U.S. FDA Publishes Final Rule on Hand Sanitizer Active Ingredients

12/04/19

Event Title

08h00 - 16h30

Event Location

Print Bulletin PDF

On April 12, 2019, the U.S. Food and Drug Administration (FDA) published the Final Rule for the Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. The final rule outlines active ingredients that are not Generally Recognized as Safe and Effective (GRASE) and therefore, not permitted in consumer over-the-counter (OTC) hand sanitizers. 


The final rule also outlines the active ingredients that currently require additional information to determine the safety and efficacy. The FDA has deferred rulemaking on Benzalkonium chloride, Ethyl alcohol (aka ethanol, alcohol), and Isopropyl alcohol for additional time to collect safety and efficacy data.


Effective April 13, 2020, manufacturers will need a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) to sell or distribute OTC hand sanitizers for consumer use containing one or more of the following 28 active ingredients:


• Benzethonium chloride

• Chloroxylenol

• Chlorhexidine gluconate

• Cloflucarban

• Fluorosalan

• Hexachlorophene

• Hexylresorcinol

• Iodine complex (ammonium ether sulfate and 

polyoxyethylene sorbitan monolaurate)

• Iodine complex (phosphate ester of alkylaryloxy 

polyethylene glycol)

• Methylbenzethonium chloride

• Nonylphenoxypoly (ethyleneoxy) ethanoliodine

• Phenol (equal to or less than 1.5% or greater 

than 1.5%)

• Poloxamer iodine complex

• Povidone-iodine 5-10%

• Secondary amyltricresols

• Sodium oxychlorosene

• Tribromsalan

• Triclocarban

• Triclosan

• Triple dye

• Undecoylium chloride iodine complex

• Polyhexamethylene biguanide

• Benzalkonium cetyl phosphate

• Cetylpyridinium chloride

• Salicylic acid

• Sodium hypochlorite

• Tea tree oil

• Combination of potassium vegetable oil solution, phosphate sequestering agent, and triethanolamine 


Click to view the Federal Register posting of the final rule:  

https://www.federalregister.gov/d/2019-06791


How Does this Impact You? Contact Us to Discuss

Our knowledgeable professionals can design a program to meet your specific needs - whether it be to demonstrate quality and safety control, identify which product offers the best value, which product your customers prefer, or if the product meets your quality requirements. 


For over 35 years, Bureau Veritas has worked successfully with top retailers and manufacturers around the world to help them better manage risk and regulatory compliance. If you have any questions, please contact your customer service representative or email: cps.info@us.bureauveritas.com


Contact Us

 

Consumer Products Services
Send an e-mail

REQUEST FOR A QUOTE

Need help or have a question?
Share on :
  • Algeria
  • Angola
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Azerbaijan
  • Bahamas
  • Bahrain
  • Bangladesh
  • Barbados
  • Belarus
  • Belgium
  • Benin
  • Bermuda
  • Bolivia
  • Bosnia and Herzegovina
  • Botswana
  • Brazil
  • Brunei
  • Bulgaria
  • Burkina-Faso
  • Burundi
  • Cambodia
  • Cameroon
  • Canada
  • Cape Verde Islands
  • Central African Republic
  • Chad
  • Chile
  • China (Peoples' Republic of)
  • Colombia
  • Congo
  • Congo (Democratic Republic of the)
  • Costa Rica
  • Cote d'Ivoire
  • Croatia
  • Cuba
  • Curacao
  • Czech Republic
  • Denmark
  • Djibouti
  • Dominican Republic
  • Ecuador
  • Egypt
  • El Salvador
  • Equatorial Guinea
  • Eritrea
  • Estonia
  • Ethiopia
  • Fidji
  • Finland
  • France
  • French West Indies
  • Gabon
  • Georgia
  • Germany
  • Ghana
  • Gibraltar
  • Greece
  • Greenland
  • Guatemala
  • Guinea
  • Guinea Bissau
  • Honduras
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Iraq
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Kenya
  • Korea (South)
  • Kuwait
  • Latvia
  • Lebanon
  • Liberia
  • Libya
  • Lithuania
  • Luxembourg
  • Madagascar
  • Malawi
  • Malaysia
  • Mali
  • Malta
  • Mauritania
  • Mexico
  • Montenegro
  • Morocco
  • Mozambique
  • Myanmar
  • Namibia
  • Netherlands
  • Netherlands Antilles
  • New Zealand
  • Nicaragua
  • Niger
  • Nigeria
  • Norway
  • Oman
  • Pakistan
  • Panama
  • Paraguay
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Qatar
  • Romania
  • Russia
  • Rwanda
  • Saint- Pierre & Miquelon
  • Saudi Arabia
  • Senegal
  • Serbia
  • Seychelles
  • Sierra Leone
  • Singapore
  • Slovakia
  • Slovenia
  • Somalia
  • South Africa (Rep.)
  • Spain
  • Sri Lanka
  • Suriname
  • Sweden
  • Switzerland
  • Syria
  • Taiwan
  • Tanzania (United Republic of)
  • Thailand
  • Togo
  • Trinidad & Tobago
  • Tunisia
  • Turkey
  • Turkmenistan
  • Uganda
  • Ukraine
  • United Arab Emirates
  • United Kingdom
  • United States of America
  • Uruguay
  • Uzbekistan
  • Venezuela
  • Vietnam
  • Yemen
  • Zambia
  • Zimbabwe
  • Other Websites
  • Africa
  • GLOBAL WEBSITE
  • Middle East
  • South East Asia
Choose your industry, asset and / or service need
Your Industry

Your Asset

Our Services