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 Trichoderma reesei strain NZYM-ER does not raise safety concerns, according to a scientific opinion published on 13 July 2026. The enzyme, produced by Novozymes A/S, was previously approved for four food manufacturing processes; the new assessment covers three additional uses: production of glucose syrups and other starch hydrolysates, refined and unrefined sugar, and plant-based analogues of milk and milk products. The Panel on Food Enzymes (FEZ) estimated the highest dietary exposure to the enzyme's total organic solids (TOS) at 0.092 mg per kg body weight per day for adults at the 95th percentile, yielding a margin of exposure of at least 11,424 based on the no-observed-adverse-effect level of 1051 mg TOS/kg bw per day from earlier studies.
The opinion updates a previous EFSA evaluation from May 2022, which had already deemed the enzyme safe for four processes: production of starch and gluten fractions, brewed products, distilled alcohol, and edible oils from plant and algae. The new application, submitted on 11 September 2025, prompted EFSA to revise the dietary exposure assessment for all seven intended uses. The enzyme is inactivated during production of brewed products and unrefined sugars due to heat, but may remain active in plant-based milk analogues depending on processing conditions. The assessment followed EFSA's 2021 guidance on food enzyme dossiers and 2023 guidance on food manufacturing processes. A public consultation from 26 February to 19 March 2026 received no comments.
The opinion impacts several stakeholders. For Novozymes A/S, the positive safety evaluation supports market expansion for the enzyme into new food sectors, potentially increasing revenue. Food manufacturers using the enzyme in glucose syrup, sugar, and plant-based milk production can proceed with the additive without safety concerns, though they must ensure compliance with use levels and processing conditions. Consumers face negligible increased exposure, with the margin of exposure indicating a wide safety margin. EU regulatory bodies, including the European Commission, will use the opinion to update the Union list of authorised food enzymes, following the procedure under Regulation (EC) No 1331/2008. The enzyme's technological benefits—improved starch release, sucrose extraction, and viscosity reduction—must be weighed against the need for continued monitoring of dietary exposure, particularly for active enzyme residues in final foods.