Polysorbate 85

INCI: POLYSORBATE 85

CAS Number
9005-70-3
Function
Emulsifying, Surfactant
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR concluded safe as cosmetic ingredient (1984); 1.0โ€“8.4% formulations showed no acute or subchronic percutaneous toxicity; FDA approved for pharmaceutical use

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Safe emulsifier and surfactant backed by CIR safety approval with extensive percutaneous toxicity data; minor 1,4-dioxane impurity risk if poorly purified.

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Concern Level: Low

Regulatory Flags

ethoxylated polysorbate nonionic-surfactant 1,4-dioxane-impurity-risk epa_safer_alternative

Frequently Asked Questions

Is Polysorbate 85 safe in cosmetics?

Safe emulsifier and surfactant backed by CIR safety approval with extensive percutaneous toxicity data; minor 1,4-dioxane impurity risk if poorly purified. The EU classifies Polysorbate 85 as "permitted". Safety rating: GOOD.

Is Polysorbate 85 allowed in the EU?

Polysorbate 85 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Polysorbate 85 do in cosmetics?

Polysorbate 85 functions as: Emulsifying, Surfactant. It is classified as a cosmetic ingredient in our database. CAS number: 9005-70-3.

What is the Margin of Safety for Polysorbate 85?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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