# Safety evaluation of an extension of use of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA

## TL;DR

This paper evaluates the safety of extending the use of a food enzyme produced by a non-genetically modified bacteria in additional food manufacturing processes.

## Contribution

The study provides an updated safety assessment for the extended use of α-amylase in nine food processes.

## Key findings

- The food enzyme is safe for use in nine food manufacturing processes.
- Dietary exposure to the enzyme was estimated at up to 0.382 mg TOS/kg body weight per day.
- The enzyme-TOS is removed in two processes, so exposure was only calculated for seven.

## 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 licheniformis strain AE‐TA 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 0.382 mg TOS/kg body weight per day in European populations. Based on the data provided for the previous evaluation and the revised dietary exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.