Cosmetic/therapeutic interface

Review of the policy framework for regulating products at the cosmetic/therapeutic interface

A review of the policy framework for regulating products at the cosmetic/therapeutic interface is being undertaken jointly by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Non-prescription Medicines Branch of the Therapeutic Goods Administration (TGA). The review began in line with recommendation 5.4 of the Final report and recommendations for NICNAS Low Regulatory Concern Chemicals Reform Initiative. This review is intended to address interface issues identified in the NICNAS LRCC report as well as separate proposals from the Australian cosmetic industry to the TGA. It was recognised that examination of the cosmetic/therapeutic interface will impact on the regulatory approach for therapeutic products adopted under the joint trans Tasman regulatory scheme. Therefore, the review will also examine the regulation of certain therapeutic products under the joint agency.

Mr David Newgreen has been engaged as a consultant to undertake the review, which includes extensive stakeholder consultation. A Steering Committee comprising senior staff from the TGA and NICNAS will provide oversight to the project. The review will be governed by the guiding principles and consultative mechanisms agreed between the relevant Australian and New Zealand regulators. Preliminary comment was sought from interested parties in Australia and New Zealand, through targeted correspondence and an open letter published on the NICNAS and TGA Internet sites <http://www.tga.gov.au/consult/2004/cosmeticrev.htm>. A draft discussion paper will be available for a period of public comment in July 2004 followed by the final report and a regulatory impact statement in October 2004.

Low regulatory concern chemicals

The Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Bill 2004 was introduced into Parliament on 31 March 2004. The bill was passed by the House of Representatives on 26 May 2004 and the Senate on 24 June 2004. The bill will come into effect in mid-August 2004. For more information, including a link to the bill, see the NICNAS website <http://www.nicnas.gov.au>.

National dioxins program

Office of Chemical Safety completes human health risk assessment for dioxins

The term dioxins is used to describe a group of toxic persistent organic chemicals which remain in the environment for a long time. Dioxins, predominantly generated as unintended by-products of combustion processes, can accumulate in the body fat of animals and humans and are resistant to metabolism, giving rise to concerns about possible adverse effects in humans and fauna. In 2001, the Australian Government Department of the Environment and Heritage (DEH) established a National Dioxins Program to generate information on the levels of dioxins in Australia, to assess the risks they pose to Australians and our environment, and to determine appropriate actions to manage dioxins. The Canberra office of the Office of Chemical Safety undertook the task of conducting the human health risk assessment.

On 28 May 2004, Dr Les Davies presented the results of the human health risk assessment to a national seminar. The overarching conclusion of the assessment was that the intake of dioxins and dioxin-like compounds by the Australian population is low by world standards and that current levels do not appear to present a significant human health risk. However, because of our incomplete knowledge about all possible human health effects, a precautionary approach should be taken. Thus, control measures which have helped to significantly reduce releases of dioxin-like compounds to the environment over the past several decades should be ongoing.

The draft final risk assessment will now be reviewed by overseas experts before the final report is prepared. Later in 2004, the OCS will take part in presenting the results of the NDP to the community and various capital cities, in order to seek inputs on possible risk management measures which could be undertaken.

To access the human health risk assessment and other reports on the levels of dioxins in the Australian environment, refer to the DEH Internet site <http://www.deh.gov.au/industry/chemicals/dioxins/index.html> (click on "technical reports").

Science Forum 3

The Australian Government Department of Health and Ageing established a "Science Forum" to identify best practice approaches for health risk assessment of chemicals as one of several reform initiatives undertaken in response to the Chemicals and Plastics Action Agenda Steering Group Industry Report, Underpinning Australia's Industrial Growth. The Forum was established under the auspices of the Office of Chemical Safety (OCS) and includes the Health portfolio regulatory agencies as well as specific agencies outside the portfolio.

The objective of the Science Forum is to enhance the efficiency of chemicals regulation in Australia through comparison of current regulatory assessment practices and methods among participating agencies, consideration of international trends and harmonisation of best practice risk assessment methodology.

The third Forum is planned for 30 July 2004 with a focus on "The Practice of Human Health Risk Assessment in Australia".