Safety evaluation of a food enzyme containing oryzin and leucyl aminopeptidase activities and a heat‐treated food enzyme containing only leucyl aminopeptidase activity from the non‐genetically modified Aspergillus sp. strain FL 72‐230

sp. strain FL 72-230 by Shin Nihon Chemical Co., Ltd. The native food enzyme contains leucyl aminopeptidase (EC 3.4.11.1) and oryzin (EC 3.4.21.63) activities. Another food enzyme containing only the leucyl aminopeptidase (EC 3.4.11.1) activity was obtained by heat treatment and filtration of the native food enzyme. Both food enzymes were considered free from viable cells of the production organism. Both food enzymes are intended to be used in 14 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 13 food manufacturing processes. It was calculated to be up to 0.532 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 585 mg TOS/kg bw per day for the native food enzyme, which when compared with the estimated dietary exposure, resulted in a margin of exposure (MoE) of at least 1100. For the heat-treated food enzyme, using a single dose tested of 2340 mg TOS/kg body weight (bw) per day, not showing adverse effects, the MoE is at least 4398. A search for the homology of the two amino acid sequences to known allergens was made and matches with two food allergens, three contact allergens and 14 respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to these food enzymes cannot be excluded. Based on the data provided, the Panel concluded that both food enzymes do not give rise to safety concerns, under the intended conditions of use.