Flavor ingredient regulatory record
trans-4-tert-Butylcyclohexanol
trans-4-tert-Butylcyclohexanol is an alcohol in the fruity family, FEMA GRAS under FEMA number 4724 (CAS 21862-63-5).
- FEMA
- 4724
- CAS
- 21862-63-5
- JECFA
- 2263
- Formula
- C10H20O
GRAS status: FEMA GRAS, publication 25. Recorded by FDA in the Substances Added to Food inventory under CAS 21862-63-5.
Structure
Identity
Also known as: Cyclohexanol, 4-(1,1-dimethylethyl)-, trans-, Cyclohexanol, 4-tert-butyl-, trans-, trans-4-(1,1-Dimethylethyl)cyclohexanol, trans-1-tert-Butylcyclohexan-4-ol, trans-4-tert-Butyl-1-cyclohexanol, trans-4-tert-Butylcyclohexyl alcohol, trans-p-tert-Butylcyclohexanol, SymSitive 1609, SymSitive DPG, FEMA 4724, 4-tert-butylcyclohexanol, cyclohexanol, 4-(1,1-dimethylethyl)-.
Can trans-4-tert-Butylcyclohexanol be labeled natural?
Nature occurrence: Not yet found in nature (provisional).
Nature occurrence has not been settled for this substance, so the natural or artificial class is not stated here. The FEMA GRAS status does not depend on it.
Regulatory status, with citations
United States
trans-4-tert-Butylcyclohexanol is FEMA GRAS under FEMA number 4724. 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 trans-4-tert-Butylcyclohexanol. 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 2263, evaluated at the 86th meeting in 2018. no safety concern at current levels of intake.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. trans-4-tert-Butylcyclohexanol appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 21862-63-5, where EPA names it Cyclohexanol, 4-(1,1-dimethylethyl)-, trans-.
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
Taste: Sweet, smooth, slightly floral.
Where it is used
trans-4-tert-Butylcyclohexanol is used in beverage, confection, fragrance, personal care and flavoring, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to trans-4-tert-Butylcyclohexanol by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 4-(1,1-Dimethylethyl)phenol | 3918 | 84% | Not determined |
| p-Menth-3-en-1-ol | 3563 | 71% | In nature |
| p-Menth-8-en-1-ol | 3564 | 68% | In nature |
| alpha-Terpineol | 3045 | 68% | In nature |
| Dihydro-beta-ionol | 3627 | 64% | In nature |
More alcohols in this index
cis-2-Octenol · 2-Hexen-1-ol · 3-Heptanol · Undecyl alcohol · 4-Hexen-1-ol · trans-2-Tridecenol
trans-4-tert-Butylcyclohexanol FAQ
Is trans-4-tert-Butylcyclohexanol on the FEMA GRAS list?
It is. FEMA number 4724 covers trans-4-tert-Butylcyclohexanol. It is also codified at 21 CFR 172.515.
What is the FEMA number for trans-4-tert-Butylcyclohexanol?
The FEMA number for trans-4-tert-Butylcyclohexanol is 4724 and its CAS registry number is 21862-63-5. FEMA files it in the fruity flavor category.
Is trans-4-tert-Butylcyclohexanol approved in the EU?
No EU FL number is on file for trans-4-tert-Butylcyclohexanol. It has a JECFA evaluation (JECFA 2263), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Has JECFA evaluated trans-4-tert-Butylcyclohexanol?
Yes. JECFA number 2263, evaluated at the 86th meeting in 2018. Conclusion: no safety concern at current levels of intake.
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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 TRANS-4-TERT-BUTYLCYCLOHEXANOL under CAS 21862-63-5 and carries its FEMA 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.