Safety evaluation of the food enzyme aspergillopepsin I from the non-genetically modified sp. strain AE-PRHF.

The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified sp. strain AE-PRHF by AMANO ENZYME INC. The food enzyme was free from viable cells of the production organism. It is intended to be used in 15 food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining 13 food manufacturing processes. It was estimated to be up to 2.172 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 2003 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 922. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with three respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.