Recital (4) · Commission Implementing Regulation (EU) 2026/1013

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2024^note that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 is safe for all poultry, all Suidae and all fin fish at the highest proposed use level of 4000 FYT/kg complete feed, as well as for the 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 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 is 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 and an authorisation for use in feed for these species was granted by Commission Implementing Regulation (EU) 2024/2177^note. 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. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 18 September 2025^note that the additive has the potential to be efficacious in all poultry and all porcine species at the minimum proposed use level of 200 FYT/kg complete feed. The Authority 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.