Biomedical Engineering Reference
In-Depth Information
15.11.5 N etherlaNds
In the Netherlands, two initiatives are noteworthy. First, the Netherlands National Institute for Public
Health and the Environment (RIVM) published a report on June 29, 2012, titled Interpretation and
implications of the European Commission's definition on nanomaterials . The Dutch ministries
requested RIVM to interpret the meaning and implications of the European Commission's (EC)
recommendation from a scientific perspective and to consider the implications for use in legislation.
RIVM intends the report to provide the basis for discussions by policy makers and stakeholders on
the use and further implementation of the recommended definition in national and international
legal frameworks. RIVM concludes that, while the EC's recommendation contains the relevant
aspects, further guidance is necessary to ensure the definition is interpreted consistently. According
to RIVM, the next step is to incorporate the definition into legal frameworks regarding the interpre-
tation of the term nanomaterial. RIVM states that this will lead to the collection of “nano-specific”
data, contributing to further insight into the “nano-specific” properties and the fate, kinetics, and
effects of nanomaterials. This will help focus on the specific needs for risk assessment and risk
management of nanomaterials. *
The second initiative announced on May 22, 2013, was when the Health Council of the Netherlands
noted the availability of a draft report proposing the implementation of an exposure registry and a
system of health monitoring when working with ENPs. The draft report states that, due to the con-
cerns and lack of knowledge, the Health Council “considers it prudent” to create an exposure registry.
The Health Council recommends that the exposure registry be created for “insoluble and poorly in
water-soluble nanoparticles in any composition or physical structure, including nanoparticles that are
present in solid materials.” The draft report acknowledges that, if solid materials are in good condi-
tion, “scarcely any nanoparticles will be released, but due to wear and tear and handling, such as
drilling and sanding, it cannot be excluded that such particles can be released with all the associated
risks.” The draft report concludes that, “[f]rom the point of view of health, it is best to also register the
solid materials.” Data submitted to the registry would need to include chemical and physical proper-
ties, determinants of emission and exposure, and exposure concentrations. Regarding medical sur-
veillance, the draft report concludes that implementation of a passive system is the best option. While
a passive system would not provide answers quickly on whether health risks exist when working with
nanoparticles, and if so, which type of health effects, when combined with other activities, such as
targeted scientific research, it “may give a valuable contribution in the future to providing insight in
the potential health risks due to exposure to nanoparticles.” According to the Health Council, it will
consider comments when preparing the final report, which will be presented to the State.
15.11.6 a ustralIa
In Australia, the Therapeutic Goods Administration (TGA) is responsible for the regulation of
medical products, pharmaceuticals and cosmetics. TGA has taken an active interest in regulation
of nanotechnology, spurred on by continuing controversy regarding the use of nanomaterials in
sunscreen products, the source of great interest given the high rate of skin cancer in Australia. TGA
describes its plans on its website:
To date, the existing regulatory framework of the TGA has proved more than adequate to identify,
assess and manage the risks associated with therapeutic products that incorporate nanotechnologies.
* National Institute for Public Health and the Environment. Ministry of Health, Welfare and Sport. 2012. Interpretation
and implications of the European Commission's definition on nanomaterials. RIVM Report 601358001. http://www.rivm.
nl/en/Library/Scientific/Reports/2012/juni/Interpretation_and_implications-of_the_European_Commission_s_defini-
tion_on_nanomaterials.
See http://www.gezondheidsraad.nl/en/publications/working-engineered-nanoparticles-exposure-registry-and-system-
health-monitoring.
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