EFSA Evaluates Safety of Amano Enzyme Inc.'s Triacylglycerol Lipase Food Enzyme

On July 5, 2024, the European Food Safety Authority (EFSA) published its expert opinion on the safety assessment of the food enzyme triacylglycerol lipase, produced by Amano Enzyme Inc. using a non-genetically modified strain of Penicillium caseifulvum, AE-LRF, and intended for use in four food manufacturing processes.

The assessment results showed that this food enzyme has an extremely high production purity, as no viable cells were detected during the manufacturing process.

The dietary exposure to this food enzyme in the European population was estimated to be no more than 0.013 mg total organic solids (TOS) per kg body weight (bw) per day. Genotoxicity testing did not raise any safety concerns. Furthermore, the expert panel assessed the systemic toxicity through a 90-day repeated dose oral toxicity study, and found no adverse effects at the highest tested dose of 69 mg TOS/kg bw/day, which represents at least a 5,308-fold margin of exposure compared to the estimated dietary exposure.

The expert panel also thoroughly investigated the amino acid sequence similarity of this food enzyme to known allergens and found no matches. However, they noted that potential residues from the manufacturing process of the triacylglycerol lipase may be present in the food enzyme. Based on this finding, the expert panel stated that, although the safety assessment was thorough, the risk of allergic reactions upon dietary exposure cannot be completely excluded, particularly for those individuals allergic to fish.

In conclusion, based on the detailed data and assessment results provided, the expert panel concluded that this food enzyme is not of safety concern under the intended conditions of use.