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Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM-JB)

EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP) et al. EFSA J. .

Abstract

The food enzyme acetolactate decarboxylase (α-acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM-JB 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 organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distillation; consequently, dietary exposure was not calculated for distilled alcohol products. For other brewery products, based on the maximum use level recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-TOS was estimated to be up to 0.003 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic 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 highest dose of 1,018 mg TOS/kg bw per day. When compared with the dietary exposure, this results in a sufficiently high margin of exposure (at least 300,000). The amino acid sequence of the food enzyme did not match to 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 is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Keywords: Bacillus licheniformis; EC 4.1.1.5; acetolactate decarboxylase; food enzyme; genetically modified microorganism; α‐acetolactate decarboxylase.

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