Steviol Glycoside
Regulation Guide
E 960a–E 960d, ADI, Labeling & Global Compliance Reference
A practical reference for formulators, regulatory teams and ingredient buyers. Understand steviol glycoside classifications, ADI calculations, claim boundaries and market requirements across the EU, United States and China.
Steviol Glycoside Regulation and Claim Guide: E 960a to E 960d, ADI and What Your Label Can Say
Steviol glycosides no longer sit under one E number, one production route or one national standard. A Reb A extracted from leaf, a Reb M made enzymatically and a Reb M made by fermentation carry three different EU entries and, in China, appear under three separate additive categories. This page is a reference, not an introduction: the current entries, the arithmetic that converts a use level into a share of the ADI, and the boundary between what a finished product may claim and what it may not. Written for the person who has to sign off a specification or a label.
01 · The E 960 family
E 960a, E 960b, E 960c and E 960d: What Each Entry Actually Covers
Steviol glycosides are authorised in Annex II to Regulation (EC) No 1333/2008, with specifications in Regulation (EU) No 231/2012. The entries do not describe different molecules so much as different ways of making them, and that is the source of most labelling errors.
| Entry | What it covers | Production route | Added |
|---|---|---|---|
| E 960a | Steviol glycosides from stevia. Not less than 95% steviolbioside, rubusoside, dulcoside A, stevioside and rebaudiosides A, B, C, D, E, F and M on the dried basis, in any combination and ratio | Water extraction of Stevia rebaudiana Bertoni leaf | Renamed from E 960, August 2021 |
| E 960b(i) | Rebaudioside M from fermentation | Fermentation using Yarrowia lipolytica | April 2025, Reg (EU) 2025/652 |
| E 960c(i) | Rebaudioside M produced via enzyme modification of steviol glycosides from stevia | Enzyme modification of a glycoside preparation | July 2021 |
| E 960c(ii) | Rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extracts | Enzymatic conversion from purified Reb A | October 2022 |
| E 960c(iii) | Rebaudioside D produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extracts | Enzymatic conversion from purified Reb A | October 2022 |
| E 960c(iv) | Rebaudioside AM produced via enzymatic conversion of highly purified stevioside stevia leaf extracts | Enzymatic conversion from purified stevioside | October 2022 |
| E 960d | Glucosylated steviol glycosides, carrying 1 to 20 additional glucose units on the parent glycosides | Cyclodextrin glucanotransferase transfers glucose from starch onto purified stevia leaf glycosides | March 2023, Reg (EU) 2023/447 |
Three consequences worth acting on
- E 960 on its own is no longer valid. The renaming carried an 18 month transition that ended on 2 February 2023. Paperwork still saying E 960 is a quick way to judge how recently a supplier reviewed their regulatory file.
- Maximum permitted levels are combined across E 960a to E 960d, as steviol equivalents. Blending an extracted glycoside with an enzymatic one does not give you two allowances.
- Each entry is defined by its manufacturing process, including the production organism. A new strain requires an amendment that EFSA assesses case by case. Ask which sub-entry and which process definition a supplier works to, and check the consolidated Annex rather than a summary.
Need the process definition and E number that apply to a specific grade?
Ask us →02 · Made rather than extracted
Two Specification Parameters That Only Apply to Enzymatic and Fermentation Products
Rebaudioside M and Rebaudioside D occur in stevia leaf at levels too low for direct extraction to be commercially viable, so commercial material is made rather than extracted. Because the biocatalyst comes from a genetically modified microorganism, two parameters appear that a leaf extract COA will never carry.
| Parameter | Requirement | What it demonstrates |
|---|---|---|
| Residual recombinant DNA | Absence shown by a method with a limit of detection not higher than 10 ng DNA per gram of product | No DNA from the production strain carries through into the finished additive |
| Residual protein | Absence shown by a method with a limit of detection not higher than 5 mg/kg | The processing enzymes have been removed |
| Kaurenoic acid | Not yet a formal specification entry. EFSA has recommended introducing one | An emerging parameter. Worth asking about before it becomes mandatory |
These are not paperwork. In 2022 an application to add an enzymatic Reb D process to the EU specifications was refused on exactly this point: EFSA found no toxicological concern with the glycoside itself, but could not conclude because the submitted PCR work failed to demonstrate the absence of residual recombinant DNA. The full account is on our Reb D page.
One labelling consequence follows. A bare "Non-GMO" claim on an enzymatically converted glycoside is not supported by the specification, because the enzymes are produced by a genetically modified microorganism. The accurate statement is that they act as processing aids, are removed during purification, and their absence is demonstrated against the two limits above.
