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Purpose
This guidance provides regulatory guidance for disinfectants, sterilants, and sanitary products in Australia. It explains how these products are regulated based on their intended purpose and offers an overview of the relevant legislation governing their use and marketing.
Legislation
Type of product and regulation
Sterilants and 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 how these products are regulated under 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 Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 |
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 Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 |
| 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* *Compliance with the Poisons Standard (SUSMP) must be considered |
| Detergent products where the ingredients do not produce a microbiocidal effect | General consumer product | These products are not regulated by the TGA* * Compliance with the Poisons Standard (SUSMP) must be considered |
| Sanitisers - (as defined in TGO104) means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface. 1 | Exempt product 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 Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 |
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 | |
| Hand sanitisers that meet the requirements of the specified excluded goods determination | Excluded goods | Therapeutic Goods (Excluded Goods - Hand Sanitisers) Determination 2020 |
| 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 | Therapeutic Goods (Excluded Goods) Determination 2018 |
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 Therapeutic Goods (Declared Goods) Order 2019 Therapeutic Goods (Excluded Goods) Order No. 1 of 2011
|
*Compliance with the Poisons Standard (SUSMP) must be considered
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
- Restricted and prohibited representations
Category permission for registered hospital grade and household grade disinfectants with specific claims - Therapeutic Goods (Prohibited Representations-Disinfectants) (COVID-19) Permission 2020
- Therapeutic Goods (Prohibited and Restricted Representations – Registered Disinfectants) Permission 2020
- Therapeutic Goods (Prohibited and Restricted Representations – Listed Disinfectants) Permission 2020
Footnotes
- A sanitiser that meets this definition must comply with Part 3 of Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 only
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