The European Food Safety Authority (EFSA) has concluded that the food enzyme α-amylase from the non-genetically modified Aspergillus oryzae strain NZYM-NA does not pose a safety concern when its use is extended to include the production of fruit and vegetable products other than juices. In a scientific opinion adopted on 24 June 2026 and published on 14 July 2026, EFSA's Panel on Food Enzymes updated the dietary exposure assessment for the enzyme, now intended for eight food manufacturing processes. The highest estimated dietary exposure was 0.137 mg total organic solids (TOS) per kg body weight per day in toddlers at the 95th percentile, yielding a margin of exposure of at least 13,591 relative to the no-observed-adverse-effect level of 1862 mg TOS/kg bw per day from previous studies.
The opinion updates a March 2023 evaluation that had already deemed the enzyme safe for seven processes. The extension request, submitted by Novozymes A/S on 6 March 2025, adds the production of fruit and vegetable products other than juices, where the enzyme is added during maceration to reduce viscosity and improve solubility. The enzyme-TOS remain in the final food in this process. EFSA conducted a public consultation from 15 December 2025 to 5 January 2026, which received no comments. The assessment follows EFSA's guidance on food enzyme dossiers and uses the Food Enzyme Intake Model (FEIM) webtool with consumption data from 51 dietary surveys across 27 European countries.
The opinion impacts several stakeholders. For Novozymes A/S, the applicant, a positive safety opinion supports market access for the extended use. Food manufacturers using the enzyme in fruit and vegetable processing gain a validated technological aid for viscosity reduction. European consumers are assured of no additional safety risk, with exposure well below levels of concern. EU regulatory bodies, including the European Commission, will use the opinion to update the Union list of authorised food enzymes, a process that requires a separate authorisation decision.