Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC

Abstract

[EN] The food enzyme pectinesterase (pectin pectylhydrolase, EC 3.1.1.11) is produced with the genetically modified Aspergillus luchuensis strain FLZSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in fruit and vegetable processing for the production of juices and other fruit or vegetable products, as well as in the manufacture of alcoholic beverages from fruits other than grapes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.274 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 833 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 3,040. A search was made for the similarity of the amino acid sequence of the food enzyme to those of known allergens and three matches with respiratory 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 olive pollen, although unlikely, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.