Flavor ingredient regulatory record
Polysorbate 60
Polysorbate 60 is a natural complex flavoring material, FEMA GRAS under FEMA number 2916 (CAS 9005-67-8). Its odor is mild, alcoholic, bitter.
- FEMA
- 2916
- CAS
- 9005-67-8
GRAS status: FEMA GRAS, publication 3. Recorded by FDA in the Substances Added to Food inventory under CAS 9005-67-8.
Structure
Material
Polysorbate 60 is a natural complex material rather than a single molecule, so it has no one structure. FEMA lists it as POLYSORBATE 60.
Identity
Also known as: Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs., Sorbitan, monostearate, polyoxyethylene derivs., Tween 18:0, Tween 61, Tween 60, Armotan PMS 20, Polyethylene glycol sorbitan monostearate, Poly(oxyethylene)sorbitan monostearate, Sorbitan polyethoxy monostearate, Ethoxylated sorbitan monostearate, Crillet 3, Sorbimacrogol stearate 300.
Can Polysorbate 60 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 60 is FEMA GRAS under FEMA number 2916. It is cited in the Code of Federal Regulations at 21 CFR 172.515 and 21 CFR 172.836 and 21 CFR 173.340.
European Union and United Kingdom
No EU FL number is on file for Polysorbate 60. 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 60 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 60 appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 9005-67-8, where EPA names it Sorbitan, monooctadecanoate, 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 60 are not on file yet.
Polysorbate 60 FAQ
Is polysorbate 60 FEMA GRAS?
Yes. The FEMA Expert Panel lists polysorbate 60 as GRAS under FEMA number 2916. It is also codified at 21 CFR 172.515 and 21 CFR 172.836 and 21 CFR 173.340.
What are the FEMA and CAS numbers for polysorbate 60?
Polysorbate 60 is FEMA 2916, CAS 9005-67-8.
How is polysorbate 60 described, and where does it show up?
Flavorists describe polysorbate 60 as 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 60 under CAS 9005-67-8 and carries its FEMA number and its 21 CFR citations. The inventory is searchable at FDA. FDA records its technical effect as boiler water additive, emulsifier or emulsifier salt, flavoring agent or adjuvant, 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.