Flavor ingredient regulatory record

Isopulegone

Isopulegone is a terpene in the mint family, FEMA GRAS under FEMA number 2964 (CAS 29606-79-9). Its odor is minty, herbal, fresh, green, slightly sweet.

FEMA
2964
CAS
29606-79-9
JECFA
754
EU FL
07.067
Formula
C10H16O
EC
249-725-6

GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 29606-79-9.

Structure

2D structure of Isopulegone
Structure of Isopulegone, C10H16O. Drawn from the canonical SMILES.

Identity

IUPAC name trans-(2S,5R)-5-methyl-2-prop-1-en-2-ylcyclohexan-1-one
CAS number 29606-79-9
FEMA number 2964
Molecular formula C10H16O
Molecular weight 152.24 g/mol
SMILES C=C(C)[C@@H]1CC[C@@H](C)CC1=O
InChIKey RMIANEGNSBUGDJ-BDAKNGLRSA-N
PubChem CID 10534862
EC number 249-725-6
FDA UNII 681XD66YSR
EPA DTXSID DTXSID101318152
Chemical class Terpene
Boiling point 95 °C
Flash point 31 °C

Also known as: Cyclohexanone, 5-methyl-2-(1-methylethenyl)-, (2R,5S)-rel-, p-Menth-8-en-3-one, trans-, Cyclohexanone, 5-methyl-2-(1-methylethenyl)-, trans-, rel-(2R,5S)-5-Methyl-2-(1-methylethenyl)cyclohexanone, trans-Isopulegone, Isopulegon, 5-methyl-2-prop-1-en-2-ylcyclohexan-1-one, cyclohexanone, 5-methyl-2-(1-methylethenyl)-, (2r,5s)-, cyclohexanone, 5-methyl-2-(1-methylethenyl)-, (2r-trans)-, d-isopulegone, (-)-isopulegone, isopulegone, (-)-.

Can Isopulegone be labeled natural?

Isopulegone occurs in nature, so the label depends on the route: isopulegone won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized isopulegone 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

Isopulegone is FEMA GRAS under FEMA number 2964. It is cited in the Code of Federal Regulations at 21 CFR 172.515.

21 CFR 172.515

European Union and United Kingdom

Listed on the Union List of flavouring substances as FL 07.067, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.

JECFA (WHO / FAO)

JECFA number 754, evaluated at the 55th meeting in 2000. No safety concern at current levels of intake when used as a flavouring agent.

JECFA monograph

Other US flags

Not on the California Proposition 65 list.

Odor and taste

Odor: Minty, herbal, fresh, green, slightly sweet.

Where it is used

Isopulegone is used in beverage, confection, flavoring and cosmetics, typically as a mint note.

Structurally similar flavor ingredients

Flavor ingredients with a GRAS determination closest to Isopulegone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.

MaterialFEMASimilarityOccurrence
Pulegone296387%In nature
l-Piperitone420086%In nature
d,l-Isomenthone346076%In nature
Dihydrocarveol237975%In nature
d-Carvone224969%In nature

More terpenes in this index

Dihydrocarveol · p-Menth-3-en-1-ol · p-Mentha-1,4-diene · l-8-p-Menthene-1,2-epoxide · d-Camphor · p-Menth-1-en-9-ol

Isopulegone FAQ

Is isopulegone FEMA GRAS?

Yes. The FEMA Expert Panel lists isopulegone as GRAS under FEMA number 2964. It is also codified at 21 CFR 172.515.

What are the FEMA and CAS numbers for isopulegone?

Isopulegone is FEMA 2964, CAS 29606-79-9. FEMA files it in the mint flavor category.

Does isopulegone count as natural in the US and the EU?

Since isopulegone is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when isopulegone is synthesized. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.

Is isopulegone on the EU Union List?

Isopulegone is on the EU Union List of flavouring substances as FL 07.067 (Annex I Part A) under Regulation 1334/2008.

Has JECFA evaluated isopulegone?

Yes. JECFA number 754, evaluated at the 55th meeting in 2000. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.

How is isopulegone described, and where does it show up?

Flavorists describe isopulegone as minty, herbal, fresh, green, slightly sweet. It is used in beverage, confection, flavoring and cosmetics.

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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification

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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 ISOPULEGONE under CAS 29606-79-9 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.