Flavor ingredient regulatory record
Rebaudioside A
Rebaudioside A is a glycoside in the sweet family, FEMA GRAS under FEMA number 4601 (CAS 58543-16-1). Its odor is sweet, fruity, herbal, green.
- FEMA
- 4601
- CAS
- 58543-16-1
- EU FL
- 16.113
- Formula
- C44H70O23
- EC
- 611-696-6
GRAS status: FEMA GRAS, publication 24. Recorded by FDA in the Substances Added to Food inventory under CAS 58543-16-1.
Structure
Identity
Also known as: Kaur-16-en-18-oic acid, 13-[(O-β-D-glucopyranosyl-(1→2)-O-[β-D-glucopyranosyl-(1→3)]-β-D-glucopyranosyl)oxy]-, β-D-glucopyranosyl ester, (4α)-, Glycoside X, Glycoside A3, from Steviarebaudiana, 4G-S, Sweetener 4G-S, Stevioside a3, Sooolite!-Pure, Rebiana, Pure Via, Reb-A 97, RA 95, Rebaudiana a.
Can Rebaudioside A be labeled natural?
Nature makes Rebaudioside A, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial Rebaudioside A, same molecule. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
- United States
- Natural or artificial, by process
- European Union and UK
- Natural only from natural material
- Mercosur and Mexico
- Natural or identical-to-natural
How each market defines the classes: natural vs artificial flavor under 21 CFR 101.22.
Regulatory status, with citations
United States
Rebaudioside A is FEMA GRAS under FEMA number 4601. It is cited in the Code of Federal Regulations at 21 CFR 170.36.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 16.113, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list. The entry carries use restrictions.
Use restrictions. Restrictions for use as a flavouring substance: In categories 1, 3, 4.2, 5, 6, 12, 14.1 and 14.2 - not more than 10 mg/kg
JECFA (WHO / FAO)
Rebaudioside A has not been evaluated by JECFA as a flavouring agent, or no evaluation is on file.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Sweet, fruity, herbal, green.
Taste: Sweet, clean, refreshing.
Where it is used
Rebaudioside A is used in beverage, confection, sweetener, dairy and bakery, typically as a sweet note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Rebaudioside A by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Neohesperidin dihydrochalcone | 3811 | 89% | In nature |
| Naringin dihydrochalcone | 4495 | 88% | Not determined |
| Trilobatin | 4674 | 81% | In nature |
| Vanillin 3-(l-menthoxy)propane-1,2-diol acetal | 3904 | 80% | In nature |
| Myricitrin | 4491 | 76% | In nature |
More glycosides in this index
Rebaudioside C · Myricitrin · Ethyl vanillin beta-D-glucopyranoside
Rebaudioside A FAQ
Is Rebaudioside A on the FEMA GRAS list?
It is. FEMA number 4601 covers Rebaudioside A. The Code of Federal Regulations lists it at 21 CFR 170.36.
What is the FEMA number for Rebaudioside A?
The FEMA number for Rebaudioside A is 4601 and its CAS registry number is 58543-16-1. Its flavor category is sweet.
What is Rebaudioside A used for?
Rebaudioside A is described as sweet, fruity, herbal, green. On the palate it is sweet, clean, refreshing. It shows up in beverage, confection, sweetener, dairy and bakery.
Is Rebaudioside A approved in the EU?
Yes. FL 16.113 is the Union List entry for Rebaudioside A, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list. Its entry carries use restrictions, listed on this page.
Is Rebaudioside A natural or artificial?
The process decides for Rebaudioside A. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic Rebaudioside A is artificial. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
Ingredient lookup
Check an ingredient
Start typing to search the ingredient corpus.
Or browse every ingredient page, A to Z.
Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Rebaudioside A in a formula
Screened against FEMA GRAS, 21 CFR and EU rules as you build. Free to start.
Sources and attribution. The identity and regulatory facts on this page are taken from the FDA Substances Added to Food inventory, a US government record, which lists this substance as REBAUDIOSIDE A under CAS 58543-16-1 and carries its FEMA number. The inventory is searchable at FDA. FDA records its technical effect as flavoring agent or adjuvant.
A FEMA GRAS conclusion is reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States, and the FEMA number names that conclusion. FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record of what the Panel decided and is worth reading alongside this page.
Ambrose Compliance is not affiliated with, endorsed by, or sponsored by FEMA. FEMA and FEMA GRAS are used here as identifiers for a published regulatory determination, not as marks of any relationship between FEMA and Ambrose.
About this page. Facts come from the FDA Substances Added to Food inventory, the Code of Federal Regulations, the EPA TSCA Inventory, the EU Union List, JECFA and the Ambrose database, with FEMA's published determination cited where it applies; parts of the text are written by Ambrose AI, which can make mistakes. Check the cited source before relying on anything here. This is not regulatory or legal advice.