Hand Sanitizer Regulations Eased in Response to Covid19
One of the most notable early responses to COVID-19 was that hand sanitizer completely sold out in countries around the world.1 We look at what constitutes a hand sanitizer and some of the ways regulations have been eased to improve supply lines during the pandemic.
The fears surrounding COVID-19 created a global behavioral shift as people began to clean and sanitize their hands more regularly. Washing with soap remains the most effective way of removing SARS-CoV-2, the virus that spreads COVID-19, from your skin. However, when handwashing isn’t an option, using a hand sanitizer allows the user to inactivate the virus.
WHAT IS A HAND SANITIZER?
The need for effective hand sanitizers has become a serious problem in many countries. In response, the World Health Organization (WHO) has published a guide for manufacturing hand sanitizer using chemicals that are readily available, even in developing countries.
Most hand sanitizers are alcohol-based and to be effective they must be a minimum of 60% alcohol by volume. Most commercial hand sanitizers contain between 60% and 80% alcohol by volume. In addition to alcohol, the WHO suggests either ethanol or isopropanol, formulations should include:
Glycerol – to prevent dry skin
Hydrogen peroxide – to remove bacterial spores
Commercially available hand sanitizers may also include additional antiseptics, such as chlorhexidine or quaternary ammonium derivatives, and non-essential ingredients such as foaming agents, colorants and/or fragrances.
In the Philippines, FDA Memorandum Circular No. 2020-001 has been issued by the Philippine Food and Drug Administration to provide temporary guidelines to all manufacturers of rubbing alcohol and sanitizers in light of the current demand due to COVID-19, some highlights of the technical requirements are as shown below:
Rubbing alcohol shall be notified per formulation regardless of the different types of packaging used
Rubbing alcohol having the same base formulation but different fragrance or colorant shall be notified as variant
In case fermentation is part of the manufacturing process of ethanol, care must be given to reduce natural methanol level as low as reasonably achievable.
Certificate of analysis of the finished product including methanol concentration
Complete labeling materials in Filipino or English language (in .png format). For products, already notified as cosmetic products, it shall follow the labelling guidelines under the ASEAN Cosmetic Directive (ACD) on labelling. For products that contain 80% ethyl alcohol or 75% isopropyl alcohol, please refer to Annex A
Refer to this link for the Cosmetic Labelling Requirement for Rubbing Alcohol and Sanitizer
For products that are previously registered as household remedies under the CDRR (Center for Drug Research & Regulatory), it shall follow the existing labelling guidelines provided under the CDRR on drug products.
To read the complete the Memorandum Circular follow the links:
COVID-19, and the need for large quantities of hand sanitizer, has challenged global supply chains. Authorities have responded by easing restrictions. As the pandemic develops, these regulations will adapt and so manufacturers should stay informed about legislative changes to ensure they remain compliant.
Backed by a global network of experts and laboratories, SGS provides a comprehensive testing and registration service to help hand sanitizer manufacturers ensure their products remain compliant with current market regulations.
Learn more about our Hand Sanitizers and Disinfectants Services.
For more information, please contact:
Maire Kim Diola
Technical Sales Specialist
Cosmetics, Personal Care & Household
t: +63 917 808 4014
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 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.