Lecithin is a naturally occuring mixture of the diglycerides of stearic, palmitic and oleic acids, linked to the choline ester of phosphoric acid whose form varies from a waxy mass to a thick, pourable liquid. Hydrogenated Lecithin is the product of controlled hydrogenation (addition of hydrogen) of Lecithin. Lecithin and Hydrogenated Lecithin are used in the formulation of a large number of cosmetics and personal care products.
The safety of Lecithin, and Hydrogenated Lecithin, has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Lecithin and Hydrogenated Lecithin are safe as used in rinse-off products. The CIR Expert Panel limited the use of Lecithin and Hydrogenated Lecithin in in leave-on products to concentrations equal to or less than 15%.CIR Safety Review: The CIR Expert Panel found that Lecithin and Hydrogenated Lecithin were safe as used in rinse-off products and, based on the results of sensitization and photosensitization studies, and safe for use at concentrations equal to or less than 15% in leave-on products. Because adverse reactions to Lecithin have been reported when it was used in a drug product intended to be inhaled, the CIR Expert Panel requested additional inhalation toxicity data.
The CIR Expert Panel noted that Lecithin-containing liposomes may enhance the penetration of other ingredients through the skin and that care should be taken in formulating products that contain ingredients that the CIR Expert Panel determined safe for use based on their lack of dermal absorption, or when dermal absorption is a concern.
The CIR Expert Panel also acknowledged that cosmetics and personal care products containing Lecithin and Hydrogenated Lecithin may give rise to nitrosoamines in the presence of nitrate or other nitrosating agents.
This link provides more information about nitrosamines.
FDA: Link to Code of Federal Regulations for Lecithin
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Lecithin and Hydrogenated Lecithin may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has not limited the daily intake of Lecithin.
http://www.inchem.org/documents/jecfa/jecmono/v05je42.htm