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 20. 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 |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Polysorbate 20, relevant to systemic exposure and MoS calculations.
Source: CIR
Expert Verdict
Highly hydrophilic nonionic emulsifier and solubilizer (HLB 16.7) confirmed safe as used by CIR. Core ingredient in micellar waters with effective cleansing at very low concentrations (CMC 0.05–0.1 mM). Ethoxylated compound requiring manufacturing control of 1,4-dioxane impurity (≤10 ppm). PEG-based, so excluded from COSMOS/ECOCERT certified formulations. Penetration enhancement of co-formulants requires formulator caution but poses no consumer hazard at typical use levels.
Regulatory Flags
Frequently Asked Questions
Is Polysorbate 20 safe in cosmetics?
Highly hydrophilic nonionic emulsifier and solubilizer (HLB 16.7) confirmed safe as used by CIR. Core ingredient in micellar waters with effective cleansing at very low concentrations (CMC 0.05–0.1 mM). Ethoxylated compound requiring manufacturing control of 1,4-dioxane impurity (≤10 ppm). PEG-based, so excluded from COSMOS/ECOCERT certified formulations. Penetration enhancement of co-formulants requires formulator caution but poses no consumer hazard at typical use levels. The EU classifies Polysorbate 20 as "permitted". Safety rating: GOOD. 9 toxicological study endpoint(s) are available in our database.
Is Polysorbate 20 allowed in the EU?
Polysorbate 20 EU regulatory status: permitted. Maximum allowed concentration: 1,4-dioxane process impurity ≤10 ppm per EU GMP guidance. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 20 do in cosmetics?
Polysorbate 20 functions as: Solubilizer; emulsifier; surfactant; cleansing agent. It is classified as a Emulsifier in our database. CAS number: 9005-64-5.
What is the Margin of Safety for Polysorbate 20?
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 20?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 20 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
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Related Ingredients
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