The European Food Safety Authority (EFSA) has concluded that the food enzyme endo-polygalacturonase produced with the non-genetically modified Aspergillus tubingensis strain SPG 10-1199 does not give rise to safety concerns under the intended conditions of use. The scientific opinion, adopted on 25 June 2026 and published on 20 July 2026, assessed the enzyme for use in seven food manufacturing processes, including fruit juice production, wine making, and edible oil extraction. The Panel on Food Enzymes (FEZ) estimated dietary exposure up to 0.517 mg total organic solids (TOS) per kg body weight per day and found a margin of exposure of at least 3366 based on a no observed adverse effect level of 1740 mg TOS/kg bw per day from a 90-day rat study. Genotoxicity tests showed no safety concern, but the Panel noted that a risk of allergic reactions cannot be excluded due to sequence matches with one food allergen and 12 respiratory allergens.
The opinion was prepared in response to an application from Shin Nihon Chemical Co., Ltd., submitted under Regulation (EC) No 1332/2008 on food enzymes. The application was originally part of a joint dossier by the Association of Manufacturers and Formulators of Enzyme Products (AMFEP) for several pectinase enzymes, later split into individual data packages. The production strain, Aspergillus tubingensis SPG 10-1199, is deposited at the National Institute of Technology and Evaluation's Biological Resource Center in Japan. The enzyme is manufactured using conventional fermentation and purification processes, with the Panel confirming that sufficient information was provided to exclude issues of concern regarding the manufacturing process.
The food enzyme is intended for use in processing fruit and vegetables (juices, other products, wine, alcoholic beverages), plant and fungal-derived products (edible oils, tea and herbal infusions), and citrus oil essences. Residual TOS are removed in one process (citrus oil essences), so dietary exposure was calculated for the remaining six processes. The Panel's conclusion supports the inclusion of the enzyme in the EU Community list of authorised food enzymes, pending the European Commission's decision. The opinion follows EFSA's guidance on food enzyme safety evaluation and characterisation of microorganisms.