Flavor ingredient regulatory record
Hexadecyl lactate
Hexadecyl lactate is an ester in the fruity family, FEMA GRAS under FEMA number 4483 (CAS 35274-05-6). Its odor is sweet, fruity, creamy, tropical, estery.
- FEMA
- 4483
- CAS
- 35274-05-6
- JECFA
- 1950
- Formula
- C19H38O3
- EC
- 252-478-7
GRAS status: FEMA GRAS, publication 24. Recorded by FDA in the Substances Added to Food inventory under CAS 35274-05-6.
Structure
Identity
Also known as: Propanoic acid, 2-hydroxy-, hexadecyl ester, Lactic acid, hexadecyl ester, Cetyl lactate, Cyclochem CL, Spermol lactate, Ceraphyl 28, cetyl lactate, propanoic acid, 2-hydroxy-, hexadecyl ester, n-hexadecyl lactate, uniester lc, cetinol la, dermol cl.
Can Hexadecyl lactate 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
Hexadecyl lactate is FEMA GRAS under FEMA number 4483. 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 Hexadecyl lactate. 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 1950, 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. Hexadecyl lactate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 35274-05-6, where EPA names it Propanoic acid, 2-hydroxy-, hexadecyl ester.
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, fruity, creamy, tropical, estery.
Where it is used
Hexadecyl lactate is used in beverage, confection, dairy, desserts and flavoring, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Hexadecyl lactate by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Ethyl hexadecanoate | 2451 | 95% | In nature |
| Butyl stearate | 2214 | 94% | In nature |
| Propylene glycol stearate | 2942 | 94% | In nature |
| Dodecyl lactate | 4482 | 94% | Not determined |
| Isopropyl myristate | 3556 | 93% | In nature |
More esters in this index
Isoamyl hexanoate · cis-Hexenyl tiglate · Ethyl 3-(furfurylthio)propionate · Ethyl 4-pentenoate · Dodecyl butyrate · Diethyl succinate
Hexadecyl lactate FAQ
Does hexadecyl lactate have FEMA GRAS status?
Hexadecyl lactate holds FEMA GRAS status under FEMA number 4483. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite hexadecyl lactate by FEMA or CAS number?
Cite hexadecyl lactate as FEMA 4483 or CAS 35274-05-6; both point to the same entry. Its flavor category is fruity.
What does hexadecyl lactate smell and taste like, and where is it used?
The odor of hexadecyl lactate is sweet, fruity, creamy, tropical, estery. Typical uses are beverage, confection, dairy, desserts and flavoring.
What did JECFA conclude about hexadecyl lactate?
JECFA evaluated hexadecyl lactate at the 73rd meeting in 2010 under JECFA number 1950. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is hexadecyl lactate approved in the EU?
No EU FL number is on file for hexadecyl lactate. It has a JECFA evaluation (JECFA 1950), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
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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 HEXADECYL LACTATE under CAS 35274-05-6 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.