29 Apr 2020 Alcohol-based hand sanitizers: are South African regulations sufficient?

Hand sanitizers are a key product and topic of interest during the COVID-19 outbreak, and subsequent lockdown, in South Africa and all over the world. This article by Hahn & Hahn Attorneys uncovers efficacy and legal technicalities around local hand-sanitizing products.

Many have flocked to the shelves of pharmacies and supermarkets to purchase these products, and the debate on whether certain brands and types of sanitizers are adequate in terms of their protection is still active and ongoing.

There are two main types of sanitizers, namely: alcohol-based and alcohol-free. With alcohol-based hand sanitizers being the purchase of preference, the purpose of this article is to:

• Investigate the South African legislative and regulatory framework, the requirements that suppliers and retailers must take cognisance of in order to sell these products; and
• Some of the regulatory shortcomings SA faces in light of the foreign and international acknowledgement of the importance of hygiene in these times.

In South Africa sanitisers and disinfectants are regulated by five different Acts as well as the Regulations and/or Standards that fall under them:

• The Medicines and Related Substances Act 101of 1965 as amended (MRS Act);
• The Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 as amended (FCD Act);
• The Standards Act, Act 8 of 2008 (Standards Act);
• The National Regulator for Compulsory Specifications Act 5 of 2008 (NRCS Act); and
• The Legal Metrology Act 9 of 2014.

Labelling of sanitizers and disinfectants is, however, not as easy as it seems. What must be taken into account is the place of usage and the risk related to that place of usage, according to the recent joint communication released by the NRCS, SAHPRA (SA Health Products Regulatory Authority) and the SABS on the “Regulatory Status of Equipment Being Used to Help Prevent Coronavirus (COVID-19)”.

Factors such as the surface, intended use, place of use and composition of the hand sanitizer determine the various different groups of categorisations.

What is important to note is that sanitizers and disinfectants are not one and the same. In a recent article by Hannah Roberts published in the Business Insider, entitled “The difference between sanitising and disinfecting. One kills more germs than the other”, it further explains the difference between the two.

One of the main differences is that disinfectants contain chemicals which decontaminate a surface and sanitizers reduce the number of germs on a surface. Alcohol is a surface disinfectant and, as highlighted in the article, is technically a disinfectant.

The following are regulated under the MRS Act. Accordingly, disinfectants used on inanimate surfaces in areas of high risk have to undergo a registration process as prescribed by the Act and fall within the mandate of SAHPRA.

• Disinfectants, antiseptics and germicides used on inanimate surfaces in areas of high risk (hospital operating rooms, intensive care units (ICU), burn units, Cath Laboratories);
• Disinfectants used to clean medical instruments;
• Products primarily claiming to kill germs, disinfect or sanitise or using an active antimicrobial ingredient such as the hand sanitisers used in hospitals and antiseptic and anti-bacterial products specifically for use as surgical scrubs in operating theatres and used on human skin in hospitals’ operating rooms, ICU, burn units etc.

The following fall under the FCD Act and do not need to be registered as a medicine unless their intended usage and claim attached to the product lies in both low and high risk areas, in which case the MRS Act will prevail.

• Hand sanitisers regarded as “Rub” or “Leave on” products, which are primarily used to sanitise the skin when soap and water are not available;
• Disinfectants and germicides used on inanimate surfaces in low risk areas within the home, public venues (schools, restaurants), health institutions, health professional consulting rooms and clinics.

However, if only the above-mentioned factors apply, like most disinfectant and sanitizers available at your local supermarket and pharmacy, less scrutiny will be placed on the product as the product does not undergo a rigorous registration process and merely has to comply with the regulations under the FCD Act.

All sanitizers, regardless of the usage and risk area, must be assessed in terms of the NRCS Act and the Legal Metrology Act. The standards that are applicable are: SANS 490:2013 that deals with “Disinfectant alcohol-based handrubs” and the most recent version of SANS 289 which deals with the labelling and general requirements of the product.

Labelling requirements

The labelling of the sanitizer products is of extreme importance as this is the first thing that a consumer looks at when purchasing and will also enable one to decipher in which category the sanitizer falls.

However, it must be noted that South African National Standards are voluntary in their application and developed by the SABS, despite being published by Notice in the Government Gazette, as they are only made compulsory if incorporated in an Act or Regulation or made into a Compulsory Specification by the NRCS.

