Hand sanitiser regulatory and market update
The Minister for Industry, Science and Technology has spearheaded industry’s response to the COVID-19 pandemic, including bringing together the first meeting of hand sanitiser stakeholders. Our department (DISER) has continued this close work with industry to understand Australia’s capacity to produce hand sanitiser, as part of the industrial response to the COVID-19 outbreak.
The advent of COVID-19 has seen a surge in demand for hand sanitiser. Australia’s local hand sanitiser industry has stepped up to meet this challenge by increasing production.
Ethanol producers, hand sanitiser manufacturers, packaging companies, and delivery and freight companies delivering hand sanitiser right around the country have all had to adapt their practices and processes.
Regulators and government agencies have played their part by adapting regulations to enable increased production, disseminating information about safety concerns, and assisting with freight and transport. This support from Government is adaptable and ongoing during this crisis.
Some of the more important changes and actions by Government are summarised in this publication.
We are grateful to all businesses and industry bodies who have contributed to the Australian Government’s work. Your actions will continue to help control the spread of COVID-19 and keep Australians safe.
Therapeutic Goods Association (TGA) Regulations
Hand sanitiser may now be used in the health care sector without TGA approval or registration, provided it meets certain specifications. These specifications include following formulas approved by the World Health Organisation and complying with manufacturing practices, advertising requirements, labelling and packaging conditions.
The Excluded Goods Order Determination that outlines these requirements was recently updated and is available online. The TGA provides information to help manufacturers, suppliers and advertisers of hand sanitisers to understand their regulatory obligations.
Additionally, the TGA offers guidance to consumers who wish to understand more about buying and using hand sanitisers.
For more information you can get in contact with the TGA via their email info [at] tga.gov.au.
Alcohol-based hand sanitisers, and some of their ingredients, are hazardous chemicals, and as such are regulated by state and territory work, health and safety authorities (WHS). A number of these authorities have released hand sanitiser specific fact sheets and alerts, an example of a factsheet from Victoria is available here. For further information, you should refer to your state or territory WHS authority and Accord Australasia’s manufacturing and transport information sheet.
Safe Work Australia (SWA) has also released a fact sheet for businesses involved in the manufacture or supply of hand sanitiser. A summary of the work health and safety requirements when manufacturing, importing, supplying, handling or storing hand sanitisers can be found here. SWA also produces industry specific information for workplaces.
Specific WHS laws apply to the decanting of hand sanitiser, some of which are covered in this NSW-specific WHS laws factsheet. There are requirements for hand sanitiser packaging, including that it is packed in a container that does not usually contain food or beverages and cannot be mistakenly identified as containing food or beverages. For further information, you should contact your state or territory WHS authority.
For more general information about safety and hand sanitiser, the World Health Organisation FAQs includes information about fire hazards, decanting, and reusing containers.
Hand sanitiser is considered a dangerous good and attracts obligations with regards to its safe and lawful transport. The Accord information sheet contains relevant information about requirements and restrictions for the transportation of dangerous goods by air and sea. The National Transport Commission has produced a checklist for the safe transport of hand sanitiser by road and rail. You can contact the National Transport Commission here.
Australia Post has temporarily increased handling limits on hand sanitiser not classified as a ‘manufactured product’ from 300ml to 500ml per consignment. For further information refer to the alert about the temporary increase to hand sanitiser limits sent via e Parcel or contact Australia Post.
In response to heightened demand for hand sanitiser and other cleaning products, Australian ethanol producers have increased their production of industrial grade ethanol. Industry participants have reported that ethanol shortages have eased as new supply has become available.
Import and export
The International Freight Assistance Mechanism (IFAM) is a temporary measure to help restore critical global supply chains which have been heavily impacted by COVID-19 containment measures around the world. Austrade is prioritising essential imports such as medical supplies and the export of high-value agriculture and fisheries products and other items of national interest. Information on the IFAM can be found here, and enquiries regarding international air freight opportunities should be directed to Airfreight [at] austrade.gov.au (Austrade).
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) requires registration when importing chemicals to make hand sanitisers. You can refer to NICNAS’ guidance on ‘Hand Sanitisers’ for more information.
There have also been changes to customs regulations temporarily prohibiting the non-commercial export of personal protective equipment, including hand sanitiser. The prohibition does not apply under certain circumstances, such as when the goods are exported by an Australian manufacturer of the goods. Please refer to this Australian Customs Notice for more information.
The Minister for Health made a Determination under the Biosecurity Act 2015, prohibiting price gouging on essential goods during the COVID-19 pandemic, including hand sanitisers.
The Australian Competition and Consumer Commission (ACCC) has adjusted the focus of its regulatory activities toward the impacts of COVID-19. You can find more information about the ACCC’s consideration of competition matters here. Businesses or industry groups suspecting price gouging on essential good are encouraged to contact the ACCC directly via adjudication [at] accc.gov.au.The ACCC has also published product safety guidance on supplying, storing and using hand sanitiser.
Hand sanitiser manufacturers seeking more information about domestic packaging options, should contact the apco [at] packagingcovenant.org.au (Australian Packaging Covenant Organisation). For information on safety and packaging refer to the ‘Safety’ section above.
Australian Taxation Office (ATO)
The ATO has made it easier for distillers to use spirits for hand sanitiser. Please refer to the ATO’s website to see how the changes to alcohol excise apply to your business.
Helping to connect supply with demand
There are a number of tools and resources available if your sector or business is in a position to meet hand sanitiser supply needs:
The Advanced Manufacturing Growth Centre’s COVID-19 Manufacturer Response Register is an interactive platform, which supports Australian manufacturers and suppliers to connect with organisations looking for critical medical and protective supplies, and to connect with potential collaborators across the entire manufacturing value chain.
The Industry Capability Network (ICN) has developed a portal on ICN Gateway. The Gateway allows suppliers to register their interest in providing key goods and services in response to COVID-19 and helps to identify any gaps in supply chains, including hand sanitiser. Several state and territory governments are developing portals for businesses interested in supplying or accessing personal protective equipment, including hand sanitiser. For example, Tasmania has recently released a temporary personal protective equipment supply register on their website. Further information about these resources will be published by state and territory governments.
Download the hand sanitiser - regulatory and market update brochure
For further information on the work on hand sanitiser capability and supply:
Email COVID [at] industry.gov.au
If your enquiry relates to a specific technical issue, please direct your enquiry to the relevant agency or organisation listed above.