Benzalkonium Chloride
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?
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.
Scientific Facts
Benzalkonium Chloride is a commonly used preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage. in contact lens solutions and can be found as an ingredient in antimicrobial soaps, skin antiseptics, and spermicides.
Safety Information
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 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. (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.
CIR Review: Benzalkonium chloride was nonmutagenic in several different cellThe basic structural and functional unit of all organisms; cells may exist as independent units of life or may form colonies or tissues as in higher plants and animals. 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 agentIngredients that kill microorganisms, or prevent or inhibit their growth and reproduction. In the United States, antimicrobial agents are regulated as Over-The-Counter (OTC) drug ingredients. 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:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
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.
Resources
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/