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The coronavirus (COVID-19) outbreak is impacting us all. Amidst the outbreak, we are seeing shortages of everyday commodities, such as toilet paper, pasta and hand sanitiser. A number of organisations are seeking to manufacture their own hand sanitiser. If you are considering doing this, it is important to understand how hand sanitisers are classified and requirements around advertising and labelling.

This article looks at the requirements for importing and manufacturing hand sanitisers and the steps the Federal Government is taking to deal with the shortages of hand sanitisers in Australia during the COVID-19 pandemic. 

Defining Hand Sanitisers 

Hand sanitisers contain antiseptic ingredients, which are substances that kill microorganisms or prevent the growth of microorganisms. Hand sanitisers, which include both hand washes and hand rubs or gels, may be regulated as a cosmetic or a therapeutic good depending on:

  • the intended use; 
  • the ingredients; and
  • the claims made in relation to what the hand sanitiser can do. 

Until recently, there were two types of hand sanitiser – cosmetic and therapeutic. Under the new laws, there is now a third class of hand sanitiser with specific formulations. 

Cosmetic Hand Sanitisers 

Hand sanitisers are general consumer products or ‘cosmetics’ if they: 

  • are for personal or domestic use only and not for use in a health care setting; 
  • claim that they are limited to general, low-level activity against bacteria or germs (such as, kills 99.9% of germs); 
  • do not claim to protect against viruses; and
  • contain low-risk ingredients only (that is, they do not contain substances included in Schedules 2, 3, 4 or 8 of the Poisons Standard). 

Cosmetic hand sanitisers, which meet the above requirements, are not regulated by the Therapeutic Goods Association (TGA).  

However, if you wish to import cosmetic hand sanitisers into Australia (or import chemicals to make cosmetic hand sanitisers into Australia) you will likely be required to register with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). 

You will also need to ensure that all the chemicals included in the hand sanitiser product are allowed for use in Australia. You can do this by checking the Australian Inventory of Chemical Substances to see if all your chemical ingredients are listed and if there are conditions for using those chemicals. 

Therapeutic Hand Sanitisers

Hand sanitisers (and any other antibacterial hand hygiene products) that:

  • claim to kill specific organisms (such as viruses or E. coli); and/or 
  • which people use in clinical or hospital settings; 

are considered therapeutic goods and therefore are regulated by the TGA.  

Hand sanitisers regulated by the TGA must be manufactured by TGA-licensed manufacturers in accordance with the principles of Good Manufacturing Practice. Any directions for use must be approved based on test data. They must also be included in the Australian Register of Therapeutic Goods before being imported into or supplied in Australia. 

New, Third Class of Hand Santisier

In light of the COVID-19 crisis, there is now a third class of hand sanitiser. That is, new laws have been passed to enable the production of hand sanitisers with one of two specific formulations. These hand sanitisers are not classified as a cosmetic but, for now, are excluded from TGA regulation. The TGA has indicated that this will be for the duration of the COVID-19 pandemic. 

The excluded hand sanitisers must only contain the particular ingredients in particular quantities in the final formulation. The formulations are based on advice by the World Health Organization as well as decisions by the US Food and Drug Administration. 

Manufacturers must:

  • test the alcohol concentrations of each batch;
  • manufacture under sanitary conditions; and 
  • maintain production record-keeping. 

There are also strict requirements for labelling and advertising of these products.

The new class of hand sanitiser is not being regulated by the TGA to help ensure large volumes of hand sanitisers can be supplied in Australia during the COVID-19 crisis.

Advertising and Labelling Requirements

There are strict advertising and labelling requirements for therapeutic goods in Australia.

The claims you can make on TGA-regulated hand sanitiser products depends on a number of things, including:

  • the proposed use of the product; and 
  • the data provided to support safety and efficacy. 

If you are supplying hand sanitiser products in Australia, be careful not to make any claims in relation to novel coronavirus, in particular around preventing the spread of coronavirus or increasing immunity to coronavirus. Such claims are therapeutic use claims and you cannot sell them without the prior approval from the TGA.  

Key Takeaways

COVID-19 is having a huge impact on our community. If you are thinking about importing or manufacturing hand sanitisers in Australia to help deal with the shortages arising as a result of the pandemic panic, make sure you are aware of your legal obligations and you comply with the relevant laws and regulatory bodies.

If you are concerned about any legal issues arising from COVID-19 or have any questions about the legal impacts of COVID-19 on you or your business, contact LegalVision’s COVID-19 legal team on 1300 544 755 or fill out the form on this page.

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