On this page we provide some handy information for members of industry who want to bring new disinfectants and hand sanitisers (both therapeutic goods and general consumer products) to Australia during the COVID-19 pandemic and to consumers who may be confused about which products to buy.
INFORMATION FOR INDUSTRY
COVID-19 has changed the way we do a lot of things. This global pandemic has seen an increased need for disinfectants and sanitisers that can protect the public from the risk of spreading the disease.
In addition to social distancing and reducing any unnecessary travel outside the home, the community is being asked to maintain good hygiene practices which includes regularly using hand sanitiser. Businesses are also trying to protect their staff and patrons by regularly disinfecting and sanitising their venues to help reduce the spread of coronavirus.
In response to the COVID-19 pandemic, the TGA has provided an exemption for particular hand sanitisers; that is, those formulations based on advice from the World Health Organization and similar decisions by the US Food and Drug Administration.
Under the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 (the Exclusion Determination), hand sanitiser products that meet the requirements specified in the Exclusion Determination are not subject to therapeutic goods regulation and do not need to be included in the Australian Register of Therapeutic Goods.
In particular, ethanol hand sanitisers and isopropyl alcohol hand sanitisers are covered by the Exclusion Determination and allowed for personal use and in the health care setting, provided that the exact formulation and specific manufacturing/labelling requirements are met. These requirements are detailed on the TGA website.
These Excluded products are still subject to regulation by the Australian Competition and Consumer Commission.
In addition, hand sanitisers are considered to be 'general consumer products' and are not regulated by the TGA if:
- they contain only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard)
- the therapeutic claims about the product are limited to general low level activity against bacteria (for example, kills 99.9% of bacteria)
An advertisement for a hand sanitiser cannot make claims about the product being virucidal or being capable of preventing or treating COVID-19.
Sponsors who have a disinfectant formulation for which they wish to make claims relating to protection from COVID-19 or killing COVID-19 need to have their products listed. with the TGA.
The TGA's website describes the different classes of disinfectants and the requirements that need to be met before a product can make particular claims. Although claims relating to the COVID-19 virus have been approved by the TGA, only specified disinfectants can make these claims.
It is important that you understand the difference between each of the different types of disinfectants so that you follow the correct guidelines and testing requirements.
Need help ensuring your product is compliant?
Drop us a line today to learn more about how we can help you to ensure that your products are compliant with the TGA & ACCC requirements.
INFORMATION FOR CONSUMERS
It can be difficult for a consumer to know whether a product they are buying is safe and whether it can protect against the transmission of COVID-19. It can be easy to get lost and confused because there are so many products flooding the market.
You should be looking for either an Ethanol hand sanitiser 80% or Isopropyl alcohol hand sanitiser 75%
You should also be aware that the TGA has advertised a list of disinfectants that have been approved by the TGA for use against the COVID-19 virus. This list can be found here.
Remember, social distancing continues to be the best way to prevent the spread of COVID-19. Continue to follow the advice of your local health authority.