# Safety evaluation of the food enzyme serine endopeptidase from the genetically modified Aspergillus niger strain NZYM‐MG

## TL;DR

This paper evaluates the safety of a genetically modified enzyme used in alcohol production and concludes it is safe for its intended use.

## Contribution

The study provides a safety evaluation of a genetically modified serine endopeptidase enzyme for use in distilled alcohol production.

## Key findings

- The genetic modifications in the enzyme do not pose safety concerns.
- The enzyme does not pose a risk of allergic reactions in its intended use.
- The enzyme is not expected to remain in the final product due to processing.

## Abstract

The food enzyme serine endopeptidase (EC 3.4.21) is produced with the genetically modified Aspergillus niger strain NZYM‐MG by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the processing of cereals and other grains for the production of distilled alcohol. Since residual amounts of food enzyme–total organic solids are removed in this process, toxicological studies were considered unnecessary by the Panel and a dietary exposure was not calculated. A search for the homology of the amino acid sequence of the serine endopeptidase to known allergens was made and a match with one contact allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure can be excluded for the production of distilled alcohol. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended condition of use.