The European Food Safety Authority (EFSA) concluded that the food enzyme thermolysin from non-genetically modified Anoxybacillus caldiproteolyticus strain AE-TP does not pose safety concerns under revised intended uses, including a new application in egg and egg product processing. In a scientific opinion adopted on 24 June 2026 and published on 9 July 2026, EFSA's Panel on Food Enzymes updated the dietary exposure assessment, finding a margin of exposure of at least 753 based on a no observed adverse effect level of 700 mg TOS/kg body weight per day and a maximum dietary exposure of 0.930 mg TOS/kg bw per day.
The opinion updates a previous safety evaluation from February 2024, which had assessed the enzyme for seven food manufacturing processes. In July 2024, the applicant, Amano Enzyme Inc., had withdrawn two processes and added one, but later requested to reintroduce one of the withdrawn processes and revise use levels. The current assessment covers eight processes: dairy products (flavouring preparations, modified milk proteins), eggs and egg products, meat and fish products (modified products, protein hydrolysates), cereals and other grains (baked products), plant- and fungal-derived products (plant-based analogues, protein hydrolysates), and yeast and yeast products. The new use in egg processing involves treating whole liquid egg, egg yolk, or egg white to improve sensory and technological properties, with the enzyme potentially remaining active in egg and baked products due to insufficient heat inactivation. EFSA noted substantial changes in recommended use levels compared to previous applications, attributed by the applicant to the availability of actual use levels. The Panel concluded that, based on the revised exposure estimation and margin of exposure, the food enzyme does not give rise to safety concerns under the intended conditions of use.