National standards body the South African Bureau of Standards (SABS) has published the amendments to the national standard SANS 490, which specifies the requirements for all alcohol-based liquid, gel, foam and aerosol hand sanitisers, driven by global guidelines such as the requirements specified by the World Health Organisation and locally by the South African Health Products Regulatory Authority (SAHPRA).
“The amended SANS 490 provides greater and more detailed requirements for hand sanitisers and hand rubs. It is now specified that a minimum of 70% alcohol content is required if alcohol, such as ethanol, isopropanol or n-propanol is the main ingredient, and that 60% alcohol content is required if there are other active ingredients, says SABS lead administrator Jodi Scholtz.
Solvents such as acetone (propanone), methanol, methylated spirits or other spirits are not allowed to be used as they can cause toxicity and even fatalities, if absorbed through one’s skin, she points out.
The amended SANS supersedes the 2013 version and is effective from the date of publication.
Manufacturers must ensure that they submit evidence that their products will retain their physicochemical properties and efficacy for the duration of the expected shelf life of the product.
Packaging must clearly indicate the details of the manufacturer, the ingredients of the product, the volume and type of alcohol and the expiry date of the product.
The process of developing, reviewing or amending national standards is underpinned by international best practice principles and consensus development within the SABS technical committees represented by a diverse portfolio of stakeholders.
“Since the outbreak of the coronavirus, the SABS and its technical committees, together with regulatory authorities, have been working vigorously to review and publish South African National Standards that are able to respond efficiently to protect the health and safety of South African citizens.
"Even though SANS 490 was amended and published in October 2020, the testing protocols of sanitisers to verify the alcohol content was implemented prior to the publication of the standard. SAHPRA published the requirements for alcohol-based hand rubs and sanitisers in July 2020 and the amended standard includes those product requirements,” says Scholtz.