The European Food Safety Authority (EFSA) has concluded that a food enzyme containing endo-polygalacturonase and pectinesterase activities, produced with the non-genetically modified Aspergillus luchuensis strain AP2 903-6 by Shin Nihon Chemical Co. Ltd, does not pose a safety concern under the intended conditions of use. The scientific opinion, adopted on 18 June 2026 and published on 21 July 2026, assessed the enzyme for use in eight food manufacturing processes, including production of baked products, fruit juices, wine, and edible oils. Dietary exposure was estimated at up to 0.584 mg total organic solids (TOS) per kg body weight per day for European populations, while a 90-day oral toxicity study in rats identified a no observed adverse effect level of 2182 mg TOS/kg bw per day, yielding a margin of exposure of at least 3736. Genotoxicity tests showed no safety concern, but the Panel noted that a risk of allergic reactions cannot be excluded due to matches with 14 respiratory allergens.
The evaluation follows the EU regulatory framework established by Regulation (EC) No 1332/2008 on food enzymes, which requires all food enzymes on the EU market to undergo a safety assessment by EFSA and approval via an 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 several pectinase enzymes from Aspergillus niger, but was later split into individual data packages. The current opinion addresses the specific data package for the enzyme produced with A. luchuensis strain AP2 903-6, which was identified as a non-genetically modified strain isolated from food. The Panel considered the food enzyme free from viable cells of the production organism and concluded that it does not give rise to safety concerns under the intended conditions of use. The opinion will inform the European Commission's decision on whether to include the enzyme in the Union list of authorised food enzymes.