Safety evaluation of the food enzyme endo-1,3(4)-β-glucanase from the non-genetically modified Trichoderma reesei...

The food enzyme 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 TG-M5-337 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 11 food manufacturing processes. Since residual amounts of the food enzyme-total organic solids (TOS) are removed in three processes, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 0.302 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 at 1958 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 6573. A search for the homology of the amino acid sequence of the endo-1,3(4)-β-glucanase 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.