Federal Register of Legislation - Australian Government

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TGO 99 Orders/Other as made
This order specifies safety and quality requirements for therapeutic goods that are menstrual cups, including in particular requirements relating to the raw materials, design, packaging and labelling of menstrual cups.
Administered by: Health
Registered 06 Nov 2018
Tabling HistoryDate
Tabled Senate12-Nov-2018
Tabled HR26-Nov-2018

 

EXPLANATORY STATEMENT

 

 Therapeutic Goods Act 1989

 

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

 

The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used, or exported from, Australia.

Therapeutic Goods (Standards for Menstrual Cups) Order 2018 (TGO 99) is an order made by the delegate of the Minister for Health under section 10 of the Act.

The purpose of TGO 99 is to succeed the existing Therapeutic Goods Order No. 37 General Requirement for Labels for Therapeutic Devices (TGO 37), which was registered on 2 April 2008 (having commenced on 13 April 1991), as TGO 37 will sunset on 1 October 2018 under the provisions of the Legislation Act 2003. TGO 37 was made under subsection 15(1) of the Therapeutic Goods Act (1966) (the 1966 Act). 

TGO 99 commences on the day after it is registered.

BACKGROUND

The Australian Government is responsible for regulating the quality of therapeutic goods, including menstrual cups. In respect of therapeutic goods other than medical devices, this is principally achieved by specifying ministerial standards for the goods which may relate to a range of matters (e.g. the quality of the goods and the procedures to be carried out in their manufacture), and otherwise by applying default standards – these are international pharmacopoeia are defined in the Act.

Subsection 10(1) of the Act relevantly provides that the Minister may, by legislative instrument, make an order determining that matters specified in the order constitute a standard for therapeutic goods or a class of therapeutic goods identified in the order. Offence and civil penalties may apply if therapeutic goods (other than medical devices) that do not comply with an applicable standard are imported, exported or supplied. The Secretary may, however, consent in writing to the import, supply or export of such goods notwithstanding their non-compliance (sections 14 and 14A of the Act refer).

Without limiting the generality of subsection 10(1), subsection 10(2) relevantly provides that an order establishing a standard for therapeutic goods may be specified by reference to a variety of matters including the quality of the goods, the quantity of the goods when contained in specified containers or the procedures to be undertaken in their manufacture. In addition, an order may require matters relating to the standard to be determined in accordance with particular tests.

TGO 99 applies to therapeutic goods that are menstrual cups, and specifies requirements for all menstrual cups including in particular requirements relating to the packaging and labelling of these products.

In particular, TGO 99 requires that:

·         the raw materials used in the manufacture of menstrual cups must be suitable for the intended purpose of the menstrual cups, and menstrual cups must not contain ingredients in a sufficient concentration to cause a toxic or irritant reaction when used as directed;

·         menstrual cups must be smooth and designed to minimise the risk of trauma to the user;

·         menstrual cups must be packaged in a closed unit pack that is capable of maintaining the menstrual cups’ quality until the unit pack is opened by the consumer;

·         a number of labelling requirements are met for the packaging of menstrual cups, including for example that the primary pack be permanently and legibly marked with a range of information including the brand name for the menstrual cups, the name and address of the manufacturer or supplier, the batch number and a warning that menstrual cups have been associated with toxic shock syndrome, which is a rare but serious condition that may cause death; and

·         a range of information must be supplied with a menstrual cup, including information about toxic shock syndrome, which although only rarely associated with menstrual cups, can still occur. 

TGO 99 updates the requirements for menstrual cups under TGO 37 (which applied generally to products that met the definition of ‘therapeutic device’ in the 1966 Act), particularly by requiring warnings relating to toxic shock syndrome for menstrual cups, in the labelling and consumer information for these products.

CONSULTATION

While TGO 99 updates the requirements for menstrual cups compared to TGO 37, it largely provides continuity in relation to the main requirements for menstrual cups under that earlier order. While the requirement to include warnings in relation to toxic shock syndrome would be new compared to TGO 37, in practice this requirement is considered to be minor in nature.

As such, the making of TGO 99 is minor and machinery in effect and, on that basis, consultation was not undertaken.

In addition, a regulation impact statement was not required (Office of Best Practice Regulation reference ID23300 ).

Details of TGO 99 are set out in Attachment A.

TGO 99 is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

This Order is a disallowable legislative instrument, and commences on the day after it is registered.


ATTACHMENT A

Details of Therapeutic Goods Order No. 99 - Standard for Menstrual Cups 2018

 

Section 1 Name

This section provides that the name of this Order is Therapeutic Goods (Standard for Menstrual Cups) Order 2018, but that it may also be cited as either Therapeutic Goods Order 99, or TGO 99.

Section 2 Commencement

This section provides that this Order commences on the day after it is registered in the Federal Register of Legislation.

Section 3 Authority

This section provides that the legislative authority for making the Order is subsection 10(1) of the Therapeutic Goods Act 1989 (the Act).

Section 4 Definitions

This section provides a number of definitions for terms used in this Order, including in particular ‘menstrual cup’, ‘batch’ and ‘packaging’.

This section also makes it clear that a number of terms have the same meaning as given in the Act, for example ‘sponsor’ and ‘therapeutic goods’.

Section 5 Application

This section identifies the kinds of therapeutic goods for which this Order constitutes a standard – being, all goods that are menstrual cups.

Section 6 Permissible raw materials

This section specifies that menstrual cups must be manufactured from materials that are suitable for the intended purpose of the menstrual cup, and that the menstrual cups must not contain ingredients in a sufficient concentration to cause a toxic reaction when the cup is used as directed. 

