Safety evaluation of the food enzyme aspergillopepsin I from the non-genetically modified strain APTC 3C-290.

The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified strain APTC 3C-290 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 1.699 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 two repeated dose 90-day oral toxicity studies in rats. The two test items have been obtained by submerged culture and by solid state fermentation, respectively. The Panel used the lowest of the two no observed adverse effect levels (1600 mg TOS/kg bw per day, the highest dose tested of the batch obtained by submerged culture), which when compared with the estimated dietary exposure, results in a margin of exposure of at least 942. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and three matches with respiratory allergens and one match with a dermal allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. 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.