Disinfectant claim guide
The regulation of disinfectants depends on the claims made by the product on labels, packaging and product information leaflets including websites.
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 testing data that meets the requirements set out in the TGA instructions for disinfectant testing.
Note
The claim "antibacterial action is subject to an industry Code of Practice - contact your relevant industry association for more information.
Note
Products where claims are limited specifically to activity against "moulds" are excluded goods and are not regulated under the Therapeutic Goods Act 1989 and TGO 104.
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.
General cleaning products and sanitisers are only exempt in the absence of other listable claims. In addition, products that are intended exclusively for the destruction of moulds are excluded.
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'.
Note
Sponsors of disinfectant products must comply with the TGA Advertising Code at all times.
| Product type | Claim | Definition | Regulatory pathway |
|---|---|---|---|
|
Hospital grade disinfectant, Household / commercial grade disinfectant |
Active against polio |
Specific claim |
Listable |
|
Active against TB/kills TB |
Specific claim |
Listable |
|
|
Active against mycobacteria/kills mycobacteria |
Specific claim |
Listable |
|
|
Kills/destroys mould |
Specific claim |
Listable* |
|
|
Kills fungi (yeast and mould) |
Specific claim |
Listable |
|
|
Kills spores |
Specific claim |
Listable |
|
|
Kills viruses |
Specific claim |
Listable |
|
| Residual activity/efficacy | Specific claim | Listable | |
| Bacteriostatic action | Non-specific claim | Exempt* | |
|
Active against gram + or gram - bacteria |
Non-specific claim |
Exempt |
|
|
Controls/reduces/removes mould |
Non-specific claim |
Exempt* |
|
|
Effective against bacteria |
Non-specific claim |
Exempt |
|
|
Germicidal |
Non-specific claim |
Exempt |
|
|
Kills bacteria/germs |
Non-specific claim |
Exempt |
|
|
Kills bacterial growth |
Non-specific claim |
Exempt |
|
|
Kills E coli |
Non-specific claim |
Exempt |
|
|
Kills Pr vulgaris |
Non-specific claim |
Exempt |
|
|
Kills Ps aeruginosa |
Non-specific claim |
Exempt |
|
|
Kills S aureus |
Non-specific claim |
Exempt |
|
|
Kills S typhosa |
Non-specific claim |
Exempt, but testing must include S typhosa |
|
|
Kills/destroys salmonella |
Non-specific claim |
Exempt, Salmonella sp must be included in the test battery |
|
|
Sanitiser - as defined in TGO 104 |
Antibacterial action |
Non-specific claim |
Exempt* |
|
Bacteriostatic action |
Non-specific claim |
Exempt* |
|
|
Inhibits bacteria |
Non-specific claim |
Exempt* |
|
|
Removes/reduces bacteria |
Non-specific claim |
Exempt* |
|
|
Mildew control |
Non-specific claim |
Exempt* |
|
|
General cleaner General cleaner - wipe/sponge A sanitiser that does not meet the definition in TGO 104 and that does not make disinfectant or specific claims |
Kills/destroys mould/mildew |
Non-specific claim |
Excluded |
|
Anti-bacterial |
Not a regulated claim |
Not regulated by the TGA |
|
|
Reduces/removes bacteria |
Not a regulated claim |
Not regulated by the TGA |
|
|
Bacteriostatic/inhibits bacteria |
Not a regulated claim |
Not regulated by the TGA |
|
|
Deodorises |
General consumer product |
Not regulated by the TGA |
|
|
Kills/reduces bacteria within the wipe/sponge |
General consumer product |
Not regulated by the TGA |
* Only in the absence of other listable claims. Products that are intended exclusively for the destruction of moulds are excluded.