Is Polysorbate 21 safe in cosmetics?
Polysorbate 21 has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Polysorbate 21
Also known as: Tween 20, Armotan pml-20, Dxewmulse poe-sml, FEMA No. 2915, Glycosperse L-20 (+15 more)
INCI: POLYSORBATE 21
Polysorbate 21 (CAS 9005-64-5) is a cosmetic cosmetic ingredient functioning as Surfactant – Emulsifying. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted. 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.
View industrial chemical safety profile for CAS 9005-64-5 →
Auto-generated CPSR Part A draft with source citations
Function
Surfactant – Emulsifying
Safety Rating
GOOD
Regulatory Status
EU EU Status
restricted
US US Status
permitted
US Notes
Permitted for cosmetic use; CIR Expert Panel concluded safe when formulated to be nonirritating
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 21.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 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 | =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 21 across SCCS product categories, with measured dermal absorption where available.
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
Additional Ingredient Properties
1 property record from structured ingredient metadata.
emulsifier
{"cas_number": "9005-64-5", "ingredient_class": "O/W_emulsifier", "chemical_type": "ethoxylated_sorbitan", "HLB_value": "13.3", "HLB_required_for_oil_phase": "12-14", "emulsion_type_primary": "O/W", "droplet_size_typical_um": "0.5-2", "critical_micelle_concentration_pct": "0.001-0.01", "surface_tension_reduction_mN_m": "28-32", "interfacial_tension_reduction": "32-36", "foam_formation": "moderate"…
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)
Expert Verdict
Expert safety assessment and concern-level summary for Polysorbate 21.
Regulatory Flags
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 21 by CAS number or substance name.
Studies
46
Lowest NOAEL
10
Highest NOAEL
14285.71
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 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 NOAEL for Polysorbate 21?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 21 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 21 used outside cosmetics?
Polysorbate 21 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 21 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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