# Safety evaluation of the food enzyme trypsin from the genetically modified Fusarium venenatum strain NZYM‐FG

## TL;DR

A genetically modified trypsin enzyme is evaluated for safety in food processing, with findings indicating it is safe under intended use.

## Contribution

The study provides a safety evaluation of a genetically modified trypsin enzyme for use in dairy processing.

## Key findings

- Genetic modifications in the trypsin enzyme do not pose safety concerns.
- The enzyme is free from viable cells and DNA of the production organism.
- The enzyme is considered safe for use in dairy processing under the intended conditions.

## Abstract

The food enzyme trypsin (EC 3.4.21.4) is produced with the genetically modified Fusarium venenatum strain NZYM‐FG 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 dairy products for the production of modified milk proteins. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 5.792 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 4462 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 770. A search for the homology of the amino acid sequence of the trypsin to known allergens was made and matches with 11 respiratory and four injected allergens were 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. 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.