Safety and efficacy of OptiPhos®PLUS for suckling and weaned piglets pigs for fattening sows other minor pig species for fattening and other minor reproductive pig species

摘要

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 OptiPhos®PLUS (6‐phytase) as a zootechnical feed additive for suckling and weaned piglets, pigs for fattening, sows, other minor pig species for fattening and other minor reproductive pig 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 two applications for its use in different species/categories. The Panel concluded in those opinions 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 skin irritant but was found to be a dermal sensitiser. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. Based on the tolerance studies provided, the Panel concluded that the additive is safe for the target species under the conditions of use with a wide margin of safety and therefore the conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species. The FEEDAP Panel concluded that the additive has the potential to be efficacious in weaned piglets, pigs for fattening and in sows at the level of 250 FTU/kg feed and this conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species.