Moderate Cosmetic Ingredient

Ethosomes

INCI: ETHOSOMES

Function
Delivery system; phospholipid vesicles with ethanol
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes No FDA-specific approval for ethosomes as delivery system. Components (lecithin, ethanol) permitted. Under MoCRA, safety substantiation must account for 5-87x enhanced dermal absorption. Marketed products (Noicellex, Cellulight EF, Decorin Cream) exist; no FDA enforcement actions identified.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Novel delivery system with no CAS number. EU: Permitted under EC 1223/2009; SCCS guidance requires nanocarrier penetration-enhanced exposure assessment; Article 16 nanomaterial rules may apply. US: Component materials permitted; MoCRA safety substantiation must account for enhanced dermal absorption (5-87x vs conventional delivery).

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Concern Level: Moderate

Regulatory Flags

enhanced-dermal-penetration nanovesicular-delivery ethanol-20-45pct no-sccs-opinion no-cir-system-review sensitization-amplification-risk mos-recalculation-required

Frequently Asked Questions

Is Ethosomes safe in cosmetics?

Novel delivery system with no CAS number. EU: Permitted under EC 1223/2009; SCCS guidance requires nanocarrier penetration-enhanced exposure assessment; Article 16 nanomaterial rules may apply. US: Component materials permitted; MoCRA safety substantiation must account for enhanced dermal absorption (5-87x vs conventional delivery). The EU classifies Ethosomes as "permitted". Safety rating: MODERATE.

Is Ethosomes allowed in the EU?

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

What does Ethosomes do in cosmetics?

Ethosomes functions as: Delivery system; phospholipid vesicles with ethanol. It is classified as a Cosmetic Ingredient in our database.

What is the Margin of Safety for Ethosomes?

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.

Compliance Tools

Check Ethosomes compliance across multiple jurisdictions:

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Ingredient Decoder
Paste a full ingredient list for instant analysis
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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