TY - JOUR

T1 - Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)

AU - Bampidis, Vasileios

AU - Azimonti, Giovanna

AU - de Lourdes Bastos, Maria

AU - Christensen, Henrik

AU - Dusemund, Birgit

AU - Fašmon Durjava, Mojca

AU - Kouba, Maryline

AU - López-Alonso, Marta

AU - López Puente, Secundino

AU - Marcon, Francesca

AU - Mayo, Baltasar

AU - Pechová, Alena

AU - Petkova, Mariana

AU - Ramos, Fernando

AU - Sanz, Yolanda

AU - Edoardo Villa, Roberto

AU - Woutersen, Ruud

AU - Dierick, Noël

AU - Prieto Maradona, Miguel

AU - Galobart, Jaume

AU - Pettenati, Elisa

AU - Anguita, Montserrat

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

N1 - Publisher Copyright: © 2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

PY - 2022

Y1 - 2022

N2 - Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser.

AB - Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser.

KW - Amaferm

KW - dairy cows

KW - digestibility enhancers

KW - renewal

KW - zootechnical additives

U2 - 10.2903/j.efsa.2022.6983

DO - 10.2903/j.efsa.2022.6983

M3 - Journal article

C2 - 35154439

AN - SCOPUS:85127063461

VL - 20

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 2

M1 - e06983

ER -