{"id":"F2019L00482","name":"Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019","slug":"therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":99082,"registerId":"commonwealth-F2019L00482-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Standard","content":"#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Application","content":"#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Requirements","content":"#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.","sortOrder":6},{"sectionNumber":"Part 2","sectionType":"part","heading":"Requirements for disinfectants","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":7},{"sectionNumber":"Division 1","sectionType":"division","heading":"General requirements","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":8},{"sectionNumber":"9","sectionType":"section","heading":"Approved names for ingredients etc","content":"#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.","sortOrder":9},{"sectionNumber":"10","sectionType":"section","heading":"Stability data","content":"#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).","sortOrder":10},{"sectionNumber":"11","sectionType":"section","heading":"Shelf life","content":"#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.","sortOrder":11},{"sectionNumber":"12","sectionType":"section","heading":"Toxicity data","content":"#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.","sortOrder":12},{"sectionNumber":"Division 2","sectionType":"division","heading":"Performance requirements","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":13},{"sectionNumber":"13","sectionType":"section","heading":"Performance requirements for hospital grade disinfectants","content":"#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.","sortOrder":14},{"sectionNumber":"14","sectionType":"section","heading":"Performance requirements for household grade disinfectants","content":"#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.","sortOrder":15},{"sectionNumber":"14A","sectionType":"section","heading":"Performance requirements for hospital and household grade disinfectants—residual activity","content":"#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.","sortOrder":16},{"sectionNumber":"Division 3","sectionType":"division","heading":"Packaging requirements","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":17},{"sectionNumber":"15","sectionType":"section","heading":"Packaging of disinfectants","content":"#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.","sortOrder":18},{"sectionNumber":"Part 3","sectionType":"part","heading":"Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":19},{"sectionNumber":"16","sectionType":"section","heading":"Labelling requirements","content":"#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.","sortOrder":20},{"sectionNumber":"Part 4","sectionType":"part","heading":"Transitional","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.\n  (2) This instrument may also be cited as TGO 104.\n\n#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) batch;\n    (b) container;\n    (c) current Poisons Standard;\n    (d) label; and\n    (e) primary pack.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> antibacterial clothes preparation means a disinfectant that is represented to be capable of reducing the number of viable micro‑organisms in water in which clothes are soaked, washed or rinsed.\n\n> approved name means the name of an ingredient as included in the Australian Approved Names List.\n\n> Australian Approved Names List has the same meaning as in the Regulations.\n\n> batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, to identify uniquely that batch, and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\n> biocide means a physical or chemical agent that kills some or all types of micro‑organisms.\n\n> common name, in relation to the goods listed in column 2 of an item in the table in Schedule 1 to this instrument, means the name or names listed in column 3 of that item.\n\n> disinfectant has the same meaning as in the Regulations.\n\n> disinfectant wipe or sponge means a cloth, towel, towelette or sponge that is pre-moistened with a disinfectant and is recommended by its manufacturer for application of the disinfectant to an inanimate object to kill microorganisms.\n\n> expiry date has the same meaning as in the Regulations.\n\n> hospital grade disinfectant has the same meaning as in the Regulations.\n\n> household grade disinfectant has the same meaning as in the Regulations.\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n> Instructions means the TGA instructions for disinfectant testing (Version 4.0, August 2025) published by the Therapeutic Goods Administration, as in force or existing on 11 August 2025.\n\n> Note: The Instructions are published at www.tga.gov.au.\n\n> main label means:\n\n    (a) where there are two or more labels, or two or more portions of a single labelthat label, or portion of the label, where the trade name (or, where there is no trade name, the name of the goods), is more or most prominent; or\n    (b) where the trade name (or where there is no trade name, the name of the goods) is equally prominent on two or more labels, or portions of a labeleither of such label or portion.\n\n> name and address, in relation to a manufacturer or sponsor, means:\n\n    (a) if the manufacturer or sponsor has a registered name:\n    (i) that registered name; and\n    (ii) the city, town or locality in which the registered office or registered place of business is situated; or\n    (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):\n    (i) the name of the manufacturer or sponsor; and\n    (ii) the address of the principal place of business of that manufacturer or sponsor including, where applicable, the street number, street name, the town or city, and the State or Territory in Australia or the name of the overseas country, as the case may be, but not including a post office, cable, telegraphic or code address.