Amidst the coronavirus (COVID-19) pandemic, government and health authorities urge that we all protect ourselves against coronavirus (COVID-19). The Australian Department of Health advises that while washing hands with soap and social distancing are the most effective hygiene practices at home and in the workplace, hand sanitisers can also play an important role in keeping hands as free from harmful microorganisms as possible.
However, alarm over the pandemic has resulted in low supplies of hand sanitisers. Where it isn’t sold out, there have been reported instances of sellers inflating prices through online sales channels as well as traditional brick and mortar retail outlets and ‘pop up’ shops. At the same time, low supplies have boosted the availability of online articles dedicated to home remedies or ‘DIY santisers.’ Manufacturers have also been repurposing their production lines, such as distilleries, who are now using their supply of high proof alcohol to alternatively produce hand sanitiser.
Recent developments in the regulatory space for hand sanitisers
Despite the increased popularity of hand sanitisers, scientific researchers have continued to demonstrate that hand sanitisers should only be considered as an alternative when handwashing is unavailable (see e.g. mSphere Study). But how do you know the broadening and availability of these new products are just as effective? Even from the perspective of a manufacturer or new entrant, how do you ensure such consumer goods supplied in the Australian marketplace are safe and fit for purpose?
The Australian Government Therapeutic Goods Administration (TGA) has recently made regulatory changes to the manufacturing of hand sanitiser, whilst maintaining strict safety requirements, to bolster supply in Australia. For example, the TGA has introduced an urgent legislative instrument and guidance to make it easier for local businesses to manufacture hand sanitiser including three classes of hand sanitisers – general consumer products ('cosmetics'), which are not regulated by the TGA, therapeutic goods, which are, and products with one of two specific formulations, which are excluded from regulation for the duration of the COVID-19 pandemic.
The three classes of hand sanitisers as advised on the 29 March 2020 are provided in summary below, and are also available with a complete explanation on the TGA website:
General consumer products ('cosmetics')
- not regulated by the TGA if:
- for personal or domestic use only and not for use in a health care setting (this includes aged care facilities)
- have claims that are limited to general low level activity against bacteria or germs (e.g. kills 99.9% of germs)
- have no claims against viruses
- contain only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard)
Therapeutic goods('cosmetics')
- regulated by the TGA if:
- claim to kill specific organisms (e.g. E.coli or viruses)
- are to be used in clinics or hospitals
- these products are regulated as registered over-the-counter (OTC) medicines - claims on product labels depends on proposed use (e.g. antiseptic hand wash/rub, hygienic hand wash/rub, healthcare personnel antiseptic hand wash/rub)
- therapeutic representations in advertising require express TGA approval before it can be made – may require evidence supporting the claim (e.g. results from clinical trials)
Specific formulations
excluded from TGA regulation during COVID-19 if:
- EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
- sterile distilled water or boiled cold water;
- glycerol 1.45% v/v (pharmacopoeial grade);
- hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
- does not contain any other active or inactive ingredients, including colours, fragrances or emollients.
Commercial laboratory testing of hand sanitisers
If there's one thing to learn from the recent changes by the TGA, it is that a product may still require efficacy or safety testing, depending on its active ingredient. For example, as a manufacturer, how do you support claims that are limited to general low level activity against bacteria and germs (e.g. 'kills 99.9% of germs'), so that your range of hand sanitisers, or antibacterial skin preparation, can be considered to be general consumer products ('cosmetics')? Perhaps you need to test for whether your product contains only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard), or you need to verify specific active or inactive ingredients?
There are several standard methods available, and different evaluating competent authorities may require different methods. MPL Laboratories’ Group Organics Manager, David Williams and Business Development Manager, Catherine North explain some of the methods and techniques considered when testing hand sanitisers in a commercial laboratory.
How Hand Sanitisers are tested
Products tested in a commercial laboratory, may undergo various methods and techniques, depending on the briefing requirements or the purpose of the testing. For example, the purpose of the method may be to test:
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Whether the product contains alcohol (either Ethanol or Iso-propyl Alcohol) as an ingredient and it’s quantity as stated on the bottle.
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Alternatively, that alcohol-free sanitisers do not contain detectable amounts of alcohol.
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Testing for other ingredients such as glycerol, benzalkonium chloride, hydrogen peroxide as well as other ingredients such as colours, fragrances and emollients would require multiple techniques and is a complex process.
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Microbiological testing for TGA approval. Multiple trials required with the organisms of interest through TGA approved laboratories.
As per the first two listed points above, Envirolab is now in a position to determine the % alcohol content of alcohols in sanitisers including Ethanol and Isopropanol, as indicated above. They can also confirm if an “alcohol free sanitiser” does indeed contain less than detectable levels of alcohol.
This is achieved using Headspace GCMSMS (Gas Chromatography - Tandem Mass Spectrometry), which provides superior selectivity and sensitivity as compared to traditional GC, and minimises interferences/matrix problems.
Supported by a Specialised Team
A special thanks to Catherine and David who helped put together this update, particularly as both have recently been working on major projects against tight deadlines, including MPL Laboratories attaining an extension of scope of NATA Accreditation for the analysis of Alcohols (list of 12) in waters and sorbents, effective 1st May 2020.
As MPL Laboratories' longest serving team member, Catherine has extensive experience in on-site sample collection, extensive laboratory analysis and systems management.
In her current role as Business Development Manager of our Perth laboratory, Catherine focuses on and takes pride in understanding client analytical requirements and ensuring that MPL Laboratories delivers scientific testing services that meets their needs.
View Catherine's full bio >
With over 25 years’ experience in organic chemistry, and an extensive knowledge in ultratrace level analysis, David joined our team in February 2012 as Group Organics Manager. Having worked on a variety of projects relating to organic analytical methods, such as steroid analysis, AOX, VOCs, low level pesticides, speciated phenols and phenoxy acid herbicides in water, soil, biota and other matrices, David plays a significant role in working with our laboratories to attain NATA Accreditation.
Recently, David has been instrumental in leading MPL Laboratories' Organics team to achieve NATA Accreditation for the analysis of Alcohols (list of 12) in waters and sorbents.
View David's full bio >
Additional resources and further information
TGA has put together valuable information on the recent changes in the regulatory space for hand sanitisers and that can also be viewed on the Federal Register of Legislation site.
Refer to media release on the regulatory changes as delivered by The Hon Greg Hunt, Minister for Health, relating to the regulatory changes, dated 30 March 2020.
Under the ACL, suppliers are responsible for ensuring consumer goods supplied in the Australian marketplace are safe, fit for purpose, and in compliance with the consumer guarantees regime set out in the ACL. It is also important that suppliers should not make false or misleading claims about their products regarding protection against viruses, where further information can also be found on this link.
Safe Work Australia also provides manufacturers with further information on the manufacture or supply of alcohol-based hand sanitisers. Information is also available at state / territory sites e.g. Work Cover Queensland.
The World Health Organization (WHO) and the US Food and Drug Administration have released guides on formulations.