Safety evaluation of the food enzyme acetolactate decarboxylase from the genetically modified Bacillus subtilis strain DP‐Ezz65

TL;DR

A genetically modified Bacillus subtilis strain produces a food enzyme that is considered safe for use in cereal processing.

Contribution

The study confirms the safety of acetolactate decarboxylase from a genetically modified Bacillus subtilis strain for food use.

Findings

The genetically modified Bacillus subtilis strain DP-Ezz65 meets the QPS approach requirements.

The food enzyme is free from viable cells and DNA of the production organism.

The likelihood of allergic reactions is considered low based on amino acid sequence analysis.

Abstract

The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with the genetically modified Bacillus subtilis strain DP‐Ezz65 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of brewed products. Dietary exposure was estimated to be up to 0.001 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 were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the acetolactate decarboxylase 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. 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.