Flavor ingredient regulatory record
(-)-Sclareol
(-)-Sclareol is a terpene in the floral family, FEMA GRAS under FEMA number 4502 (CAS 515-03-7). Its odor is sweet, floral, herbaceous, woody.
- FEMA
- 4502
- CAS
- 515-03-7
- JECFA
- 2029
- EU FL
- 02.206
- Formula
- C20H36O2
- EC
- 208-194-0
GRAS status: FEMA GRAS, publication 24. Recorded by FDA in the Substances Added to Food inventory under CAS 515-03-7.
Structure
Identity
Also known as: 1-Naphthalenepropanol, α-ethenyldecahydro-2-hydroxy-α,2,5,5,8a-pentamethyl-, (αR,1R,2R,4aS,8aS)-, Sclareol, Labd-14-ene-8,13-diol, (13R)-, 1-Naphthalenepropanol, α-ethenyldecahydro-2-hydroxy-α,2,5,5,8a-pentamethyl-, [1R-[1α(R*),2β,4aβ,8aα]]-, (αR,1R,2R,4aS,8aS)-α-Ethenyldecahydro-2-hydroxy-α,2,5,5,8a-pentamethyl-1-naphthalenepropanol, sclareol, labd-14-ene-8,13-diol, (13r)-labd-14-ene-8,13-diol, labd-14-ene-8,13-diol, (13r)-, (1r,2r,4as,8as)-1-[(3r)-3-hydroxy-3-methylpent-4-enyl]-2,5,5,8a-tetramethyl-3,4,4a,6,7,8-hexahydro-1h-naphthalen-2-ol, labd-14-ene-8alpha, 13beta-diol, 1-naphthalenepropanol, alpha-ethenyldecahydro-2-hydroxy-alpha,2,5,5,8a-pentamethyl-, (alphar,1r,2r,4as,8as)-.
Can (-)-Sclareol be labeled natural?
Since (-)-Sclareol is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when (-)-Sclareol is synthesized. 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
(-)-Sclareol is FEMA GRAS under FEMA number 4502. 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 02.206, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 2029, evaluated at the 73rd meeting in 2010. 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. (-)-Sclareol appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 515-03-7, where EPA names it 1-Naphthalenepropanol, .alpha.-ethenyldecahydro-2-hydroxy-.alpha.,2,5,5,8a-pentamethyl-, (.alpha.R,1R,2R,4aS,8aS)-.
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, herbaceous, woody.
Where it is used
(-)-Sclareol is used in fragrance, beverage, confection and cosmetics, typically as a floral note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to (-)-Sclareol by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Allyl alpha-ionone | 2033 | 76% | In nature |
| Dihydro-beta-ionol | 3627 | 73% | In nature |
| alpha-Irone | 2597 | 73% | In nature |
More terpenes in this index
Bisabolene · Tetrahydrolinalool · Linalool oxide pyranoid · beta-Ionol · Farnesol · Nerolidol oxide
(-)-Sclareol FAQ
Is (-)-Sclareol on the FEMA GRAS list?
It is. FEMA number 4502 covers (-)-Sclareol. It is also codified at 21 CFR 172.515.
What is the FEMA number for (-)-Sclareol?
The FEMA number for (-)-Sclareol is 4502 and its CAS registry number is 515-03-7. FEMA files it in the floral flavor category.
Is (-)-Sclareol natural or artificial?
(-)-Sclareol occurs in nature, so the label depends on the route: (-)-Sclareol won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized (-)-Sclareol 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.
Is (-)-Sclareol approved in the EU?
(-)-Sclareol is on the EU Union List of flavouring substances as FL 02.206 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated (-)-Sclareol?
Yes. JECFA number 2029, evaluated at the 73rd meeting in 2010. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
What is (-)-Sclareol used for?
(-)-Sclareol is described as sweet, floral, herbaceous, woody. It shows up in fragrance, beverage, confection and cosmetics.
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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 (-)-SCLAREOL under CAS 515-03-7 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.