EFSA Evaluates the Safety of β-Glucosidase Food Enzyme

On July 4, 2024, the European Food Safety Authority (EFSA) issued an opinion on the safety evaluation of the food enzyme β-glucosidase. The food enzyme is produced using the non-genetically modified Aspergillus niger strain AE-GLY, intended for application in four food manufacturing processes.

After a thorough assessment by the expert panel, although the possibility of allergic reactions from dietary exposure to the food enzyme cannot be completely excluded, the probability of such risk occurring is considered very low. Based on the submitted data, the expert panel concluded that the food enzyme is not of safety concern under the intended conditions of use. The key assessment findings are as follows:

The estimated dietary exposure to the food enzyme for the European population is up to 4.054 mg total organic solids (TOS)/kg body weight (bw) per day. The genotoxicity tests did not raise safety concerns. A 90-day repeated dose oral toxicity study in rats was used to evaluate the systemic toxicity of the food enzyme, and the highest no observed adverse effect level was determined to be 943 mg TOS/kg bw/day, which was the highest dose tested. The margin of exposure between this dose and the estimated dietary exposure is at least 233. Additionally, a search for sequence similarity between the food enzyme's amino acid sequence and known allergens did not identify any matches. Therefore, while the possibility of allergic reactions from dietary exposure cannot be completely ruled out, the expert panel considered the likelihood to be very low.

Based on the data provided, the expert panel concluded that the food enzyme is not of safety concern under the intended conditions of use.