Flavor ingredient regulatory record
Pulegone
Pulegone is a monoterpene in the mint family, FEMA GRAS under FEMA number 2963 (CAS 89-82-7). Its odor is minty, herbal, fresh, cooling.
- FEMA
- 2963
- CAS
- 89-82-7
- JECFA
- 753
- Formula
- C10H16O
- EC
- 201-943-2
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 89-82-7.
Structure
Identity
Also known as: Cyclohexanone, 5-methyl-2-(1-methylethylidene)-, (5R)-, p-Menth-4(8)-en-3-one, (R)-(+)-, Cyclohexanone, 5-methyl-2-(1-methylethylidene)-, (R)-, (5R)-5-Methyl-2-(1-methylethylidene)cyclohexanone, (+)-Pulegone, d-Pulegone, (+)-(R)-Pulegone, Pulegon, (1R)-(+)-p-Menth-4(8)-en-3-one, (R)-Pulegone, (R)-(+)-Pulegone, (R)-(+)-p-Menth-4(8)-en-3-one.
Can Pulegone be labeled natural?
The process decides for pulegone. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic pulegone is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic pulegone 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
Pulegone is FEMA GRAS under FEMA number 2963. 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 Pulegone. 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 753, evaluated at the 55th meeting in 2000. no safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Listed under California Proposition 65 for cancer since April 18, 2014; a warning may be required in California depending on exposure.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Pulegone appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 89-82-7, where EPA names it Cyclohexanone, 5-methyl-2-(1-methylethylidene)-, (5R)-.
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: Minty, herbal, fresh, cooling.
Where it is used
Pulegone is used in beverage, confection, oral care and flavoring, typically as a mint note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Pulegone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| l-Piperitone | 4200 | 96% | In nature |
| d,l-Isomenthone | 3460 | 95% | In nature |
| Isopulegone | 2964 | 81% | In nature |
| Thymol | 3066 | 66% | In nature |
| (+/-)-2-Hydroxypiperitone | 4143 | 66% | In nature |
Pulegone FAQ
Is pulegone on the FEMA GRAS list?
It is. FEMA number 2963 covers pulegone. The Code of Federal Regulations lists it at 21 CFR 172.515.
What is the FEMA number for pulegone?
The FEMA number for pulegone is 2963 and its CAS registry number is 89-82-7. Its flavor category is mint.
What is pulegone used for?
Pulegone is described as minty, herbal, fresh, cooling. It shows up in beverage, confection, oral care and flavoring.
What did JECFA conclude about pulegone?
JECFA evaluated pulegone at the 55th meeting in 2000 under JECFA number 753. The panel concluded: no safety concern at current levels of intake when used as a flavouring agent.
Is pulegone approved in the EU?
No EU FL number is on file for pulegone. It has a JECFA evaluation (JECFA 753), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Is pulegone natural or artificial?
Nature makes pulegone, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial pulegone, 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 PULEGONE under CAS 89-82-7 and carries its FEMA number, its JECFA flavor 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.