Is Polysorbate 20 safe in cosmetics?
Polysorbate 20 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Polysorbate 20
Also known as: Tween 20, Armotan pml-20, Dxewmulse poe-sml, FEMA No. 2915, Glycosperse L-20 (+15 more)
INCI: POLYSORBATE 20
Polysorbate 20 (CAS 9005-64-5) is a cosmetic emulsifier functioning as Solubilizer; emulsifier; surfactant; cleansing agent. NOAEL 1000 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, pharmaceutical, and food safety data.
Function
Solubilizer; emulsifier; surfactant; cleansing agent
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 safe as used in cosmetics. Ethoxylated sorbitan ester with 1,4-dioxane risk from manufacturing process; GMP vacuum stripping controls residuals to <10 ppm. Key ingredient in micellar water formulations (e.g., Bioderma Sensibio). HLB 16.7 makes it one of the most hydrophilic polysorbates, primarily a solubilizer for fragrance, essential oils, and light makeup removal.
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 20.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 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 | =10 mg/kg/d | oral | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =10 mg/kg/d | oral | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =10 mg/kg/d | oral | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =10 mg/kg/d | oral | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =100 mg/kg | Intravenous | Rat | General toxicity | CIR Safety Assessment |
| NOAEL | =100 mg/kg | Intravenous | Rat | General toxicity | CIR Safety Assessment |
| NOAEL | =100 mg/kg | Intravenous | Rat | General toxicity | CIR Safety Assessment |
| NOAEL | =100 mg/kg | Intravenous | Rat | General toxicity | CIR Safety Assessment |
| NOAEL | =250 mg/kg/d | oral | rat | repeated dose toxicity | CIR Safety Assessment |
| NOAEL | =250 mg/kg/d | oral | rat | repeated dose toxicity | CIR Safety Assessment |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Polysorbate 20 across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Polysorbate 20, relevant to systemic exposure and MoS calculations.
Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
1228 Da
Log P
0.5
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: CIR Expert Panel
EPA ToxValDB — Toxicity Values
2 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >33000 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =36.7 mL/kg | Rat | oral | - | ChemIDplus |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 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 |
|---|---|---|---|
| Face Cream | 0.5–3 | 10 | CIR Safety Assessment |
| Toner | 0.5–2 | 5 | CIR Safety Assessment |
| Cleanser | 1–5 | 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
Solubility enhancer
Surfactant (surface active 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 20 — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
ethoxylated
peg-derived
1,4-dioxane-risk
penetration-enhancer
solubilizer
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 20 by CAS number or substance name.
Studies
46
Lowest NOAEL
10
Highest NOAEL
1.429e+4
Units vary across source rows: mg/kg/d, mg/kg, mg/kg bw/day
CIR Safety Assessment
EFSA
Known Synonyms
Tween 20
Armotan pml-20
Dxewmulse poe-sml
FEMA No. 2915
Glycosperse L-20
Glycosperse L-20X
Hodag psml-20
Liposorb L-20
Peg sorbitan laurate
Peg-20 sorbitan laurate
Poe 20 sorbitan monolaurate
Polyoxyethylene 20 sorbitan monolaurate
Protasorb L-20
Sorbitan, monododecanote, poly(oxy-1,2-ethanediyl) derivatives
UNII-7T1F30V5YH
UNII-59IO08SBZU
Polyoxyethylene(4)sorbitan monolaurate
UNII-31JQ3WOL8T
UNII-239B50Y732
UNII-4Z93U4C2WN
Chemical Function
Emulsifier
Surfactant (surface active agent)
Regulatory Lists
children; Europe; Personal care
children; Europe; Personal care - body hygiene - body wash
children; Europe; Personal care - hair styling and care - shampoo
drinking_water; Europe; manufacturing; plastic_additive
active_ingredient; Pesticides
inert_ingredient; Pesticides
pharmaceutical
children; Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care - specialized bath products - bubble bath
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
Europe; Personal care - hair styling and care - shampoo-dandruff
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
Europe; Personal care - oral and dental care - teeth whitener
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
103
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 20
E Number
E432
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
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 NOAEL for Polysorbate 20?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 20 is =10 mg/kg/d based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR Safety Assessment.
Is Polysorbate 20 used outside cosmetics?
Polysorbate 20 also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polysorbate 20 compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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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