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Disinfectant Claim Guide - specific claims and non-specific claims

17 July 2019

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.

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.

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

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

Antibacterial action

Non-specific claim

Exempt*

Bacteriostatic action

Non-specific claim

Exempt*

Inhibits bacteria

Non-specific claim

Exempt*

Kills mould

Non-specific claim

Exempt*

Removes/reduces bacteria

Non-specific claim

Exempt*

Mildew control

Non-specific claim

Exempt*

General cleaner

Control/removal of mould/mildew

Non-specific claim

Excluded

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

General cleaner - wipe/sponge

Kills/reduces bacteria within the wipe/sponge

General consumer product

Not regulated by the TGA

* 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.