Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019

I, Miranda Lauman, as delegate of the Minister for Health, make the following Order.

Dated 29 March 2019

Miranda Lauman

Contents

Part 1—Preliminary

1  Name

2  Commencement

3  Authority

4  Definitions

5  Standard

6  Application

7  Requirements

8  Repeals

Part 2—Requirements for disinfectants

Division 1General requirements

9  Approved names for ingredients etc

10  Stability data

11  Shelf life

12  Toxicity data

Division 2Performance requirements

13  Performance requirements for hospital grade disinfectants

14  Performance requirements for household grade disinfectants

Division 3Packaging requirements

15  Packaging of disinfectants

Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders

16  Labelling requirements

Schedule 1—Acceptable common names

Schedule 2Repeals

Therapeutic Goods Order No. 54 — Standard for Disinfectants and Sterilants

Part 1—Preliminary

1  Name

 (1) This instrument is the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.

 (2) This instrument may also be cited as TGO 104.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note:  This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under section 10 of the Therapeutic Goods Act 1989.

4  Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) batch;

(b) container;

(c) current Poisons Standard;

(d) label; and

(e) primary pack.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

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.

approved name means the name of an ingredient as included in the Australian Approved Names List.

Australian Approved Names List has the same meaning as in the Regulations.

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.

biocide means a physical or chemical agent that kills some or all types of micro‑organisms.

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.

disinfectant has the same meaning as in the Regulations.

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.

expiry date has the same meaning as in the Regulations.

hospital grade disinfectant has the same meaning as in the Regulations.

household grade disinfectant has the same meaning as in the Regulations.

Note:  Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.

Instructions means the TGA Instructions for Disinfectant Testing (March 2019) published by the Therapeutic Goods Administration, as in force or existing immediately before the commencement of this instrument.

Note: The Instructions are published at www.tga.gov.au.

main label means:

 (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

 (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.

name and address, in relation to a manufacturer or sponsor, means:

 (a) if the manufacturer or sponsor has a registered name:

 (i) that registered name; and

 (ii) the city, town or locality in which the registered office or registered place of business is situated; or

 (b) if the manufacturer or sponsor does not have a registered name (and including a manufacturer whose place of business is outside Australia):

 (i) the name of the manufacturer or sponsor; and

 (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.

Poisons Standard means the current Poisons Standard.

Regulations means the Therapeutic Goods Regulations 1990.

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.

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.

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.

sporicide has the same meaning as in the Regulations.

sterilant has the same meaning as in the Regulations.

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.

TGA Disinfectant Test means the test that is specified in Part 1 of the Instructions.

Therapeutic Goods Administration has the same meaning as in the Regulations.

trade name has the same meaning as in the Regulations.

tuberculocide has the same meaning as in the Regulations.

virucide has the same meaning as in the Regulations.

5  Standard

  This instrument constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.

6  Application

 (1) Subject to subsection (2), this instrument applies to therapeutic goods that are disinfectants, sanitisers, sanitary fluids and sanitary powders.

 (2) This instrument does not apply to therapeutic goods that are:

 (a) sterilants;

 (b) sterilant gases;

 (c) antiseptics and skin disinfectants;

 (d) antibiotics;

 (e) a disinfectant that is represented to be for antifungal use only;

 (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;

 (g) a disinfectant or sanitiser that is represented to be for the treatment of water only;

 (h) contact lens care products.

Note: A standard under section 10 of the Act does not apply to a medical device unless
Part 3-2 of the Act (Registration and listing of therapeutic goods) applies to the device: see section 10A of the Act.

7  Requirements

 (1) The requirements in relation to disinfectants are those requirements specified in Parts 2 and 3 of this instrument.

 (2) The requirements in relation to sanitisers, sanitary fluids and sanitary powders are those requirements specified in Part 3 of this instrument.

8  Repeals

  Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.

Part 2—Requirements for disinfectants

Division 1General requirements

9  Approved names for ingredients etc

 (1) A disinfectant may only contain ingredients with an approved name.

 (2) The physical form of a disinfectant must be appropriate for its intended use.

10  Stability data

 (1) Subject to subsections (2) and (3):

 (a) the physical and chemical stability; and

 (b) the microbial efficacy;

of a disinfectant must be established in accordance with the requirements in:

 (c) Division 1 of Part 2 of the Instructions; and

 (d) section 1 of Division 2 of Part 2 of the Instructions;

using the final formulation of the disinfectant when stored in its proposed container and packaging material for supply.

