Quaternium-15

What Is It?

Quaternium-15 is a cream-colored powder with a pungent odor. In cosmetics and personal care products, Quaternium-15 is used in the formulation of a variety of products, including skin care lotions, eye makeup, facial makeup, shampoos and baby products.

Why is it used in cosmetics and personal care products?

Quaternium-15 is used to kill microorganisms, or to prevent or inhibit their growth and reproduction. Quaternium-15 is also used as an antistatic agent.

Follow this link for more information about how preservatives protect cosmetics and personal care products.

Scientific Facts:

Quaternium-15 is effective against yeast, molds and bacteria. The use of preservatives in cosmetics and personal care products is required to prevent product damage caused by microorganisms and to protect the product from inadvertent contamination by the consumer during use.

Safety Information:

The Food and Drug Administration (FDA) includes Quaternium-15, also called 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride, on its list of indirect food additives. It may be used in adhesives in contact with food, and as a component of paper or paperboard in contact with aqueous and fatty foods. The safety of Quaternium-15 has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Quaternium-15 was safe for use in cosmetics and personal care products at concentrations up to 0.2%.

More safety Information:

CIR Safety Review:

The CIR Expert Panel evaluated data on the absorption of Quaternium-15 through the skin. Quaternium-15, a charged highly water-soluble compound, was not absorbed through the skin in significant amounts. In a laboratry study, Quaternium-15 did not cause developmental effects when applied dermally. Quaternium-15 was not genotoxic. At concentrations above 5%, Quaternium-15 was a dermal irritant. A number of studies completed in North America have indicated an increase in the frequency of sensitization among patients tested for sensitization to Quaternium-15. Because of concern about the sensitization potential of Quaternium-15 the CIR Expert Panel set a limit on its use in cosmetics and personal care products. The CIR Expert Panel concluded that Quaternium-15 was safe for use in cosmetic and personal care products at concentrations not to exceed 0.2%.

FDA:

Link to Code of Federal Regulations for Quaternium-15 (1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Quaternium-15 is listed as methanamine 3-chloroallylochloride in Annex VI (preservatives which cosmetic products may contain) of the Cosmetics Directive of the European Union and is authorized for use at maximum concentrations of 0.2% in cosmetics and personal care products. If the concentration of released formaldehyde exceeds 0.05% in the finished product, the product must be labeled “contains formaldehyde.”

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

More information about formaldehyde.

More Scientific Information:

Quaternium-15 is a quaternary ammonium salt that functions as an preservative and as an antistatic agent in cosmetics and personal care products.

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/default.htm

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/