Standard for Disinfectants and Sterilants - Australian Government

Service summary

You may be required to comply with this standard if you intend to manufacture disinfectants and sterilants.

The standard details the requirements for the packaging, labelling, composition and performance of disinfectants and sterilants. The requirements are considered to be the minimum information that should appear on the label of a disinfectant or sterilant to ensure its safe use and to enable it to be traced to the sponsor and to a particular cycle of manufacture if the need arises. It applies to all disinfectants, sterilants, sanitisers and sanitary preparations except:

  • Sterilant gases;
  • Antiseptics and skin disinfectants;
  • Antibiotics;
  • A disinfectant that is represented to be suitable for antifungal use only;
  • A disinfectant or sanitiser registered under the Agricultural and Veterinary Chemicals Code Act 1994 for which no claim or representation for disinfectant use is made other than a use which is registered for the disinfectant;
  • A disinfectant or sanitiser that is represented to be suitable for the treatment of water only; and
  • Contact lens care products.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants 1996 (Australian Government)

Contact details

Information Officer
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
PO Box 100
Woden
Australian Capital Territory 2606

Phone:

02 62328644

Phone:

1800020653

Fax:

02 62031605
info@tga.gov.au

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