The European Food Safety Authority (EFSA) has concluded that a food enzyme containing endo-1,3(4)-β-glucanase, endo-1,4-β-xylanase and cellulase, produced with the non-genetically modified Rasamsonia emersonii strain FGB by DSM Food Specialties B.V., does not give rise to safety concerns under intended conditions of use. The scientific opinion, adopted on 19 May 2026 and published on 17 June 2026, assessed the enzyme for use in four food manufacturing processes: production of brewed products, wine and wine vinegars, plant-based analogues of milk and milk products, and processed flavour from yeast. Dietary exposure was estimated at up to 0.226 mg total organic solids per kg body weight per day, and a 90-day oral toxicity study in rats identified a no observed adverse effect level of 85 mg TOS/kg bw per day, yielding a margin of exposure of at least 376. Genotoxicity tests indicated no safety concern, and while a search for allergen homology found matches with two respiratory allergens, the panel considered the likelihood of allergic reactions upon dietary exposure low.
The opinion, published in the EFSA Journal, follows a request from the European Commission under Regulation (EC) No 1332/2008 on food enzymes, which requires safety evaluation before inclusion in the EU Community list. The application was originally part of a joint dossier submitted by the Association of Manufacturers and Formulators of Enzyme Products (AMFEP) for an enzyme from Talaromyces emersonii, but the new data package identified the production microorganism as Rasamsonia emersonii. EFSA requested additional information from the applicant on 26 January 2022, 30 June 2022, and 6 February 2026, which was provided on 26 April 2022, 31 August 2022, and 26 February 2026, respectively. The production strain, deposited at the Westerdijk Fungal Biodiversity Institute with number CBS 146317, was confirmed as R. emersonii by whole genome sequence analysis showing over 99.9% average nucleotide identity with the type strain. The food enzyme is manufactured using submerged fed-batch fermentation, with the production strain grown as a pure culture and the enzyme purified and concentrated through filtration and ultrafiltration steps.
The EFSA Panel on Food Enzymes (FEZ) concluded that the food enzyme is safe under the intended conditions of use, paving the way for potential EU authorisation. The opinion impacts several stakeholders: DSM Food Specialties B.V., the applicant, stands to benefit from a positive safety assessment that supports market approval; food manufacturers using the enzyme in brewing, winemaking, plant-based analogues, and yeast processing gain access to a new processing aid; consumers are reassured of safety, though a low risk of allergic reactions remains; and EU regulatory bodies, including the European Commission, will use the opinion to decide on inclusion in the EU Community list, balancing technological need with consumer protection.
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