Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from the non-genetically modified Aspergillus niger strain AGME 1415

The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan α-glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified Aspergillus niger strain AGME 1415 by ENMEX SA de CV, a Kerry Company. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining five processes. It was estimated to be up to 7.143 mg TOS/kg body weight 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 2000 mg TOS/kg body weight (bw) per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 280. A search for the homology of the amino acid sequence of the glucan 1,4-α-glucosidase to known allergens was made and one match with a respiratory allergen was found. The Panel considered that a risk of allergic reactions by 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.