Commission authorizes the use of rebaudioside M produced by Yarrowia lipolytica through fermentation

With the implementation of Regulation (EU) 2025/652 of 2 April 2025, the Commission amending Regulation (EC) No 1333/2008 of the European Parliament and the Council and Commission Regulation (EU) No 231/2012 as regards the use of Steviol glycosides produced by fermentation using Yarrowia lipolytica.

In September 2021, an application was received for amending the specifications for the group of steviol glycosides (E 960a-960d) to include a new method for the production of steviol glycosides, namely, of rebaudioside M produced from fermentation by Yarrowia lipolytica. Rebaudioside M from fermentation produced by Yarrowia lipolytica consists of not less than 95 % rebaudioside M, D, A and B and is obtained by fermentation of a source of simple sugar, using the genetically modified strain VRM of Yarrowia lipolytica. It is intended to be used under the same conditions as those already authorised for the group of steviol glycosides (E 960a-960d). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

On 24 October 2023, the European Food Safety Authority (‘the Authority’) adopted its opinion on the evaluation of the safety of rebaudioside M produced by fermentation using Yarrowia lipolytica. In its opinion, the Authority concluded that there is no safety concern for rebaudioside M, produced by fermentation using Yarrowia lipolytica to be used as a food additive for the proposed uses and at the proposed use levels, taking into account the existing ADI of 4 mg/kg bw per day (expressed as steviol equivalents). The Authority considered that this production method may result in impurities different from those that may be present in the other steviol glycosides, produced in accordance with the applicable respective specifications for E 960a, E 960c and E 960d. Therefore, the Authority considered that separate specifications are needed for the food additive produced via the manufacturing process described in the current application.

It is therefore appropriate to authorise the use for the proposed uses and at the proposed use levels of rebaudioside M produced by fermentation using Yarrowia lipolytica.

As the food additive steviol glycosides from fermentation (E 960b) may be used combined with additives from the group of steviol glycosides (E 960a–960d) in the food categories where those additives are currently authorised and at the same maximum levels as them, it should be added to the group of steviol glycosides (E 960a–960d) in Part C of Annex II to Regulation (EC) No 1333/2008.

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