| Title: |
Opinion on the appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials
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| Resource Type: |
document --> guidance / decision support
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| Country: |
European Union
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| Year: |
2007 |
| Availability: |
The SCENIHR approved this opinion for the public consultation at the 17th plenary on 29 March 2007
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| Author 1/Producer: |
EC DG Health and Consumer Protection, Scientific Committee on Emerging and Newly-Identified Health Risks, SCENIHR
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| Author / Producer Type: |
Agency, regulator or other governmental or inter-governmental body
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| Publisher: |
European Commission, Health & Consumer Protection DG
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| Publisher City: |
Directorate C: Public Health and Risk Assessment
Unit C7 - Risk Assessment
Office: B232
B-1049 Brussels
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| Format (e.g. PDF): |
PDF
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EUGRIS Keyword(s): |
Contaminated land-->Contaminants-->Others
Contaminated land-->Risk assessment-->Receptor: Human health
Contaminated land-->Risk assessment-->Risk assessment overview
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| Short description: |
The Committee has examined the existing base of scientific knowledge and recognised that
this subject is new and rapidly developing. The Technical Guidance Documents currently
make very little reference to substances in particulate form. With respect to human health,
the current methodologies described in the Technical Guidance Documents are generally
likely to be able to identify the hazards associated with the use of nanoparticles. For the
determination of dose – response relationships, special attention should be given to the
expression of the metrics of the nanoparticle dose since mass concentration is not
necessarily the best description of dose for these materials and number concentration and
surface area are likely to be more appropriate. Not all nanoparticle formulations have been
found to induce a more pronounced toxicity than the bulk formulations of the same
substance. This suggests that the evaluation of nanoparticle formulations should be carried
out on a case by case basis and it is important that it is determined whether test
procedures will be predictive for human health hazards for all types of nanoparticles.
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| Long description: |
With respect to environmental exposure, the validity and appropriateness of existing
technologies are not clear. In the absence of sufficient data on the fate and effect of
nanoparticles on the environment, it is neither feasible nor appropriate to propose firm rules
on how substances in nanoparticle form should be evaluated. Instead the applicability of
existing methods for risk assessment of nanoparticles should be evaluated.
A series of recommendations for improved methodologies and areas urgently requiring
additional data and scientific knowledge are presented, including observations on the
applicability of in vitro test procedures, QSAR approaches to nanoparticles, the prediction of
environmental concentrations and the need for new ecotoxicity tests and the assessment of
bioavailability.
With respect to the performance of the risk assessment of nanomaterials. it is
recommended that the staged, or tiered, approach is adopted in order to identify different
adverse effects and different exposure data with nanoparticles. It is suggested that due
consideration be given to the possibilities now emerging that translocation of nanoparticles
away from the portal of entry may occur in humans and other species, and that the passage
of nanoparticles across membranes could give rise to adverse effects, for example within
the cardiovascular system or following passage across the blood – brain barrier.
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Link to Organisation(s):
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EC European Commission
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Submitted By:
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Professor Paul Bardos WhoDoesWhat?
Last update: 30/05/2007
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