Safety evaluation of the food enzyme containing cellulase and endo‐1,3(4)‐β‐glucanase activities from the non‐genetically modified Trichoderma reesei strain 480KY

Abstract The food enzyme containing cellulase (1,4‐(1,3;1,4)‐β‐d‐glucan‐4‐glucanohydrolase; EC 3.2.1.4) and endo‐1,3(4)‐β‐glucanase (3‐(1,3,1,4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Trichoderma reesei strain 480KY by Kerry Ingredients & Flavours Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme‐total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining six food manufacturing processes. It was estimated to be up to 2.681 mg 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 1014 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 378. A search for the homology of the two amino acid sequences to known allergens was made and a match with one respiratory allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is 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.