\n\n> Poisons Standard means the current Poisons Standard.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> residual activity means the capability of a disinfectant to continue to reduce the number of viable cells of relevant test organisms on a surface, when the disinfectant is used in accordance with the information provided on the label of the disinfectant.\n\n> sanitary fluid means a fluid that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitary powder means a powder that is a chemical agent that is represented to be suitable for use in the charging of sanitary units used for the storage or disposal of human waste and which is not represented to be suitable for any other use.\n\n> sanitiser means a chemical agent that is represented to be suitable for use on surfaces with which food for human consumption may come in contact, for the purposes of reducing pathogenic or food‑spoilage micro‑organisms to a sanitary level on such a surface.\n\n> sporicide has the same meaning as in the Regulations.\n\n> sterilant has the same meaning as in the Regulations.\n\n> surface spray disinfectant means a disinfectant that is represented to be suitable for use undiluted as a spray and that is not represented to be suitable for any other method of use.\n\n> TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.\n\n> trade name has the same meaning as in the Regulations.\n\n> tuberculocide has the same meaning as in the Regulations.\n\n> virucide has the same meaning as in the Regulations.\n\n#### 5 Standard\n\n  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.\n\n#### 6 Application\n\n  (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.\n  (2) This instrument does not apply to therapeutic goods that are:\n\n(a) sterilants;\n\n(b) sterilant gases;\n\n(c) antiseptics and skin disinfectants;\n\n(d) antibiotics;\n\n(e) a disinfectant that is represented to be for antifungal use only;\n\n(f) 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 for which the disinfectant is registered under that Act;\n\n(g) a disinfectant or sanitiser that is represented to be for the treatment of water only;\n\n(h) contact lens care products.\n\n> Note: A standard under section 10 of the Act does not apply to a medical device unless  \n> Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.\n\n#### 7 Requirements\n\n  (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.\n  (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.\n\n  \n\n## Part 2—Requirements for disinfectants\n\n### Division 1General requirements\n\n#### 9 Approved names for ingredients etc\n\n  (1) A disinfectant may only contain ingredients with an approved name.\n  (2) The physical form of a disinfectant must be appropriate for its intended use.\n\n#### 10 Stability data\n\n  (1) Subject to subsections (2) and (3):\n    (a) the physical and chemical stability; and\n    (b) the microbial efficacy;\n  of a disinfectant must be established in accordance with the requirements in:\n    (c) Division 1 of Part 2 of the Instructions; and\n    (d) section 1 of Division 2 of Part 2 of the Instructions;\n  using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.\n  (2) Laboratory batches of a disinfectant may be used for the purposes of subsection (1), provided that those batches properly reflect the scaled-up production process for the manufacture of the disinfectant for supply.\n  (3) If batches of a disinfectant have been stored in a container that is not the container that is intended for supply, that container may be used for the purposes of subsection (1), if:\n    (a) the container is composed of the same material as the proposed container for supply; and\n    (b) either:\n    (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or\n    (ii) the ratio of surface area to volume of the container is different to that of the proposed container for supply, but this difference is justified.\n  (4) The physical and chemical stability of a production batch of a disinfectant must also be established in accordance with the requirements in Division 1 of Part 2 of the Instructions, including in relation to any changes made to the manufacturing process for the disinfectant, or the quality of a raw material used in its manufacture, after the establishment of the disinfectant’s stability in accordance with subsections (1) to (3).\n\n#### 11 Shelf life\n\n  A disinfectant must not have a shelf life that is more than 5 years.\n\n#### 12 Toxicity data\n\n  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:\n    (a) potential hazards to the user through accidental body contact;\n    (b) acute oral toxicity in concentrations equivalent to those likely to be encountered in use;\n    (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;\n    (d) haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;\n    (e) any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.\n\n### Division 2Performance requirements\n\n#### 13 Performance requirements for hospital grade disinfectants\n\n  General requirements\n  (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Hospital grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for single use\n  (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass any of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test;\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions;\n    (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use\n  (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14 Performance requirements for household grade disinfectants\n\n> Note: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.