Robust Safety Evaluation of Amano Enzyme Inc.'s β-Glucosidase Food Enzyme

On July 4, 2024, the European Food Safety Authority (EFSA) conducted a comprehensive assessment of the safety of the β-glucosidase (EC 3.2.1.21) food enzyme and issued its scientific opinion. This food enzyme is produced by Amano Enzyme Inc. using a non-genetically modified strain of Aspergillus niger, AE-GLY, and is expected to play a key role in four food manufacturing processes.

It is estimated that the maximum daily dietary exposure to this food enzyme (total organic solids, TOS) in the European population could reach 4.054 mg/kg body weight (bw). The genotoxicity tests did not raise any safety concerns. To evaluate systemic toxicity, the expert panel conducted a 90-day repeated-dose oral toxicity study in rats. In this study, the expert panel identified that no adverse effects were observed at the highest tested dose of 943 mg TOS/kg bw/day. The margin of exposure between this dose and the estimated dietary exposure is at least 233.

Furthermore, the expert panel searched the amino acid sequence of the food enzyme for similarity to known allergens and found no matches. While the expert panel acknowledged that the risk of allergic reactions upon dietary exposure cannot be completely excluded, they considered the likelihood to be low based on the data provided.

In conclusion, based on the overall assessment, the expert panel concluded that the β-glucosidase food enzyme from Amano Enzyme Inc. is not of safety concern under the intended conditions of use.