Flavor ingredient regulatory record
Tributyrin
Tributyrin is an ester in the dairy family, FEMA GRAS under FEMA number 2223 (CAS 60-01-5). Its odor is creamy, buttery, sweet, fatty.
- FEMA
- 2223
- CAS
- 60-01-5
- JECFA
- 922
- EU FL
- 09.211
- Formula
- C15H26O6
- EC
- 200-451-5
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 60-01-5.
Structure
Identity
Also known as: Butanoic acid, 1,2,3-propanetriyl ester, Butyrin, tri-, Butyrin, Butyryl triglyceride, Glycerol tributyrate, Glyceryl tributyrate, Tributyroin, Tri-n-butyrin, Glycerol tributanoate, Tributin, Tributyryl glyceride, Glycerin tributyrate.
Can Tributyrin be labeled natural?
The process decides for tributyrin. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic tributyrin is artificial. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material 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
Tributyrin is FEMA GRAS under FEMA number 2223. It is cited in the Code of Federal Regulations at 21 CFR 184.1903.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 09.211, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 922, evaluated at the 57th meeting in 2001. 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. Tributyrin appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 60-01-5, where EPA names it Butanoic acid, 1,2,3-propanetriyl ester.
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: Creamy, buttery, sweet, fatty.
Taste: Rich, buttery, slightly sweet.
Where it is used
Tributyrin is used in dairy, confection, bakery and flavoring, typically as a dairy note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Tributyrin by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Tributyl acetylcitrate | 3080 | 85% | In nature |
| Triethyl citrate | 3083 | 82% | In nature |
| 4,4-Dibutyl-gamma-butyrolactone | 2372 | 63% | In nature |
| Glucose pentaacetate | 2524 | 58% | In nature |
| 1,3-Diphenyl-2-propanone | 2397 | 54% | In nature |
More esters in this index
Glyceryl monostearate · Diacetyl tartaric acid esters of mono- and diglycerides · Mono- and diglycerides of fatty acids · Menthyl isovalerate · Ethyl Caprylate · Phenethyl octanoate
Tributyrin FAQ
Is tributyrin FEMA GRAS?
Yes. The FEMA Expert Panel lists tributyrin as GRAS under FEMA number 2223. The Code of Federal Regulations lists it at 21 CFR 184.1903.
What are the FEMA and CAS numbers for tributyrin?
Tributyrin is FEMA 2223, CAS 60-01-5. Its flavor category is dairy.
How is tributyrin described, and where does it show up?
Flavorists describe tributyrin as creamy, buttery, sweet, fatty. On the palate it is rich, buttery, slightly sweet. It is used in dairy, confection, bakery and flavoring.
What did JECFA conclude about tributyrin?
JECFA evaluated tributyrin at the 57th meeting in 2001 under JECFA number 922. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is tributyrin on the EU Union List?
Yes. FL 09.211 is the Union List entry for tributyrin, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Does tributyrin count as natural in the US and the EU?
Nature makes tributyrin, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial tributyrin, 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.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Tributyrin in a formula
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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 GLYCEROL TRIBUTYRATE under CAS 60-01-5 and carries its FEMA number, its JECFA flavor number and its 21 CFR citations. The inventory is searchable at FDA. FDA records its technical effect as flavoring agent or adjuvant, solvent or vehicle.
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.