Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Bacillus subtilis (strain LMG S-24584)

The food enzyme endo-1,4-β-xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S-24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.017 mg 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 rodents. A comparison of the no observed adverse effect level of 37 mg TOS/kg bw per day from this study with the dietary exposure results in a sufficiently high margin of exposure. The amino acid sequence of the food enzyme did not match those of known allergens. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions occurring 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.

Keywords: 4‐β‐d‐xylan xylanohydrolase; 4‐β‐xylanase; Bacillus subtilis; EC 3.2.1.8; endo‐1; food enzyme; genetically modified microorganism; xylanase.