Safety evaluation of the food enzyme alpha-amylase from a genetically modified Trichoderma reesei (strain DP-Nzb48)

The food enzyme alpha-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. 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. This α-amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distillation; consequently, dietary exposure was not calculated for this use. Based on the maximum use levels recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-TOS was estimated to be up to 1.701 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic 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 (NOAEL) at the highest dose of 230 mg TOS/kg 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 is considered low. Based on the removal of residues of the food enzyme during distillation, the Panel concluded that the use of this enzyme in the distilled alcohol production is safe. When used in brewing processes, the margin of exposure calculated from the data provided is only (at least) 135, but no safety issues were identified.