Following an extensive review of the Cosmetic/Therapeutic interface by NICNAS in partnership with the TGA, the Government on 1 November 2005 announced a major reform outcome. Details of the review process are described in Appendix 04.

Cosmetic reforms were pursued arising from Recommendation 5.4 of the Final Report and Recommendations for NICNAS Low Regulatory Concern Chemicals Reform Initiative (June 2003), and separate proposals from the Australian cosmetic industry to the TGA that certain products containing sunscreens should be regulated as cosmetics.

The key outcome was the development of new NICNAS Cosmetic Guidelines that consist of a set of cascading instruments which comprise: Criteria for Defining Cosmetics, a Table of Product Categories including mandated conditions to ensure compliance with performance or other standards as required, and a new mechanism for publicly identifying those chemicals that are prohibited or restricted for use in cosmetics in Australia. These guidelines provide for a fundamental change in the manner in which cosmetics were defined previously, by repositioning the regulatory responsibility for defining cosmetics back to the cosmetic regulator, NICNAS. Benefits to the community from this reform are that a greater number of personal care products will now have full ingredient disclosure and these will also have OHS and environmental risk assessment elements undertaken (medicines only have public health assessments).

The draft NICNAS Cosmetic Guidelines were developed in consultation with a Cosmetic Reform Implementation Working Group (IWG), comprising representatives from industry, Government and the community and in accordance with the NICNAS Community Engagement Charter 2005-06. Details of the IWG are given at A ppendix 04.

The NICNAS Cosmetic Guidelines allow for changes to regulatory approaches for antiperspirants, antidandruff products, primary sunscreens with SPF less than 4, moisturisers with secondary sunscreens (SPF > 4 to < 15), anti-acne skin cleansers and antibacterial skin products. These products will be regulated as cosmetics and not therapeutic goods, within specified conditions. The guidelines will be maintained and updated on the advice of an expert Cosmetic Advisory Group yet-to-be-formed by NICNAS.

In order to allow industry access to the outcomes of this reform initiative, NICNAS commenced interim arrangements on 1 February 2006 to regulate six product categories that were therapeutic goods; namely anti-acne products, antibacterial skin products, antidandruff products, antiperspirants, moisturisers containing secondary sunscreen, up to SPF15 and primary sunscreens less than SPF4. Interim arrangements apply on a product-by-product basis, by written agreement directly between the company and the Director, NICNAS, enforceable via an interim permit system.

At 30 June 2006, NICNAS had received a total of 63 applications and issued 42 interim cosmetic permits, with a conservative estimate of direct savings to industry in terms of regulatory costs of $104,290. Details of applications received and permits issued is at Figure 3

Figure 3: Cosmetic applications received and permits issued

Product Category

New products

Existing products

Applications received

Permits issued

Applications received

Permits issued

Moisturisers with secondary sunscreens

28

21

5

4

Antibacterial skin products

27

15

2

1

Antidandruff products

1

1

-

-

No applications were received under interim arrangements for anti-acne skin cleansers, antiperspirants or primary sunscreens SPF<4.

In 2006-07, mandatory sections of the NICNAS Cosmetic Guidelines will be underpinned in the ACT including penalties for non-compliance. Interim arrangements will cease to operate upon legislative underpinning of these guidelines.