- Alcohol-based hand sanitisers which require approval by the South African Bureau of Standards will need to meet a host of new requirements.
- These new standards apply to liquids, gels, foams, and aerosols.
- The minimum allowable concentration of alcohol has been sat at 70%, if ethanol, isopropanol, or n-propanol are the main ingredients.
- Solvents, like acetone, are prohibited ingredients, for fear of toxicity levels which could enter the human body through application on the skin.
New standards have been set for alcohol-based hand sanitisers in South Africa, with amendments to the minimum concentration of active ingredients and a list of banned solvents. The new regulations have been issued by the South African Bureau of Standards (SABS) in response to the Covid-19 pandemic.
The global use of alcohol-based hand sanitisers has surged in the past year. Medical researchers list the regular washing of hands as one of the most effective non-pharmaceutical interventions in preventing the spread of Covid-19.
National regulations require restaurants, shopping centres and banks to provide hand sanitisation stations for use by clientele.
But the sudden surge demand for effective alcohol-based hand sanitisers has led to some manufacturers falling short of the national standard, making false claims about the concentration of ingredients, and adding counterfeit SABS certification logos to the unverified products.
Due to a rise in consumer complaints and concerns, the bureau has amended the South African National Standard (SANS) 490 approval criteria which is specific to alcohol-based sanitisers for the purposes of disinfecting. This was done in consultation with the South African Health Products Regulatory Authority (SAHPRA) with international guidelines set by the World Health Organisation (WHO).
“The amended SANS 490 provides greater and more detailed requirements for hand sanitisers and hand rubs,” says lead administrator of SABS, Jodi Scholtz. The new standards require that all SABS-approved alcohol-based hand sanitisers and hand rubs in the form of liquids, gels, foams, and aerosols must contain:
- A minimum of 70% alcohol content (if alcohol like ethanol, isopropanol or n-propanol is the main ingredient)
- 60% alcohol content if there are other active ingredients
The new standards also prohibit certain ingredients in alcohol-based hand sanitisers, citing serious concerns over toxicity levels and the solvents’ danger to human health if absorbed through the skin. These banned solvents include:
- acetone (propanone)
- methylated spirits
Additionally, manufacturers will need to submit evidence which proves that their alcohol-based sanitisers are efficacious until the date of expiry. Products submitted to SABS for testing in accordance with the newly amended SANS 490 will be studied for approximately 20 days.
Official certification of the alcohol-based sanitiser – which will bear the ‘SABS Approved’ Mark Scheme, classifying the product as safe to use and effective in line with what is noted on the product’s label – can take approximately three months.
The product’s packaging will need to meet the following requirements and contain the following information on the label:
- Expiry date
- Mandatory warnings (flammable, do not ingest, store below certain temperature)
- Type of sanitiser (liquid or gel)
- Mass or volume (generally ml)
- Percentage of alcohol
- A statement that it is a “disinfectant alcohol rub”
- Registration number and address of the manufacturer
- Ingredients and type of alcohol
- Batch number and manufacture date
- Instructions for use
“Since the outbreak of the coronavirus, the SABS and its technical committee, 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,” adds Scholtz.