Flavor ingredient regulatory record
Cyclohexanone
Cyclohexanone is a ketone in the fruity family, FEMA GRAS under FEMA number 3909 (CAS 108-94-1). Its odor is sweet, fruity, solvent-like, floral, slightly pungent.
- FEMA
- 3909
- CAS
- 108-94-1
- JECFA
- 1100
- EU FL
- 07.148
- Formula
- C6H10O
- EC
- 203-631-1
GRAS status: FEMA GRAS, publication 19. Recorded by FDA in the Substances Added to Food inventory under CAS 108-94-1.
Structure
Identity
Also known as: Anone, Hexanon, Hytrol O, Nadone, Pimelic ketone, Pimelin ketone, Sextone, Anon, NSC 5711, C 0489, HJT 187231, ketohexamethylene.
Can Cyclohexanone be labeled natural?
Nature makes cyclohexanone, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial cyclohexanone, same molecule. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic cyclohexanone 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
Cyclohexanone is FEMA GRAS under FEMA number 3909. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 07.148, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1100, evaluated at the 59th meeting in 2002. 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. Cyclohexanone appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 108-94-1, where EPA names it Cyclohexanone.
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, fruity, solvent-like, floral, slightly pungent. Detectable at about 1 ppm.
Taste: Sweet, slightly bitter, solvent-like.
Where it is used
Cyclohexanone is used in beverage, confection, flavoring agent and baked goods, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Cyclohexanone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 2-cyclohexenone | 4517 | 95% | In nature |
| 2-Methylcyclohexanone | 3946 | 80% | In nature |
| 3-Methylcyclohexanone | 3947 | 77% | In nature |
| Propylene Glycol | 2940 | 74% | In nature |
| 2-Butanone | 2170 | 72% | In nature |
More ketones in this index
1-(Methylthio)-3-octanone · 4-Acetyl-6-t-butyl-1,1-dimethylindan · Tetramethyl ethylcyclohexenone · 3-(hydroxymethyl)-2-heptanone · Cyclohexanone diethyl ketal · 6-Hydroxycarvone
Cyclohexanone FAQ
Is cyclohexanone FEMA GRAS?
Yes. The FEMA Expert Panel lists cyclohexanone as GRAS under FEMA number 3909. The Code of Federal Regulations lists it at 21 CFR 172.515.
What are the FEMA and CAS numbers for cyclohexanone?
Cyclohexanone is FEMA 3909, CAS 108-94-1. Its flavor category is fruity.
How is cyclohexanone described, and where does it show up?
Flavorists describe cyclohexanone as sweet, fruity, solvent-like, floral, slightly pungent. On the palate it is sweet, slightly bitter, solvent-like. Its odor threshold is about 1 ppm. It is used in beverage, confection, flavoring agent and baked goods.
What did JECFA conclude about cyclohexanone?
JECFA evaluated cyclohexanone at the 59th meeting in 2002 under JECFA number 1100. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is cyclohexanone on the EU Union List?
Yes. FL 07.148 is the Union List entry for cyclohexanone, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Does cyclohexanone count as natural in the US and the EU?
The process decides for cyclohexanone. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic cyclohexanone is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic cyclohexanone 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 CYCLOHEXANONE under CAS 108-94-1 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.