Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01546 In force Legislative Instrument

Select Document

made under subsection 10(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 7 September 2023

Includes amendments up to: F2023L01190

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018 that shows the text of the law as amended and in force on 7 September 2023 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

1 Name

3 Authority

4 Definitions

5 Application

6 Permissible Raw Materials

7 Design Requirements

8 Packaging

9 Labelling

10 Information to be supplied with menstrual cups

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

1 Name

(1) This instrument is the Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018.

(2) This instrument may also be cited as Therapeutic Goods Order 99, or TGO 99.

3 Authority

This instrument is made under subsection 10(1) of the Act.

4 Definitions

Note: A number of expressions used in this instrument are defined in definitions section of the Act, including the following:

(a) Secretary;

(b) sponsor;

In this instrument:

Act means the Therapeutic Goods Act 1989.

batch means a quantity of menstrual cups which, as far as practicable, consists of material or items of the same type, grade, class and composition, which have been manufactured under essentially the same conditions within a specified period of time.

Menstrual cup means a product made from permissible raw materials that is inserted into the vagina and used to collect or capture menstrual discharge.

Packaging means any of the following layers:

unit pack (the pack enclosing a single menstrual cup);
primary pack (the pack containing one or more unit packs);
supply pack (the pack that is supplied to the consumer). The supply pack may consist of a single primary pack, or may contain one or more primary packs; or

5 Application

(1) The requirements set out in this instrument apply to all therapeutic goods that are menstrual cups.

6 Permissible Raw Materials

(1) Menstrual cups must be manufactured from materials that are suitable for the intended purpose of the menstrual cup.

(2) Menstrual cups must not contain ingredients in sufficient concentration to cause a toxic or irritant reaction when used as directed.

7 Design Requirements

(1) The surface and shape of a menstrual cup must be smooth and designed to minimise the risk of trauma.

8 Packaging

(1) The following requirements apply to the packaging for menstrual cups:

(a) the menstrual cup must be packed in a closed unit pack that is capable of maintaining the menstrual cup’s quality until the unit pack is opened by the consumer; and

(b) the unit pack must be packed in a primary pack which is sufficiently robust to maintain the integrity of, and protect, the menstrual cup during normal transport and storage; and

9 Labelling

(1) The primary pack must be permanently and legibly marked with the following information:

(a) words identifying the brand name;

(b) the name and address of the manufacturer or supplier;

(c) if the primary pack contains more than one unit pack, the name and quantity of all the menstrual cups within the primary pack;

(d) the batch number of the menstrual cup(s), identified with the use of the words “Batch No.” or “Lot No.”;

(e) words identifying the size (if applicable) of the menstrual cup; and

(f) the following warning in letters with a height of not less than 1mm:

“IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information.”

10 Information to be supplied with menstrual cups

(1) The following information must be supplied with the menstrual cup, in a form that is legible and accessible to the consumer:

(a) the manufacturer’s or supplier’s identifying information, including their name and address;

(b) an information leaflet containing the following information:

(i) detailed instructions for use, including the need for hygiene and care in insertion;

(ii) a limit to the duration of use, not exceeding 12 hours;

(iii) detailed instructions for cleaning and maintaining the integrity of the menstrual cup;

(iv) a notification that the menstrual cup is not supplied in a sterile state;

(v) information about Toxic Shock Syndrome, noting that while it is rarely associated with the use of menstrual cups, it can still occur;

(vi) the following warning in letters with a height of not less than 1mm:

“IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information.”

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2—Abbreviation key

ad = added or inserted	orig = original
am = amended	par = paragraph(s)/subparagraph(s)
amdt = amendment	/sub‑subparagraph(s)
c = clause(s)	pres = present
C[x] = Compilation No. x	prev = previous
Ch = Chapter(s)	(prev…) = previously
def = definition(s)	Pt = Part(s)
Dict = Dictionary	r = regulation(s)/rule(s)
disallowed = disallowed by Parliament	reloc = relocated
Div = Division(s)	renum = renumbered
exp = expires/expired or ceases/ceased to have	rep = repealed
effect	rs = repealed and substituted
F = Federal Register of Legislation	s = section(s)/subsection(s)
gaz = gazette	Sch = Schedule(s)
LA = Legislation Act 2003	Sdiv = Subdivision(s)
LIA = Legislative Instruments Act 2003	SLI = Select Legislative Instrument
(md not incorp) = misdescribed amendment	SR = Statutory Rules
cannot be given effect	Sub‑Ch = Sub‑Chapter(s)
mod = modified/modification	SubPt = Subpart(s)
No. = Number(s)	underlining = whole or part not
o = order(s)	commenced or to be commenced
Ord = Ordinance

