遺伝子組換えトリコデルマ・リーセイ株AR-715由来の食品酵素セルラーゼの安全性評価

The food enzyme cellulase (4-(1,3; 1,4)-β-D-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain AR-715 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. It is intended to be used in seven food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in four processes, dietary exposure was calculated for the remaining three food manufacturing processes. It was estimated to be up to 0.070 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 1000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 14,286. A search for the homology of the amino acid sequence of the cellulase to known allergens was made and no match 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.