Safety evaluation of the food enzyme containing endo‐1,3(4)‐β‐glucanase, endo‐1,4‐β‐xylanase and cellulase activities from the non‐genetically modified Rasamsonia emersonii strain FGB

The food enzyme containing endo‐1,3(4)‐β‐glucanase (3‐(1,3;1,4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6), endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) and cellulase (4‐(1,3;1,4)‐β‐d‐glucan‐4‐glucanohydrolase EC 3.2.1.4) is produced with the non‐genetically modified Rasamsonia emersonii strain FGB by DSM Food Specialties B.V. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.226 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 85 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 376. A search for the homology of the amino acid sequences of the food enzyme to known allergens was made and matches with two respiratory allergens were 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 concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use.