Endnote 3—Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
Therapeutic Goods (Standard for Menstrual Cups) Order 2018	6 Nov 2018 (F2018L01546)	7 Nov 2018	—
Therapeutic Goods (Standard for Menstrual Cups) Amendment Order 2023	6 Sep 2023 (F2023L01190)	7 Sep 2023	—

Endnote 4—Amendment history

Provision affected	How affected
s 1………………………………..	am F2023L01190
s 2………………………………..	rep LA s 48D
s 10………………………………	am F2023L01190

Overview

The Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018, made under subsection 10(1) of the Therapeutic Goods Act 1989, was introduced to establish standards for menstrual cups, which are therapeutic goods used for collecting menstrual discharge. The order aims to ensure the safety, quality, and efficacy of menstrual cups by setting requirements for their raw materials, design, packaging, labelling, and accompanying information. The enacting body is the Parliament of Australia, and the primary policy objective is to protect public health by ensuring menstrual cups are safe and properly labelled, thereby reducing the risk of adverse health effects such as Toxic Shock Syndrome (TSS). This legislative instrument applies to all therapeutic goods classified as menstrual cups and mandates that they must be made from suitable materials that do not cause toxic or irritant reactions when used as directed. It specifies design requirements to minimise the risk of trauma and sets out stringent packaging and labelling standards to ensure the cups are protected and their contents are clearly identified. Additionally, manufacturers and suppliers are required to provide comprehensive information leaflets with each menstrual cup, including instructions for use, cleaning, and hygiene practices, as well as warnings about the potential risks associated with their use.

Scope and Application

The Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018 applies to all therapeutic goods that are menstrual cups, governing the permissible raw materials, design requirements, packaging, labelling, and information that must be supplied with these products. This legislative instrument is applicable nationally across Australia, ensuring that menstrual cups meet certain safety and quality standards. The order specifies that menstrual cups must be made from materials suitable for their intended use and free from ingredients that could cause toxic or irritant reactions when used as directed. It also mandates specific design features to minimise the risk of trauma, robust packaging to maintain product integrity, and clear labelling that includes critical information such as brand name, manufacturer details, batch number, and warnings about the potential risk of Toxic Shock Syndrome (TSS). Additionally, the order requires detailed information leaflets to be provided with each menstrual cup, detailing usage instructions, hygiene practices, and warnings. The order's provisions can be extended or modified through subordinate instruments, ensuring that it remains relevant and effective in regulating menstrual cup standards.

Key Provisions

The Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018 outlines the standards that menstrual cups must adhere to in Australia. This legislative instrument is made under the Therapeutic Goods Act 1989 and came into effect on 7 November 2018. The primary sections of this order, such as sections 6, 7, 8, 9, and 10, detail the permissible raw materials, design requirements, packaging, labelling, and the information that must be supplied with menstrual cups, respectively. These sections provide clear guidelines on the materials and processes that must be followed to ensure the safety and effectiveness of menstrual cups. Section 6 mandates that menstrual cups must be made from suitable materials that do not cause toxic or irritant reactions, and section 7 specifies the design requirements, such as ensuring the surface and shape of the menstrual cup are smooth to reduce the risk of trauma. Section 8 requires that menstrual cups be packaged in a way that maintains their quality until opened by the consumer, and section 9 stipulates that the primary pack must be clearly labelled with essential information, including the brand name, manufacturer's details, batch number, and a warning about Toxic Shock Syndrome (TSS). Section 10 mandates that an information leaflet with detailed instructions and warnings be supplied with each menstrual cup. The Act imposes specific obligations on parties involved in the manufacturing and supply of menstrual cups. Manufacturers and suppliers must ensure that their products meet the standards set out in the order. This includes using permissible raw materials, adhering to design requirements, properly packaging and labelling their products, and providing the necessary information leaflets. The Act also requires that all information provided on packaging and in accompanying leaflets be accurate and legible, ensuring consumers can easily access and understand the necessary information. Failure to comply with these requirements can result in serious health risks, as improper use or contamination of menstrual cups can lead to infections, including TSS. Breaches of the standards set by the Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018 can result in significant legal consequences. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for non-compliance. Civil penalties can include fines up to a substantial amount, as specified by the Act, and in severe cases, criminal penalties may apply. These can include fines and imprisonment for individuals and corporations found guilty of manufacturing or supplying non-compliant therapeutic goods. Additionally, the Act allows for the recall of non-compliant products and the potential for the Therapeutic Goods Administration (TGA) to take enforcement actions against offending parties. These measures are in place to ensure the safety and well-being of consumers using menstrual cups and to maintain the integrity of the therapeutic goods market in Australia.

Area of Law: Medical Law
Instrument: Legislative Instrument
Concepts: Definitions & Interpretation; Design Requirements; Labelling

Interactions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

Legislation content

Overview

Scope and Application

Key Provisions

Legal classification tags

Interactions

Authorises

All Versions