US FDA Prohibits 19 Antibacterial Soap Ingredients
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.
- (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.
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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]
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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
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