Safety evaluation of the food enzyme triacylglycerol lipase from non-genetically modified Limtongozyma cylindracea strain MS-5-OF.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the non-genetically modified yeast Limtongozyma cylindracea strain MS-5-OF by Meito Sangyo Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in five food manufacturing processes: brewing processes, baking processes, milk processing for cheese production, production of free fatty acids by hydrolysis and production of flavouring preparations from dairy products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.033 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 2,084 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 2,017. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions by dietary exposure cannot be excluded, but 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.