Flavor ingredient regulatory record
Betaine
Betaine is a quaternary ammonium compound in the sweet family, FEMA GRAS under FEMA number 4223 (CAS 107-43-7). Its odor is slightly sweet, earthy, marine, umami.
- FEMA
- 4223
- CAS
- 107-43-7
- JECFA
- 2265
- Formula
- C5H11NO2
- EC
- 203-490-6
GRAS status: FEMA GRAS, publication 22. Recorded by FDA in the Substances Added to Food inventory under CAS 107-43-7.
Structure
Identity
Also known as: Methanaminium, 1-carboxy-N,N,N-trimethyl-, inner salt, Methanaminium, 1-carboxy-N,N,N-trimethyl-, hydroxide, inner salt, Ammonium compounds, substituted, (carboxymethyl)trimethyl-, hydroxide, inner salt, α-Earleine, Glycine, trimethylbetaine, Glycine betaine, Glycocoll betaine, Lycine, Oxyneurine, Trimethylglycine, Trimethylglycocoll, Glycylbetaine.
Can Betaine be labeled natural?
The process decides for betaine. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic betaine is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic betaine identical-to-natural.
- 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
Betaine is FEMA GRAS under FEMA number 4223. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for Betaine. That is not a finding either way. The Union List covers defined flavouring substances, so natural complex materials are handled as flavouring preparations under Parts B to F and never receive a number, and substances used as additives sit under Regulation 1333/2008 instead. Confirm the position before EU or UK use.
JECFA (WHO / FAO)
JECFA number 2265, evaluated at the 89th meeting in 2020. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Betaine appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 107-43-7, where EPA names it Methanaminium, 1-carboxy-N,N,N-trimethyl-, inner salt.
Active in US commerce
EPA designates this substance active, so no Notice of Activity Form B is required before manufacturing. What active and inactive mean.
EPA publishes no regulatory flags on this listing. What the flags mean.
From the EPA non-confidential TSCA Inventory, July 2026 release. EPA also maintains a confidential portion it does not publish. Search the Inventory by CAS number.
Odor and taste
Odor: Slightly sweet, earthy, marine, umami.
Where it is used
Betaine is used in beverage, nutritional supplements, food flavoring and animal feed, typically as a sweet note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Betaine by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 3-Methylcrotonic acid | 3187 | 39% | In nature |
| Isovaleric acid | 3102 | 39% | In nature |
| Trimethylamine oxide | 4245 | 38% | In nature |
| Nitrous Oxide | 2779 | 28% | In nature |
| 4-Methyl-3-penten-2-one | 3368 | 27% | In nature |
More quaternary ammonium compounds in this index
Trimethylamine oxide · DL-(3-Amino-3-carboxypropyl)dimethylsufonium chloride · Choline chloride
Betaine FAQ
Is betaine on the FEMA GRAS list?
It is. FEMA number 4223 covers betaine. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for betaine?
The FEMA number for betaine is 4223 and its CAS registry number is 107-43-7. Its flavor category is sweet.
What is betaine used for?
Betaine is described as slightly sweet, earthy, marine, umami. It shows up in beverage, nutritional supplements, food flavoring and animal feed.
What did JECFA conclude about betaine?
JECFA evaluated betaine at the 89th meeting in 2020 under JECFA number 2265. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is betaine approved in the EU?
No EU FL number is on file for betaine. It has a JECFA evaluation (JECFA 2265), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Is betaine natural or artificial?
Nature makes betaine, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial betaine, same molecule. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
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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 BETAINE under CAS 107-43-7 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.