Food additives: Steviol glycosides
- Food additives
- Food safety
Summary
The European Union (EU) has authorised the use of steviol glycosides made from rebaudioside M produced by fermentation using Yarrowia lipolytica (E 960b) as a food additive (sweetener).
EU authorises steviol glycosides produced by fermentation using Yarrowia lipolytica as food additive (sweetener)
Commission Regulation (EU) 2025/652 of 2 April 2025 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
Update
The European Union (EU) has authorised the use of steviol glycosides made from rebaudioside M produced by fermentation using Yarrowia lipolytica (E 960b) as a food additive (sweetener).
Impacted Products
Sweeteners (steviol)
What is changing?
The EU has authorised the use of steviol glycosides made from rebaudioside M produced by fermentation using Yarrowia lipolytica (E 960b) as a food additive for sweetening purposes. This additive is included in the existing group of steviol glycosides (E 960a–960d), meaning that it can be used in the same food categories as those additives and at the same maximum levels (see Regulation 2023/447).
As the production of E 960b may lead to different impurities from other steviol glycosides, separate specifications are established for this additive in Annex II of the Regulation.
Why?
The European Food Safety Authority (EFSA 2023) has concluded that there is no safety concern for rebaudioside M produced by fermentation using Y. lipolytica to be used as a food additive within an acceptable daily intake (ADI) of 4 mg/kg body weight per day (expressed as steviol equivalents).
EFSA considers that separate specifications are needed for the food additive rebaudioside M produced by fermentation using Y. lipolytica, as the production method may result in different impurities.
Timeline
This authorisation applies from 23 April 2025.
Background
The EU approves food additives and sets out their conditions of use. The list of approved food additives can be updated on request by the EU, or following an application.
Steviol glycosides obtained by three different manufacturing processes are regulated in combination as food additives (Regulation 1333/2008, Annex II, Part C) with maximum limits expressed as steviol equivalents. The other authorised steviol glycosides are:
- steviol glycosides from Stevia (E 960a)
- enzymatically produced steviol glycosides (E 960c)
- glucosylated steviol glycosides (E 960d).
In September 2021, an application was received to include a new method for the production of steviol glycosides: rebaudioside M produced from fermentation by Yarrowia lipolytica. 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 Y. lipolytica.
For the most recently updated list of approved food additives and conditions of use, see Regulation 1333/2008: click on the date that follows “Current consolidated version”.
Resources
EFSA (2023) Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolytica VRM. EFSA Journal, 21: e8387.
Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
Regulation 1333/2008 on food additives
Sources
Regulation 2025/652 as regards the use of Steviol glycosides produced by fermentation using Yarrowia lipolytica
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EU authorises steviol glycosides produced by fermentation using Yarrowia lipolytica as food additive (sweetener)
Regulation 2025/652 as regards the use of Steviol glycosides produced by fermentation using Yarrowia lipolytica
What is changing and why?
Following an assessment of its safety by the European Food Safety Authority, the European Union (EU) has authorised the use of steviol glycosides as a sweetener made from rebaudioside M produced by fermentation using Yarrowia lipolytica (E 960b).
E 960b is added to the existing group of steviol glycosides (E 960a–960d), meaning that it can be used in the same food categories as those additives and at the same maximum levels.
As the production of E 960b may lead to different impurities from other steviol glycosides, separate specifications are established for this additive.
Timeline
This authorisation applies from 23 April 2025.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.