Safety evaluation of the food enzyme thermomycolin from the genetically modified Trichoderma reesei strain AR-201

The food enzyme thermomycolin (EC 3.4.21.65) is produced with the genetically modified Trichoderma reesei strain AR-201 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in seven food manufacturing processes. Dietary exposure was estimated to be up to 0.461 mg total organic solids (TOS)/kg body weight (bw) 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 1000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2169. A search for the homology of the amino acid sequence of the thermomycolin to known allergens was made and matches with 1 food allergen, 19 respiratory allergens and 3 contact allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.