Flavor ingredient regulatory record
Sorbitan Monostearate
Sorbitan Monostearate is an ester, FEMA GRAS under FEMA number 3028 (CAS 1338-41-6). Its odor is sLIGHT ODOR.
- FEMA
- 3028
- CAS
- 1338-41-6
- Formula
- C24H46O6
- EC
- 215-664-9
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 1338-41-6.
Structure
Identity
Also known as: Sorbitan, monooctadecanoate, Sorbitan, monostearate, Stearic acid, monoester with sorbitan, Sorbitan monooctadecanoate, Span 60, Crill 3, MS 33, Span 55, Crill K 3, Arlacel 60, Sorbitan S, Sorgen 50.
Can Sorbitan Monostearate be labeled natural?
Sorbitan Monostearate occurs in nature, so the label depends on the route: Sorbitan Monostearate won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized Sorbitan Monostearate is artificial. 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
Sorbitan Monostearate is FEMA GRAS under FEMA number 3028. It is cited in the Code of Federal Regulations at 21 CFR 172.515 and 21 CFR 172.842 and 21 CFR 173.340.
European Union and United Kingdom
No EU FL number is on file for Sorbitan Monostearate. 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)
Sorbitan Monostearate has not been evaluated by JECFA as a flavouring agent, or no evaluation is on file.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Sorbitan Monostearate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 1338-41-6, where EPA names it Sorbitan, monooctadecanoate.
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: SLIGHT ODOR.
Taste: BLAND TASTE.
Where it is used
Typical applications for Sorbitan Monostearate are not on file yet.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Sorbitan Monostearate by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 3-Oxohexadecanoic acid glyceride | 3769 | 91% | Not determined |
| Hexadecyl lactate | 4483 | 90% | Not determined |
| 3-Oxotetradecanoic acid glyceride | 3772 | 90% | In nature |
| Butyl stearate | 2214 | 87% | In nature |
| Dodecyl lactate | 4482 | 85% | Not determined |
Sorbitan Monostearate FAQ
Does Sorbitan Monostearate have FEMA GRAS status?
Sorbitan Monostearate holds FEMA GRAS status under FEMA number 3028. It is also codified at 21 CFR 172.515 and 21 CFR 172.842 and 21 CFR 173.340.
How do I cite Sorbitan Monostearate by FEMA or CAS number?
Cite Sorbitan Monostearate as FEMA 3028 or CAS 1338-41-6; both point to the same entry.
Can Sorbitan Monostearate be labeled a natural flavor?
Since Sorbitan Monostearate is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when Sorbitan Monostearate 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.
What does Sorbitan Monostearate smell and taste like, and where is it used?
The odor of Sorbitan Monostearate is sLIGHT ODOR. On the palate it is bLAND TASTE.
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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 SORBITAN MONOSTEARATE under CAS 1338-41-6 and carries its FEMA 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, processing aid, solvent or vehicle, stabilizer or thickener, surface-active agent, surface-finishing 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.