Scientific Opinion on the safety and efficacy of ENZY PHOSTAR® (6‐phytase) as a feed additive for avian and porcine species

Abstract

ENZY PHOSTAR ® is a preparation of 6-phytase produced by a genetically modified strain of Komagataella pastoris to be used as a zootechnical additive in avian and porcine species. Neither the production strain nor its recombinant DNA was detected in the final products. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in the tolerance studies performed, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe at the minimum recommended dose for the species/categories studied. The conclusion was extended to chickens reared for laying and turkeys reared for breeding and it was extrapolated to other avian species and minor porcine species at the corresponding dose. The recipient strain is considered to qualify for the Qualified Presumption of Safety approach to safety assessment and the genetic modification to which it was subject to does not give rise to concern; consequently, it was concluded that the use of ENZY PHOSTAR ® as a feed additive gives rise to no concern for consumers. The additive is hazardous by inhalation. The solid formulation of the additive is not a dermal or eye irritant, but it is a skin sensitiser, and the liquid formulation should be considered a potential irritant and a potential skin sensitiser. No risks to the environment are expected. It was concluded that the additive has the potential to be efficacious at the dose of 125 U/kg in laying hens, 250 U/kg in chickens for fattening and all pig categories and at 500 U/kg in turkeys for fattening. The conclusions were extended to chickens reared for laying and turkeys reared for breeding and extrapolated to all minor poultry species, other avian species and minor porcine species.