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

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

(c) therapeutic goods.

  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

(c)           the primary pack must be designed, overwrapped or sealed in such a manner that tampering will be easily detected.

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

Endnote 3—Legislation history

Endnote 4—Amendment history