Flavor ingredient regulatory record
Acetoin
Acetoin is a ketone in the fruity family, FEMA GRAS under FEMA number 2008 (CAS 513-86-0). Its odor is sweet, buttery, creamy, vanilla, nutty.
- FEMA
- 2008
- CAS
- 513-86-0
- JECFA
- 405
- EU FL
- 07.051
- Formula
- C4H8O2
- EC
- 208-174-1
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 513-86-0.
Structure
Identity
Also known as: 2-Butanone, 3-hydroxy-, 3-Hydroxy-2-butanone, 2,3-Butanolone, Dimethylketol, γ-Hydroxy-β-oxobutane, Methanol, acetylmethyl-, Acetyl methyl carbinol, 2-Hydroxy-3-butanone, 1-Hydroxyethyl methyl ketone, 3-Hydroxybutanone, 3-Oxo-2-butanol, (±)-3-Hydroxybutan-2-one.
Can Acetoin be labeled natural?
Acetoin occurs in nature, so the label depends on the route: acetoin won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized acetoin 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.
- 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
Acetoin is FEMA GRAS under FEMA number 2008. It is cited in the Code of Federal Regulations at 21 CFR 182.60.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 07.051, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 405, evaluated at the 51st meeting in 1998. 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. Acetoin appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 513-86-0, where EPA names it 2-Butanone, 3-hydroxy-.
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: Sweet, buttery, creamy, vanilla, nutty.
Where it is used
Acetoin is used in dairy, beverage, confection, bakery and flavoring, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Acetoin by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Hydroxyacetone | 4462 | 94% | In nature |
| Lactic acid | 2611 | 93% | In nature |
| Propylene Glycol | 2940 | 93% | In nature |
| 2-Butanone | 2170 | 93% | In nature |
| Isobutyric acid | 2222 | 89% | In nature |
More ketones in this index
Isophorone · 2-Hepten-4-one · 1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one · Tetramethyl ethylcyclohexenone · 2-Methylacetophenone · Dihydroxyacetone dimer
Acetoin FAQ
Does acetoin have FEMA GRAS status?
Acetoin holds FEMA GRAS status under FEMA number 2008. It is also codified at 21 CFR 182.60.
How do I cite acetoin by FEMA or CAS number?
Cite acetoin as FEMA 2008 or CAS 513-86-0; both point to the same entry. FEMA files it in the fruity flavor category.
Can acetoin be labeled a natural flavor?
Since acetoin is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when acetoin is synthesized. 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.
Can acetoin be used in the EU and UK?
Acetoin is on the EU Union List of flavouring substances as FL 07.051 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated acetoin?
Yes. JECFA number 405, evaluated at the 51st meeting in 1998. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
What does acetoin smell and taste like, and where is it used?
The odor of acetoin is sweet, buttery, creamy, vanilla, nutty. Typical uses are dairy, beverage, confection, bakery and flavoring.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Acetoin 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 ACETOIN under CAS 513-86-0 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.
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.