The European Food Safety Authority (EFSA) has concluded that the food enzyme α-amylase produced with the genetically modified Aspergillus niger strain NZYM-SB by Novozymes A/S does not pose safety concerns under revised intended conditions of use, including an additional food manufacturing process. In a scientific opinion adopted on 24 June 2026 and published on 15 July 2026, EFSA updated its safety evaluation to cover four food manufacturing processes: production of baked products, cereal-based products other than baked, glucose syrups and other starch hydrolysates, and distilled alcohol. The dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated at up to 3.817 mg TOS/kg body weight per day in toddlers at the 95th percentile, based on the two processes where the enzyme remains in the final food. Combined with a no observed adverse effect level of 1220 mg TOS/kg bw per day from a previous evaluation, the margin of exposure is at least 320, which the Panel considered sufficient to conclude safety.
The assessment updates a previous EFSA evaluation from June 2018, which had found no safety concerns for the enzyme when used in three processes. The new application, submitted by Novozymes on 15 September 2025, sought to extend use to the production of cereal-based products other than baked, such as breakfast cereals or pasta, where the enzyme is added to flour during dough preparation to reduce viscosity. EFSA noted that while the enzyme is inactivated during most processes, residual activity may remain in baked products, based on kinetic models and studies detecting activity in white bread after baking. The exposure assessment used the FEIM webtool with consumption data from 51 dietary surveys across 27 European countries. A public consultation from 26 February to 19 March 2026 received no comments. The opinion was adopted by the EFSA Panel on Food Enzymes (FEZ), chaired by Holger Zorn, and follows the EU procedures under Regulation (EC) No 1332/2008 for food enzyme authorisation. The European Commission will now consider the opinion for inclusion of the extended use in the Union list of authorised food enzymes.
The decision impacts several stakeholders. For Novozymes A/S, the positive opinion opens the door to a broader market for its enzyme product in the EU, potentially increasing sales in the cereal-based products sector. Food manufacturers using the enzyme can benefit from improved processing efficiency, such as reduced dough viscosity, without additional safety compliance costs. Consumers face a negligible increase in dietary exposure to the enzyme, but EFSA's margin of exposure analysis indicates no health risk, maintaining consumer protection. EU regulatory bodies, including the Commission and EFSA, see their risk assessment framework validated, though the process required updated exposure data and modelling, reflecting the ongoing need for scientific evaluation of novel food enzyme uses.