# Safety evaluation of an extension of use of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain AE‐NP

## 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 confirms the safety of the food enzyme bacillolysin for extended use in fifteen food manufacturing processes.

## Key findings

- Dietary exposure to the food enzyme–TOS was estimated at up to 35.251 mg/kg body weight per day.
- The enzyme was deemed safe for use in the revised conditions across European populations.

## Abstract

The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain AE‐NP 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 thirteen food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of fifteen food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed in two food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining thirteen processes. Dietary exposure was calculated to be up to 35.251 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.