The European Food Safety Authority (EFSA) concluded that the food enzyme pectinesterase produced with the non-genetically modified Aspergillus luchuensis strain AP2 903-6 does not pose a safety concern under intended conditions of use. In a scientific opinion adopted on 18 June 2026 and published on 21 July 2026, the EFSA Panel on Food Enzymes estimated dietary exposure up to 0.551 mg total organic solids per kg body weight per day in European populations. Toxicity studies showed no adverse effects at the highest dose tested, yielding a margin of exposure of at least 3960. The Panel noted a risk of allergic reactions cannot be excluded due to matches with two respiratory allergens.
The opinion addresses an application by Shin Nihon Chemical Co., Ltd., submitted as part of a joint dossier originally filed by the Association of Manufacturers and Formulators of Enzyme Products (AMFEP). The production strain is the same as that used for another food enzyme previously evaluated by EFSA (EFSA-Q-2023-00244), for which no safety concern was identified. The food enzyme is intended for use in three food manufacturing processes: production of baked products, fruit and vegetable juices, and other fruit and vegetable products. The assessment followed EFSA guidance on food enzyme dossiers and the characterisation of microorganisms. The Panel considered the food enzyme free from viable cells of the production organism and concluded that, under the intended conditions of use, it does not give rise to safety concerns.