Safety evaluation of a food enzyme containing endo‐polygalacturonase, pectinesterase and pectin lyase activities from the non‐genetically modified Aspergillus niger strain CCTCC M 2023236

Abstract The food enzyme containing endo‐polygalacturonase (1,4‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) and pectin lyase (1,4‐6‐O‐methyl‐α‐d‐galacturonan lyase; EC 4.2.2.10) activities is produced with the non‐genetically modified Aspergillus niger strain CCTCC M 2023236 by Suntaq International Limited. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 1.221 mg total organic solids (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 2000 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 1638. A search for the homology of the three amino acid sequences to known allergens was made and matches with 14 respiratory allergens were found. The Panel considered that under the intended conditions of use, 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.