Section 7 Design requirements

This section specifies that a menstrual cup must be smooth, and be designed in such a way as to minimise the risk of trauma when used. 

Section 8 Packaging

This section specifies requirements relating to the packaging for menstrual cups, including that the menstrual cup must be packed in a closed unit pack that is capable of maintaining the cup’s quality until the unit pack is opened by the consumer, and that the primary pack must be designed, overwrapped or sealed in such a way that tampering will be easily detected (‘unit pack’, ‘primary pack’ are layers of packaging identified in the definition of ‘packaging’ in section 4 of the Order). 

 

 

Section 9 Labelling

This section specifies requirements relating to the labelling for menstrual cups, including that the primary pack for the menstrual cups must be permanently and legibly marked with the information set out in paragraphs 9(1)(a) – (f).

These include, for example: the name and address of the manufacturer or supplier; the name and quantity of all the menstrual cups within the primary pack (if there are more than one); the batch number of the menstrual cups; and a warning that menstrual cups have been associated with toxic shock syndrome, a rare but serious disease that may cause death (and a direction to read and keep the information required to be enclosed with a menstrual cup, referred to in section 10 below).

Section 10 Information to be supplied with menstrual cups

This section specifies information must be supplied with a menstrual cup, and that such information must be in a form that is legible and accessible to the consumer. This information includes, for example, detailed instructions for use including the need for hygiene and care in insertion, a limit to the duration of use, not exceeding 8 hours, and information about toxic shock syndrome, noting that while it is rarely associated with the use of menstrual cups it can still occur.


ATTACHMENT B

STATEMENT OF COMPATIBILITY FOR A DISALLOWABLE LEGISLATIVE INSTRUMENT THAT RAISES HUMAN RIGHTS ISSUES

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Therapeutic Goods (Standard for Menstrual Cups) Order 2018

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

Therapeutic Goods (Standard for Menstrual Cups) Order 2018 (TGO 99) is an order made by the delegate of the Minister for Health under section 10 of the Act.

The purpose of TGO 99 is to succeed the existing Therapeutic Goods Order No. 37 General Requirement for Labels for Therapeutic Devices (TGO 37), which was registered on 2 April 2008 (having commenced on 13 April 1991), as TGO 37 will sunset on 1 October 2018 under the provisions of the Legislation Act 2003. TGO 37 was made under subsection 15(1) of the Therapeutic Goods Act (1966) (the 1966 Act). 

Subsection 10(1) of the Act allows the Minister to, by legislative instrument, make an order determining that matters specified in the order constitute a standard for therapeutic goods or a class of therapeutic goods identified in the order. Offence and civil penalties may apply if therapeutic goods (other than medical devices) that do not comply with an applicable standard are imported, exported or supplied, and therapeutic goods may have their marketing approval cancelled if they do not comply with an applicable standard (paragraph 30(2)(e) of the Act refers). The Secretary may, however, consent in writing to the import, supply or export of such goods notwithstanding their non-compliance (sections 14 and 14A of the Act refer).

TGO 99 is a standard that applies to therapeutic goods that are menstrual cups, and specifies requirements for all menstrual cups including in relation to the packaging and labelling of these products.

 

In particular, TGO 99 requires that:

·         the raw materials used in the manufacture of menstrual cups must be suitable for the intended purpose of the menstrual cups, and menstrual cups must not contain ingredients in a sufficient concentration to cause a toxic or irritant reaction when used as directed;

·         menstrual cups must be smooth and designed to minimise the risk of trauma to the user;

·         menstrual cups must be packaged in a closed unit pack that is capable of maintaining the menstrual cups’ quality until the unit pack is opened by the consumer;

·         a number of labelling requirements are met for the packaging of menstrual cups, including for example that the primary pack be permanently and legibly marked with a range of information including the brand name for the menstrual cups, the name and address of the manufacturer or supplier, the batch number and a warning that menstrual cups have been associated with toxic shock syndrome, which is a rare but serious condition that may cause death; and

·         a range of information must be supplied with a menstrual cup, including information about toxic shock syndrome, which although only rarely associated with menstrual cups, can still occur. 

TGO 99 updates the requirements for menstrual cups under TGO 37 (which applied generally to products that met the definition of ‘therapeutic device’ in the 1966 Act), particularly by requiring warnings relating to toxic shock syndrome for menstrual cups, in the labelling and consumer information for these products.

Human rights implications

TGO 99 engages the right to health in article 12 of the International Covenant on Economic, Social and Cultural Rights (the ICESCR). This right is understood as the right of everyone to enjoy the highest attainable standard of physical and mental health, and includes an obligation to take reasonable measures within available resources to progressively secure broader enjoyment of the right.

By specifying minimum requirements for the safe packaging and labelling of menstrual cups (including alerting users to the risk of toxic shock syndrome), requiring that menstrual cups be manufactured from materials that are non-toxic and suitable for use for such products, and by requiring that menstrual cups be designed in such a manner as to minimise trauma and are comfortable to use, TGO 99 is designed to support the safe use of these products for women. 

In so doing, TGO 99 addresses the element of the right to health that relates to the quality of goods that are used for health, including in particular that they are scientifically and medically appropriate, and of good quality.

The requirements of the Order are further bolstered in this regard by the criminal, civil and regulatory sanctions that apply under the Act for persons who import, supply or export therapeutic goods that do not comply with applicable standards.

Conclusion

TGO 99 is compatible with human rights because it promotes the right to health in article 12 of the ICESCR as outlined above, and otherwise does not raise any human rights issues.

 

Ben Noyen, delegate of the Minister for Health