The Authority was not able to conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6-phytase), the additive is considered a respiratory sensitiser. However, exposure by inhalation was considered unlikely. The Authority further concluded that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 has the potential to be efficacious in all poultry for fattening and reared for laying or breeding and in all reproductive Suidae at the minimum proposed use level of 200 FYT/kg complete feed and in all fin fish at the minimum proposed use level of 1000 FYT/kg complete feed. Due to the lack of sufficient data, the Authority was not able to conclude on the efficacy for laying and reproductive poultry, and for Suidae for fattening or reared for reproduction. 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 6-phytase produced with Aspergillus oryzae DSM 33737 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 or reared for breeding, sows of all Suidae species and all fin fish. 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. Regarding the target species for which the Authority’s opinion was inconclusive, the applicant committed to providing supplementary information. 

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