Benzethonium Chloride
What Is It?
Benzethonium Chloride and Methylbenzethonium Chloride are colorless or white ingredients that have been used in cosmetics and personal care products in the formulation of bath, skin, personal cleanliness, shaving, and suntan products, as well as eye makeup and fragrances.
Why Is It Used?
Benzethonium Chloride and Methylbenzethonium Chloride are man-made ingredients used in cosmetics and personal care products, primarily as topical antimicrobial agents and preservatives, and secondarily as cationic surfactants. Methylbenzethonium Chloride may also be used as an antistatic agentIngredients that prevent or inhibit the buildup of static electricity..
When used as preservatives, Benzethonium Chloride and Methylbenzethonium Chloride kill microorganisms or prevent or inhibit their growth and are regulated by the U.S. FDA as Over-the-Counter (OTC) drug products.
Get more information about how preservatives protect cosmetics and personal care products.
Scientific Facts
As antimicrobial agents, Benzethonium Chloride and Methylbenzethonium Chloride adsorb onto the negatively charged 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. wall of microorganisms, interrupt normal cell metabolism, and lead to cell death or growth inhibition. These antimicrobial properties and demonstrated safety have led to their widespread use in restaurants, hospitals, and swimming pools, as well as for veterinary and agricultural applications.
Safety Information
On September 6, 2016, the FDA issued a final rule on the ‘Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,’ concluding that consumer antiseptic products intended for use with water (including antibacterial soaps, hand washes, and body washes) that contain any of 19 specific active ingredients can no longer be marketed. The FDA concluded that manufacturers had not adequately demonstrated products containing these ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Prior to the FDA ruling, some manufacturers had already started removing these ingredients from their products.
FDA deferred rulemaking on three specific additional ingredients used in OTC consumer antiseptic wash products, including benzethonium chloride. This deferral was made to allow manufacturers to develop and submit new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients (including benzethonium chloride) may continue to be marketed during this time while data are being collected.
In addition to the U.S. FDA, the safety of Benzethonium Chloride and Methylbenzethonium Chloride have also been evaluated by a number of other authoritative scientific and regulatory bodies.
The safety of Benzethonium Chloride and Methylbenzethonium 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. In 1985, the CIR Expert Panel evaluated the scientific data and concluded that Benzethonium Chloride and Methylbenzethonium Chloride were safe at concentrations of 0.5% in cosmetics and personal care products applied to the skin. A maximum concentration of 0.02% is safe for cosmetics and personal care products used in the eye area.
In 2004, as part of CIR’s regular procedures, the CIR Expert Panel considered available new data on Benzethonium Chloride and Methylbenzethonium Chloride and reaffirmed the above conclusion.
Health Canada permits the use of Benzethonium Chloride in leave-on products and rinse-off products at concentrations equal to or less than 0.2% and 0.3%, respectively. The use of Benzethonium Chloride in products to be applied to mucous membranes is not permitted.
Benzethonium Chloride is listed in the Cosmetics Directive the European Union and may be used as a cosmetic ingredient and also as a preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage. (see Annex V) at a maximum concentration of 0.1% in rinse-off and leave-on products, except for oral care products. Methylbenzethonium Chloride may be used as a cosmetic ingredient in Europe. However, since it is not listed in Annex V, it may not be used as a preservative in cosmetic products.