The European Food Safety Authority (EFSA) has concluded that the food enzyme dextransucrase, produced with the genetically modified Bacillus subtilis strain DP-Eyp97 by Genencor International B.V., does not give rise to safety concerns under its intended conditions of use. The scientific opinion, adopted on 20 May 2026 and published on 24 June 2026, estimates dietary exposure up to 27.598 mg total organic solids per kg body weight per day in European populations. Given the qualified presumption of safety (QPS) status of the production strain and the absence of concerns from the manufacturing process, the EFSA Panel on Food Enzymes deemed toxicity tests unnecessary. A search for allergen homology found no matches, and while a risk of allergic reactions cannot be excluded, the likelihood is considered low.
The opinion follows an application submitted on 15 December 2023 by Genencor International B.V. for authorisation of the food enzyme under Regulation (EC) No 1332/2008. The enzyme, a dextransucrase (EC 2.4.1.5), catalyses the conversion of sucrose into dextrans and fructose, and is intended for use in the processing of sugars to produce oligo- and polysaccharides in situ. EFSA carried out a public consultation on the non-confidential dossier from 4 March to 25 March 2026, receiving no comments. The production strain, B. subtilis DP-Eyp97, was identified by phylogenomic analysis and meets QPS criteria, with no acquired antimicrobial resistance genes or toxigenic activity detected. The genetic modifications were considered safe by the Panel.
The food enzyme is manufactured using a submerged fermentation process, with cells lysed mechanically and the enzyme purified via filtration and ultrafiltration. The Panel confirmed that the manufacturing process and quality assurance system exclude issues of concern. The enzyme has a temperature optimum around 40–45°C and pH optimum around 7.0, with activity decreasing above 45°C. The opinion will inform the European Commission's decision on whether to include the enzyme in the Union list of authorised food enzymes.