Safety evaluation of a food enzyme containing leucyl aminopeptidase and Xaa-Pro dipeptidyl-peptidase activities from the non-genetically modified Aspergillus sp. strain DAP 19-109.

The food enzyme containing leucyl aminopeptidase (EC 3.4.11.1) and Xaa-Pro dipeptidyl-peptidase (EC 3.4.14.11) activities is produced with the non-genetically modified Aspergillus sp. strain DAP 19-109 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 0.929 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 2310 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 2487. A search for the homology of the two amino acid sequences to known allergens was made and matches with three injected allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this 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.