Safety and efficacy of Amylofeed® (endo‐13(4)‐β‐glucanase and endo‐14‐β‐xylanase and α‐amylase) as a feed additive for piglets and minor growing porcine species

摘要

Amylofeed is a feed additive that contains glucanase, xylanase and amylase activities, and it is intended to be used as a zootechnical additive for weaned piglets and minor porcine species. In previous assessments, the additive was characterised and the safety for the target species, consumers and environment was established. Considering the safety for the user, the Panel on Additives and Products or Substances used in Animal Feed ( ) concluded that the additive should be considered as a potential skin and eye irritant and a potential skin and respiratory sensitiser. Furthermore, the Panel concluded that the additive has a potential to be efficacious in the target species. However, the efficacy at the recommended enzyme activities could not be established. In order to overcome this limitation, the applicant proposed to modify the specifications of the additive whilst keeping the recommended level of addition of 500 mg additive/kg feed. The Panel evaluated the new specifications and their impact on the relevant aspects of the safety and efficacy of the additive. The newly proposed specifications of the additive were supported by analytical data. The Panel considered that the modification proposed by the applicant on the specifications would not have an impact on the safety aspects related to the consumer, user and environment. Therefore, the conclusions previously drawn would still apply. Moreover, it was considered that the tolerance trial previously evaluated would still support the safety for the target species. The addition of the additive with the new specifications would result in higher enzyme activities than those that were found in the efficacy studies that supported the efficacy of the product. Therefore, the additive has the potential to be efficacious at the newly proposed level of enzyme activities.