The European Food Safety Authority (EFSA) has concluded that the food enzyme α-amylase, produced with the genetically modified Aspergillus niger strain NZYM-MC by Novozymes A/S, does not pose safety concerns when used in an additional food manufacturing process — the production of brewed products. In a scientific opinion adopted on 24 June 2026 and published on 16 July 2026, EFSA updated its safety evaluation to cover a total of four food manufacturing processes, after the applicant requested an extension of use. The dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated at up to 3.524 mg TOS/kg body weight per day in children at the 95th percentile, yielding a margin of exposure of at least 397, which the Panel considered sufficient.
The opinion revises an earlier EFSA assessment from September 2018, which had evaluated the enzyme's safety in three processes — production of baked products, glucose syrups and other starch hydrolysates, and distilled alcohol — and had found no safety concerns. The new application, submitted by Novozymes on 23 October 2025, sought authorisation to also use the enzyme in brewing, where it is added during mashing to hydrolyse liquefied starch. The food enzyme–TOS remain in the final brewed products, though the enzyme is inactivated during the brewing process. However, the Panel noted that residual activity may persist in baked products, as a kinetic model suggested incomplete inactivation during baking.
EFSA calculated chronic exposure using the FEIM webtool, combining maximum recommended use levels with individual consumption data from 51 dietary surveys across 27 European countries. The highest exposure was estimated for children, while the lowest was for infants. The Panel derived a margin of exposure of at least 397 based on the no observed adverse effect level of 1400 mg TOS/kg bw per day from the previous evaluation. The opinion also noted that a public consultation from 26 February to 19 March 2026 received no comments. The assessment follows the EU regulatory framework under Regulation (EC) No 1332/2008, which requires that food enzymes be authorised only if they pose no safety concern, fulfil a technological need, and do not mislead consumers. The European Commission will now consider the opinion in the authorisation process for the enzyme's inclusion in the EU Union list.