The Australian Therapeutic Goods Administration (TGA) has temporarily excluded specific hand sanitizer formulations from the usual regulatory obligations for therapeutic goods in an effort to address market shortages. For the duration of the Covid-19 pandemic, hand sanitizer may be produced by following the formulation, production, testing, record-keeping, and labelling requirements outlined in the Therapeutic Goods (Excluded Goods-Hand Sanitisers) Determination 2020.
Hand sanitizers normally fall under the scope of therapeutic goods in Australia according to the Therapeutic Goods Act 1989 (the Act). Anyone wishing to market a therapeutic good in Australia must apply for market authorization from the TGA. If market authorization is granted after assessment by the TGA, the therapeutic good is entered on the Australian Register of Therapeutic Goods (ARTG). Typically, hand sanitizers must be entered on the ARTG prior to import to, sale within, and export from Australia.
Production of the specified World Health Organization (WHO) hand sanitizer formulations can now proceed without the requirement for TGA notification or approval. Food grade alcohol, which is cheaper and more readily available than medical grade alcohol, may be used to manufacture the hand rubs. These sanitizer formulations are intended for use in healthcare facilities as well as for consumer use.
The WHO hand sanitizer formulas that are exempt from the Act are instead regulated under Australian Consumer Law (ACL). Under the ACL, it is the supplier’s responsibility to ensure that consumer products supplied in the Australian marketplace are safe and fit for purpose. Suppliers must also comply with the consumer guarantees scheme, which includes a promise that the goods are of acceptable quality, safe, durable, and with no faults.
TGA approval is still required for new hand sanitizer recipes with non-WHO formulations. The TGA has stated they will prioritize these applications and review them as quickly as possible.
There have been incidents of hand sanitizer ingestion due to children confusing packaging with food items. Suppliers are urged to carefully consider packaging choices to ensure that they are clearly labeled and do not resemble consumable products or appeal to children. Australian Competition and Consumer Commission (ACCC) recently published Safer packaging and labelling guidance for hand sanitiser suppliers. The guidance provides advice and suggestions for container safety, including dispensing mechanisms, as well as key labelling requirements and other safety considerations.
As some businesses such as distilleries change directions to cater to the high demand for hand sanitizer products, the ACCC is encouraging them to make sure that products are packaged and labelled correctly to ensure safety and avoid confusion. Suppliers should also refrain from making false or misleading claims on their products regarding protection against viruses.
For more information about Australia consumer product regulations, contact Nexreg today!