Safety Assessment RP185 6-Phytase from Komagataella Phaffii DSM 23036

An application was submitted to the Food Standards Agency in February 2021 from Huvepharma EOOD (“the applicant”) for the authorisation of an additive (OptiPhos®), as a renewal and new authorisation under the category of ‘zootechnical’ additives, functional group ‘digestibility enhancers’. The additive is produced in three formulations: OptiPhos® 4000 G, solid, 22.79% phytase content with an activity of 20,000 Optiphos activity (OTU) /g; OptiPhos® 4000 CT, solid, 30% phytase content, activity of 20,000 OTU/g; OptiPhos® 8000 L, liquid, 20% phytase content, activity of 40,000 OTU/g. It is proposed to be used in concentrations between 125-250 OTU/kg of complete feed. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The AFFAJEG evaluated the literature review presented in the application and the previous EFSA opinion and concluded that the additive can be considered safe for the target species, the consumer and the environment. Further information was requested on skin sensitisation testing and, after re-evaluating the information provided, the AFFAJEG concluded that the additive should be considered to be a respiratory sensitiser and to not be a skin sensitiser or eye irritant. No demonstration of efficacy was required for the renewal of authorisation. For the extension of use, the AFFAJEG concluded that previous data demonstrating efficacy could be extrapolated to breeding hens, ornamental birds, minor pig species for fattening/breeding and suckling piglets, at the doses proposed by the applicant. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.