Flavor ingredient regulatory record
Ethyl hexadecanoate
Ethyl hexadecanoate is an ester in the fruity family, FEMA GRAS under FEMA number 2451 (CAS 628-97-7). Its odor is sweet, fruity, waxy, tropical, floral.
- FEMA
- 2451
- CAS
- 628-97-7
- JECFA
- 39
- EU FL
- 09.193
- Formula
- C18H36O2
- EC
- 211-064-6
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 628-97-7.
Structure
Identity
Also known as: Hexadecanoic acid, ethyl ester, Palmitic acid, ethyl ester, Ethyl palmitate, NSC 8918, ethyl palmitate, hexadecanoic acid, ethyl ester, palmitic acid, ethyl ester, ethyl cetylate, palmitic acid ethyl ester, hexadecanoic acid ethyl ester, ethyl n-hexadecanoate, hexadecanoic acid ethyl.
Can Ethyl hexadecanoate be labeled natural?
The process decides for ethyl hexadecanoate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic ethyl hexadecanoate is artificial. 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
Ethyl hexadecanoate is FEMA GRAS under FEMA number 2451. 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 09.193, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 39, evaluated at the 46th meeting in 1996. 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. Ethyl hexadecanoate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 628-97-7, where EPA names it Hexadecanoic acid, ethyl 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, waxy, tropical, floral.
Where it is used
Ethyl hexadecanoate is used in beverage, confection, fruit flavors, bakery and dairy, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Ethyl hexadecanoate by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Isopropyl myristate | 3556 | 99% | In nature |
| Dodecyl butyrate | 4340 | 99% | In nature |
| Butyl stearate | 2214 | 99% | In nature |
| Butyl laurate | 2206 | 98% | In nature |
| Methyl myristate | 2722 | 98% | In nature |
More esters in this index
Ethyl alpha-acetylcinnamate · Methyl anthranilate · Ethyl trans-2-cis-4-decadienoate · Propyleneglycol dibutyrate · Ethyl 4-(acetylthio)butyrate · Isoamyl acetate
Ethyl hexadecanoate FAQ
Is ethyl hexadecanoate FEMA GRAS?
Yes. The FEMA Expert Panel lists ethyl hexadecanoate as GRAS under FEMA number 2451. The Code of Federal Regulations lists it at 21 CFR 172.515.
What are the FEMA and CAS numbers for ethyl hexadecanoate?
Ethyl hexadecanoate is FEMA 2451, CAS 628-97-7. Its flavor category is fruity.
How is ethyl hexadecanoate described, and where does it show up?
Flavorists describe ethyl hexadecanoate as sweet, fruity, waxy, tropical, floral. It is used in beverage, confection, fruit flavors, bakery and dairy.
What did JECFA conclude about ethyl hexadecanoate?
JECFA evaluated ethyl hexadecanoate at the 46th meeting in 1996 under JECFA number 39. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is ethyl hexadecanoate on the EU Union List?
Yes. FL 09.193 is the Union List entry for ethyl hexadecanoate, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Does ethyl hexadecanoate count as natural in the US and the EU?
Nature makes ethyl hexadecanoate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial ethyl hexadecanoate, same molecule. 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.
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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 ETHYL PALMITATE under CAS 628-97-7 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.