Disinfectants: information for new sponsors

Test for microbial efficacy

All tests should be carried out by a GMP-licensed laboratory or laboratory accredited to ISO/IEC 17025 or equivalent, such as National Association of Testing Authorities, Australia (NATA), TGA, US FDA, PIC/S, US EPA, or NAMAS UK. 

To ensure a particular laboratory is accredited to perform the required testing, you are able to search through the NATA - external site using the test codes references in the disinfectant testing instructions. You may also contact laboratories directly for further discussions to ensure suitability.

If you are having trouble identifying suitable laboratories, you may wish to contact a regulatory affairs consultant.

Include a claim against COVID-19

Disinfectants that claim to be effective against COVID-19 will be asked to provide testing data that shows the product is effective against COVID-19, and must:

• have data that complies with the requirements of the TGA Instructions for Disinfectant Testing;
• use an acceptable surrogate virus to support the COVID-19 claim, and
• have evidence of adherence to Good Laboratory Practice.

Packaging and labelling requirements

Information about packaging and labelling requirements for disinfectants can be found in Division 3 of Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 Therapeutic Goods Order 104 and Guidance for listed disinfectants.

Review of disinfectant applications

While there are no statutory timeframes for disinfectant reviews, the TGA is currently expediting applications for disinfectants with specific claims against the COVID-19 virus. Whilst every effort is taken to expedite these applications, we still need to ensure the products meet the requirements of safety, quality and performance.

General claim against viruses

If you wish to include a general virucidal claim (such as "kills 99.9 % viruses"), the minimum testing requirement is testing using both poliovirus and herpes simplex. Parvovirus can be substituted for poliovirus. The TGA Instructions for Disinfectant Testing outlines the acceptable test methods.

Disinfectants that make virucidal claims are regulated as listed disinfectants.

Residual effect claims

A claim of residual activity (such as "protects for up to 24 hours") is considered to be a specific claim which requires review by the TGA. Disinfectants that make specific claims are regulated as listed disinfectants. 

All claims made about residual effectiveness must be substantiated with suitable test data. In December 2021 the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 was updated to include a definition of residual activity. 

The approved methodologies, acceptance criteria and maximum claim duration for a residual efficacy claim are outlined in the TGA Instructions for Disinfectant Testing. Disinfectants that claim residual efficacy must demonstrate compliance with these requirements.

Add a new ingredient to the TGA ingredient database

Ingredients included in the product's formulation must be identified using the relevant Australian Approved Names (AANs) or Proprietary Ingredient (PI) codes. If the formulation of the disinfectant contains ingredient(s) which do not have an AAN/PI you are required to submit a notification of a new proprietary ingredient form/proposed Australian Approved Name (AAN) application form.

New ingredient notifications are usually processed within 20-30 working days. Contact tganames@tga.gov.au for more information.

Virucidal claims

If a sanitiser includes claims against viruses, unless it is specifically for food surfaces, the product will be regulated as a disinfectant.

Statements such as "kills COVID-19 virus" are specific claims. Disinfectants that make specific claims are regulated as listed disinfectants.

Approved product claims against COVID-19

Refer to our list of disinfectants approved to make claims against the COVID-19 virus.

Report illegal or misleading advertisements

If you want to make a complaint about advertising directed to the public, see Report non-compliant advertising.

Application by fogging claim

For a sponsor to make a claim for fogging, specific instructions for use on how to apply the disinfectant to the room and ideally what size room could be treated should be included on the label for the disinfectant. Test data also should be submitted for review to validate the fogging method of application.

Manufacturing

All disinfectants are exempt from GMP requirements under Item 13 Schedule 7 of the Therapeutic Goods Regulation 1990).