Eu evaluation of the safety of a 1, 4-alpha-glucan branching enzyme

On February 22, 2023, the European Union Food Safety Authority issued an opinion on the safety evaluation of a food enzyme, 1, 4-alpha-glucan branching enzyme.

It is understood that the food enzyme is produced by the non-genetically modified Geobacillus thermorificans strain TRBE14 and is intended for use in cereal processing, baking, and meat and fish processing.

After assessment, the panel noted that the food enzyme contains lysozyme, a known allergen. Therefore, sensitization cannot be ruled out. Based on the data provided, the Panel concluded that the food enzyme did not raise safety concerns under the intended conditions of use.

Some of the original reports are as follows:

The food enzyme 1, 4-alpha-glucan branching enzyme ((1 -- 4)-α-d-glucan branching enzyme ((1 -- 4)-α-d-glucan branching enzyme ((1 -- 4)-α-d-glucan branching enzyme ((1 -- 4)-α-d-glucano]-transferase; EC 2.4.1.18) is produced with the non-genetically modified Geobacillus thermodenitrificans strain TRBE14 by Nagase. 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. 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.