Assessment of the application for renewal of the authorisation of Amaferm® (fermentation product of Aspergillus oryzae NRRL 458) as a feed additive for dairy cows

Abstract

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 cows. This scientific opinion concerns the renewal of the authorisation of this additive for its use in dairy cows. In its former opinion, the EFSA Panel on Additives and Product or Substances used in Animal Feed (FEEDAP), based on the data and knowledge available at that time, concluded that the additive is safe for cows, for the consumers and the environment. In that assessment, the Panel also concluded that the additive is non‐irritant or a dermal sensitiser but should be considered a potential respiratory sensitiser. The applicant provided new information regarding the characterisation of the additive in terms of enzyme activities as well as information concerning the production strain. Regarding the enzyme activities in the fermentation product, weaknesses and limitations in the methods of analysis were noted. The information regarding the production strain did not permit to confirm its taxonomic classification, moreover uncertainty remains regarding the presence of viable cells/spores in the final product. Therefore, the FEEDAP Panel could not confirm the previously drawn conclusions regarding the safety of the production strain and consequently could not confirm the safety for the target species and consumers. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

“…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.…”

“…oryzae . Although the herein data provided do not allow to conclusively exclude the presence of viable cells/spores of the production strain in the additive, in the previous assessment (EFSA FEEDAP Panel, 2020), no antimicrobial activity was found in the final additive, and mycotoxins that may be potentially produced by strains of the A . oryzae clade (including ochratoxin A, aflatoxin and fumonisin) were not detected.…”

“…In the assessment for the renewal of the authorisation (EFSA FEEDAP Panel, 2020), the Panel noted that enzyme activities given, 3 IU 12 cellulase/g and 40 IU 13 amylase/g, were not in line with the enzyme activities reported in the previous EFSA opinion (EFSA, 2006). Following a request for clarification, the applicant confirmed that the new minimum specifications for Amaferm ® should be 0.3 mIU 14 cellulase/g and 20 mIU 15 amylase/g 16 .…”

“…Finally, the Panel considered that no comparison was possible with the enzyme activities present in the additive now and those established at the time of the first assessment and, therefore, the Panel could not compare the composition of the additive to the one previously assessed/authorised. In the current submission, the applicant provided clarifications on the differences in the two enzyme activities present in the additive reported previously (EFSA FEEDAP Panel, 2020), which were of administrative nature and including errors in the description of the method and during the assessment/authorisation process.…”

“…The additive is authorised as a mixture of 4-5% of the fermentation product of A. oryzae NRRL 458, with 94-95% wheat bran and 1% stainless steel grit (containing 5% cobalt carbonate) as a microtracer. The composition of the additive was described in full in 2006 by the FEEDAP Panel (EFSA, 2006), and the new formulation without the stainless-steel grit was described in the assessment done in 2020 (EFSA FEEDAP Panel, 2020).…”