Safety evaluation of a food enzyme with glucan 1,4-alpha-glucosidase and alpha-amylase activities from the genetically modified Aspergillus niger strain NZYM-BX

The food enzyme with glucan 1,4-α-glucosidase (EC 3.2.1.3) and α-amylase (EC 3.2.1.1) activities is produced with the genetically modified strain of Aspergillus niger NZYM-BX by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in starch processing for the production of glucose syrups and distilled alcohol. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The repeated dose 90-day oral toxicity study in rats made with a substitute enzyme was not considered suitable. However, since no exposure was expected from the intended uses, this study was not considered necessary. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and two matches were 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 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.