Safety Assessment of a Food Enzyme (Phenol 2-Oxidoreductase) from Non-Genetically Modified Aspergillus Strain

On July 11, 2024, the European Food Safety Authority (EFSA) issued a formal opinion on the safety evaluation of the food enzyme phenol 2-oxidoreductase (EC 1.10.3.2) for use in the production of nine food items. The food enzyme is produced from a non-genetically modified strain of Aspergillus and is provided by Amano Enzyme Inc.

In previous assessments, EFSA had concluded that the use of this food enzyme in the manufacturing process of six food items posed no safety concerns. Subsequently, the applicant requested to extend the use of the enzyme to three additional processes and revised the use levels. In this latest assessment, EFSA has updated the safety evaluation of the use of this food enzyme in a total of nine food manufacturing processes.

Based on the data provided, the estimated total daily dietary exposure to the organic solids (TOS) of this food enzyme for the European population is up to a maximum of 0.030 mg TOS/kg body weight (bw). Using the previously reported no-observed-adverse-effect-level (i.e., the highest tested dose of 862 mg TOS/kg bw per day), the Panel derived an exposure margin of at least 28,733. Based on the data from the previous assessment and the revised exposure margin in this assessment, the Panel concluded that the use of this food enzyme under the revised intended conditions of use would not raise safety concerns.