Disinfectant claim guide

The regulation of disinfectants depends on the claims made by the product on labels, packaging and product information leaflets.

Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as "specific claims". Products that make specific claims are required to be Listed in the ARTG prior to their supply. The testing set out in the TGA instructions for disinfectant testing must be conducted to validate specific claims.

Claims of general antibacterial action or activity against vegetative bacteria (excluding mycobacteria) covered by the battery of test organisms included in the TGA Disinfectant test, or bacteria of the same genus, are known as "non-specific claims". If label claims are made for vegetative bacterial species in addition to or other than those covered by the required test organisms, the testing as set out in the TGA instructions for disinfectant testing must be conducted using these additional organisms.

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. All claims made about residual effectiveness must be substantiated with suitable test data demonstrating the claims are true, valid and not misleading.

The following table provides a guide to commonly used claims for disinfectant products to assist sponsors in determining the regulatory pathway for a product, based on the claims made and the manufacturer’s intended use for the product.

This guide is not intended to be an exhaustive list of allowable claims. Sponsors may use other wording for claims that do not contradict the table, for example, claims for 'germicidal' action may be labelled as 'bactericidal'.

* Only if labelled as a disinfectant or sanitiser or where other antimicrobial claims are made. Products that are intended exclusively for the destruction of moulds are Excluded.