03 · ADI and intake
The ADI, the Conversion Factors and Where Your Product Sits
The acceptable daily intake is 0 to 4 mg per kg body weight per day, expressed as steviol equivalents. Two things trip people up: the limit is in steviol rather than in the glycoside you actually add, and it is shared across every steviol glycoside in the formula.
A worked example
A 330 ml soft drink sweetened at 300 ppm Rebaudioside A contains 99 mg of Reb A. Multiplied by 0.33 that is 32.7 mg of steviol equivalents. For a 60 kg adult the ADI is 4 × 60, or 240 mg per day. One can therefore accounts for roughly 14% of the ADI.
Run the same arithmetic across every glycoside in a multi-sweetener formula and add the results, because the allowance is shared. A formula using both an extracted Reb A and an enzymatic Reb M draws on one budget, not two.
Conversion factors
| Glycoside | Multiply by | To get |
|---|---|---|
| Rebaudioside A | 0.33 | Steviol equivalents |
| Stevioside | 0.40 | Steviol equivalents |
| Other glycosides | Molecular weight ratio of steviol to the glycoside | Steviol equivalents |
Why the limit is expressed in steviol
Steviol glycosides are not absorbed as intact molecules. They pass to the colon, where bacteria hydrolyse them to steviol. The steviol is absorbed, conjugated in the liver, and the resulting steviol glucuronide is excreted in urine. Steviol is the sole absorbed common metabolite of the whole class, whichever glycoside you started from and however it was made, which is why one ADI covers all of them and why the conversion factors exist.
Where the number 4 comes from
A two year rat carcinogenicity study with a no observed adverse effect level of 970 mg/kg body weight per day of stevioside, equivalent to 383 mg/kg body weight per day of steviol, with a hundredfold uncertainty factor applied. In 2024 EFSA assessed an application to raise the ADI to 6 or 16 mg/kg body weight per day and concluded there was insufficient justification. Exposure calculations should continue to use 4.
We can run this calculation against your formula and destination market.
Send us your spec →04 · Claims
What a Finished Product May Say, and What It May Not
The claim risk sits with the finished product manufacturer, not with the ingredient supplier. This is the boundary as it currently stands.
Compositional statements, which are not health claims
Steviol glycosides contribute no calories and no sugar at use level, and are not fermented by oral bacteria. Sugar reduction, no added sugar and reduced calorie positioning are compositional routes and remain fully available, subject to the nutrition labelling rules for those descriptors in your market.
Authorised in the European Union
Two health claims are authorised for sugar replacers, a category that includes intense sweeteners, under Commission Regulation (EU) No 432/2012 following EFSA assessment in 2011: that consuming foods or drinks containing sugar replacers instead of sugar contributes to the maintenance of tooth mineralisation by decreasing tooth demineralisation, and that it induces a lower blood glucose rise after consumption compared with sugar-containing foods or drinks.
Both are conditional. The claim belongs to the finished food rather than to the sweetener, it requires actual replacement of sugars rather than merely the presence of a sweetener, and each carries specific conditions of use in the Annex to that Regulation. Read the conditions from the regulation text before wording any artwork, because a claim that is authorised in principle can still fail on the threshold.
Not authorised, and worth understanding why
The same 2011 EFSA assessment considered intense sweeteners in relation to the maintenance or achievement of a normal body weight alongside the two claims above. Only the tooth mineralisation and post-prandial glycaemic claims entered the authorised list. Separately, the World Health Organization issued a guideline in 2023 recommending against the use of non-sugar sweeteners for weight control or to reduce the risk of noncommunicable diseases, applying to everyone other than people with pre-existing diabetes, and naming stevia and stevia derivatives among the sweeteners covered.
The short version
Sugar reduction: available. Tooth mineralisation and post-prandial glucose: available with conditions. Weight management and disease risk: not available for this ingredient class in the EU, and against current WHO guidance.
05 · Markets
EU, United States, China and JECFA Side by Side
| Market | Framework | What to know |
|---|---|---|
| European Union | Annex II to Reg (EC) No 1333/2008 for uses; Reg (EU) No 231/2012 for specifications | E 960a to E 960d with combined maximum levels as steviol equivalents. Entries are defined by production process including the organism |
| United States | GRAS, established by notification to FDA | FDA completed its first stevia GRAS notice in 2008, for rebaudioside A, and has since issued no-questions letters covering many preparations. GRAS attaches to high-purity glycoside preparations, not to leaf or crude extract. "FDA approved" and "GRAS certified" do not exist for any steviol glycoside |
| China | GB 1886.355-2022 for the extracted additive; GB 2760 for use levels | GB 1886.355-2022 applies to glycosides obtained from stevia leaf by extraction and refining. On the current documents, enzymatically converted and fermentation-derived glycosides appear to be handled as separate new food additive varieties, usable together and calculated as steviol equivalents. Confirm the approval reference against the announcements in force at import |
| JECFA and Codex | Specifications and ADI | Not less than 95% total steviol glycosides on the dried basis, with limits for moisture, ash, lead, arsenic, ethanol and methanol. ADI 0 to 4 mg/kg body weight per day as steviol equivalents |
The China distinction is the one most often missed
GB 1886.355-2022 replaced GB 8270-2014 and covers thirteen named glycosides including stevioside, rebaudiosides A, B, C, D, E, F, M, N and O, dulcoside A, rubusoside and steviolbioside. Its scope is material obtained from stevia leaf by extraction and refining.
