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Updated TGO 64 - Standard for Tampons - Menstrual

Consultation

5 December 2008

This consultation closed on 5 December 2008.

Stakeholder letter

The following letter was sent to key industry organisations in October 2008. All interested stakeholders were invited to comment on this proposal.

Dear stakeholder

Consultation on updated Therapeutic Goods Order 64 - Standard for Tampons - Menstrual

The Therapeutic Goods Administration (TGA) is seeking your comments on a proposal to amend Therapeutic Goods Order No. 64 Standard for Tampons - Menstrual (TGO 64) to adopt the new Standards Australia standard AS/NZS 2869:2008 Tampons - Menstrual. Attached please find a copy of the proposed draft TGO 64.

AS/NZS 2869:2008 effects major changes to the way in which tampon absorbency is measured by adopting the EDANA/FDA 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.

Background

TGO 64, gazetted in July 1999, determines that the matters specified in AS/NZS 2869:1998 Tampons - Menstrual constitute the standard for menstrual tampons in Australia. AS/NZS 2869:1998 Tampons - Menstrual specifies permissible materials from which tampons may be manufactured, design requirements, performance requirements (including absorptive capacity), microbial content limits, packaging requirements and marking requirements (including absorbency labelling) and provides a number of test methodologies including that for determination of absorptive capacity.

In response to an industry submission, Standards Australia has developed AS/NZS 2869: 2008 Tampons - Menstrual, which adopts the EDANA/FDA absorbency test methodology for tampons. TGO 64 needs to be updated to reference AS/NZS 2869: 2008 in order to permit the use of the alternate absorbency test methodology for tampons that are listed on the Australian Register of Therapeutic Goods.

Effect on absorbency and labelling

Both the old and the new, EDANA/FDA, test methods provide a reliable and accurate measure of tampon absorbency. The EDANA/FDA test method takes longer to perform and 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.

Submission of comments

It is proposed that the new TGO be registered on the Federal Register of Legislative Instruments (FRLI) as soon as practicable after the consultation period and that it commences on the day after it is registered in FRLI.

It is proposed that there be a 2 year transition period before compliance with the new TGO 64 becomes mandatory. We would also appreciate your comments on the proposed transition period. The attached draft TGO will be amended to reflect the agreed transition period.

Yours sincerely

Larry Kelly
Head
Office of Devices, Blood and Tissues
October 2008

Attachment

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