# Safety evaluation of the food enzyme protein‐glutamine γ‐glutamyltransferase from the genetically modified Bacillus licheniformis strain NZYM‐TR

## TL;DR

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

## Contribution

The paper provides a safety assessment of a novel food enzyme from a genetically modified Bacillus licheniformis strain.

## Key findings

- The enzyme production strain meets the qualified presumption of safety (QPS) criteria.
- Dietary exposure estimates are below levels of concern for European populations.
- No homology to known allergens was found, though a low risk of allergic reactions cannot be excluded.

## Abstract

The food enzyme protein‐glutamine γ‐glutamyltransferase (EC 2.3.2.13) is produced with the genetically modified Bacillus licheniformis strain NZYM‐TR by Novozymes A/S. The production strain meets the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in eight food manufacturing processes. Dietary exposure was estimated to be up to 0.651 mg total organic solids (TOS)/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the protein‐glutamine γ‐glutamyltransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. A risk of contribution to coeliac disease cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.