Flavor ingredient regulatory record
4-Methylheptan-3-one
4-Methylheptan-3-one is a ketone in the fruity family, FEMA GRAS under FEMA number 4966 (CAS 6137-11-7). Its odor is sweet, fruity, creamy, nutty, buttery.
- FEMA
- 4966
- CAS
- 6137-11-7
- Formula
- C8H16O
GRAS status: FEMA GRAS. Source: FEMA Flavor Ingredient Library.
Structure
Identity
Also known as: 3-Heptanone, 4-methyl-, 4-Methyl-3-heptanone, (±)-4-Methyl-3-heptanone, 4-methyl-3-heptanone, 3-heptanone, 4-methyl-, ethyl 1-methylbutyl ketone, 4-methylheptan-3-one, (+/-)-, en300-99015.
Can 4-Methylheptan-3-one be labeled natural?
Since 4-Methylheptan-3-one is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when 4-Methylheptan-3-one is synthesized. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 4-Methylheptan-3-one 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
4-Methylheptan-3-one is FEMA GRAS under FEMA number 4966. 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 4-Methylheptan-3-one. 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)
4-Methylheptan-3-one 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.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. 4-Methylheptan-3-one appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 6137-11-7, where EPA names it 3-Heptanone, 4-methyl-.
Inactive in US commerce
EPA designates this substance inactive, so a Notice of Activity Form B is required before anyone manufactures or processes it again. Being FEMA GRAS does not change that. 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, fruity, creamy, nutty, buttery.
Where it is used
4-Methylheptan-3-one is used in beverage, confection, dairy, bakery and flavoring, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 4-Methylheptan-3-one by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 2-Methylheptan-3-one | 4000 | 95% | In nature |
| 3-Heptanone | 2545 | 93% | In nature |
| 3-Heptanol | 3547 | 87% | In nature |
More ketones in this index
2,3-Undecadione · 2-Octen-4-one · 5-Methyl-5-hexen-2-one · 6-Hydroxycarvone · 1,1'-(Tetrahydro-6a-hydroxy-2,3a,5-trimethylfuro[2,3-d]-1,3-dioxole-2,5-diyl)bis-ethanone · 3-Methyl-4-phenyl-3-buten-2-one
4-Methylheptan-3-one FAQ
Does 4-Methylheptan-3-one have FEMA GRAS status?
4-Methylheptan-3-one holds FEMA GRAS status under FEMA number 4966. It is also codified at 21 CFR 172.515.
How do I cite 4-Methylheptan-3-one by FEMA or CAS number?
Cite 4-Methylheptan-3-one as FEMA 4966 or CAS 6137-11-7; both point to the same entry. FEMA files it in the fruity flavor category.
Can 4-Methylheptan-3-one be labeled a natural flavor?
4-Methylheptan-3-one occurs in nature, so the label depends on the route: 4-Methylheptan-3-one won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized 4-Methylheptan-3-one is artificial. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
What does 4-Methylheptan-3-one smell and taste like, and where is it used?
The odor of 4-Methylheptan-3-one is sweet, fruity, creamy, nutty, buttery. Typical uses are beverage, confection, dairy, bakery and flavoring.
Ingredient lookup
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check 4-Methylheptan-3-one in a formula
Screened against FEMA GRAS, 21 CFR and EU rules as you build. Free to start.
Sources and attribution. The FEMA number and GRAS status on this page name a conclusion reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States. FDA does not list this substance by FEMA number in its Substances Added to Food inventory. Its identity is attested by EPA TSCA Chemical Substance Inventory, matched on CAS 6137-11-7.
FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record 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.