Flavor ingredient regulatory record
Palmitic acid
Palmitic acid is an acid in the fatty family, FEMA GRAS under FEMA number 2832 (CAS 57-10-3). Its odor is fatty, waxy, slightly sweet, creamy.
- FEMA
- 2832
- CAS
- 57-10-3
- JECFA
- 115
- EU FL
- 08.014
- Formula
- C16H32O2
- EC
- 200-312-9
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 57-10-3.
Structure
Identity
Also known as: Hexadecanoic acid, n-Hexadecoic acid, 1-Pentadecanecarboxylic acid, Pentadecanecarboxylic acid, n-Hexadecanoic acid, Palmitinic acid, Prifac 2960, Hydrofol Acid 1690, PA 900, Neo-Fat 16, Lunac P 95KC, Emersol 143.
Can Palmitic acid be labeled natural?
Palmitic acid occurs in nature, so the label depends on the route: palmitic acid won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized palmitic acid 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
Palmitic acid is FEMA GRAS under FEMA number 2832. 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 08.014, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
Purity. At least 80%; secondary components 8-11% octadecanoic acid; 5-7% tetradecanoic acid; 3-5% heptadecanoic acid;<1% pentadecanoic acid
JECFA (WHO / FAO)
JECFA number 115, evaluated at the 49th meeting in 1997. 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. Palmitic acid appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 57-10-3, where EPA names it Hexadecanoic acid.
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 regulatory flags
| Flag | EPA definition | What it obliges |
|---|---|---|
| TP | Indicates a substance that is the subject of a proposed TSCA section 4 test rule or order. | Nothing yet. Worth tracking, because a final rule carries testing obligations and a lower reporting threshold. |
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: Fatty, waxy, slightly sweet, creamy.
Taste: Fatty, creamy, mild.
Where it is used
Palmitic acid is used in dairy, confection, baked goods and snack foods, typically as a fatty note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Palmitic acid by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Pentadecanoic acid | 4334 | 100% | In nature |
| Stearic acid | 3035 | 99% | In nature |
| Myristic acid | 2764 | 98% | In nature |
| Tridecanoic acid | 4336 | 96% | In nature |
| Oleic acid | 2815 | 94% | In nature |
More acids in this index
Stearic acid · Octanoic acid · Succinic acid · L-Aspartic acid · 4-Aminobutyric acid · 2-Oxopentanedioic acid
Palmitic acid FAQ
Is palmitic acid FEMA GRAS?
Yes. The FEMA Expert Panel lists palmitic acid as GRAS under FEMA number 2832. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for palmitic acid?
Palmitic acid is FEMA 2832, CAS 57-10-3. FEMA files it in the fatty flavor category.
Does palmitic acid count as natural in the US and the EU?
Since palmitic acid is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when palmitic acid is synthesized. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
Is palmitic acid on the EU Union List?
Palmitic acid is on the EU Union List of flavouring substances as FL 08.014 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated palmitic acid?
Yes. JECFA number 115, evaluated at the 49th meeting in 1997. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
How is palmitic acid described, and where does it show up?
Flavorists describe palmitic acid as fatty, waxy, slightly sweet, creamy. On the palate it is fatty, creamy, mild. It is used in dairy, confection, baked goods and snack foods.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
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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 PALMITIC ACID under CAS 57-10-3 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 flavor enhancer, flavoring agent or adjuvant, lubricant or release agent, surface-active agent.
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.