Safety evaluation of the food enzyme triacylglycerol lipase from the pregastric tissues of calves, kids and lambs.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is prepared from the pregastric tissues of calves, kids and lambs by RENCO New Zealand Limited. No issue of concern was identified from the food enzyme manufacturing process. The food enzyme is intended to be used in two food manufacturing processes. As cheese production is a traditional use of this food enzyme, dietary exposure was not calculated. For the use in the production of flavouring preparations from dairy products, a dietary exposure was estimated to be up to 0.645 mg total organic solids/kg body weight per day in European populations, which is lower than the intake of the corresponding fraction from pregastric tissues. The Panel considered toxicological testing unnecessary. Adverse reactions upon dietary exposure to triacylglycerol lipases have not been reported and allergies to proteins from calves, kids and lambs are rare. 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, uncertainty remains with respect to the microbiological safety of the food enzyme. Therefore, the Panel cannot conclude on the safety of the food enzyme triacylglycerol lipase obtained from the pregastric tissues of calves, kids and lambs.