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On December 26, 2024, the Thai Food and Drug Administration (Thai FDA) released the Guidelines for Consideration of Notification of Alcohol Products for Hand Hygiene (Revised Edition, November 2024). This update builds upon the "Criteria and Requirements for the Notification of Cosmetics Containing Alcohol for Hand Hygiene" in the Cosmetic Notification Review Standards (2021 Edition), and incorporates the latest regulatory revisions for alcohol-based hand hygiene products. The revised Guidelines provides manufacturers and importers with clearer instructions on product formulation, naming, labeling, and notification dossiers.
Key Highlights of the Revised Guidelines
1. Minimum Alcohol Concentration
Alcohol-based hand hygiene products must contain at least 70% alcohol by volume (v/v) or 65% by weight (w/w) in all product specifications. These products must serve exclusively for hand hygiene purposes and fall within the scope of cosmetics. They cannot be marketed as capable of killing pathogens or cleaning surfaces, walls, or equipment, as such uses would categorize them as hazardous substances for household or public health use rather than cosmetics.
2. Product Composition
The formulation of alcohol-based hand hygiene products must comply with the Ministry of Public Health's announcement on determining the main ingredients and characteristics of cosmetics containing alcohol for hand hygiene that are prohibited from production, import, or sale.
3. Product Naming Requirements
Product names must not imply germ-killing properties, reference diseases, or use terms like "ANTI-VIRUS" or "ANTI-BACTERIA/ANTI-BACTERIAL."
Product names must not indicate the type or concentration of alcohol in the product, though such details are required on the label.
4. Labeling Requirements
Usage instructions must specify: "Use to clean hands by rubbing thoroughly for at least 20 seconds, then allow to dry."
Alcohol concentration must be displayed as a percentage by volume (v/v) or in similar terms, or it must state “alcohol content not less than 70% by volume” or equivalent phrases.
Claims like "reducing the accumulation of germs/bacteria," "reducing the amount of germs," or "ANTI-BACTERIA/ANTI-BACTERIAL" require validated efficacy test results from government agencies or ISO 17025-accredited laboratories. These documents need not be submitted during the notification process but must be retained in the Product Information File (PIF) for inspection upon request.
Disease names, specific pathogens, or terms implying safety from germs (e.g., COVID-19, Escherichia coli, Pseudomonas aeruginosa, "kill," or "safe") must not appear on the label.
Symbols, signs, or images suggesting treatment, relief, cure, or prevention of germs, such as a plus sign (+), shield/sword symbols, or images of germs, must not be displayed. For trademarks, appropriate consideration must be given, and the ® or ™ symbol must be clearly visible.
5. Documentation for Notification
Applicants must submit a letter confirming compliance with the guidelines and labeling requirements for cosmetics containing alcohol for hand hygiene. The letter must be signed by the authorized company representative.
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