EFSA Affirms Safety of Amano Enzyme Inc.'s Bacillolysin Food Enzyme

On July 4, 2024, the European Food Safety Authority (EFSA) published its official safety assessment report on the food enzyme bacillolysin (EC 3.4.24.28). This food enzyme is produced by Amano Enzyme Inc. using a non-genetically modified strain of Bacillus amyloliquefaciens, AE-NP, and is intended to be used in the manufacturing processes of up to 15 different food products.

After a thorough and detailed assessment, the expert panel unanimously concluded that this food enzyme is not of safety concern under the intended conditions of use.

The previous safety evaluation had already established the safe use of this food enzyme in 13 food manufacturing processes. The applicant then submitted an application to extend the use of this enzyme to two additional processes. In this latest assessment, EFSA updated the safety evaluation of the use of this food enzyme in a total of 15 food manufacturing processes.

Given that the total organic solids (TOS) of the food enzyme will be removed in the production of two of these food items, the dietary exposure to the food enzyme-TOS was estimated only for the remaining 13 food manufacturing processes. The results showed that the dietary exposure to the food enzyme-TOS in the European population could reach up to 35.251 mg/kg body weight per day.

Based on the data provided in the previous assessment and the revised dietary exposure data, the expert panel concluded that the food enzyme is not of safety concern under the revised intended conditions of use.