Is Polysorbate 65 safe in cosmetics?
Polysorbate 65 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Polysorbate 65
Also known as: Polyoxyethylene 20 sorbitan tristearate, Ethoxylated sorbitan tristearate
INCI: POLYSORBATE 65
Polysorbate 65 (CAS 9005-71-4) is a cosmetic cosmetic ingredient functioning as Emulsifying, Surfactant. Reported NOAEL =2500 mg/kg bw/day in Rat (EFSA); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.
View industrial chemical safety profile for CAS 9005-71-4 →
Auto-generated CPSR Part A draft with source citations
Function
Emulsifying, Surfactant
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR concluded Polysorbate 65 safe as cosmetic ingredient; FDA permits as direct food additive; used in skin care, makeup, and hair products
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 65.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Polysorbate 65. 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: unspecified | Rat | chronic/long term toxicity | EFSA |
| NOAEL | =2500 mg/kg bw/day | oral: unspecified | Rat | chronic/long term toxicity | EFSA |
Additional Ingredient Properties
2 property records from structured ingredient metadata.
emulsifier
{"cas_number": "9005-71-4", "ingredient_class": "O/W_emulsifier", "chemical_type": "ethoxylated_sorbitan", "HLB_value": "10.5", "HLB_required_for_oil_phase": "10-12", "emulsion_type_primary": "O/W", "droplet_size_typical_um": "1-3", "critical_micelle_concentration_pct": "0.001-0.01", "surface_tension_reduction_mN_m": "26-30", "interfacial_tension_reduction": "29-33", "foam_formation": "low", "foam…
surfactant
{"cas_number": "9005-71-4", "surfactant_type": "nonionic", "chemical_class": "polysorbate", "charge_at_use_ph": "neutral", "cmc_critical_micelle_concentration_mm": "0.024724579977230363", "hlb_value": "10.5", "foam_volume_ml_ross_miles": "81", "foam_quality": "light", "foam_stability_5min_pct": "63", "cleansing_power_rating_1_to_10": "4.591488844956552", "oil_emulsification_capacity": "moderate", …
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Emulsifier
Flavouring and nutrient
Pharmaceutical
Surfactant (surface active agent)
Thickening agent
Wetting agent (non-aqueous)
Regulatory List Membership (2)
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Polysorbate 65.
Regulatory Flags
ethoxylated
polysorbate
nonionic-surfactant
1,4-dioxane-impurity-risk
epa_safer_alternative
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Polysorbate 65 by CAS number or substance name.
Studies
2
Lowest NOAEL
2500 mg/kg bw/day
Highest NOAEL
2500 mg/kg bw/day
EFSA
Known Synonyms
Polyoxyethylene 20 sorbitan tristearate
Ethoxylated sorbitan tristearate
Chemical Function
Surfactant (surface active agent)
Emulsifier
Wetting agent (non-aqueous)
Flavouring and nutrient
Regulatory Lists
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
active_ingredient; Pesticides
pharmaceutical
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
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 65
E Number
E436
ADI
25 mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Polysorbate 65 allowed in the EU?
Polysorbate 65 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 65 do in cosmetics?
Polysorbate 65 functions as: Emulsifying, Surfactant. It is classified as a cosmetic ingredient in our database. CAS number: 9005-71-4.
What is the NOAEL for Polysorbate 65?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 65 is =2500 mg/kg bw/day based on a chronic/long term toxicity study via oral: unspecified route in Rat. A total of 2 study endpoints are available. Source: EFSA.
Is Polysorbate 65 used outside cosmetics?
Polysorbate 65 also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polysorbate 65 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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