Safety evaluation of a food enzyme containing carboxypeptidase C, oryzin and leucyl aminopeptidase activities from the non-genetically modified Aspergillus sp. strain FP 12-385

Abstract

The food enzyme containing carboxypeptidase C (EC 3.4.16.5), oryzin (EC 3.4.21.63) and leucyl aminopeptidase (EC 3.4.11.1) activities is produced with the non-genetically modified Aspergillus sp. strain FP 12-385 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 1.146 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 2010 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 1754. A search for the homology of the three amino acid sequences of the food enzyme to known allergens was made and matches with three food allergens, 20 respiratory allergens and three contact 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.