Federal Register of Legislation - Australian Government

Primary content

TGO No. 82 Orders/Other as made
This Order revokes and replaces Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual (21/07/1999) and Therapeutic Goods Order No. 64A - Amendment to Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual (23/08/2001) to adopt the recently updated Australia/New Zealand Standard AS/NZS 2869:2008 Tampons - Menstrual, as the standard to be complied with by therapeutic goods that are tampons (menstrual).
Administered by: Health
General Comments: Transitional Arrangements On the commencement of this Order and up to 5 March 2011, therapeutic goods required to comply with the standard specified in this Order that are entered in the Australian Register of Therapeutic Goods as listed goods on the date of commencement of this Order can comply with either of the following: (a) The standard set out in the Therapeutic Goods Order No. 64 Standard for Tampons – Menstrual as amended by Therapeutic Goods Order No. 64A Amendment to TGO 64: Standard for Tampons – Menstrual; or (b) The standard set out in this Order.
Made 25 Feb 2009
Registered 03 Mar 2009
Tabled HR 10 Mar 2009
Tabled Senate 10 Mar 2009

EXPLANATORY STATEMENT

 

 

         

Subject:  THERAPEUTIC GOODS ORDER NO. 82 - STANDARD FOR TAMPONS – MENSTRUAL

 

(Section 10, Therapeutic Goods Act 1989)

 

 

OUTLINE

 

Therapeutic Goods Order No. 82 - Standard for Tampons-Menstrual (TGO 82) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act). 

 

TGO 82 revokes and replaces Therapeutic Goods Order No. 64 Standard for Tampons-Menstrual (TGO 64), as amended by TGO 64A Amendment to TGO 64: Standards for Tampons – Menstrual (TGO 64A), made on 21 July 1999 and 23 August 2001 respectively.  TGO 82 adopts the recently updated Australia/ New Zealand Standard AS/NZS 2869:2008 Tampons – Menstrual, as the standard to be complied with by therapeutic goods that are tampons (menstrual)AS/NZS 2869:2008 replaces AS/NZS 2869: 1998 Tampons – Menstrual as the standard applicable for menstrual tampons and sets out the minimum requirements for permissible materials, absorbency, microbial content, package labelling and patient information leaflets.  AS/NZS 2869: 1998 Tampons – Menstrual is the standard determined under TGO 64 (as amended by TGO 64A).

 

AS/NZS 2869: 2008 effects major changes to the way in which tampon absorbency is measured by adopting the European (EU) and USA absorbency test methods. AS/NZS 2869: 2008 has also been amended to remove the specific reference to the Toxic Shock Syndrome Information Service (TSSIS) following the move from the TSSIS telephone line services and PO Box to a web-based service.

 

TGO 82 commences on 6 March 2009.  However, all menstrual tampons that are entered in the Australian Register of Therapeutic Goods as listed goods on or before 6 March 2009 can comply with the standard set out in either TGO 82 or TGO 64 (as amended by TGO 64A) for two years from the commencement of TGO 82.  The two years commence on 6 March 2009 and ends on 5 March 2011.  At the end of the two years (from 6 March 2011) all menstrual tampons supplied in Australia will be required to comply with TGO 82.    

 

BACKGROUND

 

The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods that are used in Australia or exported from Australia.

 

Section 10 of the Act authorises the Minister or a delegate of the Minister to determine standards for therapeutic goods, or to amend or revoke existing standards after consultation with the Therapeutic Goods Committee, a committee established under the Therapeutic Goods Regulations 1990 to advise the Minister in relation to standards.

 

Unless consent is granted by the Secretary under section 14 or 14A of the Act, therapeutic goods imported into Australia, or supplied in Australia, or exported from Australia must comply with any applicable standard.

 

Standards Australia has developed AS/NZS 2869: 2008 Tampons – Menstrual, which adopts the EU and USA absorbency test methodology for tampons, in response to a submission from ACCORD, the national advocate for the consumer, cosmetic, hygiene and specialty products sector. 

 

TGO 82 adopts AS/NZS 2869: 2008 in order to permit the use of the alternate absorbency test methodology for menstrual tampons that are listed on the Australian Register of Therapeutic Goods.  Electronic or hard copies of AS/NZS 2869: 2008 can be purchased on-line from SAI Global Limited at the following website: http://www.saiglobal.com.

 

Effect on Absorbency and Labelling

 

Both the old and the new, EU and USA, test methods provide a reproducible and repeatable measure of tampon absorbency. The EU and USA test method yields a lower absorbency result (approximately 1g lower) than the old method.  To compensate for the lower absorbency results, the upper limit of absorbency for each range of tampons has been reduced by 1g in AS/NZS 2869: 2008. As a result the absorbency labelling on Australian tampons will remain the same.  This will avoid any confusion among consumers and it is expected that the change to the Australian Standard will go unnoticed by Australian consumers.

 

CONSULTATION

 

ACCORD actively sought reform to the Australian Standard to harmonise tampon test methodologies with European and US regulatory requirements. 

 

The Therapeutic Goods Committee, at their 33rd meeting on 15-16 October 2008, noted the development of AS/NZS 2869: 2008 and recommended that TGO 64 be amended to adopt AS/NZS 2869: 2008.

 

Key stakeholders including ACCORD, the Medical Technology Association of Australia, Standards Australia, Consumers Health Forum of Australia and Choice, as well as all sponsors with tampons listed on the Australian Register of Therapeutic Goods were consulted on the adoption of an updated version of TGO 64 in late 2008.  Only two stakeholders provided comment.  ACCORD supported the proposal to update TGO 64, indicating that they see the recognition of the new standard AS/NZS 2869:2008 Tampons Menstrual as a significant step forward in achieving harmonisation.  One sponsor of tampons also supported the proposal to update TGO 64.

 

REGULATION IMPACT STATEMENT

 

International ‘ISO’ and ‘EN’ device standards are living documents that are developed and constantly being updated by groups of international experts.  Australian representatives are involved in some of these committees.  Updates to international device standards reflect changes to international best practice as well as the emergence of new technologies and new manufacturing procedures.  Where relevant, the latest international standards are adopted by leading regulators including Australia, Europe, the USA and Canada.  With both industry and the TGA seeking to optimise Australia’s position in the global device market, it is imperative that Australia’s standards do not fall out of step with the international market.

 

Australia will very quickly fall behind if it fails to adopt the latest international standards.  In the longer term not keeping up with changes to the relevant international standards will lead to a unique regulatory system in Australia, making regulatory compliance more difficult and costly for importers and/or exporters of medical devices into Australia.  The updated AS/NZS 2869: 2008 referenced in TGO 82 reflects the current international test methods for tampon absorbency.

 

The update of TGOs to adopt the latest international standards is considered minor machinery of government.  A preliminary assessment using the Office of Best Practice Regulation -  Preliminary Assessment form indicates “the compliance costs are low because only a few businesses are affected and the costs are negligible or trivial”.

 

APPLICATION OF THE LEGISLATIVE INSTRUMENTS ACT 2003 (THE LIA)

 

Under paragraph 6(d)(i) of the LIA, an instrument is a legislative instrument for the purposes of the LIA if it is declared to be a disallowable instrument under legislation in force before the commencement of the LIA.  This determination is a legislative instrument and it is subject to tabling and disallowance in the Parliament under sections 38 and 42 of the LIA, respectively.