\n\n  General requirements\n  (1) A household grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested:\n    (a) at the highest dilution recommended on the label for that use; and\n    (b) at the end of the shelf life for that use.\n  Household grade disinfectants for general purpose use on surfaces\n  (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must:\n    (a) pass one of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; or\n    (iii) an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a household grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectants that are surface spray disinfectants\n  (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for single use\n  (4) Subject to paragraph (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (a) pass either of the following tests:\n    (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or\n    (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and\n    (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and\n    (c) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use\n  (5) Subject to paragraph (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol.\n  Household grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed\n  (6) If the disinfectant is a disinfectant wipe or sponge for single use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n  Household grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed\n  (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:\n    (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or\n    (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;\n  then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:\n    (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and\n    (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.\n\n#### 14A Performance requirements for hospital and household grade disinfectants—residual activity\n\n  If a claim of residual activity is made in relation to a disinfectant, the claim must:\n    (a) only relate to bacteria, yeast or viruses; and\n    (b) be based on residual activity that is established in accordance with the requirements in Division 2 of Part 2 of the Instructions.\n\n### Division 3Packaging requirements\n\n#### 15 Packaging of disinfectants\n\n  (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.\n  (2) If the disinfectant is, or contains a substance that is, included in a Schedule to the Poisons Standard, then the container for the disinfectant must comply with any applicable requirements in relation to such a container specified in the Poisons Standard.\n\n## Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders\n\n#### 16 Labelling requirements\n\n  (1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard.\n  (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:\n    (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name);\n    (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”;\n    (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning;\n    (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;\n    (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:\n    (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed;\n    (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;\n    (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except \\[name of detergent or chemical\\] as directed below”, together with directions in relation to the safe use of such a mix;\n    (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”;\n    (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent;\n    (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;\n    (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”;\n    (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.\n  (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label.\n  (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on:\n    (a) the container or primary pack; or\n    (b) a label attached to, or on, the container or primary pack;\n  instead of being set out on the main label.\n  (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.\n  (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution.\n  (7) The information referred to in subsection (2) must be clearly visible and written:\n    (a) in English; and\n    (b) on the outer face of the label; and\n    (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and\n    (d) in metric units of measurement; and\n    (e) in a colour or colours that will provide a distinct contrast to the background colour.\n  (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n  (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.\n\n## Part 4—Transitional\n\n#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":21},{"sectionNumber":"17","sectionType":"section","heading":"Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021","content":"#### 17 Transitional arrangements relating to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021\n\n  Despite the amendments made by items 2 and 5 of Schedule 1 to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Amendment (Residual Activity) Order 2021, those amendments do not apply for the period from their commencement on 1 January 2022 to 30 June 2022 in relation to:\n    (a) disinfectants included in the Register before 1 January 2022; and\n    (b) disinfectants included in the Register on or after 1 January 2022, on the basis of an application for listing in the Register under section 26 of the Act made before 1 January 2022.\n\n  \n\nSchedule 1—Acceptable common names\n\nNote: See section 4, definition of common name.\n\n```html\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:403.5pt; margin-left:6pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:392.