Safety evaluation of the food enzyme containing endo‐1,4‐β‐xylanase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus tubingensis strain CBS 138353

Abstract The food enzyme containing endo‐1,4‐β‐xylanase (4‐β‐D‐xylan xylanohydrolase; EC 3.2.1.8) 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 Aspergillus tubingensis strain CBS 138353 by Solyve. 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 food enzyme–total organic solids (TOS) are removed during three processes, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 2.635 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 1230 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 467. A search for the homology of the amino acid sequences of the food enzyme 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.