Biomedical Engineering Reference
In-Depth Information
The TGA, however, recognizes that the development of nanotechnologies, as well as other tech-
nologies, will continue to pose challenges to regulators into the future.
The best response to such challenges is the maintenance and continued development of high quality
scientific expertise within the agency together with ongoing interaction with sponsors, researchers,
regulators and policy makers throughout Australia and internationally, to which the TGA is committed.
As such, the TGA is conducting a comprehensive review of current regulatory arrangements to
ensure that those arrangements remain adequate to assess and manage the risks that may be associated
with products manufactured using increasingly sophisticated nanotechnologies.
The TGA is also continuing to closely monitor developments around nanotechnology internationally
to ensure a rapid response to any new issues identified.* *
What Australia is doing is in the same vein as the action in the United States and the EU. There
is no rush to expand the regulatory framework because the existing rules seem adequate, with the
reservation that amendments can always be made if needed. The attitude in Australia, as in other
jurisdictions, stems from a lack of any hard proof of a present health hazard, thus permitting more
time to accumulate information to assist with a meaningful risk assessment.
One review that TGA has made is of the safety of two primary sunscreen ingredients: nanoparti-
cle titanium dioxide and zinc oxide. TGA stated as follows, about the nanomaterials and sunscreens:
Nanotechnology is used in some sunscreen products containing zinc oxide and titanium dioxide. These
two chemicals are particularly valuable in sunscreens because they give broad protection from damag-
ing sunlight. In conventional applications zinc oxide and titanium dioxide leave a white layer on the
skin, but when they are reduced to nanoparticles this white layer does not appear while still providing
the same level of protection from the sun. As such, this has proved a popular option with consumers.
Recently, concern has been raised as to whether nanoparticles in sunscreen might be absorbed into via-
ble cells below the skin's surface, risking damage to these cells. The Therapeutic Goods Administration
actively monitors matters relating to the regulation of nanotechnologies and has found no current evi-
dence to suggest that sunscreen nanoparticles pose greater safety risks than conventional products.
In support of its position, TGA states that the potential for the two nanomaterials to cause adverse
effects depends primarily on the ability of the nanoparticles to reach viable skin cells. On that score,
TGA notes: “To date, the current weight of evidence suggests that TiO2 and ZnO nanoparticulates
do not reach viable skin cells, rather, they remain on the surface of the skin and in the outer layer
(stratum corneum) of the skin that is composed of non-viable, keratinized cells.” The situation with
sunscreen ingredients illustrates the situation facing regulatory agencies. There is a scientific and
public clamor to take action to thwart the risks, but there is no real evidence of risk. This is the rea-
son why there is an increased desire to require the submission of any information on adverse events
in the use of the products incorporating nanomaterials. (Note: In Australia, all active ingredients,
such as zinc oxide and titanium dioxide, must be declared on sunscreen labels, to help consumers
make informed choices. It is not a requirement, however, for sunscreen labels to declare the particle
size of the active ingredients.)
On October 22, 2012, Safe Work Australia announced the availability of a report titled Human
Health Hazard Assessment and Classification of Carbon Nanotubes , as well as an information
sheet on the report. The report recommends that MWCNTs should be classified as hazardous unless
toxicological or other data for specific types imply otherwise. The National Industrial Chemicals
Notification and Assessment Scheme (NICNAS) prepared the report in support of Safe Work
Australia's Nanotechnology Work Health and Safety Program. NICNAS extensively reviewed the
* Australian Government. Department of Health and Ageing, Therapeutic Goods Administration. 2009. Nanotechnology
and therapeutic products. http://www.tga.gov.au/industry/nanotechnology-qa.htm.
Department of Health and Ageing. 2012. Current Issues. Sunscreen containing Nanoparticles. http://www.health.gov.au/
internet/main/publishing.nsf/Content/currentissue-P10000045.
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