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Acceptable common names</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Descriptive name</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Common names</span></p></td></tr></thead><tbody><tr><td style=\"width:46.6pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:165.25pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>antibacterial clothes preparation</span></p></td><td style=\"width:159.4pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:165.25pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span>disinfectant wipe or sponge</span></p></td><td style=\"width:159.4pt; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant wipe or disinfectant sponge – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – disinfectant wipe or disinfectant sponge</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – disinfectant wipe or disinfectant sponge</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>hospital grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note:</span><span style=\"width:10.1pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant - hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade disinfectant</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 1:</span><span style=\"width:3.35pt; text-indent:0pt; font-size:9pt; display:inline-block\"> </span><span style=\"font-size:9pt\">If the disinfectant is primarily for use as a spray</span><span style=\"font-family:Symbol, serif; font-size:9pt\"></span><span style=\"font-size:9pt\">see item 8</span></p><p class=\"Tabletext\" style=\"margin-left:30.1pt; text-indent:-30.1pt\"><span style=\"font-size:9pt\">Note 2: Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>disinfectant – household grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>household grade disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span></span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary fluid</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitary powder</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>sanitiser</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>sanitiser</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>sanitising solution</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>antibacterial (together with a word or words indicating the nature of the goods)</span></p></td></tr><tr><td style=\"width:46.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:165.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>surface spray disinfectant</span></p></td><td style=\"width:159.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(a)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>commercial grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(b)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>hospital grade – surface spray – disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(c)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>household grade – surface spray disinfectant</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(d)</span><span style=\"width:11.34pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – commercial grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(e)</span><span style=\"width:11.9pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – hospital grade</span></p><p class=\"Tabletext\" style=\"margin-left:23pt; text-indent:-23pt\"><span>(f)</span><span style=\"width:13.01pt; text-indent:0pt; display:inline-block\"> </span><span>surface spray disinfectant – household grade</span></p></td></tr></tbody></table>\n```","sortOrder":22}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This instrument retains the original purpose of setting a standard for disinfectants and related sanitary products, but subsequent amendments and the current drafting have increased its technical scope and prescriptiveness. Concretely: (a) it now contains explicit, technology‑specific performance-testing requirements (including multiple Options of the TGA Disinfectant Test and acceptance of \"equivalent\" tests) and ties those tests to labelling obligations (sections 13–14, 14A, 16(8)–(9)); (b) it adds a defined residual‑activity rule that restricts permissible residual claims and requires demonstrable supporting data (section 14A); (c) it formalises detailed stability, toxicity and packaging rules (sections 10–12, 15) and cross-references the TGA Instructions (an external, regularly updated technical instrument). The transitional provision (section 17) records that amendments (Residual Activity Order 2021) changed requirements and needed a grandfathering window. Those changes make the instrument more technically prescriptive and increase compliance obligations beyond the simpler rule‑setting that might have been the Act’s original baseline."},"complexity_factors":["Extensive definitions section cross-referencing the Therapeutic Goods Regulations and Poisons Standard (section 4).","Dependence on an external technical document: TGA Instructions for disinfectant testing (Version 4.0, August 2025) — creates an external source of detailed rules and options (defined in s4; used throughout, e.g. s10, s13–14A).","Multiple conditional branches for product type and format in performance tests: hospital v household; surface spray v general purpose; wipes/sponges single v multiple use (sections 13–14).","Multiple test options and equivalents (TGA Disinfectant Test Options A/B/C or an \"appropriate\" equivalent) introducing interpretive discretion (sections 13–14).","Detailed labelling requirements with many subitems, formatting and language rules (section 16, subsections (2)–(7)).","Toxicology data list requiring multiple complex endpoints (haemocompatibility, sub‑chronic toxicity, mutagenicity, carcinogenicity) (section 12).","Transitional carve-out with time-limited application to listed products and pending applications (section 17) increases administrative complexity. ","Schedule 1 table of acceptable common names that must be used for labelling (Schedule 1).","Packaging rules tied to Poisons Standard schedules (section 15(2)), adding cross-regulatory compliance obligations.","Repetition of similar conditional rules across hospital/household and wipe/spray permutations (sections 13–14 and subsections) creating many permutations to check for compliance. "],"plain_english_summary":"**What this instrument does (mechanically)**\n\n- Establishes a mandatory standard for disinfectants, sanitisers, sanitary fluids and sanitary powders that are regulated as therapeutic goods (the instrument is called TGO 104). (see: sections 5–7)\n- Sets definitional rules and an accepted list of \"common names\" for product types (Schedule 1; definitions in section 4).  \n- Requires that disinfectant formulations only contain ingredients with an approved name (section 9).  \n- Requires stability and efficacy data using the final formulation and proposed packaging, and allows limited use of representative laboratory batches (section 10).  \n- Caps maximum labelled shelf life at 5 years for disinfectants (section 11).  \n- Requires specified toxicity/safety data to be established for disinfectants (skin/eye/inhalation toxicity; haemocompatibility; mutagenicity; carcinogenicity; etc.) (section 12).  \n- Imposes minimum performance/testing requirements depending on product grade and format (hospital grade v household grade; surface sprays; wipes/sponges; single v multiple use). Tests required are either the TGA Disinfectant Test (Options A/B/C) or an equivalent test specified in the TGA Instructions (sections 13–14, and definition of TGA Disinfectant Test in section 4).  \n- Limits and controls claims of \"residual activity\" so that such claims must relate only to bacteria, yeast or viruses and must be supported by testing in the TGA Instructions (section 14A).  \n- Requires products to be supplied in appropriate containers and to meet any Poisons Standard container requirements where relevant (section 15).  \n- Prescribes detailed labelling requirements (trade name and common name, active ingredient names and concentrations, quantity, batch number, expiry date, manufacturer/sponsor name & address, instructions for use, warnings and specific mandatory statements in some cases). It also prescribes minimum legibility, language and formatting rules and forbids labelling a household grade product as \"hospital grade\" (section 16).  \n- Contains a short transitional (grandfathering) provision for amendments dealing with residual activity so some already-registered products and applications received before 1 January 2022 were given a time-limited exemption (section 17).\n\n(External technical methods and options referenced in this instrument are the TGA instructions for disinfectant testing (Version 4.0, August 2025), the Poisons Standard and the Therapeutic Goods Regulations — the Order depends on those documents for detail on test methods and some packaging/poison-related requirements.) (see: definitions in section 4 and cross-references in sections 10, 13, 15, 16)\n\n**Who this affects**\n\n- Manufacturers, importers and sponsors of disinfectants, sanitisers, sanitary fluids and sanitary powders who supply those products as therapeutic goods (sections 6–7, 16). They must provide data, arrange testing, and change labels/packaging to comply.  \n- Test laboratories and contract research organisations that will perform the required stability, efficacy and toxicity testing under the TGA-specified Instructions (sections 10, 13–14A, and the definition of TGA Disinfectant Test).  \n- Distributors and packers who must ensure packaging/engraving/label layout meet the instrument’s rules (sections 15 and 16).  \n- Purchasers/consumers and institutional buyers (hospitals, food premises) insofar as product claims, required warnings and instructions on labels change (section 16; pre-cleaning statements in subsections 16(8)–(9)).\n\n**Why it matters (claimed purpose, and how it is implemented mechanically)**\n\n- The instrument purports to ensure disinfectants and related products supplied as therapeutic goods are safe, stable and effective for the claims made on their labels. That is implemented by requiring manufacturers to hold stability and microbial efficacy data (s10), toxicity data (s12), and to demonstrate performance against TGA tests or accepted equivalents before a claim can be made (s13–14).  \n- It seeks to reduce misleading claims and make product use safer by: (a) prescribing accepted common names for product types (Schedule 1 / s4), (b) forbidding household products being labelled as \"hospital grade\" (s16(5)), (c) limiting residual-activity claims to specified organism groups and linking those claims to specified tests (s14A), and (d) requiring explicit label statements (pre-cleaning, dilution instructions, warnings) where tests were carried out under certain conditions (s16(8)–(9), s16(2)(i)).\n\n**Testing those purpose-claims against practical trade-offs and implementation mechanics**\n\n- Compliance costs and who pays: The instrument places the costs of generating stability, efficacy and toxicology data on manufacturers/sponsors (s10, s12, s13–14). For many products this will require laboratory programmes, potentially GLP testing, and, for some toxicity endpoints, substantial toxicology studies. Smaller suppliers face proportionally higher fixed costs.  \n- Market effects and entry: Because the instrument requires specified test performance or accepted equivalents, market entry for new products will require access to qualified labs and may favour larger suppliers with in‑house or contracted testing capacity. The requirement to use approved ingredient names (s9) and established test methods (Instructions) reduces uncertainty on regulators’ expectations but raises the upfront compliance hurdle.  \n- Regulatory dependence and discretion: Many operative rules refer to external documents that the TGA maintains — notably the TGA Instructions (defined in s4) and the Poisons Standard (s16(1), s15(2)). This design concentrates technical decision-making in the TGA (and in the authors of the Instructions) and creates a moving boundary: compliance depends on the version of the Instructions in force (the instrument fixes an Instructions version date in the definition).  \n- Testing detail and interpretive space: The Order accepts either the TGA Disinfectant Test (Options A/B/C) or an \"appropriate test equivalent\" as specified in the Instructions (s13(2)(a), s14(2)(a)). The phrase \"appropriate\" and the option of an equivalent test leave evaluative judgment to the Instructions/TGA, which can be helpful (technical flexibility) but increases legal and operational uncertainty for sponsors until the Instructions and TGA guidance are clear.  \n- Claim restriction trade-offs: Limiting residual activity claims to bacteria, yeast or viruses (s14A) narrows marketing language and requires sponsors to demonstrate any such claim to specified standards; that reduces scope for ambiguous marketing but may constrain product differentiation that relied on broader or different residual-activity claims.  \n- Label and packaging friction: The Order requires detailed label content, minimum character size, language, and specific statements for certain test conditions (s16). Those rules will require relabelling, repackaging and potentially redesign of primary packs — direct cost to suppliers and packaged‑goods supply chains; benefit to purchasers is clearer information at point of use.  \n- Transitional relief: The transitional provision (s17) carves out a limited grandfathering window for residual-activity amendments for products listed or applied for listing before 1 January 2022 — which reduces immediate disruption for existing listings but imposes a deadline for new compliance.  \n- Implementation risk: The Order depends on laboratory capacity to perform TGA-specified tests and on the clarity of the Instructions. Bottlenecks in accredited test capacity, varying international standards that are claimed as \"equivalent\", and disputes about whether a test is \"appropriate\" are practical risks.\n\n**Concrete behavioural effects**\n\n- Manufacturers will need to commission stability and efficacy studies using final formulation + packaging (s10), prepare comprehensive toxicity dossiers (s12), and ensure performance testing is carried out at the highest dilution recommended and at end of shelf life (s13(1)).  \n- Sponsors must change labels to include mandatory statements (s16(2)–(7)), must not call household products \"hospital grade\" (s16(5)), and must, where relevant, add warnings that surfaces must be pre‑cleaned (s16(8)–(9)).  \n- Firms may narrow or withdraw some product claims (e.g., residual activity not supported by the specified tests) rather than invest in expensive testing programs (s14A).  \n\n**Key provisions to read first if you are a supplier**\n\n- Definitions and cross-references (section 4) — identifies the TGA Instructions, Poisons Standard and Regulations that supply technical detail.  \n- Performance & testing (sections 13–14 and 14A) — spells out tests required for claims.  \n- Stability, shelf life and toxicity (sections 10–12) — sets data expectations.  \n- Labelling & packaging (sections 15–16) — sets mandatory label content, format and container rules.  \n- Transitional rules (section 17) — indicates limited grandfathering for residual activity amendments.\n\n"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"_metrics":{"completionTokens":612},"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The legislation appears consistent with its original purpose as a technical standard for disinfectants and sanitary products. The 2021 amendment regarding residual activity was incorporated with transitional arrangements, but this represents a natural evolution of the standard rather than scope creep."},"complexity_factors":["Extensive cross-referencing to external documents (TGA Instructions for Disinfectant Testing Version 4.0, Therapeutic Goods Regulations 1990, Poisons Standard)","Multiple nested conditional requirements based on product type (hospital vs household grade, surface spray vs general purpose, wipes/sponges vs liquids)","Detailed labelling specifications with 9 mandatory information categories and multiple sub-requirements","Parallel but slightly different testing requirements for hospital grade (Options A/B) vs household grade (Option C)","Exception handling for wipes/sponges where disinfectant cannot be expressed from the substrate","Transitional provisions referencing amendments from 2021 with specific date-based carve-outs","Definitions section with 25+ defined terms, many referencing other legislation"],"plain_english_summary":"The TGO 104 Order 2019 is an Australian legal standard that governs how disinfectants, sanitisers and sanitary fluids/powders are formulated, tested, packaged and labelled. It applies to makers and suppliers serving healthcare, commercial and household markets and sets mandatory rules to ensure products are effective, safe and accurately claimed. Compliance protects users and supports consistent public‑health outcomes."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019","history":"/api/acts/therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019/history","analysis":"/api/acts/therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-disinfectants-and-sanitary-products-tgo-104-order-2019/documents"}}