Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Trichoderma reesei...

The food enzyme glucoamylase (4-α-D-glucan glucohydrolase; EC 3.2.1.3) is produced with the genetically modified Trichoderma reesei strain DP-Nzh38 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 its DNA. The food enzyme is intended to be used in distilled alcohol production, starch processing for glucose syrup production, baking and brewing processes. Since residual amounts of total organic solids (TOS) are removed by distillation and by purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated for these uses. Based on the maximum use levels recommended for baking and 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 5.8749 mg TOS/kg body weight per day. The toxicity studies were carried out with another glucoamylase from T. reesei (strain DP-Nzh49) considered by the Panel as a suitable substitute. Genotoxicity tests did not raise safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified no observed adverse effect level (NOAEL) at the highest dose tested of 1,149 mg TOS/kg body weight (bw) per day resulting in a margin of exposure of at least 195. Similarity of the amino acid sequence to those of known allergens was searched for and one match was 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 for this to occur 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.