Safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: Rebaudioside M produced via enzyme-catalysed bioconversion of purified stevia leaf extract.

Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive, in particular related to rebaudioside M produced via enzyme‐catalysed bioconversion of purified stevia leaf extract. Rebaudioside M (95% on dry basis) is produced via enzymatic bioconversion of purified stevia leaf extract using uridine diphosphate (UDP)‐glucosyltransferase and sucrose synthase enzymes produced by the genetically modified yeasts K. phaffii UGT‐a and K. phaffii UGT‐b, that facilitates the transfer of glucose to purified stevia leaf extract via glycosidic bonds. The Panel considered that the parental strain K. phaffii ATCC 20864 qualifies for the qualified presumption of safety (QPS) approach for safety assessment and, therefore, is considered to be safe for production purposes. The Panel concluded that there is no safety concern for Rebaudioside M produced via enzymatic bioconversion of purified stevia leaf extract using UDP‐glucosyltransferase and sucrose synthase enzymes produced by the genetically modified yeasts K. phaffii UGT‐a and K. phaffii UGT‐b, to be used as a food additive. However, the Panel recommended that the European Commission considers establishing separate specifications for Rebaudioside M produced via enzymatic bioconversion of purified stevia leaf extract in Commission Regulation (EU) No 231/2012.