What Is It?
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.
Why Is It Used?
The PEG Stearates clean the skin and hair by helping water to mix with oil and dirt so that they can be rinsed away.
Scientific Facts
The PEG Stearates are produced from stearic acid, a naturally occurring fatty acidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides.. The numerical value of each PEG Stearate corresponds to the average number of ethylene oxide monomers in the polyethylene chain. Polyethylene glycol ingredients may also be named with a number that indicates molecular weight, for example polyethylene glycol (400) stearate is another name for PEG-8 Stearate.
Safety Information
The Food and Drug Administration (FDA) reviewed the safety of PEG-8 Stearate and approved its use as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage.. It is approved for use as defoaming agent for the coating of paper and paperboard used to package food. The safety of the PEG Stearates has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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. FDA Code of Federal Regulations for Polyethylene glycol (400) monostearate (PEG-8 Stearate) 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 Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions.. Ingredients of animal origin must comply with European Union animal by-products regulations.
More Scientific Information
PEG Stearates are the polyethylene glycol esters of stearic acid. In cosmetics and personal care products, they are used as surfactants – cleansing agents and emollients.
Resources
Find out more about the regulation of Food Additives by the Food and Drug Administration
