US FDA Prohibits 19 Antibacterial Soap Ingredients

Top Quote Following a consultation period, the US FDA has issued a final rule prohibiting the use of 19 active ingredients in antibacterial soaps. The ruling becomes effective on September 6, 2017. End Quote
  • (1888PressRelease) January 24, 2017 - The US Food and Drug Administration (FDA) has issued a final rule regarding 19 ingredients in over-the-counter (OTC) consumer antiseptic products intended for use with water. The FDA has now determined that these 19 ingredients are not generally recognized as safe and effective (GRAS/GRAE) and so, without an approved new drug application, products containing these ingredients are now considered misbranded - effective September 6, 2017.

    The US FDA issued its final rule on the Safety and Effectiveness of Antibacterial Soaps on September 2, 2016, following a request for manufacturers to submit additional information on the safety and effectiveness of antibacterial soaps, issued on December 16, 2013. The final rule was issued when no additional data was received, or the data submitted was not sufficient to support the monograph conditions for the 19 ingredients.

    This ruling prohibits the use of the following ingredients:
    Cloflucarban
    Fluorosalan
    Hexachlorophene
    Hexylresorcinol
    Iodophors (Iodine-containing ingredients)
    Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
    - Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
    - Nonylphenoxypoly (ethyleneoxy) ethanoliodine
    - Poloxamer-iodine complex
    - Povidone-iodine 5 to 10 percent
    - Undecoylium chloride iodine complex
    Methylbenzethonium chloride
    Phenol (greater than 1.5 percent)
    Phenol (less than 1.5 percent)
    Secondary amyltricresols
    Sodium oxychlorosene
    Tribromsalan
    Triclocarban
    Triclosan
    Triple dye

    The US FDA has deferred rulemaking on a further three substances, used in OTC consumer antiseptic wash products, to allow more time for the submission of new safety and effectiveness data. These active ingredients are: Benzalkonium chloride, Benzethonium chloride and Chloroxylenol. Products containing these ingredients can continue to be marketed while the data is collected.

    SGS Cosmetic Regulation Services
    It is crucial that all cosmetic, personal care and household products are safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories provide custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

    Learn more about SGS's Cosmetic Regulation Services (www.sgs.com/en/consumer-goods-retail/cosmetics-personal-care-and-household/cosmetics-and-personal-care/regulations)

    SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full Final Rule on Safety and Effectiveness of Antibacterial Soaps Issued by the US FDA SafeGuardS. (www.sgs.com/en/news/2016/09/safeguards-15516-final-rule-on-safety-and-effectiveness-of-antibacterial-soaps]

    Subscribe here, www.sgs.com/subscribesg, to receive SGS SafeGuardS direct to your inbox.

    For further information contact:
    Queenie Tse
    Technical Service Executive
    Cosmetics, Personal Care and Household (CPCH)
    Tel: +852 2765 3672 (ext 1672)
    Email: cts.media ( @ ) sgs dot com
    Website: www.sgs.com/cpch

    About SGS
    SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.

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