Excellent Emulsifier Dermal Penetration

Lecithin

INCI: LECITHIN

CAS Number
8002-43-5
Function
Complex phospholipid mixture (principally phosphatidylcholine, PC) from soybean, sunflower, or egg sources. Functions as natural emulsifier, skin-conditioning agent, penetration enhancer, and liposomal bilayer-forming material. Commercial grades range from ≥45% PC (lecithin fractions) to ≥94% PC (high-purity fractions). COSMOS-approved non-GMO sunflower variants available. Platform for liposomal delivery of hydrophilic actives (vitamin C, caffeine) and lipophilic actives (CoQ10, vitamins A/E).
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA GRAS under 21 CFR 184.1400 (direct food substance, no numerical limit). Listed in FDA Inactive Ingredients Database for topical, oral, injection, and other routes. CIR 2020 safety assessment covers lecithin and 16 other phosphoglycerides — safe as used in all cosmetic categories without concentration restriction. BSE/TSE: FDA prohibits bovine specified risk materials; verify source for animal-derived lecithin.

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.

Dermal Penetration Profile

Skin absorption and penetration characteristics of Lecithin, relevant to systemic exposure and MoS calculations.

Absorption %
4-10%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
2-8%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation

Source: Eur J Pharm Biopharm 2007

Expert Verdict

EXCELLENT safety profile. CIR 2020 concluded 17 phosphoglycerides including lecithin safe as used in all cosmetics. EU permitted with no Annex restrictions. FDA GRAS (21 CFR 184.1400). COSMOS/ECOCERT approved. Oral LD50 >5,000 mg/kg; mutagenicity negative; non-reproductive toxicant.

⚠️
Concern Level: None

Regulatory Flags

penetration-enhancer allergen-risk-soy allergen-risk-egg gmo-consideration cosmos-approved gras-fda liposomal-delivery eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Lecithin safe in cosmetics?

EXCELLENT safety profile. CIR 2020 concluded 17 phosphoglycerides including lecithin safe as used in all cosmetics. EU permitted with no Annex restrictions. FDA GRAS (21 CFR 184.1400). COSMOS/ECOCERT approved. Oral LD50 >5,000 mg/kg; mutagenicity negative; non-reproductive toxicant. The EU classifies Lecithin as "permitted". Safety rating: EXCELLENT.

Is Lecithin allowed in the EU?

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

What does Lecithin do in cosmetics?

Lecithin functions as: Complex phospholipid mixture (principally phosphatidylcholine, PC) from soybean, sunflower, or egg sources. Functions as natural emulsifier, skin-conditioning agent, penetration enhancer, and liposomal bilayer-forming material. Commercial grades range from ≥45% PC (lecithin fractions) to ≥94% PC (high-purity fractions). COSMOS-approved non-GMO sunflower variants available. Platform for liposomal delivery of hydrophilic actives (vitamin C, caffeine) and lipophilic actives (CoQ10, vitamins A/E).. It is classified as a Emulsifier in our database. CAS number: 8002-43-5.

What is the Margin of Safety for Lecithin?

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 Lecithin 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 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

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Glycol Palmitate
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Phosphatidylcholine
Excellent
Polyglyceryl-2 Laurate
Excellent
Almond Oil PEG-6 Esters
Good
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