COVID-19: Supplying, storing & using hand sanitiser
Update: The ACCC is aware of incidents of hand sanitiser ingestions due to children confusing the packaging with food items. This safety alert was updated on 12 May 2020 with additional guidance on packaging and safe use tips for consumers.
The Therapeutic Goods Administration (TGA) has temporarily exempted a particular handrub (also known as hand sanitiser) from the usual regulatory requirements for therapeutic goods. This means it is regulated under the Australian Consumer Law (ACL). If you are a business supplying hand sanitiser, here is what you need to know.
WHO-recommended handrub formulation
To address Australian shortages of hand sanitiser, the TGA has temporarily exempted a particular handrub from the usual regulatory requirements for therapeutic goods. For the duration of the COVID-19 pandemic, manufacturers may produce hand sanitisers, provided they exactly follow the formulation, production, testing, record-keeping and labelling requirements outlined in the Therapeutic Goods (Excluded Goods-Hand Sanitisers) Determination 2020.
The WHO formulation does not replace the existing TGA-regulated and approved therapeutic hand sanitiser formulations present on the Australian Register of Therapeutic Goods (ARTG). More information on therapeutic hand sanitisers is available under background information.
About the formulation
The exempted hand sanitiser is a World Health Organisation-recommended handrub formulation. This formulation is suitable for use in healthcare facilities and by consumers. See the WHO Guide to Local Production: WHO-recommended Handrub Formulations for relevant technical background and information on the safety and cost of this formulation.
Following the formula
The formulation must be followed exactly with no additional active or inactive ingredients, including colours, fragrances or emollients. As per the Determination, this handrub will be regulated as a cosmetic and a consumer good under the ACL. These cosmetic hand sanitisers will also need to meet the mandatory standard for Cosmetics ingredients labelling.
Any departures from the required formulation and labelling will mean that the goods can be considered to be either therapeutic or cosmetic goods. See the background information below on the differences between therapeutic and cosmetic hand sanitisers.
Packaging and labelling precautions
In addition to the above requirements, suppliers should carefully consider how their products are packaged and whether they may be confused with other household or food items. Hand sanitiser packaging should not resemble consumable products or products that may be considered appealing to children. Products should also be clearly labelled as hand sanitiser.
If the ACCC has evidence to suggest that a supplier is not taking adequate safety precautions to ensure consumer safety or a product is causing serious consumer harm, the ACCC would expect the supplier to implement a range of safety measures, which may include reconsidering its product packaging and labelling or conducting a product recall.
ACL and consumer guarantees
More broadly, under the ACL, suppliers are responsible for ensuring consumer goods supplied in the Australian marketplace are safe and fit for purpose. Suppliers also need to comply with the consumer guarantees regime set out in the ACL, which contains a guarantee that the goods are of acceptable quality, including that they are safe, durable and with no faults.
It is also important that suppliers should not make false or misleading claims about their products regarding protection against viruses.
Safe use tips for consumers
With so many new hand sanitisers in the market and many more Australians buying and using hand sanitiser than ever before, here are some tips for you and your family:
- When buying hand sanitiser, check the ingredients label for any ingredients that may cause an allergic reaction to you or your family.
- If no ingredients are listed on the product or provided in other forms prior to purchase, report the product to the ACCC.
- If you are using your own bottles at an in-store hand sanitiser refill station, ensure you mark your bottles clearly to avoid confusion with other household or food items.
- Keep hand sanitiser out of reach of children at all times. Children should only apply hand sanitiser under adult supervision.
- Keep hand sanitiser away from any type of open flame as its ingredients are highly flammable.
Therapeutic hand sanitisers
Certain hand sanitisers are regulated by the TGA. If you are manufacturing or supplying therapeutic hand sanitisers, your product must comply with specific requirements outlined by the TGA. For more information, refer to the TGA web page: Hand sanitisers and COVID-19.
Cosmetic hand sanitisers
Other hand sanitisers, or antibacterial skin preparations, are considered to be 'general consumer products' (cosmetics) and are not regulated by the TGA if they:
are 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 particular levels of activity against bacteria or germs (for example, kills 99.9 per cent of germs)
have no claims against viruses
that contain only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard).
Cosmetic hand sanitisers must also meet the mandatory standard for Cosmetics ingredients labelling.