Steareth-2

INCI: STEARETH-2

CAS Number
16057-43-5
Function
Emulsifier, surfactant
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 10%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted in the US under the FD&C Act; FDA does not pre-approve cosmetic ingredients. No specific FDA restrictions apply to Steareth-2. FDA VCRP data shows use in 593 formulations (2010). FDA recommends manufacturers limit 1,4-dioxane contamination via vacuum stripping during production. CIR Expert Panel concluded safe as used (1988, reaffirmed 2012).

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Steareth-2 is a lipophilic emulsifier and surfactant used in cosmetic formulations at concentrations up to 21%. It is restricted in the EU under Regulation (EC) No 1223/2009 with a maximum concentration of 10%. CIR safety assessment (1988, reaffirmed 2012) concluded the ingredient is safe as used, with no sensitization potential and low acute toxicity. Formulators should ensure finished products minimize 1,4-dioxane contamination to โ‰ค10 ppm as a byproduct of ethoxylation.

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Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion non-sensitizing

Frequently Asked Questions

Is Steareth-2 safe in cosmetics?

Steareth-2 is a lipophilic emulsifier and surfactant used in cosmetic formulations at concentrations up to 21%. It is restricted in the EU under Regulation (EC) No 1223/2009 with a maximum concentration of 10%. CIR safety assessment (1988, reaffirmed 2012) concluded the ingredient is safe as used, with no sensitization potential and low acute toxicity. Formulators should ensure finished products minimize 1,4-dioxane contamination to โ‰ค10 ppm as a byproduct of ethoxylation. The EU classifies Steareth-2 as "restricted". Safety rating: GOOD.

Is Steareth-2 allowed in the EU?

Steareth-2 EU regulatory status: restricted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.

What does Steareth-2 do in cosmetics?

Steareth-2 functions as: Emulsifier, surfactant. It is classified as a UV Filter / Sunscreen in our database. CAS number: 16057-43-5.

What is the Margin of Safety for Steareth-2?

not established 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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