Health and Environmental Risks (Netherlands)

RIVM is the acronym for the Dutch National Institute for Public Health and Environment. Its main tasks include conducting research, providing policy support, coordinating policy implementation programs, and providing information to the general public in the area of integrated risk assessment in the health, environment, food, and nonfood sectors. It is independent in its functioning and uses its research activities to support the Dutch government in policy formulation on public health and the environment. RIVM is also involved in the activities of various international organizations, such as the World Health Organization (WHO) and the European Union (EU).

In the context of nanotechnology, RIVM has published a number of reports on the risk aspects of nanomaterials and has made recommendations on regulation and standard setting for nanotechnology. RIVM along with the VROM (Ministry of Housing, Spatial Planning, and Environment), VWS (Ministry of Health, Welfare, and Sports) and SZW (Ministry of Social Affairs and Employment) has launched the Knowledge and Information Risks Nanotechnology (KIR-Nano) that it is hosting. KIR-Nano provides an overview of potential risks from free, nondegradable and insoluble nanoparticles in four crucial areas of applications: medicine and medical technology, consumer products, nutrition, and the environment.

In 2005, RIVM published two reports: one on the state of art of nanotechnology in medical applications and the second on the possible risks to human health. The first report provided an overview of novel nanomaterials and their applications in medical technology (materials and devices). It identified surgery, therapy, diagnostics, imaging, implant technology, bionics, bio-active surfaces, tissue engineering, textiles, actuators, and delivery systems as areas in which products containing nanomaterials are being developed. The second report focused on the health risks that could result from these medical applications.

The report differentiates between medical applications, such as surgical implants that have immobilized nanostructures in or on their surfaces from those medical applications that utilize free nanoparticles and structures, namely novel drug delivery systems. In the case of former, it was expected that the risk would be minimal compared to the latter. In the absence of general rules or scientific paradigms for estimating the toxicity of nanostructures and nanoparticles, and given that basic knowledge of their absorption, distribution, metabolism and excretion were lacking, it was recommended [Page 306]that specific toxicological properties need to be investigated and that classical toxicity testing of chemicals and materials was not a good indicator while assessing risks of nanoparticles and/or nanostructures. The report also mentions the proposal to establish nanotoxicology as a particular subcategory of toxicology.

The report pointed out that the implementation of a risk management strategy included a risk assessment and was a mandatory obligation for the manufacturer of medical technology applications. The stakeholders, however, needed to be made aware of that nanostructures and nanoparticles could have specific toxicological properties. It recommended that the evaluation of these specific toxicological properties should be made part of the risk assessment performed by the manufacturer, and also that further guidance should be developed at the European level for the relevant stakeholders on this issue.

In early 2007, the report, “New and Emerging Medical Technologies: A Horizon Scan of Opportunities and Risks” reiterated that product development was outpacing our knowledge of the associated toxicological risks. It also underlined that a reduction to nanolevels not only distinctly alters the properties of the materials, but also affects their chemical composition, which in turn influences their intrinsic toxic properties. It concluded that therefore very small size of particles seems to be the predominant indicator for toxic effects of particles. Thereafter RIVM published an advisory report and an inventory of consumer products containing nanomaterials; it identified around 143 such consumer products. Most of the products fell in the “home furnishings and household” product category. The report differentiated based on the methodology of their incorporation of nanomaterials.

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