Is Polysorbate 40 safe in cosmetics?
Polysorbate 40 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Good
Cosmetic Ingredient
Polysorbate 40
Also known as: Tween 40, Polyoxyethylene sorbitan monopalmitate, Polyethylene glycol-sorbitan monopalmitate adduct, Ethoxylated sorbitan monopalmitate, Sorbitan polyethoxy monopalmitate (+14 more)
INCI: POLYSORBATE 40
Polysorbate 40 (CAS 9005-66-7) is a cosmetic cosmetic ingredient functioning as Emulsifying, Surfactant, Dispersing. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.
View industrial chemical safety profile for CAS 9005-66-7 →
Auto-generated CPSR Part A draft with source citations
Function
Emulsifying, Surfactant, Dispersing
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR concluded Polysorbate 40 safe as cosmetic ingredient; FDA approved as indirect food additive; potential trace 1,4-dioxane impurity managed at manufacturing
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 40.
Calculate MoS for your specific formulation with the MoS Calculator.
EPA ToxValDB — Toxicity Values
1 toxicity value from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >38400 mg/kg | Rat | oral | - | ChemIDplus |
Additional Ingredient Properties
5 property records from structured ingredient metadata.
comedogenicity_detail
{"comedogenicity_rating": "1", "irritancy_rating": "1", "skin_type_suitability": "all,combination,normal", "acne_safe": "yes", "source": "Emulsifier"}
emulsifier
{"cas_number": "9005-66-7", "ingredient_class": "O/W_emulsifier", "chemical_type": "ethoxylated_sorbitan", "HLB_value": "15.6", "HLB_required_for_oil_phase": "14-16", "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": "30-34", "interfacial_tension_reduction": "32-36", "foam_formation": "moderate"…
emulsion_hlb
{"hlb_value": "15.6", "hlb_required_as_emulsifier": "yes", "emulsifier_type": "o_w", "critical_packing_parameter": "0.25-0.35", "emulsion_stabilization_mechanism": "steric_stabilization", "co_emulsifier_pairs": "sorbitan_palmitate,cetearyl_alcohol", "optimal_oil_phase_pct": "5-20", "optimal_water_phase_pct": "80-95", "electrolyte_tolerance": "low", "pH_emulsion_stability_range": "3.0-8.0", "viscos…
solubility_hlb
{"water_soluble": "yes", "oil_soluble": "no", "hlb_value": "15.6", "soluble_in": "water, ethanol, propylene glycol", "insoluble_in": "oils", "log_p": "-0.1", "appearance": "amber liquid", "source": "Croda"}
surfactant
{"cas_number": "9005-66-7", "surfactant_type": "nonionic", "chemical_class": "polysorbate", "charge_at_use_ph": "neutral", "cmc_critical_micelle_concentration_mm": "0.04973043649920948", "hlb_value": "15.6", "foam_volume_ml_ross_miles": "74", "foam_quality": "light", "foam_stability_5min_pct": "53", "cleansing_power_rating_1_to_10": "4.676034373340559", "oil_emulsification_capacity": "moderate", "…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Dispersing agent
Emulsifier
Lubricating agent
Surfactant (surface active agent)
Regulatory List Membership (2)
EPA Safer Chemical Ingredients List (SCIL)
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Polysorbate 40.
Regulatory Flags
ethoxylated
polysorbate
nonionic-surfactant
1,4-dioxane-impurity-risk
epa_safer_alternative
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 40 by CAS number or substance name.
Studies
4
Lowest NOAEL
1600 mg/kg/d
Highest NOAEL
1600 mg/kg/d
CIR Safety Assessment
Known Synonyms
Tween 40
Polyoxyethylene sorbitan monopalmitate
Polyethylene glycol-sorbitan monopalmitate adduct
Ethoxylated sorbitan monopalmitate
Sorbitan polyethoxy monopalmitate
Sorbimacrogol palmitate 300
Sorbitan monopalmitate polyethylene glycol ether
Polyoxyethylene sorbitan monohexadecanoate
Polyethylene sorbitan monopalmitate
Polyethylene glycol sorbitan monohexadecanoate
Polyoxyethylene sorbitol monopalmitate
Sorbitan, monohexadecanoate, poly(oxy-1,2-ethanediyl) derivs.
Sorbitan, monopalmitate, polyoxyethylene derivs.
Tween 16:0
Nissan Nonion PT 221
Durfax 60
Crill 7
Emsorb 6910
Glycosperse P 20
Chemical Function
Surfactant (surface active agent)
Emulsifier
Lubricating agent
Anti-static agent
Dispersing agent
Regulatory Lists
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
pharmaceutical
Indirect additives food contact (10/2018)
SCIL (9/2019)
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
100
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 40
E Number
E434
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Polysorbate 40 allowed in the EU?
Polysorbate 40 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 40 do in cosmetics?
Polysorbate 40 functions as: Emulsifying, Surfactant, Dispersing. It is classified as a cosmetic ingredient in our database. CAS number: 9005-66-7.
Is Polysorbate 40 used outside cosmetics?
Polysorbate 40 also appears in 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 40 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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