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Disinfectants, sterilants and sanitary products
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- Disinfectant Claim Guide
Update - 21 December 2020
Please note that the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) Amendment Order 2020 was registered and published on the Federal Register of Legislation (F2020L01650) on 18 December 2020, and came into effect on 19 December 2020.
This instrument amends the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019, principally to incorporate the most recent version of the TGA instructions for disinfectant testing and to clarify a small number of matters.
Sterilants & disinfectants are regulated in a variety of ways in Australia, depending on the intended purpose of the product as discerned from the claims made in the instructions for use, labelling and promotional material. The following table provides an overview of the manner in which these products are regulated in accordance with the following legislation:
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Therapeutic Goods Regulations 1990
- Therapeutic Goods Advertising Code (No.2) 2018
- Therapeutic Goods (Single Therapeutic Goods) Order No.1 of 1991
- Therapeutic Goods (Standard for Disinfectants and Sanitary Products (TGO 104) Order 2019
More information about specific claims as referenced in the table below can be found in the Disinfectant Claim Guide.
Type of product |
Regulation |
Relevant legislation and guidance |
---|---|---|
Hospital grade or household/ commercial grade disinfectant liquids, sprays, wipes*, sponges and aerosols that do not make specific claims** and that are:
* A disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms ** Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as "specific claims". More information can be found in the Disinfectant Claim Guide. |
Exempt disinfectant These products are not required to be included in the Australian Register of Therapeutic Goods before they are supplied to the market but they must still meet all regulatory requirements as set out in the relevant legislation and guidance |
Therapeutic Goods Regulations 1990 |
Hospital grade or household/ commercial grade disinfectant liquids, sprays, wipes, sponges and aerosols that make specific claims** to kill microorganisms and that are;
* A disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms ** Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as "specific claims". More information can be found in the Disinfectant Claim Guide. |
Listed disinfectant These products are required to be included in the Australian Register of Therapeutic Goods before they are supplied to the market and must meet all regulatory requirements as set out in the relevant legislation and guidance |
Therapeutic Goods Regulations 1990 |
Liquids, sprays, wipes and aerosols that are intended to be used on medical devices |
Medical devices These products must be included in the Australian Register of Therapeutic Goods as a Class IIb medical device before they can be supplied |
Guidelines for the evaluation of sterilants and disinfectants* Therapeutic Goods (Medical Devices) Regulations 2002 * These guidelines are no longer used as a regulatory instrument and are now provided for information and guidance to assist sponsors with meeting the testing requirements for disinfectant products that are regulated as a medical device only. No section of the Guidelines should be used when assessing a Listed disinfectant that is regulated as outlined earlier in this table. |
Cleaners intended to be used on medical devices that do not claim to be a device disinfectant or sterilant |
Medical devices These products must be included in the Australian Register of Therapeutic Goods as a Class I medical device before they can be supplied |
|
Bedding, clothing, towels and other articles made principally of fabric that are intended to be used primarily on or in close contact with the human body; and are represented expressly to be effective against the virus that causes COVID-19 |
Medical devices |
Therapeutic Goods (Medical Devices-Specified Articles) Instrument 2020 |
General cleaners in all forms without disinfectant claims |
General consumer product |
These products are not regulated by the TGA |
Detergent products where the ingredients do not produce a microbiocidal effect |
General consumer product |
These products are not regulated by the TGA |
Sanitisers - products which implicitly or explicitly reduce micro‑organisms other than viruses to a sanitary level and which while making specific claims against a limited number of micro‑organisms are the subject of user specifications, or are subject to a recognised industry standard and are not for the retail market |
General consumer product |
These products are not regulated by the TGA |
Skin antiseptic products (including alcohol swabs that claim to disinfect) |
Over-the-counter medicines These products must be included in the Australian Register of Therapeutic Goods as an over-the-counter medicine before they can be supplied |
Guidance and legislation governing over-the-counter medicines can be accessed at OTC medicines regulation basics |
Alcohol swabs that claim to clean the skin only (and do not claim to disinfect or act as an antiseptic) |
Medical devices These products must be included in the Australian Register of Therapeutic Goods as a Class I medical device before they can be supplied |
|
Antibacterial skin care products where claims are limited to general low level activity against bacteria (for example, "Kill 99.9% of bacteria") |
General consumer product |
These products are not regulated by the TGA but must not contain substances that are included in Schedule 2, 3, 4 or 8 of the Poisons Standard (SUSMP) |
Antibacterial skin care products where claims are limited to general low level activity against bacteria (for example, "Kill 99.9% of bacteria") |
General consumer product |
These products are not regulated by the TGA but must not contain substances that are included in Schedule 2, 3, 4 or 8 of the Poisons Standard (SUSMP) |
The following products are typically applied to surfaces to provide a long lasting protective barrier are excluded from regulation:
|
General consumer product |
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The following products are excluded from regulation under different legislative mechanisms:
|
Excluded goods These products are excluded from regulation by the TGA. While they may be required to meet relevant legislative requirements under consumer legislation, they are not required to meet any of the legislative requirements regulated by the TGA |
Therapeutic Goods (Excluded Goods) Determination 2018 |
Retained registered disinfectants
Registered hospital, household and commercial grade disinfectants, registered prior to downregulation (before 4 October 2007) can continue to be supplied under the terms and conditions of Chapter 3 of the Therapeutic Goods Act 1989 (the Act).
See DR4 Appendices for guidance.
This does not apply to listed disinfectants or medical devices regulated under the new regulatory system (since 4 October 2007).
Regulatory decisions and notices
Information about regulatory decisions made by the TGA for disinfectants & sterilants.
- Coronavirus (COVID-19): Information on medicines and medical devices
- Explanatory notice: Restricted and prohibited representations
Category permission for registered hospital grade and household grade disinfectants with specific claims - 42DK(1) Permitted representation: Hospital grade disinfectant or household grade disinfectant
Permission under subsection 42DK(1) for restricted representations of the kind set out in this notice to be used on the label or in information in the packaging - 42DK(1) Permitted representation: Hospital grade disinfectant or household grade disinfectant
Permission under subsection 42DK(1) for restricted representations of the kind set out in this notice to be used on the label or in information in the packaging - 42DK(2) Permitted representation: Hospital grade disinfectant or household grade disinfectant
Permission under subsection 42DK(2) for restricted representations of the kind set out in this notice to be used on the label or in information in the packaging