Enzymatically converted and fermentation-derived glycosides fall outside that scope. The fermentation route registered in China, for example, starts from glucose using a recombinant E. coli BL21(DE3) strain, followed by inactivation, resin treatment, concentration, crystallisation and drying, and is described as usable alone or together with the other two, calculated as steviol equivalents under GB 2760.
Quoting GB 1886.355-2022 on an enzymatically converted product is very likely the wrong reference, and it is the kind of mismatch that surfaces at customs rather than at purchase order. Because these approvals are issued as individual announcements rather than consolidated into one standard, take the approval reference and the applicable clauses from the announcements in force at the time of import rather than from any summary, this page included.
Three contaminants the additive specifications do not cover
Assay and glycoside profile tell you what the product is, not what came in with the leaf. None of the three below will ever appear in a glycoside profile, and no limit is written for steviol glycosides as a food additive specifically. Ask a supplier these three questions rather than accepting a general assurance.
- Pyrrolizidine alkaloids. Common in stevia plants and recommended for supplier monitoring. Ask: which category level under Regulation (EU) 2023/915 do you benchmark against, is it the sum of the 21 regulated alkaloids plus the 14 interfering isomers, and is it tested per batch or per raw material campaign?
- Glyphosate and other pesticide residues. EU maximum residue levels apply under Regulation (EC) No 396/2005, with a default of 0.01 mg/kg where no specific MRL exists. Ask: is the screen multi-residue or targeted, and does it include glyphosate specifically, which many standard panels omit?
- Polycyclic aromatic hydrocarbons. Benzo(a)pyrene and the PAH4 sum are the regulated markers under Regulation (EU) 2023/915. Ask: which category level is applied, and is PAH tested at all or only on request?
We supply the specification, process description and residue reports for the market you are shipping to.
Request documentation →06 · Questions
Steviol Glycoside Regulation FAQ
What is the difference between E 960a and E 960c?
Production route, not molecule. E 960a is extracted from stevia leaf. E 960c is made enzymatically, with sub-entries for Reb M, Reb D and Reb AM depending on the starting material. An enzymatic Reb M cannot be labelled E 960a. Maximum levels are shared across the whole E 960a to E 960d group rather than allocated per entry.
Can I still label a product E 960?
No. E 960 became E 960a in August 2021, and the transition ended on 2 February 2023. Anything still carrying E 960 is out of date, which also makes it a quick test of how recently a supplier reviewed their regulatory file.
Is stevia "FDA approved"?
No, and neither is any other steviol glycoside from any supplier. The US route is GRAS, established by notification, to which FDA responds with a no-questions letter rather than an approval. FDA completed its first stevia GRAS notice in 2008, for rebaudioside A. Two further points: GRAS attaches to high-purity glycoside preparations rather than to leaf or crude extract, and "GRAS certified" is not a thing that exists. A page claiming either is describing its own standards rather than the product.
If I blend two different steviol glycosides, do I get two allowances?
No. Maximum levels are combined across E 960a to E 960d and expressed as steviol equivalents. Convert each glycoside using its own factor, add the results, then compare the total against the limit for your food category. Section 03 works it through with an example.
Does GB 1886.355-2022 cover enzymatically converted Reb M and Reb D?
Very likely not. GB 1886.355-2022 applies to steviol glycosides obtained from stevia leaf by extraction and refining. Enzymatically converted and fermentation-derived glycosides appear to be approved as separate new food additive varieties, each with its own production description, and all three may be used together under GB 2760 calculated as steviol equivalents. Because these are issued as individual announcements rather than consolidated into one standard, take the approval reference from the announcements in force at the time of import. Quoting GB 1886.355-2022 on an enzymatic product tends to surface at customs.
Can a product sweetened with stevia claim to help with weight management?
Not in the EU, and not in line with current WHO guidance. EFSA assessed intense sweeteners in relation to body weight in 2011, and only the tooth mineralisation and post-prandial glycaemic claims entered the authorised list under Regulation (EU) No 432/2012. WHO issued a guideline in 2023 recommending against non-sugar sweeteners for weight control or noncommunicable disease risk reduction, naming stevia derivatives among those covered. Sugar reduction, no added sugar and reduced calorie positioning remain fully available, and for most products they are the stronger message anyway.
