The South African Bureau of Standards (SABS) has amended SANS 490, the national standard that defines alcohol-based hand rubs and sanitisers, to specify the minimum alcohol content of liquids, gels, foams and aerosols.
The SABS said in a statement the changes were driven by global guidelines, such as the requirements specified by the World Health Organisation and the South African Health Products Regulatory Authority (SAHPRA) to fight the coronavirus pandemic.
“The amended standard provides more detailed requirements for hand sanitisers and hand rubs and specifies that a minimum of 70% alcohol content is required if alcohol, such as ethanol, isopropanol or n-propanol is the main ingredient and 60% if it contains other active ingredients,” said Jodi Scholtz, lead administrator at the SABS.
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Manufacturers are not allowed to use solvents such as acetone (propanone), methanol, methylated spirits or other spirits because they can cause toxicity and even fatalities if absorbed through the skin.
Duty of manufacturers
According to Scholtz, manufacturers must ensure they submit evidence their products will retain their physicochemical properties and efficacy for the duration of the expected shelf life of the product as stated on the product label.
Packaging must also clearly indicate the details of the manufacturer, ingredients, volume and type of alcohol used and expiry date.
Drafting the amendment
“The SABS and its technical committee worked with regulatory authorities since the start of the pandemic to review and publish South African National Standards to protect the health and safety of South African citizens.
“Although SANS 490 was amended and published in October 2020, we implemented the testing protocols of sanitisers to verify the alcohol content before publishing the standard. The amended standard includes the requirements for alcohol-based hand rubs and sanitisers SAHPRA published in July 2020,” Scholtz said.
International best practice principles underpin the process of developing, reviewing or amending national standards and are underpinned by international best practice principles and consensus development in the SABS technical committees.
The SABS technical committee 1022 for antiseptics, disinfectants and detergent-disinfectants was responsible for drafting the amendments.
It takes the SABS about 20 days to test products against SANS 490 and about three months for certification, or the SABS Approved Mark Scheme, as audits of the product and the production processes have to be conducted. These audits include providing the required documentation of the production processes and shelf testing by the manufacturer.
The amended SANS 490 was published in October 2020 and is available on the SABS website. The amended SANS supersedes the 2013 version and is effective from the date of publication.