Safety evaluation of the food enzyme pectinesterase from the non‐genetically modified Aspergillus luchuensis strain CBS 148463

Abstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the non‐genetically modified Aspergillus luchuensis strain CBS 148463 by Solyve. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used in 12 food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in four processes, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 24.388 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 2401 mg TOS/kg bw per day, the highest dose tested. The calculated margin of exposure for each age group was 119 (infants), 98 (toddlers), 147 (children), 175 (adolescents), 543 (adults) and 649 (the elderly). 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 the 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, for adults and the elderly. However, the margin of exposure is insufficient to exclude safety concerns for infants, toddlers, children and adolescents.