Safety evaluation of the food enzyme dextranase from Collariella gracilis strain ATCC-16153

The food enzyme dextranase (6-α-d-glucan 6-glucanohydrolase, EC 3.2.1.11) is produced with the non-genetically modified Collariella gracilis strain ATCC-16153 by Mitsubishi-Kagaku Foods Corporation. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in sugar production and processing. As residual amounts of total organic solids (TOS) are removed during the production of refined sugars, dietary exposure was calculated only for unrefined sugar products. Based on the maximum use levels, dietary exposure to the food enzyme TOS was estimated to be up to 15 μg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 (NOAEL) of 110 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) of at least 7,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no 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 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.