Flavor ingredient regulatory record
Butyl stearate
Butyl stearate is an ester in the fruity family, FEMA GRAS under FEMA number 2214 (CAS 123-95-5). Its odor is sweet, fruity, creamy, tropical.
- FEMA
- 2214
- CAS
- 123-95-5
- JECFA
- 184
- EU FL
- 09.246
- Formula
- C22H44O2
- EC
- 204-666-5
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 123-95-5.
Structure
Identity
Also known as: Octadecanoic acid, butyl ester, Stearic acid, butyl ester, Apex 4, n-Butyl octadecanoate, Kesscoflex BS, Polycizer 332, RC Plasticizer B 17, n-Butyl stearate, Witcizer 200, Witcizer 201, Butyl octadecanoate, Emerest 2325.
Can Butyl stearate be labeled natural?
Since butyl stearate is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when butyl stearate is synthesized. 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.
- 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
Butyl stearate is FEMA GRAS under FEMA number 2214. 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 09.246, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 184, evaluated at the 49th meeting in 1997. no safety concern at current levels of intake.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Butyl stearate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 123-95-5, where EPA names it Octadecanoic acid, butyl 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.
Where it is used
Butyl stearate is used in beverage, confection, dairy, ice cream and fruit flavors, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Butyl stearate 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 | 99% | In nature |
| Isopropyl myristate | 3556 | 97% | In nature |
| Dodecyl butyrate | 4340 | 96% | In nature |
| Butyl laurate | 2206 | 96% | In nature |
| Hexadecyl lactate | 4483 | 96% | Not determined |
More esters in this index
(Z)-3-Hexenyl 2-oxopropionate · Trilobatin · Propyl phenylacetate · Carvyl propionate · Phenethyl propionate · Ethyl 2-acetyloctanoate
Butyl stearate FAQ
Is butyl stearate FEMA GRAS?
Yes. The FEMA Expert Panel lists butyl stearate as GRAS under FEMA number 2214. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for butyl stearate?
Butyl stearate is FEMA 2214, CAS 123-95-5. FEMA files it in the fruity flavor category.
Does butyl stearate count as natural in the US and the EU?
Butyl stearate occurs in nature, so the label depends on the route: butyl stearate won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized butyl stearate is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic butyl stearate identical-to-natural.
Is butyl stearate on the EU Union List?
Butyl stearate is on the EU Union List of flavouring substances as FL 09.246 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated butyl stearate?
Yes. JECFA number 184, evaluated at the 49th meeting in 1997. Conclusion: no safety concern at current levels of intake.
How is butyl stearate described, and where does it show up?
Flavorists describe butyl stearate as sweet, fruity, creamy, tropical. It is used in beverage, confection, dairy, ice cream and fruit flavors.
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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 BUTYL STEARATE under CAS 123-95-5 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, formulation aid.
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.