EFSA Warns: New Food Enzyme May Cause Allergies, Daily Intake Up to 0.315 mg

On October 16, 2024, the European Food Safety Authority (EFSA) officially published a safety assessment report on triacylglycerol lipase. This enzyme, produced by the non-transgenic Limtongozyma cylindracea strain AE-LAYH (B), is used in six different food production processes to optimize food processing characteristics and quality.

In the evaluation process, the expert team conducted a thorough review and analysis of the available scientific data, with a particular focus on the stability of the enzyme in food processing, possible degradation products and potential impact on consumers. After in-depth research, the expert team concluded that the use of this food enzyme is unlikely to cause serious health problems under normal conditions of use. However, it is also noted that the risk of allergic reactions due to dietary exposure cannot be completely ruled out, especially in people sensitive to honey components, although this risk is assessed as extremely low.

Triacylglycerol acylhydrolase; EC 3.1.1.3), produced by Amano Enzyme Inc., using non-GMO Monella AE-LAYH (B), is planned for use in six food production stages. Since residues of total organic solids (TOS) of food enzymes have been removed from one of these processes, dietary exposures were calculated for the remaining five processes only. The daily TOS intake of the European population is estimated to be about 0.315 mg per kilogram of body weight (bw). Given that the production strain had passed the safety assessment under the safety quality presumption method and no significant problems were found in the production process, the Panel considered that there was no need for further toxicology studies beyond the assessment of allergenicity.

In addition, the amino acid sequences of food enzymes were homologous compared with known allergens, and the results showed that there was a match with a bee venom allergen. The expert team therefore believes that although the risk of allergic reactions is low, the possibility of allergies due to dietary exposure cannot be completely ruled out, especially in individuals allergic to honey.

Based on a comprehensive evaluation and analysis of the available data, the expert team concluded that the food enzyme does not raise safety concerns under the conditions of intended use. This conclusion covers a comprehensive consideration of the toxicological properties, allergenic potential and residue levels of the enzyme in food. EFSA's advice provides a solid scientific basis for EU member States to make decisions on food legislation and supervision, ensuring that consumers enjoy good food while enjoying adequate safety.