Why does the specification name a production strain?
Because for enzymatically produced glycosides the EU specification defines the additive by its manufacturing process, and the organism producing the biocatalyst is part of that process. Adding a new strain requires an amendment that EFSA assesses case by case, which is why new entries keep appearing. When qualifying a supplier, ask which sub-entry and which process definition they work to rather than accepting "E 960c" on its own.
Has the ADI changed recently?
No. An application to raise it to 6 or 16 mg/kg body weight per day was assessed by EFSA in 2024, which concluded there was insufficient justification. The figure remains 4 mg/kg body weight per day as steviol equivalents, derived from a two year rat study with a NOAEL of 970 mg/kg bw/day of stevioside, equivalent to 383 mg/kg bw/day of steviol, with a hundredfold uncertainty factor. Any supplier suggesting higher use levels are now permissible is mistaken.
07 · Our range
Which Product Sits Under Which Entry
The full line is on the stevia extract page. Choosing between the three rebaudiosides is worked through in our Reb A, Reb D or Reb M guide.
| Product | Grades | EU entry | Production route |
|---|---|---|---|
| Total steviol glycosides | 40 · 80 · 95 · 98% | E 960a | Extraction and refining from stevia leaf |
| Stevioside | 90 · 95% | E 960a | Extraction and refining from stevia leaf |
| Rebaudioside A | RA60 · RA80 · RA97 | E 960a | Extraction and refining from stevia leaf |
| Rebaudioside D | RD95 · RD98 | E 960c(iii) | Enzymatic conversion from our own high-purity Reb A |
| Rebaudioside M | RM95 · RM98 | E 960c(ii) | Enzymatic conversion from our own high-purity Reb A |
| Glucosylated steviol glycosides | GSG 80% | E 960d | Glucosylation of purified stevia leaf glycosides |
All grades are available conventional or certified organic under Regulation (EU) 2018/848 and USDA NOP, from our own 400 hectare cultivation base. Enzymatically converted grades ship with recombinant DNA and residual protein reports on every batch alongside the COA.
08 · Evidence base
References
[1] EFSA Panel on Food Additives and Flavourings. Safety of the proposed amendment of the specifications of the food additive E 960c(i) or E 960c(ii). EFSA Journal. 2025;23:e9396. DOI: 10.2903/j.efsa.2025.9396 →
[2] EFSA Panel on Food Additives and Flavourings. Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract. EFSA Journal. 2022;20(5):7291. DOI: 10.2903/j.efsa.2022.7291 →
[3] EFSA Panel on Food Additives and Flavourings. Scientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a–d) and the modification of the acceptable daily intake (ADI) for steviol. EFSA Journal. 2024;22:e9045. DOI: 10.2903/j.efsa.2024.9045 →
[4] European Union. Commission Regulation (EU) 2023/447 of 1 March 2023 amending Annex II to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 as regards the use of glucosylated steviol glycosides as a sweetener. EUR-Lex official text →
[5] European Union. Commission Regulation (EU) 2025/652 of 2 April 2025, introducing specifications for steviol glycosides from fermentation. EUR-Lex official text →
[6] European Union. Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health. EUR-Lex official text →
[7] EFSA Panel on Dietetic Products, Nutrition and Allergies. Scientific opinion on the substantiation of health claims related to intense sweeteners and contribution to the maintenance or achievement of a normal body weight, reduction of post-prandial glycaemic responses, maintenance of normal blood glucose concentrations, and maintenance of tooth mineralisation. EFSA Journal. 2011;9(6):2229. DOI: 10.2903/j.efsa.2011.2229 →
[8] World Health Organization. WHO advises not to use non-sugar sweeteners for weight control in newly released guideline. 15 May 2023. WHO official statement →
[9] FAO/WHO JECFA. Steviol Glycosides: Chemical and Technical Assessment, 63rd JECFA. FAO/JECFA official document →
[10] European Union. Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food, repealing Regulation (EC) No 1881/2006. EUR-Lex official text →
[11] Manoharan et al. Steviol Glycosides (E960) from Stevia rebaudiana: Technological Innovations, Safety Assessment, Regulatory Aspects and their Role in Sustainable Food Systems. Food Science & Nutrition. 2026. DOI: 10.1002/fsn3.71891 →
Reviewed by
Xinjuan XuScientific Advisor, PhytoVale · Associate Professor, Stevia Agronomy & Crop Physiology Expert. Research focus: stevia cultivation, crop physiology, glycoside accumulation and raw material quality.
Written by
FloraContent Editor, PhytoVale · Product Content & Editorial Specialist. Focuses on botanical ingredient specifications, sourcing information and B2B technical content.
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