Safety evaluation of the food enzyme 1,4-α-glucan branching enzyme from the non-genetically modified Geobacillus thermodenitrificans strain TRBE14

The food enzyme 1,4-alpha-glucan branching enzyme ((1-4)-alpha-d-glucan:(1-4)-alpha-d-glucan 6-alpha-d-[(1-4)-alpha-d-glucano]-transferase; EC 2.4.1.18) is produced with the non-genetically modified Geobacillus thermodenitrificans strain TRBE14 by Nagase (Europa) GmbH. The production strain has been shown to qualify for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in cereal-based processes, baking processes as well as meat and fish processing. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.29 mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary given the QPS status of the production strain and the nature of the manufacturing process. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel noted that the food enzyme contains lysozyme, a known allergen. Therefore, allergenicity 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. (c) 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

Automated summary

This study introduces a food enzyme called 1,4-alpha-glucan branching enzyme, which is produced by the non-genetically modified Geobacillus thermodenitrificans strain TRBE14. The production strain meets the qualified presumption of safety (QPS) approach. The food enzyme is commonly used in cereal-based processes, baking processes, and meat and fish processing. Although no allergens were found in the amino acid sequence of the food enzyme, it contains lysozyme, a known allergen. However, based on the provided data, the Panel concludes that this food enzyme does not pose any safety concerns under the intended conditions of use.