According to the purposes in the Standards Act, standards are developed to ensure we are at an international level upon review of foreign Standards that are relevant to South Africa. Despite the above, section 55(2)(d) of the Consumer Protection Act 58 of 2008 states that “every consumer has a right to receive goods that comply with any applicable standards set out under the Standards Act”.

Due to the fact that SANS 490 deals with the safety and quality of disinfectant alcohol-based handrubs, SANS 490 is an applicable standard and it is quite possible for it to be considered as compulsory under the CPA.

According to SANS 490, the following information should be found on the label:

• the registration number and full address of manufacturer/producer;
•  a statement that it is a “disinfectant alcohol-based rub”;
• the type of sanitizer (liquid or gel), type of alcohol and percentage of alcohol; the mass if in gel form or the volume if in liquid form;
• expiry information (if applicable); and
• instructions for use as well as mandatory warnings.

In SANS 490, the standards writer states that “disinfectants for use on skin shall be registered with the Medical Control Council in South Africa”. This brings the intention of the legislator into question as this statement has the ability to ensure that all “disinfectant alcohol-based handrub” products must comply with the strict registration process under the MRS Act.

Perhaps the intention was for these products to fall under both low and high risk and thus requires for the MRS Act to be applicable. The Standard also defines a disinfectant as a “chemical agent that kills most vegetative forms of pathogen and other micro-organisms (but not necessarily all bacterial and fungal spores, mycobacteria, rickettsiae or viruses)”.

By this definition alone it is clear that the disinfectant, on its own, is not able to kill all viruses, and when it comes to “alcohol-based”, SANS 490 does not contain a prescribed minimum alcohol percentage, only that the type of alcohol and percentage of alcohol must be indicated.

This poses a problem which has now been highlighted by the Coronavirus outbreak. Consumers purchase alcohol-based handrubs believing that even a small percentage of alcohol present in the handrub will ensure that the virus is denatured.

The US FDA (Food and Drug Administration) released a ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry’ in March 2020.

This Policy contains non-binding recommendations in terms of hand hygiene as well as recommendations from their Center for Disease Control and Prevention (CDC). An absolute minimum percentage of 60% ethanol has been recommended by the CDC for all consumers if soap and water is not available.

However, the FDA prescribed six requirements for producers of both consumer handrubs and health care personnel handrubs to follow in order to avoid action being taken against them during this health emergency.

Within these requirements it is included that hand sanitizers for the purposes listed above must either be 80% ethanol solutions or 75% isopropyl alcohol solutions. This indicates that they are clearly adamant about suppliers ensuring that their sanitizers are up to hygienic, disinfectant and microbial standards due to COVID-19 as the general public are unaware of the specific levels of chemicals needed to kill the virus.

The World Health Organisation (WHO) also released a ‘Guide to Local Production: WHO-recommended Handrub Formulations’ in 2010. This Guide provided for 2 formulations; one with 80% ethanol and one with 75% isopropyl alcohol.

This guide was released for the purpose of assisting countries with system change through the identification of formulations which are logistically and economically viable as well as safety orientated for worldwide usage and it is evident that the FDA used this document to guide them in prescribing the levels of alcohol for their formulations.

Conclusion…

Upon review of our local framework, as compared to the international progression in guidelines for sanitizers, it is clear that there are still gaps when it comes to adequate sanitizer regulation in South Africa.

It is evident that SANS 490 should be viewed as compulsory through the lens of the Consumer Protection Act’s right to safe, good quality goods in order to ensure compliance with the Standard. SANS 490 still requires further development and a prescribed alcohol percentage should be prioritised for future sanitiser standards and regulations in order to ensure that the viruses and bacteria are adequately denatured and the public is not falsely misled to believe that any percentage of alcohol is sufficient as long as it is displayed on the packaging.

It is also clear that the medical usage versus the household and public usage differences in South Africa are far greater and more complex which allows for discrepancies to occur due to the different Acts that govern the products.

This is particularly important and suppliers and retailers must bear this in mind when ensuring that their products comply with the relevant legislation as consumers have a right to protection against false, misleading or deceptive representations in terms of the Consumer Protection Act.

Albeit that soap and water are, in fact, more effective than hand sanitizers, the latter are still in high demand. Perhaps a review of our current Regulations and Standards should be considered, especially after a crisis like the one that we are currently in, in order to prevent misleading representations and ensure higher protection of those vulnerable to infection.

This article was written by Isabella Mazzone and Janet Tomkow-Coetzer. For more information on the labelling of disinfectants and sanitizers please contact the writers at Hahn & Hahn Attorneys, specialists in Consumer and Food Law.