Flavor ingredient regulatory record
Stearic acid
Stearic acid is an acid in the fatty family, FEMA GRAS under FEMA number 3035 (CAS 57-11-4). Its odor is fatty, waxy, slightly sweet, mild.
- FEMA
- 3035
- CAS
- 57-11-4
- JECFA
- 116
- EU FL
- 08.015
- Formula
- C18H36O2
- EC
- 200-313-4
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 57-11-4.
Structure
Identity
Also known as: Octadecanoic acid, Kam 1000, Kam 2000, Kam 3000, 1-Heptadecanecarboxylic acid, Neo-Fat 18-59, Neo-Fat 18-53, Neo-Fat 18-54, Stearex Beads, Stearophanic acid, Hydrofol Acid 150, PD 185.
Can Stearic acid be labeled natural?
The process decides for stearic acid. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic stearic acid is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic stearic acid 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
Stearic acid is FEMA GRAS under FEMA number 3035. It is cited in the Code of Federal Regulations at 21 CFR 184.1090.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 08.015, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
Purity. At least 40%; secondary components 5-50% hexadecanoic acid; <3% tetradecanoic acid; <5% 9-octadecenoic acid; <3%heptadecanoic acid; <2% eicosanoic acid; <1% pentadecanoic acid
JECFA (WHO / FAO)
JECFA number 116, 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. Stearic acid appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 57-11-4, where EPA names it Octadecanoic 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 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: Fatty, waxy, slightly sweet, mild.
Taste: Fatty, creamy, bland.
Where it is used
Stearic acid is used in confection, dairy, baked goods and emulsifier, typically as a fatty note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Stearic acid by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Palmitic acid | 2832 | 99% | In nature |
| Pentadecanoic acid | 4334 | 97% | In nature |
| Myristic acid | 2764 | 97% | In nature |
| Oleic acid | 2815 | 96% | In nature |
| Ethyl hexadecanoate | 2451 | 95% | In nature |
More acids in this index
Palmitic acid · Octanoic acid · (E,Z)-4-Methylpent-2-enoic acid · Propionic acid · (E)-2-Pentenoic acid · N-Benzoylanthranilic acid
Stearic acid FAQ
Is stearic acid on the FEMA GRAS list?
It is. FEMA number 3035 covers stearic acid. The Code of Federal Regulations lists it at 21 CFR 184.1090.
What is the FEMA number for stearic acid?
The FEMA number for stearic acid is 3035 and its CAS registry number is 57-11-4. Its flavor category is fatty.
What is stearic acid used for?
Stearic acid is described as fatty, waxy, slightly sweet, mild. On the palate it is fatty, creamy, bland. It shows up in confection, dairy, baked goods and emulsifier.
What did JECFA conclude about stearic acid?
JECFA evaluated stearic acid at the 49th meeting in 1997 under JECFA number 116. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is stearic acid approved in the EU?
Yes. FL 08.015 is the Union List entry for stearic acid, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Is stearic acid natural or artificial?
Nature makes stearic acid, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial stearic acid, same molecule. 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 STEARIC ACID under CAS 57-11-4 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 emulsifier or emulsifier salt, flavoring agent or adjuvant, formulation aid, lubricant or release agent, masticatory substance, 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.