Quaternium-15

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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.

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, as a component of paper or paperboard in contact with aqueous and fatty foods, and in polyurethane resins used as food contact surfaces.

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.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. At concentrations above 5%, Quaternium-15 was a dermal irritant. Some studies indicate that Quaternium-15 is a dermal sensitizer.

Quaternium-15 releases small amounts of formaldehyde. Persons sensitive to formaldehyde may also be sensitive to Quaternium-15.

The CIR Expert Panel concluded that Quaternium-15 was safe for use in cosmetic products at the current use concentrations which were reported to be less than or equal to 1%.

More information about formaldehyde.

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/CFRS... http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

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 Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

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