Flavor ingredient regulatory record
l-Menthol
l-Menthol is a terpene alcohol in the cooling family, FEMA GRAS under FEMA number 2665 (CAS 2216-51-5). Its odor is strong mint, cooling, fresh.
- FEMA
- 2665
- CAS
- 2216-51-5
- JECFA
- 427
- Formula
- C10H20O
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 89-78-1.
Structure
Identity
Also known as: (-)-menthol, levomenthol, peppermint camphor, l-(-)-menthol, levomentholum, u.s.p. menthol, (-)-menthyl alcohol, (1r)-(-)-menthol, (-)-(1r,3r,4s)-menthol, d-(-)-menthol, (-)-trans-p-menthan-cis-ol, levomentol.
Can l-Menthol be labeled natural?
Nature makes l-Menthol, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial l-Menthol, same molecule. 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
l-Menthol is FEMA GRAS under FEMA number 2665. It is cited in the Code of Federal Regulations at 21 CFR 182.20 and 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for l-Menthol. 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 427, evaluated at the 86th meeting in 2018. ADI 0 to 4 mg/kg body weight.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. l-Menthol appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 2216-51-5, where EPA names it Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1R,2S,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: Strong mint, cooling, fresh.
Taste: Intense cooling, minty, fresh.
Where it is used
l-Menthol is used in confection, oral care and beverage, typically as a cooling note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to l-Menthol by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| d,l-Isomenthone | 3460 | 92% | In nature |
| p-Menthane-3,8-diol | 4053 | 91% | In nature |
More terpene alcohols in this index
Nerol · alpha-Terpineol · Geraniol · Linalool · 4-(p-Hydroxyphenyl)-2-butanone
l-Menthol FAQ
Does l-Menthol have FEMA GRAS status?
l-Menthol holds FEMA GRAS status under FEMA number 2665. The Code of Federal Regulations lists it at 21 CFR 182.20 and 21 CFR 172.515.
How do I cite l-Menthol by FEMA or CAS number?
Cite l-Menthol as FEMA 2665 or CAS 2216-51-5; both point to the same entry. Its flavor category is cooling.
What does l-Menthol smell and taste like, and where is it used?
The odor of l-Menthol is strong mint, cooling, fresh. On the palate it is intense cooling, minty, fresh. Typical uses are confection, oral care and beverage.
What did JECFA conclude about l-Menthol?
JECFA evaluated l-Menthol at the 86th meeting in 2018 under JECFA number 427.
Is l-Menthol approved in the EU?
No EU FL number is on file for l-Menthol. It has a JECFA evaluation (JECFA 427), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Can l-Menthol be labeled a natural flavor?
The process decides for l-Menthol. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic l-Menthol is artificial. 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 MENTHOL under CAS 89-78-1 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.