Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
9 study endpoints found for Polysorbate 21. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 25000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 3000 mg/kg bw/day | oral | hamster | Chronic | COSMOS_DB |
| NOAEL | 25000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 6000 mg/kg bw/day | oral | hamster | Short Term Toxicity | COSMOS_DB |
| NOAEL | >=1000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | >=2 other | oral | rat | oral | REACH |
| NOAEL | >=2 other | oral | rat | oral | REACH |
| NOAEL | >=2 other | oral | rat | oral | REACH |
| NOAEL | >=2 other | oral | rat | oral | REACH |
Expert Verdict
Restricted in EU with concentration limits; safe for cosmetic use when formulated to be nonirritating and not applied to compromised skin at very high concentrations.
Regulatory Flags
Frequently Asked Questions
Is Polysorbate 21 safe in cosmetics?
Restricted in EU with concentration limits; safe for cosmetic use when formulated to be nonirritating and not applied to compromised skin at very high concentrations. The EU classifies Polysorbate 21 as "restricted". Safety rating: GOOD. 9 toxicological study endpoint(s) are available in our database.
Is Polysorbate 21 allowed in the EU?
Polysorbate 21 EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 21 do in cosmetics?
Polysorbate 21 functions as: Surfactant – Emulsifying. It is classified as a cosmetic ingredient in our database. CAS number: 9005-64-5.
What is the Margin of Safety for Polysorbate 21?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Polysorbate 21?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 21 is 25000 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
Check Polysorbate 21 compliance across multiple jurisdictions:
Related Ingredients
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