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(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.
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This Order sets mandatory product standards for menstrual cups classified as therapeutic goods. It requires suitable non‑toxic materials, a smooth design to minimise trauma, tamper‑evident packaging, batch traceability, specified labelling including a Toxic Shock Syndrome (TSS) warning, and a consumer information leaflet with cleaning instructions and a maximum 12‑hour use limit. It affects manufacturers, sponsors, importers and suppliers who must meet these obligations and consumers who receive the mandated safety information.
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Direct links to the current provisions in Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018.
(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.
This instrument is made under subsection 10(1) of the Act.
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:
(1) The requirements set out in this instrument apply to all therapeutic goods that are menstrual cups.
(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.
(1) The surface and shape of a menstrual cup must be smooth and designed to minimise the risk of trauma.
(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.
(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.”
(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.”
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(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.
This instrument is made under subsection 10(1) of the Act.
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:
(1) The requirements set out in this instrument apply to all therapeutic goods that are menstrual cups.
(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.
(1) The surface and shape of a menstrual cup must be smooth and designed to minimise the risk of trauma.
(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.
(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.”
(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.”