Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual
as amended
made under section 10 of the
Therapeutic Goods Act 1989
This compilation was prepared on 22 May 2007
taking into account amendments up to Therapeutic Goods Order No. 64A - Amendment to Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual
Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra
Therapeutic Goods Order No. 64
Standard for Tampons - Menstrual
I, TERRY SLATER, delegate of the Minister of State for Health and Aged Care and acting
Under Section 10 of the Therapeutic Goods Act 1989, having consulted with the Therapeutic Goods Committee in accordance with subsection 10 (4) of the said Act, HEREBY:
REVOKE, Therapeutic Goods Order 51, “Standards for Tampons – Menstrual”, Gazetted in Gazette No 23 of 14 June 1995; and
DETERMINE that the matters specified in Australian/New Zealand Standard “AS/NZS 2869:1998, Tampons – Menstrual” shall constitute the standard for menstrual tampans, subject to the following additional requirement:
Where no sample size for sampling tampons is stipulated in the Order under paragraphs 6.1, 9, 10.1 & 10.2, a sample size of 13 must not have more than one non‑complier tampon.
This order commences on the date this Order is gazetted.
Notes to the Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual
Note 1
The Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual (in force under section 10 of the Therapeutic Goods Act 1989) as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
Title | Date of notification
in Gazette | Date of
commencement | Application, saving or
transitional provisions |
Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual | 28 July 1999 (see Gazette 1999,
No. S347) | 28 July 1999 | |
Therapeutic Goods Order No. 64A - Amendment to Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual | 5 Sept 2001 (see Gazette 2001,
No. GN35) | 5 Sept 2002 | — |
Note 2
The proposed amendment in the Therapeutic Goods Order No. 64A - Amendment to Therapeutic Goods Order No. 64A - Standard for Tampons - Menstrual provides as follows:
Under the heading “Information Leaflet” in Clause 11 of TGO 64, insert after paragraph 11 (b) the following new paragraph:
“(c) the following statement:
“Please note that tampons are not sterile and neither are your hands or vagina.
Tampons, while containing very small amounts of bacteria normally present in the air, have not been shown to carry the bacteria which cause Toxic Shock Syndrome (TSS).”
The proposed amendment was misdescribed and is not incorporated in this compilation.
Overview
The Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual, made under section 10 of the Therapeutic Goods Act 1989, was enacted in 1999 to establish the Australian/New Zealand Standard “AS/NZS 2869:1998, Tampons – Menstrual” as the regulatory standard for menstrual tampons. This legislative instrument was introduced to ensure tampons meet specific safety and quality standards, thus protecting public health by minimising risks associated with their use. The order was revoked and subsequently re-enacted with amendments in 2001 and 2002, demonstrating a commitment to updating and refining the regulatory framework in response to emerging health concerns and technological advancements. The enacting body was the delegate of the Minister of State for Health and Aged Care, Terry Slater, who acted under the authority conferred by the Therapeutic Goods Act 1989.
Scope and Application
The Therapeutic Goods Order No. 64, which sets the standard for tampons intended for menstrual use, applies to the manufacture, import, and supply of these products within Australia. This regulation is grounded in the Therapeutic Goods Act 1989 and is administered by the Minister for Health and Aged Care. The scope of this Order encompasses all entities involved in the production and distribution of menstrual tampons, ensuring they adhere to the specified standards to maintain safety and quality. The geographic reach of this Order is nationwide, covering the entirety of Australia, and it extends to products regardless of whether they are produced locally or imported. The application of the standard is comprehensive, encompassing all tampons intended for menstrual use, and it includes a specific additional requirement that mandates a sample size of 13 tampons, where no specific sample size is mentioned, with no more than one non-compliant tampon permitted. The Order supersedes the previous Therapeutic Goods Order 51 from 1995, which was previously the governing standard for menstrual tampons. The amendment process for this Order is facilitated through subordinate instruments, allowing for updates and refinements as necessary to reflect advancements in standards or to address emerging safety concerns.
Key Provisions
The Therapeutic Goods Order No. 64 sets forth the standard for menstrual tampons in Australia, as amended. It revokes the previous Therapeutic Goods Order 51, which was gazetted on 14 June 1995, and adopts the Australian/New Zealand Standard "AS/NZS 2869:1998, Tampons – Menstrual" as the new standard for menstrual tampons. This means that manufacturers, importers, and suppliers must ensure that their tampons comply with the specified standard. Section 6.1 and related sections detail the requirements for sample sizes during testing, where a sample size of 13 must not have more than one non-compliant tampon.
Entities governed by this Act must adhere to stringent manufacturing, quality control, and labelling requirements to ensure that tampons meet the specified standards. This includes proper documentation and record-keeping of manufacturing processes, testing results, and compliance with safety and quality specifications. Manufacturers and suppliers are also required to provide information leaflets with their products, ensuring consumers are informed about the nature and safe usage of tampons.
Breaches of the Therapeutic Goods Order No. 64 may result in severe civil and criminal penalties. Under the Therapeutic Goods Act 1989, non-compliance can lead to fines and imprisonment for individuals and corporate entities. The maximum penalties vary depending on the severity of the breach but can include substantial fines for corporations and imprisonment for individuals responsible for the non-compliance. Additionally, the Therapeutic Goods Administration has the authority to seize and destroy non-compliant products, further enforcing compliance with the standards set forth in the Order.