Safety evaluation of the food enzyme containing endo‐polygalacturonase and pectinesterase activities from the non‐genetically modified Aspergillus luchuensis strain AP2 903‐6

Abstract The food enzyme containing endo‐polygalacturonase (1,4‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15) and pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) activities is produced with the non‐genetically modified Aspergillus luchuensis strain AP2 903‐6 by Shin Nihon Chemical Co. Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining seven food manufacturing processes. It was estimated to be up to 0.584 mg TOS/kg body weight (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 2182 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 3736. A search for the homology of the amino acid sequences to known allergens was made and matches with 14 respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure 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.