Lecithin
Also known as Phosphatidylcholine (primary component), Soybean lecithin, Soy lecithin, Egg lecithin, E322, Phospholipids from soybean/egg yolk
“CIR Expert Panel says: safe as used in cosmetics.”
Lecithin (CAS 8002-43-5) is a naturally-occurring mixture of phospholipids extracted from soybean or egg yolk, primarily composed of phosphatidylcholine with smaller amounts of phosphatidylethanolamine, phosphatidylinositol, and phosphatidic acid. In cosmetic formulations it functions as a natural amphiphilic emulsifier, liposome-forming agent (for delivery of lipid-soluble actives), and skin conditioning agent. The phospholipid bilayer structure mimics the stratum corneum intercellular lipid matrix, giving lecithin excellent skin compatibility. The Cosmetic Ingredient Review Expert Panel originally assessed Lecithin and Hydrogenated Lecithin in 2001 (Int J Toxicol 20(Suppl 1):21-45, PMID 11358109) and concluded that Lecithin and Hydrogenated Lecithin are safe as used in rinse-off products and safe in leave-on products at concentrations up to 15% (the highest concentration tested in clinical irritation and sensitization studies). The 2015 amended assessment (CIR Final Report March 2015, subsequently published as Johnson, Bergfeld, Belsito et al., Int J Toxicol 2020, PMID 32975152) expanded the scope to 17 phosphoglyceride ingredients (lecithin, hydrogenated lecithin, lysolecithin, phospholipids, hydrolyzed phospholipids, phosphatidic acid, lysophosphatidic acid, phosphatidylglycerol, lysophosphatidylglycerol, phosphatidylserine, ammonium phosphatidyl rapeseedate, phosphatidylcholine, hydrogenated phosphatidylcholine, hydrogenated lysophosphatidylcholine, lysophosphatidylethanolamine, and phosphatidylinositol) and concluded they are all safe in the present practices of use and concentration. The QRT row records 'S' without a concentration qualifier, reflecting the updated 2015 conclusion. The 2015 assessment flagged one formulation-context restriction: because of the theoretical possibility of nitrosamine formation, lecithin should not be used in cosmetic products in which N-nitroso compounds may be formed (a standard caution that applies to many nitrogen-containing cosmetic ingredients). Lecithin is FDA GRAS as a direct food additive (E322 in the EU) and is widely consumed in its natural form as a component of egg yolk, soybeans, and other dietary phospholipid sources.
Natural amphiphilic emulsifier — the phosphatidylcholine backbone has both hydrophilic (phosphate/choline head) and lipophilic (fatty acid tails) character, making it an effective natural alternative to synthetic emulsifiers
Liposome former — lecithin is the basis of many cosmetic liposome delivery systems, enabling encapsulation and targeted release of lipid-soluble actives like retinol and tocopherol
Skin-identical phospholipids — the phospholipid bilayer structure mimics the stratum corneum intercellular lipid matrix, giving lecithin excellent skin compatibility and barrier-support properties
CIR Expert Panel concluded safe as used in cosmetics across three assessments (2001 original PMID 11358109, 2015 amended, 2020 published version PMID 32975152) — 2015 assessment extended to 17 related phosphoglycerides
FDA Generally Recognized As Safe (GRAS) as a direct food additive; approved as food additive E322 in the European Union; natural component of egg yolk and soybeans
- · Inhalation exposure was noted in the 2001 assessment as not substantiated; inhaled cosmetic products (sprays, aerosols) warrant formulator attention even though topical use is broadly safe
Theoretical nitrosamine formation risk in products containing nitrite-donating ingredients — the CIR 2015 assessment flagged that lecithin should not be used in cosmetic formulations in which N-nitroso compounds may be formed
The 2001 original assessment included a 15% concentration cap for leave-on products based on the highest tested concentration; the 2015 amended re-review concluded safe without carrying forward that numeric cap — the QRT reflects the updated 'safe as used' finding
CIR Quick Reference Table (12/2017, revised 07/2018) - Lecithin row: Finding 'S' (Safe), Citation 'IJT 20(S1):21-45, 2001; Final report 0…
“Lecithin | S | [no detail column entry] | IJT 20(S1):21-45, 2001; Final report 03/2015 available from CIR”— QRT-122017revised072018.pdf, p. 70