Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6-phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of APSA PHYTAFEED ^® 20,000 GR/L (6-phytase) as a feed additive for piglets and growing minor porcine species. The additive is a preparation of 6-phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel in the context of an application for its use in feed for chickens for fattening. The Panel concluded in that opinion that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be irritant to skin or eyes or a dermal sensitiser but that should be considered as a respiratory sensitiser. The Panel considered that the new use in piglets would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the Panel concluded that the additive is safe for piglets (suckling and weaned) and for growing minor porcine species at the recommended enzyme activity of 250 U/kg feed with a wide margin of safety. The applicant submitted three efficacy trials to support the efficacy of the additive. In the trials, the apparent faecal digestibility of phosphorus and bone ash/phosphorus content were measured. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED ^® GR/L is efficacious for piglets (suckling and weaned) and for growing minor porcine species at an enzyme activity of 1,000 U/kg feed.

Keywords: Example: safety; digestibility enhancers; efficacy; phytase; piglets; zootechnical additives.