 (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.

 (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:

 (a) the container is composed of the same material as the proposed container for supply; and

 (b) either:

 (i) the ratio of surface area to volume of the container is the same as that of the proposed container for supply; or

 (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.

 (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).

11  Shelf life

  A disinfectant must not have a shelf life that is more than 5 years.

12  Toxicity data

  The safety of a disinfectant in relation to its toxicity must be established, and toxicity data for the disinfectant must include the following:

 (a) potential hazards to the user through accidental body contact;

 (b)  acute oral toxicity in concentrations equivalent to those likely to be encountered in use;

 (c) inhalation toxicity, skin irritation, sensitisation and eye irritation;

 (d)  haemocompatibility, sub-chronic toxicity, mutagenicity and carcinogenicity;

 (e)  any other forms of toxicity that are relevant in relation to the disinfectant and that may present a hazard.

Division 2Performance requirements

13  Performance requirements for hospital grade disinfectants

  General requirements

 (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:

 (a) at the highest dilution recommended on the label for that use; and

 (b) at the end of the shelf life for that use.

  Hospital grade disinfectants for general purpose use on surfaces

 (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:

 (a) pass either of the following tests:

 (i)  the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or

 (ii)  an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and

 (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Hospital grade disinfectants that are surface spray disinfectants

 (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:

 (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Disinfectant wipes or sponges for single use

 (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:

 (a) pass either of the following tests:

 (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test; or

 (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and

 (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Disinfectant wipes or sponges for multiple use

 (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.

  Disinfectant wipes or sponges for single use where disinfectant cannot be expressed

 (6) If the disinfectant is a disinfectant wipe or sponge for single use and:

 (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or

 (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;

then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:

 (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed

 (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:

 (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or

 (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;

then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:

 (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

 (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.

14  Performance requirements for household grade disinfectants

Note:  Household grade disinfectants may be marketed and labelled as being for household and/or commercial use.

  General requirements

 (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:

 (a) at the highest dilution recommended on the label for that use; and

 (b) at the end of the shelf life for that use.

  Household grade disinfectants for general purpose use on surfaces

 (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:

 (a) pass either of the following tests:

 (i) the TGA Disinfectant Test under the conditions specified in Option C of that test; or

 (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and

 (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and

 (c) if it is 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.

  Hospital grade disinfectants that are surface spray disinfectants

 (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:

 (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Disinfectant wipes or sponges for single use

 (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:

 (a) pass either of the following tests:

 (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test; or

 (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and

 (b) pass an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Disinfectant wipes or sponges for multiple use

 (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.

  Disinfectant wipes or sponges for single use where disinfectant cannot be expressed

 (6) If the disinfectant is a disinfectant wipe or sponge for single use and:

 (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or

 (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;

then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:

 (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and

 (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.

  Disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed

 (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and:

 (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or

 (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge;

then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must:

 (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

 (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.

Division 3Packaging requirements

15  Packaging of disinfectants

 (1) A disinfectant must be enclosed in a container that is suitably designed to ensure that the disinfectant is adequately protected and contained.

 (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.

Part 3—Requirements for disinfectants, sanitisers, sanitary fluids and sanitary powders

16  Labelling requirements

 (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.

 (2) Subject to subsections (3) and (4), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information:

 (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder;

 (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);

 (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder;

 (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;

 (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder;

 (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)”;

 (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;

 (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder;

 (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including:

 (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;

 (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods;

 (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;

 (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”;

 (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;

 (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation;

 (vii) for a disinfectant intended to be used on hard surfaces onlythe words “Hard surface disinfectant only” and “Not to be used on skin”;

 (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder.

 (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.

 (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:

 (a) the container or primary pack; or

 (b) a label attached to, or on, the container or primary pack.

 (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”.

 (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.

 (7) The information referred to in subsection (2) must be clearly visible and written:

 (a) in English; and

 (b) on the outer face of the label; and

 (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and

 (d) in metric units of measurement; and

 (e) in a colour or colours that will provide a distinct contrast to the background colour.

 (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.

 (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.

Schedule 1—Acceptable common names

Note: See section 4, definition of common name.

Schedule 2Repeals

Note: See section 8.

Therapeutic Goods Order No. 54 — Standard for Disinfectants and Sterilants

1  The whole of the instrument

Repeal the instrument.