EFSA Approves the Safety of Bacillolysin Food Enzyme

On July 4, 2024, the European Food Safety Authority (EFSA) issued an official opinion on the safety evaluation of the food enzyme bacillolysin (EC 3.4.24.28).

According to reliable information, this food enzyme is produced by Amano Enzyme Inc. using the non-genetically modified Bacillus strain AE-NP, intended for application in 15 food manufacturing processes.

After a thorough assessment, the expert panel concluded that the food enzyme is not of safety concern under the intended conditions of use. Some key details from the initial assessment report are as follows:

The food enzyme was initially evaluated for safety in 13 food manufacturing processes, and EFSA confirmed that its use does not raise safety concerns. The applicant then submitted a request to extend the use of the enzyme to two additional food manufacturing processes. In this latest assessment, EFSA updated the safety evaluation of the food enzyme for its use in a total of 15 food manufacturing processes. Since two of the processes can remove the total organic solids (TOS) from the food enzyme, the dietary exposure assessment was only conducted for the remaining 13 processes. Based on the data provided in the previous assessment and the revised dietary exposure estimates in this assessment, the expert panel concluded that the food enzyme is not of safety concern under the revised intended conditions of use. The estimated dietary exposure for the European population was calculated to be up to 35.251 mg TOS/kg body weight per day.