Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus oryzae strain AR‐962

Abstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus oryzae strain AR‐962 by AB Enzymes GmbH. The genetic modifications did not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juice, production of wine and wine vinegar, production of plant extracts as flavouring preparations and coffee demucilation. Since residual amounts of total organic solids are removed by repeated washing or distillation, dietary exposure to the food enzyme total organic solids (TOS) from the production of flavouring extracts and coffee demucilation was considered not necessary. For the remaining three food processes, dietary exposure to the food enzyme‐TOS was estimated to be up to 0.647 mg TOS/kg bw per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,546. A search for the similarity of the amino acid sequence to those of known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to pollen allergens, cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.