Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from a genetically modified Aspergillus niger (strain NZYM-BW)

Abstract

The food enzyme glucan 1,4-α-glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BW 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 recombinant DNA. The glucan 1,4-α-glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel identified a no observed adverse effect level at the highest dose of 1,244 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions occurring is considered to be low. Based on the data provided and the removal of TOS during the intended food production processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Keywords: Aspergillus niger; EC 3.2.1.3; food enzyme; genetically modified microorganism; glucan 1,4‐α‐glucosidase; glucoamylase.