Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Ogataea polymorpha strain DP-Jzk33

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with the genetically modified Ogataea polymorpha strain DP-Jzk33 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. It is intended to be used in baking and cereal-based processes. Based on the maximum use levels recommended for baking and cereal-based processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.520 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise 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 669 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure results in a margin of exposure of at least 1,287. A search was made of the similarity of the amino acid sequence of the lipase to those of known allergens and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is likely to be 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.

Keywords: EC 3.1.1.3; Hansenula polymorpha; Ogataea polymorpha; food enzyme; genetically modified microorganism; triacylglycerol lipase.