Safety evaluation of the food additive rebaudioside M produced via enzymatic conversion of purified steviol glycosides leaf extracts

The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a modified manufacturing process for the food additive enzymatically produced steviol glycosides (E 960c). The new process converts purified steviol glycosides extracted from Stevia rebaudiana leaves through enzymatic bioconversion catalysed by UDP-glucosyltransferase, UTP-glucose-1-phosphate uridylyltransferase and sucrose synthase enzymes, produced using a newly developed genetically modified strain of Escherichia coli (K-12 DSM 35119). The modification leads to changes in the definition of the food additive, residual protein, residual solvents and particle size. The Panel considered that the introduction of a new entry for the proposed food additive in Commission Regulation (EU) No 231/2012 would be more appropriate than amending the existing specifications for E 960c. The food additive is composed predominantly of rebaudioside M (> 95%) with minor amounts of other steviol glycosides. The manufacturing process does not raise a safety concern since no viable cells nor DNA of the production strain remained in the final product; in addition, the food enzyme–total organic solid (TOS) are removed to at least 99%, and consequently, the exposure to the food enzyme–TOS can be considered negligible. The Panel considered that rebaudioside M produced by this new manufacturing process have the same physicochemical characteristics as the corresponding rebaudioside M present in E 960c(i) and (ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the present safety assessment. The Panel concluded that there is no safety concern with respect to rebaudioside M (Reb M) produced via enzymatic conversion of purified steviol glycosides leaf extracts (95% steviol glycosides), using UDP-glucosyltransferase, UTP-glucose-1-phosphate uridylyltransferase and sucrose synthase enzymes produced by a genetically modified strain of Escherichia coli (named E. coli K-12 DSM 35119).