What Is It?
In cosmetics and personal care products, Benzalkonium Chloride is used in the formulation of shampoos, personal cleanliness products, skin cleansers, and skin care and eye makeup preparations.
Why is it used in cosmetics and personal care products?
Benzalkonium Chloride is used to prevent or inhibit the growth and reproduction of microorganisms in finished products. It also functions as a foam booster and as a detergent, where it helps water to mix with oil and dirt so that they can be rinsed away.
Benzalkonium Chloride is a commonly used preservative in contact lens solutions and can be found as an ingredient in antimicrobial soaps, skin antiseptics, and spermicides.
The Food and Drug Administration (FDA) permits Benzalkonium Chloride to be used in Over-the-Counter (OTC) first aid antiseptic drug products. The safety of Benzalkonium Chloride has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Benzalkonium Chloride, at concentrations up to 0.1% free, active ingredient, was safe as a cosmetic ingredient.
More safety Information:
CIR Review: Benzalkonium chloride was nonmutagenic in several different cell assays. It was a skin and ocular irritant at concentrations greater than 0.1%. This cosmetic ingredient was not a sensitizer to humans at concentrations of 0.1%, but may be a sensitizer among individuals with diseased skin. It was concluded that Benzalkonium Chloride can be safely used as antimicrobial agent at concentrations up to 0.1%.
FDA: Link to Tentative Final Monograph for Topical Antimicrobial Drug Products http://www.fda.gov/cder/otcmonographs/Antimicrobial/antimicrobial_topica…
Benzalkonium Chloride is listed in the Cosmetics Directive of the European Union in Annex III and in Annex VI. It is authorized for use at maximum concentrations of 3% in rinse-off hair care products and 0.1% in other products, and must be labeled with conditions of use and warnings.
Link to the EU Cosmetic Regulation:
More Scientific Information:
Benzalkonium Chloride is a mixture of alkylbenzyldimethylammonium chlorides and is used as an antimicrobial agent, conditioner, and as a foaming and cleansing agent in cosmetics products.
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration
OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…
Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
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/