New rules for COVID-19 hand sanitisers in South Africa – What you should know

The South African Bureau of Standards (SABS) recently amended the national standard for alcohol-based hand rubs and sanitisers for use in curbing 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 It has superseded a previous version of the standard from 2013.

“These changes have been 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) in the fight against the coronavirus pandemic,” SABS stated.

SABS Lead Administrator Jodi Scholtz said that the amended standard provided greater and more detailed requirements for hand sanitisers and hand rubs, which may come in the form of liquids, gels, foams, or aerosols.

In order to be effective in neutralising the COVID-19 virus, the sanitisers now have to meet the following requirements to be SABS-approved:

• Minimum of 70% alcohol content if alcohols like ethanol, isopropanol or n-proponal are the main ingredients.
• Minimum of 60% alcohol content if there are other active ingredients, like benzalkonium chloride.
• No solvents such as acetone/propanone, methanol, methylated spirits, or other spirits are allowed.

According to SANS 490, hand sanitisers may not use cork closure lids, while their packaging  should also include the following minimum information:

• The registration number and full address of the manufacturer/producer.
• Alcohol percentage
• “Flammable” warning
• “Do not ingest” warning
• “Store below certain temperature” warning
• Whether the sanitiser is a gel or liquid
• Volume or mass of the liquid or gel
• The ingredients, and specifically the type of alcohol
• Expiry date and batch number
• Instructions for use
• SABS-approved mark, if the manufacturer is a SABS-approved manufacturer or brand

Scholtz said that manufacturers must now ensure they submit evidence that their products will retain their physiochemical properties and efficacy for the duration of the expected shelf life of the product until the indicated expiry date on the sanitiser’s label.

Law firm Webber Wentzel advised that these new standards don’t only apply to only manufacturers, but also employers who distribute hand sanitisers in the workplace.

“By distributing hand sanitisers that comply with the amended SANS 490, employers will ensure that the health and safety of their employees and anyone else who may enter the workplace is sufficiently safeguarded,” the firm stated.

SABS’s product labelling guidelines for alcohol-based hand sanitisers are outlined in the image below.

Price and content controversies

The use of hand sanitisers in combatting the spread of COVID-19 in South Africa has come with its fair share of controversies.

During the early days of the COVID-19 pandemic in South Africa in March 2020, the government implemented an emergency price freeze on several products – including hand sanitisers – in order to stop price-gouging by retailers amid soaring demand.

In July 2020 an investigation by SciCorp Laboratories found that almost half of popular hand sanitisers used in South Africa did not comply with government regulations, which required that they should contain at least 70% alcohol.

11 hand sanitisers 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 acquired hand sanitisers far below the requirements for use by schools in the province.

One of the department’s personal protective equipment (PPE) suppliers, Mkhiva Trading, had provided sanitisers with alcohol content as low as 4%.

Government spending on sanitisers also came under the spotlight earlier this year when Rapport newspaper reported that Johannesburg’s City Power had paid R158,700 for 46 small bottles of sanitisers, which worked out to R3,450 each.

The exact same product was available at Clicks for R29.99, which meant that the utility had paid 11,400% more than the going price.

Approved by SABS

While the SABS standards are voluntary at this stage, they offer a clear indication to consumers that a sanitiser meets the minimum requirements to be effective against COVID-19.

SABS said that the duration of testing against SANS 490, if conducted by itself, was approximately 20 days.

For certification, however, which allows for the use of the ‘SABS Approved’ Mark Scheme on the product’s bottle, the duration is approximately three months as audits of the product and the production processes need to be conducted, SABS said.

The Bureau previously warned that many hand sanitiser manufacturers falsely claim to be SABS compliant by putting the SABS logo on their products.

Below is the full list of SABS Mark Approved manufacturers and brands, which can also be found on its website.

Now read: At the current rate, it will take 18 years to vaccinate 67% of South Africans