Is Polysorbate 80 safe in cosmetics?
Polysorbate 80 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Good
Emulsifier
Polysorbate 80
INCI: POLYSORBATE 80
Polysorbate 80 (CAS 9005-65-6) is a cosmetic emulsifier functioning as Emulsifier; solubilizer; surfactant. 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 pharmaceutical data.
View industrial chemical safety profile for CAS 9005-65-6 →
Auto-generated CPSR Part A draft with source citations
Function
Emulsifier; solubilizer; surfactant
Safety Rating
GOOD
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. Widely used in pharmaceutical applications (solubilizer for injectable formulations) with well-characterized safety profile. HLB 15.0. CMC 0.05–0.15 mM. 1,4-dioxane GMP control required as ethoxylated ingredient.
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 80.
Calculate MoS for your specific formulation with the MoS Calculator.
Expert Verdict
Expert safety assessment and concern-level summary for Polysorbate 80.
Regulatory Flags
ethoxylated
peg-derived
1,4-dioxane-risk
penetration-enhancer
pharmaceutical-grade
not-cosmos
endocrine_disruptor
epa_safer_alternative
ifra_fragrance
fda_food_additive
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
polysorbate 80
ChEMBL ID
CHEMBL1697847
Adverse Event Associations
105
Frequently Asked Questions
Is Polysorbate 80 allowed in the EU?
Polysorbate 80 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 80 do in cosmetics?
Polysorbate 80 functions as: Emulsifier; solubilizer; surfactant. It is classified as a Emulsifier in our database. CAS number: 9005-65-6.
Is Polysorbate 80 used outside cosmetics?
Polysorbate 80 also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Polysorbate 80 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
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