Borderline Disinfectants

Sep 21, 2021

TGA has released a new guidance document on borderline disinfectants and related products.

This has provided clearer guidance on Excluded goods that are exempt from regulation under the therapeutic goods framework. While these products may be required to meet relevant legislative requirements under consumer or other legislation, they are not required to meet any of the legislative requirements regulated by the TGA.

The Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination) specifies goods that are not regulated by the TGA. According to Schedule 1 of the Determination, the following relevant goods are excluded goods:

  • disinfectants or sanitisers that are represented to be for the treatment of water only
  • disinfectant and sterilant gases
  • sanitation, environmental control and environmental detoxification equipment (including films and coatings), other than articles specified in item 3 of Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020.

Products that fall within Schedule 1 to the Determination are excluded from the operation of the Therapeutic Goods Act 1989 irrespective of the manner in which those goods are advertised or presented for supply.

A number of products that are used to sanitise the environment, which do not meet the definition of a disinfectant, are considered to be excluded goods under Schedule 1 of the Determination. Such products generally have claims relating to air or environmental sanitation, and do not make claims in connection with treating a person or having a direct influence in or on the human body.

Examples include

  • air sanitisers and deodorisers (e.g. ozone)
  • machinery including robotic equipment and drones for dispensing disinfectant
  • UV lights/systems for the sanitation or disinfection of a built environment, such as a room
  • antimicrobial articles such as copper tape, sanitizing film, paints and other coatings applied to inanimate surfaces such as door handles
  • laundry detergents that clean by mechanical action
  • clothing, towels, bedsheets, and other items for sanitation purposes that are claimed to have general antiviral properties and do not make claims relating to COVID-19

It is also relevant to note then even though a product is not regulated by the TGA these products are still subject to the Competition and Consumer Act 2010, which is administered by the Australian Competition and Consumer Commission. Among other things, manufacturers and suppliers must ensure that any advertising does not mislead or deceive the public.