Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from the non-genetically modified Rhizopus arrhizus strain AE-G.

Abstract

The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified Rhizopus arrhizus strain AE-G by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The applicant proposed the use of the food enzyme in baking processes, coffee processing and manufacture of enzymatically modified dairy ingredients (EMDI). The Panelconsidered only the baking processes as the relevant intended use of this food enzyme. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.94mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panelidentified a no observed adverse effect level of 1,868mg 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 1,987. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panelconsidered that under the intended conditions of use the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panelconcluded that this food enzyme does not give rise to safety concerns when used in baking processes under the intended conditions of use.