Safety evaluation of the food enzyme containing aspergillopepsin I and carboxypeptidase C activities from the non‐genetically modified Aspergillus sp. strain ACP 112–311

sp. strain ACP 112-311 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 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 estimated to be up to 0.079 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 180 mg TOS/kg bw per day, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2278. A search for the homology of the two amino acid sequences to known allergens was made and matches with one food, three respiratory and one injected 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.