# Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Bacillus licheniformis strain DSM 34099

## TL;DR

This paper evaluates the safety of a genetically modified enzyme used in food manufacturing and concludes it is safe under intended use conditions.

## Contribution

The study confirms the safety of β-galactosidase from a genetically modified Bacillus licheniformis strain for food use.

## Key findings

- The genetically modified Bacillus licheniformis strain meets the qualified presumption of safety (QPS) criteria.
- Dietary exposure to the enzyme is estimated at up to 7.263 mg/kg body weight per day.
- A potential allergenic risk from kiwi fruit allergens was identified, but overall safety is confirmed under intended use.

## Abstract

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Bacillus licheniformis strain DSM 34099 by Kerry Group Services International, Ltd. (KGSI). The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure was estimated to be up to 7.263 mg total organic solids/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, other than an assessment of allergenicity, were considered unnecessary by the Panel. A search for the identity of the amino acid sequence of the food enzyme to known allergens was made and one match with a food allergen from kiwi fruit was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to kiwi fruit, 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.