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The South African Bureau of Standards (SABS) recently modified the national standard for alcohol-based hand sanitizers and sanitizers to slow the spread of COVID-19 in the country.
The amended South African National Standard (SANS) 490 was first published in October 2020 and is currently available on the SABS website. It has superseded an older version of the 2013 standard.
“These changes have been driven by global guidelines such as requirements specified by the World Health Organization and locally by the South African Health Products Regulatory Authority (SAHPRA) in the fight against the coronavirus pandemic,” stated SABS.
SABS Senior Administrator Jodi Scholtz said the amended standard provided larger and more detailed requirements for hand sanitizers and sanitizers, which can come in the form of liquids, gels, foams or sprays.
To be effective in neutralizing the COVID-19 virus, disinfectants must now meet the following requirements to be approved by SABS:
- Minimum of 70% alcohol content if the main ingredients are alcohols such as ethanol, isopropanol or n-proponal.
- Minimum of 60% alcohol content if there are other active ingredients, such as benzalkonium chloride.
- Solvents such as acetone / propanone, methanol, methylated alcohols, or other alcohols are not allowed.
According to SANS 490, hand sanitizers cannot use cork closure caps, while their packaging must also include the following minimum information:
- The registration number and full address of the manufacturer / producer.
- Alcohol percentage
- Warning “flammable”
- Warning “do not ingest”
- “Store below a certain temperature” warning
- If the disinfectant is a gel or liquid
- Volume or mass of the liquid or gel
- The ingredients, and specifically the type of alcohol.
- Expiration date and lot number
- Instructions for use
- SABS approved brand, if the manufacturer is a SABS approved manufacturer or brand
Scholtz said manufacturers must now ensure that they provide evidence that their products will retain their physicochemical properties and effectiveness for the expected shelf life of the product until the expiration date indicated on the disinfectant label.
Webber Wentzel Law Firm advised These new standards apply not only to manufacturers, but also to employers who distribute hand sanitizers in the workplace.
“By distributing hand sanitizers that comply with the amended SANS 490, employers will ensure that Health Y safety of its employees and any other person who may enter the workplace is sufficiently protected, ”said the firm.
SABS product labeling guidelines for alcohol-based hand sanitizers are outlined in the image below.
Price and content disputes
The use of hand sanitizers to combat the spread of COVID-19 in South Africa has been accompanied by a fair amount of controversy.
During the first days of the COVID-19 pandemic in South Africa in March 2020, the government implemented an emergency price freeze on several products, including hand sanitizers, to stop price gouging by retailers amid rising demand.
In July 2020, an investigation by SciCorp Laboratories found that nearly half of the popular hand sanitizers used in South Africa did not meet government regulations, which required that they contain at least 70% alcohol.
Eleven hand sanitizers were tested for ethanol, propanol, and isopropanol, and five were found to contain less than 70% alcohol.
In the same month, it was revealed that the Eastern Cape Department of Education had purchased hand sanitizers well below the requirements for use in schools in the province.
One of the department’s personal protective equipment (PPE) suppliers, Mkhiva Trading, had provided disinfectants with an alcohol content as low as 4%.
Government spending on disinfectants was also in the spotlight earlier this year when the Rapport newspaper reported that City Power of Johannesburg had paid R158,700 for 46 small bottles of disinfectant, which resulted in R3,450 each.
The exact same product was available at Clicks for R29.99, which meant that the company had paid 11,400% more than the current price.
SABS approved
While the SABS standards are voluntary at this stage, they provide a clear indication to consumers that a disinfectant meets the minimum requirements to be effective against COVID-19.
SABS said the duration of the tests against SANS 490, if conducted on its own, was approximately 20 days.
However, for certification, which allows the use of the ‘SABS Approved’ branding scheme on the product bottle, the duration is about three months as audits of the product and production processes must be performed, SABS said.
The Office previously warned that many hand sanitizer manufacturers falsely claim to be SABS compliant by placing the SABS logo on their products.
Below is the full list of SABS brand approved manufacturers and brands, which can also be found on their website.
Now read: At the current rate, it will take 18 years to vaccinate 67% of South Africans.
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