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Risk assessment

Safety Assessment RP1112 Modification of use of Steviol Glycosides (E 960) produced by Fermentation

This section summaries the safety assessment of the modification of use of steviol glycosides (E 960) produced by fermentation (Rebaudioside M) using Saccharomyces cerevisiae.


An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in May 2021 from Amyris Inc (“the Applicant”) for changes of the existing production method of steviol glycosides (formerly E 960) to include fermentation by Saccharomyces cerevisiae.

The production method uses a genetically modified strain of S. cerevisiae to convert sugar into rebaudioside M (reb M) at a final purity of no less than 95% reb M (anhydrous).

To support the FSA and FSS in evaluating the dossier the Joint Expert Group on Additives, Enzymes and other regulated products (AEJEG) were asked to review the dossier and the supplementary information from the applicant. The AEJEG concluded that the new method for the production of steviol glycosides from fermentation by Saccharomyces cerevisiae was safe under the proposed conditions of use. The proposed uses and use levels for rebaudioside M, produced via fermentation with Saccharomyces cerevisiae remain the same as the already authorised food additive steviol glycosides (E 960a and E960c).

The views of the AEJEG have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on the modification of the production for steviol glycosides using enzymatic bioconversion.

Safety assessment