Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Rhizopus arrhizus strain AE-TL(B).

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified Rhizopus arrhizus strain AE-TL(B) by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the modification of fats and oils by interesterification and in the manufacture of enzyme-modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.057 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 1,960 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 34,386. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon 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.