The European Food Safety Authority (EFSA) has concluded that the food enzyme pullulanase, produced from a genetically modified Bacillus licheniformis strain NZYM-LU by Novozymes A/S, does not pose safety concerns when used in five food manufacturing processes, including three newly requested applications. The updated safety evaluation, published on 9 July 2026 and adopted on 24 June 2026, extends the enzyme's permitted uses to the production of baked products, cereal-based products other than baked, and distilled alcohol, in addition to the previously authorised uses in brewed products and glucose syrups or other starch hydrolysates.
The assessment revises the dietary exposure estimate, now calculated at up to 1.394 mg total organic solids (TOS) per kg body weight per day for toddlers at the 95th percentile, based on consumption data from 27 European countries. The enzyme is inactivated in most processes, though it may remain active in baked products depending on heat treatment. The opinion follows a public consultation from 26 February to 19 March 2026, which received no comments. The European Commission requested the evaluation on 5 December 2025 under Regulation (EC) No 1331/2008, which requires a safety assessment before a food enzyme can be added to the EU's Union list of authorised substances. The previous safety evaluation in May 2022 had already cleared the enzyme for two processes; the current update confirms no new risks arise from the extended uses.