The European Food Safety Authority (EFSA) has concluded that the food enzyme bacillolysin, produced from a non-genetically modified Bacillus amyloliquefaciens strain HPN 131, does not pose safety concerns when used in thirteen food manufacturing processes, including six newly requested applications. In a scientific opinion adopted on 24 June 2026 and published on 13 July 2026, EFSA updated its previous 2023 evaluation, which had already deemed the enzyme safe for seven processes. The new uses cover flour production, starch and gluten fractionation, cereal-based products (excluding baked goods), wine and wine vinegar, plant extracts, and plant-based analogues of milk and milk products. The applicant, Kerry Ingredients & Flavours Ltd., submitted the extension request on 4 December 2024. EFSA estimated dietary exposure to the enzyme's total organic solids (TOS) at up to 13.800 mg per kg body weight per day for European populations, based on the eleven processes where TOS remain in the final food (TOS are removed in two processes). The Panel on Food Enzymes concluded that the revised intended conditions of use do not raise safety concerns. The opinion follows a public consultation from 16 December 2025 to 6 January 2026, which received no comments. The assessment was conducted under Regulation (EC) No 1332/2008 on food enzymes and Regulation (EC) No 1331/2008 establishing a common authorisation procedure. The enzyme, a bacillus metalloendopeptidase (EC 3.4.24.28), hydrolyses peptide bonds in proteins and is inactivated at temperatures above 80°C. The extension broadens the enzyme's technological applications, potentially benefiting food manufacturers seeking improved processing efficiency, yield, and product quality in sectors such as baking, brewing, wine production, and plant-based alternatives. For consumers, the updated exposure estimate remains within safety margins, with no anticipated health risks. The European Commission will now consider the opinion in the authorisation process for the extended uses.
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