Safeguarding the Food Chain: EU Agency Affirms Safety of α-Amylase Enzyme

On July 3rd, 2024, the European Food Safety Authority (EFSA) issued a detailed opinion on the safety evaluation of the food enzyme α-amylase (α-amylase, also known as 4-α-D-glucan glucanohydrolase, EC 3.2.1.1). This food enzyme is produced by Amano Enzyme Inc. using a non-genetically modified strain of the bacterium Bacillus licheniformis, AE-TA, and is designed to function in nine different food manufacturing processes.

After a thorough assessment, the expert panel concluded that there are no safety concerns under the intended use conditions of this food enzyme. In a previous safety evaluation, EFSA had already determined that the use of this food enzyme in eight food manufacturing processes does not raise any safety issues. The applicant subsequently requested to expand the use of this food enzyme to another manufacturing process and revised the use levels.

In this latest assessment, EFSA updated the safety evaluation of the use of this food enzyme in a total of nine food manufacturing processes. Since the total organic solids (TOS) of the food enzyme are removed from the final products in two of the manufacturing processes, the expert panel estimated the dietary exposure to the food enzyme-TOS only for the remaining seven manufacturing processes. Based on the data from the previous assessment and the revised dietary exposure estimates in this assessment, the expert panel calculated that the maximum daily dietary exposure to the food enzyme-TOS for the European population could reach up to 0.382 mg/kg body weight.

Given all the information provided, the expert panel ultimately concluded that there are no safety concerns under the revised intended use conditions for this food enzyme.