Therapeutic Goods - disinfectants & sterilants
Also see Drugs and Poisons
Preparations labelled or promoted for use as disinfectants and
sterilants are subject to a Therapeutic Goods Order (TGO). Such goods
are subject to testing and labelling requirements as outlined in the Standard
for Composition Packaging Labelling and Performance of Disinfectants and
Antiseptics (TGO 54/54A).
Where the primary use is industrial, agricultural or veterinary, the
responsibility will be with NICNAS (section 0), National Registration Authority
(see section 0) or the Australian Quarantine Investigation Service respectively
though multiple applications may be required where there is overlap.
Scope
Products labelled as being a disinfectant are subject to registration
or listing on the Australian Register of Therapeutic Goods. Specific testing
and labelling requirements will be required for registrable products.
The TGO will apply to products which are primarily for use in human
situations (eg. hospitals, the home etc.)
Exempt
Exempt products include household disinfectants without virucidal, tuberculocidal,
fungicidal or sporocidal claims, sanitisers, detergents, laundry soaps
etc., the primary purpose of which is household and commercial cleaning,
deoderisers and cleaning wipes claiming an antibacterial action
Manufacturers
From January 1997, manufacturers of registrable or listable disinfectants
have to be licensed. Manufacturers, including overseas manufacturers, will
have to demonstrate compliance with Good Manufacturing Practice and assessed
by TGO.
Testing varies with the application such as hospital grade disinfectants
(as indicated on the label on the primary pack) is required to pass required
sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal tests
where specific activities are claimed.
Specific packaging and labelling requirements are defined including
the quantity of disinfectant, batch number, expiry date, name and addresses,
and use requirements.