Safety evaluation of the food enzyme aminopeptidase Y from the genetically modified strain DP-Nyf80.

The food enzyme aminopeptidase Y (EC 3.4.11.15) is produced with the genetically modified strain DP-Nyf80 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. Recombinant DNA was not detected under standard testing conditions. However, the absence of viable cells could not be excluded. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 1.861 mg total organic solids (TOS)/kg body weight 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 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 537. A search for the homology of the amino acid sequence of the aminopeptidase Y to known allergens was made and no match was 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.