The European Food Safety Authority (EFSA) has concluded that an extension of use of the food enzyme endo 1,4-β-xylanase from the genetically modified Aspergillus oryzae strain NZYM-FB, produced by Novozymes A/S, does not raise safety concerns when used in a total of six food manufacturing processes, including the production of plant-based analogues of milk and milk products. In a scientific opinion adopted on 18 June 2026 and published on 6 July 2026, EFSA's Panel on Food Enzymes estimated that dietary exposure to the enzyme's total organic solids (TOS) could reach up to 0.390 mg per kg of body weight per day in toddlers at the 95th percentile, yielding a margin of exposure of at least 272 based on a no-observed-adverse-effect level of 106 mg TOS/kg bw per day from earlier studies.
The opinion updates a previous safety evaluation from April 2014, which had cleared the enzyme for five processes (starch and gluten production, baked products, cereal-based products, brewed products, and distilled alcohol). In 2024, EFSA had recalculated dietary exposure using its Food Enzyme Intake Model (FEIM) webtool and revised the margin of exposure. The new application, submitted by Novozymes on 2 June 2025, sought to add a sixth process: production of plant-based analogues of milk and milk products, where the enzyme is added to slurries of cereals, nuts, or seeds to reduce viscosity and increase yield. In this process, the enzyme-TOS remain in the final food. EFSA noted that while the enzyme is inactivated in most processes, it may retain residual activity in baked products, as earlier baking studies have shown. The dietary exposure estimate for the four processes where TOS remain (excluding starch/gluten and distilled alcohol, where TOS are removed) was revised upward from the 2024 calculation to account for the new use. The Panel concluded that the revised margin of exposure, combined with the absence of safety concerns in the previous evaluations, supports the safety of the enzyme under the expanded conditions of use.
The opinion follows EFSA's public consultation from 15 December 2025 to 5 January 2026, which received no comments. The assessment was conducted under Regulation (EC) No 1331/2008, which establishes a common authorisation procedure for food enzymes. The European Commission will now consider the opinion in deciding whether to update the Union list of authorised food enzymes to include the new use. The decision affects Novozymes, which gains a potential new market for its enzyme in the growing plant-based dairy alternatives sector, and food manufacturers who can use the enzyme to improve processing efficiency. Consumers are not expected to face increased health risks, as the exposure remains well below the no-effect level. However, the use of a genetically modified production organism may raise transparency concerns for some consumer groups, though EFSA's assessment found no safety issues.