Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM-SO)

Abstract

The food enzyme maltogenic amylase (glucan 1,4-α-maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM-SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme-total organic Solids (TOS) was estimated to be up to 0.556 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 rats. The Panel identified a no observed adverse effect level at the mid-dose of 318.4 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). Similarity of the amino acid sequence to those of known allergens was searched and three 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 of such reactions to occur 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‐α‐d‐glucan α‐maltohydrolase; 4‐α‐maltohydrolase; Bacillus subtilis; EC 3.2.1.133; food enzyme; genetically modified microorganism; glucan 1; maltogenic amylase.