Safety evaluation of the food enzyme α-glucosidase from the Aspergillus niger strain AE-TGU

The food enzyme alpha-glucosidase (alpha-D-glucoside glucohydrolase; EC 3.2.1.20) is produced with the non-genetically modified Aspergillus niger strain AE-TGU by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, cereal-based processes, brewing processes and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was only calculated for the remaining three food processes. Based on the maximum use levels recommended, dietary exposure was estimated to be up to 0.64 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1,062 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,650. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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. (C) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

Automated summary

The food enzyme alpha-glucosidase, produced with non-genetically modified Aspergillus niger strain AE-TGU, is safe for use in various food processes with low risk of allergic sensitization. The estimated dietary exposure in European populations is within acceptable limits. Toxicity tests and studies indicate that the enzyme does not raise safety concerns under the intended conditions of use.