EU Warns: Daily Intake of This Food Enzyme May Cause Allergies, Safety Margin Only 6004 Times!

On October 10, 2024, the European Food Safety Authority (EFSA) issued a report on a specific food enzyme, triacylglycerol lipase (triacylglycerol lipase). Also known as triacylglycerol acylhydrolase, EC 3.1.1.3) for safety evaluation comments. The food enzyme was produced by Shin Nihon Chemical Co., Ltd., using the non-genetically modified Aspergillus tubingus strain NL151. The enzyme is designed to play a role in six different food production processes.

After an exhaustive assessment, the panel concluded that although the risk of allergic reactions caused by dietary exposure to this food enzyme cannot be completely ruled out, the likelihood is very low. To ensure the accuracy of the assessment, experts conducted genotoxicity tests, which did not reveal any safety concerns. In addition, through a 90-day repeated dose oral toxicity study in rats, The panel determined the no observed adverse effect level (NOAEL) to be 1,669 milligrams of total organic solids (TOS) per kilogram of body weight per day, the highest dose used in the test. Comparing this value with the estimated dietary exposure of the European population (0.278 mg TOS per kilogram of body weight per day) results in a margin of exposure (MOE) of at least 6004.

To further ensure safety, the expert team also conducted a homology search of the amino acid sequence of the food enzyme with known allergens and did not find any matches. Based on this data, the panel concluded that this food enzyme does not raise safety concerns under the conditions of intended use. Therefore, this opinion of the European Food Safety Authority provides a scientific basis and safety guarantee for the application of this food enzyme in food production.