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
8 study endpoints found for Polysorbate 60. 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 | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 15000 mg/kg bw/day | oral | mouse | Subchronic | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | hamster | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 15000 mg/kg bw/day | oral | mouse | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 7693 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| dose_tested | 7693 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
Expert Verdict
O/W emulsifier with HLB 14.9 confirmed safe by CIR. Ethoxylated ingredient requiring 1,4-dioxane process control (≤10 ppm), PEG-derived (COSMOS ineligible), with potential penetration enhancement of co-formulated actives at class level.
Regulatory Flags
Frequently Asked Questions
Is Polysorbate 60 safe in cosmetics?
O/W emulsifier with HLB 14.9 confirmed safe by CIR. Ethoxylated ingredient requiring 1,4-dioxane process control (≤10 ppm), PEG-derived (COSMOS ineligible), with potential penetration enhancement of co-formulated actives at class level. The EU classifies Polysorbate 60 as "permitted". Safety rating: GOOD. 8 toxicological study endpoint(s) are available in our database.
Is Polysorbate 60 allowed in the EU?
Polysorbate 60 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 60 do in cosmetics?
Polysorbate 60 functions as: Emulsifier; solubilizer; surfactant. It is classified as a Emulsifier in our database. CAS number: 9005-67-8.
What is the Margin of Safety for Polysorbate 60?
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 60?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 60 is 5000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
Check Polysorbate 60 compliance across multiple jurisdictions:
Related Ingredients
Is Polysorbate 60 in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Polysorbate 60 in your formulation.