Flavor ingredient regulatory record
Sucrose monopalmitate
Sucrose monopalmitate is an ester in the sweet family, FEMA GRAS under FEMA number 4713 (CAS 26446-38-8). Its odor is sweet, creamy, buttery, slightly fruity.
- FEMA
- 4713
- CAS
- 26446-38-8
- Formula
- C28H52O12
- EC
- 247-706-7
GRAS status: FEMA GRAS, publication 25. Recorded by FDA in the Substances Added to Food inventory under CAS 26446-38-8.
Structure
Identity
Also known as: α-D-Glucopyranoside, β-D-fructofuranosyl, monohexadecanoate, Sucrose, monopalmitate, Palmitic acid, monoester with sucrose, Sucrose palmitate, Palmitic acid sucrose monoester, Palmitic sucrose monoester, Sucrodet, Sucrapan P, Nitto Ester P 1570, P 1670, P 1570, Nitto Ester P 1670.
Can Sucrose monopalmitate be labeled natural?
Nature makes sucrose monopalmitate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial sucrose monopalmitate, same molecule. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic sucrose monopalmitate 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
Sucrose monopalmitate is FEMA GRAS under FEMA number 4713. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for Sucrose monopalmitate. 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)
Sucrose monopalmitate 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. Sucrose monopalmitate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 26446-38-8, where EPA names it .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl, monohexadecanoate.
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, creamy, buttery, slightly fruity.
Where it is used
Sucrose monopalmitate is used in baked goods, confectionery, dairy and desserts, typically as a sweet note.
Sucrose monopalmitate FAQ
Is sucrose monopalmitate FEMA GRAS?
Yes. The FEMA Expert Panel lists sucrose monopalmitate as GRAS under FEMA number 4713. The Code of Federal Regulations lists it at 21 CFR 172.515.
What are the FEMA and CAS numbers for sucrose monopalmitate?
Sucrose monopalmitate is FEMA 4713, CAS 26446-38-8. Its flavor category is sweet.
How is sucrose monopalmitate described, and where does it show up?
Flavorists describe sucrose monopalmitate as sweet, creamy, buttery, slightly fruity. It is used in baked goods, confectionery, dairy and desserts.
Does sucrose monopalmitate count as natural in the US and the EU?
The process decides for sucrose monopalmitate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic sucrose monopalmitate is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic sucrose monopalmitate 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 SUCROSE MONOPALMITATE under CAS 26446-38-8 and carries its FEMA number. The inventory is searchable at FDA. FDA records its technical effect as flavoring agent or adjuvant.
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.