Safety and efficacy of Amylofeed® (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase and α‐amylase) as a feed additive for piglets and minor growing porcine species

zootechnical additive, digestibility enhancer, endo-1, 3(4)-b-glucanase, endo-1, 4-b-xylanase,a-amylase, safety, efficacy
First published in the EFSA Journal
16 May 2018
Adopted
17 April 2018
Type
Scientific Opinion

Abstract

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 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 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.

Panel members at the time of adoption

Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López‐Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5271
EFSA Journal 2018;16(5):5271
Question Number
On request from
European Commission