Safety evaluation of the food enzyme endo-1,3(4)-β-glucanase from the genetically modified Bacillus subtilis strain DP-Ezm28.

The food enzyme endo-1,3(4)-β-glucanase (3(or 4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with a genetically modified Bacillus subtilis strain DP-Ezm28 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production and brewing processes. Since residual amounts of total organic solids (TOS) are removed by distillation, dietary exposure was only calculated for brewing processes. Based on the maximum use levels recommended for brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-total organic solids was estimated to be up to 0.183 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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 5464. Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered 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.