The European Food Safety Authority (EFSA) has concluded that a food enzyme containing arabinan endo-1,5-α-l-arabinanase and endo-polygalacturonase activities, produced with the non-genetically modified Aspergillus tubingensis strain PX22-272 by Shin Nihon Chemical Co., Ltd., 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 production of fruit juices, wine, edible oils, and tea infusions. The Panel on Food Enzymes (FEZ) estimated dietary exposure up to 0.639 mg total organic solids (TOS) per kg body weight per day, and a no observed adverse effect level of 2083 mg TOS/kg bw per day from a 90-day rat study, resulting in a margin of exposure of at least 3260. Genotoxicity tests showed no safety concern, but the Panel noted that a risk of allergic reactions cannot be excluded due to matches with one food allergen and 12 respiratory allergens.
The opinion is part of the EU's regulatory framework under Regulation (EC) No 1332/2008, which requires all food enzymes on the EU market to undergo safety evaluation by EFSA and approval via an EU Community list. The application was originally submitted as part of a joint dossier by the Association of Manufacturers and Formulators of Enzyme Products (AMFEP) in 2015, but was later split into individual data packages. The current assessment addresses the data package from Shin Nihon Chemical Co., Ltd., identified as EFSA-Q-2023-00270. The production strain, deposited at the National Institute of Technology and Evaluation's Biological Resource Center in Japan, was confirmed as A. tubingensis, not A. niger as initially indicated. 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. The Panel concluded that the enzyme is safe under the intended conditions, with no viable cells of the production organism present.