What Is It?
Quaternium-18 is a mixture of quaternary ammonium chloride salts made from fatty acids of tallow. Quaternium-18 Hectorite and Quaternium-18 Bentonite are organic modified clay compounds that are the reaction products of clays, bentonite or hectorite and Quaternium-18. In cosmetics and personal care products, they are used in the formulation of lipstick, face makeup, eye shadows, rouge, mascara, skin gels, skin creams, skin lotions, hair care products, and other personal cleanliness products.
Why Is It Used?
Quaternium-18 functions as an Ingredients that prevent or inhibit the buildup of static electricity.. Quaternium-18 Bentonite and Quaternium-18 Hectorite help to distribute or suspend an insoluble solid in a liquid. When used in the formulation of lotions and creams, these ingredients help to keep the product from separating into its oil and liquid components.
Quaternium-18 is a quaternary ammonium salt that is formed from hydrogenated fatty acids of tallow. Quaternium-18 Bentonite and Quaternium-18 Hectorite have a gel-like consistency that becomes more fluid when the gel is disturbed.
The Food and Drug Administration (FDA) includes bentonite on its list of direct food substances affirmed as Generally Recogonized as Safe (“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.). The safety of Quaternium-18, Quaternium-18 Bentonite and Quaternium-18 Hectorite has been assessed by the The 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 Quaternium-18 Bentonite, Quaternium-18, and Quaternium-18 Hectorite were safe as cosmetic ingredients in the present practices of use and concentration. In 2001, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Quaternium-18, Quaternium-18 Bentonite and Quaternium-18 Hectorite and reaffirmed the above conclusion.
CIR Safety Review: The CIR Expert Panel noted that Quaternium-18 Bentonite and Hectorite are chemically, physically, and biologically inert. Quaternium-18 compounds are poorly absorbed through the skin. Acute oral and percutaneous toxicity tests showed little or no systemic effects. No evidence of systemic toxicity was observed in subchronic oral and dermal tests with Quaternium-18 and Quaternium-18 Bentonite.
In humans, Quaternium-18 was practically nonirritating and nonsensitizing to skin. Quaternium-18 Hectorite was classified as nonirritating and nonsensitizing, and it was not phototoxic or photoallergenic. Quaternium-18 Bentonite as not an skin irritant, or sensitizer, and exhibited no eye irritation in humans.
FDA: Link to Code of Federal Regulations for bentonite
As long as components used to make Quaternium-18, Quaternium-18 Bentonite and Quaternium-18 Hectorite, comply with European Union regulations regarding animal by-products, these ingredients may be used in cosmetics and personal care products marketed in Europe according to the Under 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:
More Scientific Information
Quaternium-18 Bentonite and Quaternium-18 Hectorite are reaction products of Quaternium-18, a mixture of quaternary ammonium chloride salts, and Bentonite or Hectorite, respectively. Bentonite is an aluminum silicate clay and hectorite is magnesium silicate clay. Quaternium-18 functions as an antistatic agent. Quaternium-18 Bentonite and Quaternium-18 Hectorite function as suspending agents.
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): 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/