Propylene Glycol Stearate
What Is It?
Propylene Glycol Stearate is a mixture of esters of propylene gylcol and stearic acid. Propylene Glycol Stearate SE is a self-emulsifying grade of Propylene Glycol Stearate that contains some sodium and/or potassium stearate. In cosmetics and personal care products, Propylene Glycol Stearate is used in a wide variety of cosmetics and personal care products with the most prevalent uses in face and eye makeup.
Why Is It Used?
Propylene Glycol Stearate and Propylene Glycol Stearate SE function as surfactants. Propylene Glycol Stearate also functions as a skin conditioning agent – emollient.
Scientific Facts
Propylene Glycol Stearate is a white to cream-colored waxy solid with a slight fatty odor and taste. It is 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., and is marketed in the form of beads or flakes.
Safety Information
The Food and Drug Administration (FDA) includes propylene glycol mono and diesters of fats and fatty acids on its list of substances permitted to be directly added to food. The safety of Propylene Glycol Stearate, and Propylene Glycol Stearate SE, 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 Propylene Glycol Stearate and Propylene Glycol Stearate SE were safe as cosmetic ingredients in the present practices of use. In 2002, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Propylene Glycol Stearate and Propylene Glycol Stearate SE and reaffirmed the above conclusion.
CIR Review: Propylene Glycol Stearate produced no significant dermal toxicity, skin irritation, or eye irritation in acute tests. Subchronic studies produced no toxicity after oral or dermal exposure. Propylene glycol monostearate was negative in in vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal. microbial assays for mutagenicity. In clinical studies, Propylene Glycol Stearate produced no significant skin irritation at concentrations or skin sensitization. Photo-contact allergenicity tests on product formulations were negative.
FDA: Link to Code of Federal Regulations for Propylene glycol mono-and diesters of fats and fatty acids (includes Propylene Glycol Stearate) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
When made from plants, Propylene Glycol Stearate and Propylene Glycol Sterate SE may be used in cosmetics and personal care products marketed in 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 the European Union animal by-products regulations.
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake (ADI) for propylene glycol esters of fatty acids of 0-20 mg/kg body weight. The ADI may be up to 20-60 mg/kg body weight if expert suppervision is available.
http://www.inchem.org/documents/jecfa/jecmono/40abcj27.htm
More Scientific Information
Propylene Glycol Stearate and Propylene Glycol Stearate SE are mixtures of the mono- and diesters of triple-pressed stearic acid and propylene glycol. They are used as surfactants. Propylene Glycol Stearate is also used as used as a skin conditioning agent – emollient.
Resources
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/