The European Food Safety Authority (EFSA) has concluded that the food enzyme α-amylase produced with the genetically modified Bacillus licheniformis strain NZYM-KE does not pose safety concerns under revised intended conditions of use, including four additional food manufacturing processes. In a scientific opinion adopted on 24 June 2026 and published on 16 July 2026, EFSA updated its dietary exposure assessment, estimating intake up to 0.710 mg TOS/kg body weight per day for European populations.
The enzyme, produced by Novozymes A/S, was previously evaluated in January 2021 and deemed safe for use in two processes: production of glucose syrups and other starch hydrolysates, and production of distilled alcohol. The applicant subsequently requested an extension to include production of baked products, cereal-based products other than baked, refined and unrefined sugar, and plant-based analogues of milk and milk products, as well as extending raw materials in the distilled alcohol process to include soluble fractions from grains. EFSA's assessment considered that the enzyme is inactivated in most processes due to heat treatment, though it may remain active in baked products. The dietary exposure was calculated only for the four processes where the enzyme–Total Organic Solids (TOS) remain in final foods, as TOS are removed in sugar refining and distilled alcohol production.
The opinion follows a public consultation from 22 December 2025 to 12 January 2026, which received no comments. The European Commission requested the safety assessment on 20 February 2025 as part of the authorization procedure under Regulation (EC) No 1331/2008. The enzyme is intended for inclusion in the EU Union list of authorized food enzymes. The Panel concluded that, based on the revised dietary exposure and previous evaluation, the food enzyme does not give rise to safety concerns under the revised intended conditions of use.