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 Organization-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. For background information on therapeutic and cosmetic hand sanitisers, see our Hand sanitiser product page.
Packaging and labelling precautions
The ACCC is aware of incidents of hand sanitiser ingestions due to children confusing the packaging with food items.
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.
For more information, see our safety alert on Safer packaging and labelling guidance for hand sanitiser suppliers.
Other safety considerations when producing hand sanitiser
Suppliers should also consider the consistency of and the ingredients used in their hand sanitisers to reduce the impact of accidental ingestion:
- Where possible, ensure your hand sanitiser is highly viscous (similar to a gel-like consistency) to minimise the volume that could be accidentally ingested by young children, and thus help reduce any adverse effects.
- If you are unable to adjust the viscosity of your hand sanitiser, then ensure that it is in packaging that would be difficult for a child to easily access. For information on dispensing mechanisms, see our safety alert on Safer packaging and labelling guidance for hand sanitiser suppliers.
- Avoid adding flavourings or fragrances that mimic food items.
- Consider the ingredients you are using in your hand sanitiser as some ingredients, such as essential oils, may increase the toxicity of your product.
- Consider using a bittering agent in your product to help discourage prolonged ingestion.
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.