Flavor ingredient regulatory record
Bisabolene
Bisabolene is a terpene in the floral family, FEMA GRAS under FEMA number 3331 (CAS 495-62-5). Its odor is sweet, floral, herbal, citrus, woody.
- FEMA
- 3331
- CAS
- 495-62-5
- JECFA
- 1336
- EU FL
- 01.016
- Formula
- C15H24
- EC
- 207-805-8
GRAS status: FEMA GRAS, publication 6. Recorded by FDA in the Substances Added to Food inventory under CAS 495-62-5.
Structure
Identity
Also known as: Cyclohexene, 4-(1,5-dimethyl-4-hexen-1-ylidene)-1-methyl-, 2-Heptene, 2-methyl-6-(4-methyl-3-cyclohexen-1-ylidene)-, Cyclohexene, 4-(1,5-dimethyl-4-hexenylidene)-1-methyl-, 4-(1,5-Dimethyl-4-hexen-1-ylidene)-1-methylcyclohexene, γ-Bisabolene, cyclohexene, 4-(1,5-dimethyl-4-hexenylidene)-1-methyl-, 1-methyl-4-(6-methylhept-5-en-2-ylidene)cyclohexene, cyclohexene, 4-(1,5-dimethyl-4-hexen-1-ylidene)-1-methyl-, 2-heptene, 2-methyl-6-(4-methyl-3-cyclohexen-1-ylidene)-, 1-methyl-4-(1,5-dimethyl-4-hexenylidene)-1-cyclohexene, 2-methyl-6-(4-methyl-3-cyclohexen-1-ylidene)-2-heptene, gamma-bisabolene.
Can Bisabolene be labeled natural?
The process decides for bisabolene. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic bisabolene 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
Bisabolene is FEMA GRAS under FEMA number 3331. 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 01.016, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1336, evaluated at the 63rd meeting in 2004. 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. Bisabolene appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 495-62-5, where EPA names it Cyclohexene, 4-(1,5-dimethyl-4-hexen-1-ylidene)-1-methyl-.
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, floral, herbal, citrus, woody.
Taste: Sweet, herbal, slightly bitter.
Where it is used
Bisabolene is used in beverage, fragrance, confection and cosmetics, typically as a floral note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Bisabolene by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| alpha -Bisabolene | 5067 | 97% | In nature |
| beta-Bisabolene | 4940 | 86% | In nature |
| Farnesene | 3839 | 79% | In nature |
| 3,7,11-Trimethyl-2,6,10-dodecatrienal | 4019 | 79% | In nature |
| 2,6,10-Trimethyl-2,6,10-pentadecatrien-14-one | 3442 | 77% | In nature |
More terpenes in this index
(+/-)-Dihydrofarnesol · Nerolidol oxide · Farnesol · beta-Bisabolene · alpha-bisabolol · alpha -Bisabolene
Bisabolene FAQ
Does bisabolene have FEMA GRAS status?
Bisabolene holds FEMA GRAS status under FEMA number 3331. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite bisabolene by FEMA or CAS number?
Cite bisabolene as FEMA 3331 or CAS 495-62-5; both point to the same entry. Its flavor category is floral.
What does bisabolene smell and taste like, and where is it used?
The odor of bisabolene is sweet, floral, herbal, citrus, woody. On the palate it is sweet, herbal, slightly bitter. Typical uses are beverage, fragrance, confection and cosmetics.
What did JECFA conclude about bisabolene?
JECFA evaluated bisabolene at the 63rd meeting in 2004 under JECFA number 1336. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Can bisabolene be used in the EU and UK?
Yes. FL 01.016 is the Union List entry for bisabolene, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Can bisabolene be labeled a natural flavor?
Nature makes bisabolene, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial bisabolene, same molecule. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic bisabolene 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 BISABOLENE under CAS 495-62-5 and carries its FEMA number, its JECFA flavor number. The inventory is searchable at FDA. FDA records its technical effect as antimicrobial agent, flavor enhancer, 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.