Safety evaluation of the food enzyme cyclomaltodextrin glucanotransferase from the genetically modified Escherichia coliK12 strain DSM 34230.

The food enzyme cyclomaltodextrin glucanotransferase (1,4-α-d-glucan 4-α-d-[1,4α-d-glucano]-transferase (cyclising); EC 2.4.1.19) is produced with the genetically modified strain Escherichia coli K12 DSM 34230 by Wacker Chemie AG. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism, but not from recombinant DNA. It is intended to be used in the processing of sugars for the production of specialty carbohydrates (γ-cyclodextrins). Since residual amounts of food enzyme-total organic solids are removed during the production of γ-cyclodextrins, dietary exposure was not calculated and toxicological testing was not needed. A search for the homology of the amino acid sequence of the cyclomaltodextrin glucanotransferase to known allergens was made and matches with two respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure 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.