Polyethylene Glycol (PEG) Stearates (PEG-2 Stearate, PEG-6 Stearate, PEG-8 Stearate, PEG-12 Stearate, PEG-20 Stearate, PEG-32 Stearate, PEG-40 Stearate, PEG-50 Stearate, PEG-100 Stearate, PEG-150 Stearate) are esters of polyethylene glycol and stearic acid. The PEG Stearates are soft to waxy solids that are white to tan in color. In cosmetics and personal care products, PEG Stearates are used in skin creams, conditioners, shampoos, body cleansers and soapless detergents.
The safety of the PEG Stearates has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that PEG-2, -6, -8, -12, -20, -32, -40, -50, -100 and -150 Stearates are safe for use in cosmetics and personal care products. In 2002, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on the PEG Stearates and reaffirmed the above conclusion.CIR Safety Review: The PEG Stearates, whose average number of ethylene oxide monomers range from 2 to 150, were nonlethal at levels up to 10 g/kg. They gave evidence of only minimal skin irritation and minimal eye irritation when tested at 100%. PEG-8, -40 and -100 Stearates produced no significant changes in growth, histopathologic observations or hematologic values in long-term feeding studies. Multiple generation studies of PEG-8 and -40 Stearates were negative for effects on reproduction.
Clinical studies on the PEG Stearates indicated that these ingredients were neither irritants nor sensitizers at concentrations of 25% or greater. There was no evidence of phototoxicity or photosensitization of PEG-2 or -8 Stearates. Because the smaller PEG Stearates were not photosensitizing the CIR Expert Panel did not expect the larger ingredients to be photosensitizing. The CIR Expert Panel concluded that safety data on individual PEG Stearates were sufficient for a decision regarding the safety of the entire group.
Link to the FDA Code of Federal Regulations for Polyethylene glycol (400) monostearate (PEG-8 Stearate)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
If the stearic acid used to make PEG-2, -6, -8, -12, -20, -32, -40, -50, -100, and -150 Stearates is from plants, these ingredients may be used in in cosmetics and personal care products marketed in the Europe according to the general provisions of the Cosmetics Directive of the European Union. Ingredients of animal origin must comply with European Union animal by-products regulations.
Link EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...