# Updated safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain BABSC

## TL;DR

This paper evaluates the safety of a food enzyme produced by a genetically modified bacterium and concludes it is safe for use.

## Contribution

The study provides new data confirming the safety of a genetically modified Bacillus subtilis strain for food enzyme production.

## Key findings

- The genetically modified Bacillus subtilis strain qualifies for the QPS approach.
- No toxicological studies are needed for the enzyme under its intended use.
- The enzyme is considered safe for food applications based on updated evaluations.

## Abstract

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain BABSC by Advance Enzyme Technologies, Ltd. In a previous opinion, the Panel on Food Contact Materials, Enzymes and Processing Aids of the European Food Safety Authority could not conclude on the safety of this food enzyme due to insufficient data to consider the production strain to qualify for the qualified presumption of safety (QPS) approach, and the absence of toxicological studies. The new data provided by the applicant showed that the production strain qualifies for the QPS approach and therefore, no toxicological studies are considered necessary. Based on the new data provided and the evaluation of the data previously submitted, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.