Propylene Carbonate
What Is It?
Propylene Carbonate is a clear, odorless solventSubstances, usually liquids, that are used to dissolve other substances. with a high boiling point. In cosmetics and personal care products, Propylene Carbonate is used in the formulation of makeup, primarily lipstick, eye shadow, and mascara, as well as in skin cleansing products.
Why Is It Used?
Propylene Carbonate is used to dissolve other substances and is frequently used with clay gellants (such as montmorillonite or bentonite).
Scientific Facts
Propylene Carbonate, also known as cyclic propylene carbonate, is an organic chemical. It is an esterAn organic compound formed by the reaction of an acid with an alcohol. of propylene glycol and carbonic acid. Propylene Carbonate is flammable and chemically stable.
Safety Information
The Food and Drug Administration (FDA) has reviewed the safety of Propylene Carbonate 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. as a component of adhesives. The safety of Propylene Carbonate 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. Expert (CIR) Panel. The CIR Expert Panel evaluated the scientific data and concluded that Propylene Carbonate was safe as a cosmetic ingredient in the present practices of use and concentration. In 2004, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Propylene Carbonate and reaffirmed the above conclusion.
CIR Safety Review: The CIR Expert Panel noted that Propylene Carbonate is generally used in cosmetics and pesonal care products at concentrations ranging from less than 0.1% to 5%. Undiluted Propylene Carbonate was moderately irritating to the eye and skin. Undiluted Propylene Carbonate was nontoxic by inhalation exposure. Propylene Carbonate was negative for mutagenicity in bacteria and negative for genotoxicity in the rat liver cells. Products containing up to 20% Propylene Carbonate were determined to be nonsensitizing, and, at most, moderately irritating to human skin, nonphototoxic and nonphotosensitizing.
FDA: Link to Code of Federal Regulations for Propylene Carbonate http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Propylene Carbonate 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..
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
Propylene Carbonate functions as a solvent in cosmetics and personal care products. Solvents are liquids employed to dissolve components found useful in cosmetics or drugs. Water is the most common solvent found in cosmetics. Nonaqueous solvents are required in a variety of cosmetics, such as colognes, hair sprays, and nail lacquers. Specific solvent capabilities of certain cosmetic ingredients can be used, e.g., to remove sebum from the skin, to loosen make-up, to extractThe mixture of substances drawn out of a material by solution, heat, or another physical or chemical process. essential oils, or to dissolve dyes.
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/