Therapeutic Goods Order No. 82 - Standard for Tampons - Menstrual (25/02/2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L00756 Not in force Legislative Instrument

Legislation content

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.

 

 

Overview

The Therapeutic Goods Order No. 82 - Standard for Tampons-Menstrual (TGO 82) was enacted in 2009 to update and replace the existing Therapeutic Goods Order No. 64 (TGO 64), which was made under section 10 of the Therapeutic Goods Act 1989. This legislation was introduced to address the need for modernising the standards governing menstrual tampons in Australia, aligning them with international best practices, particularly those of the European Union and the United States. The Therapeutic Goods Order was made by the delegate of the Minister for Health and Ageing, following consultations with the Therapeutic Goods Committee and other key stakeholders, to ensure the updated standard facilitates compliance with international standards and enhances consumer safety and product quality. The primary policy objective of TGO 82 was to harmonise the Australian standard for menstrual tampons with international methodologies, particularly in terms of absorbency testing, while maintaining consumer safety and product efficacy. The updated standard, AS/NZS 2869:2008, was adopted to reflect current international practices, ensuring that Australian tampons remain competitive in the global market and that consumer expectations regarding product safety and efficacy are met. This change also aimed to streamline the regulatory process, reducing potential compliance costs and complexities for manufacturers and importers.

Scope and Application

The Therapeutic Goods Order No. 82 – Standard for Tampons – Menstrual (TGO 82) applies to all menstrual tampons that are supplied in Australia, ensuring they comply with the specified standards to maintain quality, safety, and efficacy. This order, made under section 10 of the Therapeutic Goods Act 1989, adopts the Australia/New Zealand Standard AS/NZS 2869:2008, which includes criteria for materials, absorbency, microbial content, and labelling. The Act's jurisdiction spans nationally, ensuring uniformity across states and territories in Australia. Importantly, products listed on the Australian Register of Therapeutic Goods prior to the commencement of TGO 82 on 6 March 2009 have a two-year grace period, until 5 March 2011, to comply with either the new or old standards. After this period, all menstrual tampons must adhere to the new TGO 82 standards. The application of TGO 82 is subject to the Legislative Instruments Act 2003, meaning it is subject to parliamentary disallowance and tabling.

Key Provisions

Therapeutic Goods Order No. 82 (TGO 82) sets the standard for menstrual tampons in Australia, replacing the previous Therapeutic Goods Order No. 64 (TGO 64) and its amendments. Specifically, section 10 of the Therapeutic Goods Act 1989 (the Act) authorises the Minister or a delegate to determine the standards for therapeutic goods, and TGO 82 adopts the Australian/New Zealand Standard AS/NZS 2869:2008 Tampons – Menstrual. This standard includes minimum requirements for materials, absorbency, microbial content, packaging labelling, and patient information leaflets. Tampons must comply with the new standards set by AS/NZS 2869:2008, which adopts the European and USA absorbency test methods, and includes adjustments to the upper limit of absorbency to maintain consistency in labelling. Menstrual tampons listed in the Australian Register of Therapeutic Goods on or before 6 March 2009 have a two-year grace period, until 5 March 2011, to comply with either the new or old standards. Under TGO 82, manufacturers and suppliers of menstrual tampons must ensure that their products meet the updated standard. This includes using the appropriate materials and labelling, adhering to the new absorbency test methods, and providing necessary patient information. The standards ensure that tampons are safe and effective for use in Australia. Additionally, the transition to the new standard requires manufacturers to update their processes and documentation to align with AS/NZS 2869:2008, ensuring that all tampons supplied in Australia after 5 March 2011 comply with the new requirements. Breach of the standards set out in TGO 82 can result in significant legal consequences. Under section 26 of the Therapeutic Goods Act 1989, supplying therapeutic goods that do not comply with the relevant standards is an offence. This can result in criminal penalties, including fines and imprisonment. For example, section 31A imposes a maximum penalty of $504,000 for individual offenders and $2,520,000 for corporate offenders for supplying non-compliant therapeutic goods. Furthermore, civil penalties can also be imposed for breaches, which can include fines up to the maximum amount prescribed by the regulations. Continuous non-compliance can also lead to the revocation of the Australian Register of Therapeutic Goods listing, effectively barring the product from the market. These penalties underscore the importance of adhering to the standards to ensure the safety and quality of menstrual tampons in Australia.

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