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SCENIHR concludes consultation and adopts final opinion
Published: Thursday 14 August 2008
The EC’s Scientific Committee on Emerging and Newly Identified Health Risks today published its 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, adopted by the SCENIHR during the 19th plenary meeting of 21-22 June 2007. Prior to its official adoption, interested parties had been invited to submit comments or pertinent scientific information on the preliminary report. (Follow this link to download the NIA’s comments on the preliminary report.)
The SCENIHR opinion concludes that, while the current methodologies are generally likely to be able to identify the hazards associated with the use of nanoparticles, modifications for the existing guidance will be necessary. The SCENIHR identifies issues requiring improvements in the technical guidance and methodologies as well as proposes a staged strategy for the risk assessment of nanomaterials.
Highlights of the SCENHR Opinion:
- 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,
- surface area metrics than mass concentration are likely to be more appropriate to express the nanoparticle dose,
- evaluation of nanoparticle formulations should be carried out on a case by case basis, because not all nanoparticle formulations have been found to induce a more pronounced toxicity than the bulk formulations of the same substance.
- the validity and appropriateness of existing environmental exposure assessment technologies is not always 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,
- existing methods for risk assessment of nanoparticles should be evaluated,
- it is recommended that the tiered approach to risk assessment is adopted in order to identify different adverse effects and different exposure data with nanoparticles.
Follow these links to find out more about the SCENIHR, to read the all consultation responses, or to download the full Opinion Paper.