Safety evaluation of an extension of use of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain AE-BAA.

Abstract

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain AE-BAA by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in eight food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed from the final foods in two food manufacturing processes, the dietary exposure to the food enzyme-TOS was estimated only for the remaining seven processes. Dietary exposure was calculated to be up to 5.833 mg TOS/kg body weight per day in European populations. Based on the previous evaluation, the assessment of the new data and the revised dietary exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.