Safety evaluation of the food enzyme d-tagatose 3-epimerase from the genetically modified Escherichia coli strain PS-Sav-001

The food enzyme d-tagatose 3-epimerase (EC 5.1.3.31) is produced with the genetically modified Escherichia coli strain PS-Sav-001 by SAVANNA Ingredients GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is used while retained inside a membrane reactor to convert d-fructose into the speciality carbohydrate d-allulose (syn. d-psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d-allulose, dietary exposure was not calculated and toxicological studies were not considered necessary. 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 considered that under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but 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. (c) 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

Automated summary

The food enzyme d-tagatose 3-epimerase (EC 5.1.3.31) is produced using genetically modified Escherichia coli strain PS-Sav-001 by SAVANNA Ingredients GmbH. The genetic modifications do not raise safety concerns and the enzyme is considered free from viable cells and DNA of the production organism. It is used in a membrane reactor to convert d-fructose into d-allulose, and dietary exposure and toxicological studies were considered unnecessary due to purification steps. The enzyme does not pose safety concerns under the intended conditions of use, although the risk of allergic reactions by dietary exposure cannot be completely excluded.