Safety evaluation of the food enzyme chymosin from the genetically modified strain DP-Nyj88.

The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified strain DP-Nyj88 by Genencor International BV. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of dairy products for the production of cheese. Dietary exposure was estimated to be up to 0.013 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 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 76,923. A search for the homology of the amino acid sequence of the chymosin to known allergens was made, and matches with five 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. 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.