Safety evaluation of the food enzyme AMP deaminase from the non‐genetically modified Aspergillus pallidofulvus strain AE‐DN

TL;DR

This paper evaluates the safety of AMP deaminase enzyme from Aspergillus pallidofulvus, concluding it is safe for use in yeast processing.

Contribution

The study provides a safety evaluation of a novel food enzyme derived from a non-genetically modified fungal strain.

Findings

Genotoxicity tests showed no safety concerns for the food enzyme.

The no observed adverse effect level was 152 mg TOS/kg body weight per day.

Allergenic potential was low based on amino acid sequence homology analysis.

Abstract

The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non‐genetically modified Aspergillus pallidofulvus strain AE‐DN by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.030 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 152 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 5067. A search for the homology of the amino acid sequence of the AMP deaminase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.