Flavor ingredient regulatory record
Polysorbate 80
Polysorbate 80 is a natural complex flavoring material, FEMA GRAS under FEMA number 2917 (CAS 9005-65-6). Its odor is mild, alcoholic, bitter.
- FEMA
- 2917
- CAS
- 9005-65-6
- EC
- 500-019-9
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 9005-65-6.
Structure
Material
Polysorbate 80 is a natural complex material rather than a single molecule, so it has no one structure. FEMA lists it as POLYSORBATE 80.
Identity
Also known as: Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs., Sorbitan, monooleate, polyoxyethylene derivs., Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs., (Z)-, Glycols, polyethylene, ether with sorbitan monooleate, Olothorb, Polyoxyethylene sorbitan monooleate, Polysorban 80, Sorlate, Tween 80A, Tween 81, Tween 80, Crillet 4.
Can Polysorbate 80 be labeled natural?
Nature occurrence: Not yet found in nature (provisional).
Nature occurrence has not been settled for this substance, so the natural or artificial class is not stated here. The FEMA GRAS status does not depend on it.
Regulatory status, with citations
United States
Polysorbate 80 is FEMA GRAS under FEMA number 2917. It is cited in the Code of Federal Regulations at 21 CFR 173.340 and 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for Polysorbate 80. 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)
Polysorbate 80 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. Polysorbate 80 appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 9005-65-6, where EPA names it Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs..
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 regulatory flags
| Flag | EPA definition | What it obliges |
|---|---|---|
| FRI | Indicates a polymeric substance containing no free-radical initiator in its Inventory name but is considered to cover the designated polymer made with any free-radical initiator regardless of the amount used. | Nothing directly. It widens what the listing covers, so a polymer made with a different initiator is still the listed substance rather than a new one. |
| XU | Indicates a substance exempt from reporting under the Chemical Data Reporting Rule, (40 CFR 711). | Nothing, for this substance, in the CDR census. The exemption belongs to the chemical and not to your company, so every other substance you make above the reporting threshold still counts. Read more |
XU does not establish: Says nothing about hazard, about commercial activity status, or about obligations under any other part of TSCA.
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: mild, alcoholic, bitter.
Where it is used
Typical applications for Polysorbate 80 are not on file yet.
Polysorbate 80 FAQ
Does polysorbate 80 have FEMA GRAS status?
Polysorbate 80 holds FEMA GRAS status under FEMA number 2917. The Code of Federal Regulations lists it at 21 CFR 173.340 and 21 CFR 172.515.
How do I cite polysorbate 80 by FEMA or CAS number?
Cite polysorbate 80 as FEMA 2917 or CAS 9005-65-6; both point to the same entry.
What does polysorbate 80 smell and taste like, and where is it used?
The odor of polysorbate 80 is mild, alcoholic, bitter.
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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 POLYSORBATE 80 under CAS 9005-65-6 and carries its FEMA number and its 21 CFR citations. The inventory is searchable at FDA. FDA records its technical effect as color or coloring adjunct, emulsifier or emulsifier salt, flavor enhancer, flavoring agent or adjuvant, solvent or vehicle, stabilizer or thickener, 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.