Is Polysorbate 60 safe in cosmetics?
Polysorbate 60 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 9 toxicological study endpoint(s) are available in our database.
Polysorbate 60
Also known as: Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs., Ethoxylated sorbitan monostearate, Polyethylene glycol sorbitan monostearate, Polyoxyethylene sorbitan monostearate, FEMA No. 2916 (+9 more)
INCI: POLYSORBATE 60
Polysorbate 60 (CAS 9005-67-8) is a cosmetic emulsifier functioning as Emulsifier; solubilizer; surfactant. NOAEL 960 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 1,4-dioxane process impurity ≤10 ppm per EU GMP guidance. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and food safety data.
Function
Emulsifier; solubilizer; surfactant
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
1,4-dioxane process impurity ≤10 ppm per EU GMP guidance
US US Status
permitted
US Notes
CIR assessed polysorbate esters as safe as used in cosmetics. Ethoxylated sorbitan stearate (C18). HLB 14.9 positions it as an O/W emulsifier. 1,4-dioxane GMP control required. Same class-level penetration enhancement caution as Polysorbate 20.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Polysorbate 60.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
9 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 | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS DB |
| NOAEL | 7500 mg/kg bw/day | oral | hamster | Chronic | COSMOS DB |
| NOAEL | 7693 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | =960 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =5000 mg/kg bw/day | oral | Mouse | chronic | ECHA |
| NOAEL | =7693 mg/kg bw/day | oral | Rat | developmental | ECHA |
| NOAEL | =52000 mg/kg bw/day | oral | Mouse | developmental | ECHA |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Polysorbate 60 across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| ADI | <=25 mg/kg | Human | oral | - | WHO/JECFA |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA |
| LD50 | >20000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >5000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >60000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >38000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >33800 mg/kg | Rat | oral | - | ECHA |
| LOAEL | =5000 ppm | Mouse | oral | - | ECHA |
| NOAEL | =52000 mg/kg-day | Mouse | oral | - | ECHA |
| NOAEL | =52000 mg/kg-day | Mouse | oral | - | ECHA |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Body Lotion | 0.5–3 | 10 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Dispersing agent
Emulsifier
Flavouring and nutrient
Fragrance
Lubricating agent
Pharmaceutical
Processing aids not otherwise specified
Surfactant (surface active agent)
Thickening agent
Regulatory List Membership (4)
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Polysorbate 60 — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
ethoxylated
peg-derived
1,4-dioxane-risk
penetration-enhancer
not-cosmos
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 60 by CAS number or substance name.
Studies
9
Lowest NOAEL
960 mg/kg bw/day
Highest NOAEL
5.200e+4 mg/kg bw/day
ECHA
COSMOS DB
Known Synonyms
Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.
Ethoxylated sorbitan monostearate
Polyethylene glycol sorbitan monostearate
Polyoxyethylene sorbitan monostearate
FEMA No. 2916
Glycosperse S-20
Peg sorbitan stearate
Peg-20 sorbitan stearate
Polyoxyethylene 20 sorbitan monostearate
Polyoxyethylene-40-sorbitan monostearate
UNII-CAL22UVI4M
UNII-3453J8557N
UNII-X61U1UH01B
UNII-073G38N8GC
Chemical Function
Emulsifier
Surfactant (surface active agent)
Regulatory Lists
fracking; water
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
pharmaceutical
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
pharmaceutical
SCIL (9/2019)
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in food safety data.
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Polysorbate 60
E Number
E435
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
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 NOAEL for Polysorbate 60?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 60 is 2500 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS DB.
Is Polysorbate 60 used outside cosmetics?
Polysorbate 60 also appears in industrial chemical safety and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polysorbate 60 compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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