Challenges of Regulation and Risk Assessment of Nanomaterials
Challenges of Regulation and Risk Assessment of Nanomaterials
Challenges of Regulation and Risk Assessment of Nanomaterials
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REACH Implementation Project on <strong>Nanomaterials</strong> -<br />
RIP-oN3: Specific Advice on Exposure <strong>Assessment</strong> <strong>and</strong> Hazard/<strong>Risk</strong><br />
Characterisation for <strong>Nanomaterials</strong> under REACH<br />
Aitken R.J. 1 , Hankin S.M. 1 , Peters S.A.K. 1 , Pol<strong>and</strong> C.A. 1 , Tran C.L. 1 , Foss Hansen S. 2 , Friedrichs<br />
S. 3 , <strong>and</strong> Holmqvist J. 4<br />
1 Institute <strong>of</strong> Occupational Medicine; 2 DTU; 3 NIA; 4 Cefic<br />
In 2010, the European Commission launched two REACH Implementation Projects on <strong>Nanomaterials</strong><br />
with the purpose <strong>of</strong> advising how the Information Requirements (IR) <strong>and</strong> Chemical Safety <strong>Assessment</strong><br />
guidance could be updated to better reflect the registration requirements for nanomaterials.<br />
The objectives <strong>of</strong> the RIP-oN 3 project were tw<strong>of</strong>old. The first was to develop specific advice on how<br />
to do exposure assessment for nanomaterials within the REACH context including, development <strong>of</strong><br />
Exposure Scenarios, evaluation <strong>of</strong> operational conditions <strong>and</strong> risk management/mitigation measures<br />
<strong>and</strong> exposure estimation. The second was to develop ideas on how to conduct hazard <strong>and</strong> risk<br />
characterisation for nanomaterials.<br />
The initial activity was the collection <strong>and</strong> review <strong>of</strong> information from a wide range <strong>of</strong> sources (Task A).<br />
This was followed by an evaluation <strong>of</strong> the evidence base to identify the key scientific issues arising<br />
which had the possibility <strong>of</strong> implications for the REACH guidance. This included, in relation to<br />
exposure <strong>and</strong> exposure scenarios, examination <strong>of</strong> industry case studies (Task B1), <strong>and</strong> harvesting<br />
results from on-going activities in relation to operational conditions <strong>and</strong> risk management measures<br />
(Task B2) <strong>and</strong> exposure estimation (Task B3). In relation to hazards, similar harvesting <strong>and</strong> analysis<br />
considered how no effect levels could be established (Task C1) <strong>and</strong> hazard <strong>and</strong> risk characterisation<br />
(Task C2). The issue <strong>of</strong> metrics was carefully considered (Task D).<br />
The Final stage <strong>of</strong> the project was a section by section analysis <strong>of</strong> the existing REACH guidance. The<br />
assessment considered in detail the optimum set <strong>of</strong> changes which could be made to the guidance.<br />
Based on this analysis, detailed guidance changes were developed along with recommendations for<br />
research where this was indicated.<br />
Findings from the project, concluding in mid-2011, are being finalised to form advice on specific<br />
issues related to nanomaterials for further consideration <strong>and</strong> integration into the REACH guidance<br />
documents, <strong>and</strong> to identify further research <strong>and</strong> development on relevant issues.<br />
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