Abstract
Abstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) 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 three food manufacturing processes. Dietary exposure was estimated to be up to 0.551 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a food enzyme containing endo‐polygalacturonase and pectinesterase activities, which is further processed to obtain the food enzyme under assessment. 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 3960. A search for the homology of the amino acid sequence of the pectinesterase to known allergens was made and matches with two respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme 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.