Flavor ingredient regulatory record
Glyceryl monostearate
Glyceryl monostearate is an ester in the dairy family, FEMA GRAS under FEMA number 2527 (CAS 123-94-4). Its odor is creamy, fatty, slightly sweet, mild.
- FEMA
- 2527
- CAS
- 123-94-4
- JECFA
- 918
- Formula
- C21H42O4
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 31566-31-1.
Structure
Identity
Also known as: Octadecanoic acid, 2,3-dihydroxypropyl ester, Stearin, 1-mono-, Aldo 33, Aldo 75, Glycerol α-monostearate, α-Monostearin, 1-Monostearin, Stearic acid 1-monoglyceride, Glycerin 1-monostearate, 1-Monostearoylglycerol, Glycerol 1-monostearate, Glyceryl 1-monostearate.
Can Glyceryl monostearate be labeled natural?
The process decides for glyceryl monostearate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic glyceryl 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
Glyceryl monostearate is FEMA GRAS under FEMA number 2527. It is cited in the Code of Federal Regulations at 21 CFR 184.1324.
European Union and United Kingdom
No EU FL number is on file for Glyceryl 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)
JECFA number 918, evaluated at the 57th meeting in 2001. 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. Glyceryl monostearate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 123-94-4, where EPA names it Octadecanoic acid, 2,3-dihydroxypropyl 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: Creamy, fatty, slightly sweet, mild.
Where it is used
Glyceryl monostearate is used in dairy, baked goods, confection and emulsifier, typically as a dairy note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Glyceryl monostearate by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Glyceryl monooleate | 2526 | 94% | In nature |
| Propylene glycol stearate | 2942 | 94% | In nature |
More esters in this index
Tributyrin · Diacetyl tartaric acid esters of mono- and diglycerides · Mono- and diglycerides of fatty acids · Carvyl propionate · Cyclohexyl cinnamate · Triethyl citrate
Glyceryl monostearate FAQ
Does glyceryl monostearate have FEMA GRAS status?
Glyceryl monostearate holds FEMA GRAS status under FEMA number 2527. The Code of Federal Regulations lists it at 21 CFR 184.1324.
How do I cite glyceryl monostearate by FEMA or CAS number?
Cite glyceryl monostearate as FEMA 2527 or CAS 123-94-4; both point to the same entry. Its flavor category is dairy.
What does glyceryl monostearate smell and taste like, and where is it used?
The odor of glyceryl monostearate is creamy, fatty, slightly sweet, mild. Typical uses are dairy, baked goods, confection and emulsifier.
What did JECFA conclude about glyceryl monostearate?
JECFA evaluated glyceryl monostearate at the 57th meeting in 2001 under JECFA number 918. The panel concluded: No safety concern at current levels of intake when used as a flavouring agent.
Is glyceryl monostearate approved in the EU?
No EU FL number is on file for glyceryl monostearate. It has a JECFA evaluation (JECFA 918), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Can glyceryl monostearate be labeled a natural flavor?
Nature makes glyceryl monostearate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial glyceryl monostearate, same molecule. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic glyceryl monostearate 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 GLYCERYL MONOSTEARATE under CAS 31566-31-1 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, firming agent, flavor enhancer, lubricant or release agent, masticatory substance, texturizer.
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.