NANOPARTICLES

In reply to the Hon. T.A. FRANKS (19 May 2011) (First Session).

The Hon. G.E. GAGO (Minister for Agriculture, Food and Fisheries, Minister for Forests, Minister for Regional Development, Minister for Tourism, Minister for the Status of Women): The Minister for Health has been advised:

1. The development of zinc and titanium oxide nanoparticles has enabled the production of highly protective sunscreens with favourable cosmetic properties. As with any new and emerging technologies, the benefits of nanoparticles need to be weighed against their risks, especially if used as a therapeutic agent. In early 2009, the Therapeutic Goods Administration (TGA) conducted an updated review of the scientific literature in relation to the use of nanoparticulate zinc oxide and titanium dioxide in sunscreens.

The TGA review concluded that the potential for titanium dioxide and zinc oxide nanoparticles in sunscreens to cause adverse effects depends primarily upon the ability of the nanoparticles to reach viable (cells able to divide) skin cells.

They found that, to date, the current weight of evidence indicates that titanium dioxide and zinc oxide nanoparticles do not reach viable skin cells, but rather, the nanoparticles remain on the surface of the skin and in the outer layer of the skin, which is composed of non-viable cells. The TGA has indicated that it is continuing to monitor the emerging scientific literature to ensure appropriate action is taken should any tangible safety concerns be identified.

2. Users are encouraged to read and follow label directions and that these products are stored in an appropriate manner out of reach of children.

3. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on CosmeticProduct, as recorded in the Official Journal of the European Union L 342/59 outlines the safety assessment requirements in Article 10 and the mandatory labelling requirements in Article 19 that expressly deal with ingredients which are nanoparticles.

4. The regulation of sunscreen products is carried out by the Commonwealth. Specifically, most sunscreens are regulated as medicines under the Therapeutic Goods Act 1989. The labelling of cosmetics is regulated by the Australian Competition and Consumer Commission (ACCC). The safety of ingredients used in cosmetics is regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). These agencies are well aware of the issue.

5. Since the TGA has recently reviewed nanoparticles, there is no need to influence the Commonwealth's position on the labelling of cosmetics containing nanoparticles.

6. There is no requirement for a moratorium on the use of nanoparticles, given the TGA review. Furthermore, it is understood that the TGA is continuing to monitor the emerging scientific literature to ensure appropriate action is taken should any tangible safety concerns be identified. The Department of Health also keeps informed of these developments.