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Challenges of Regulation and Risk Assessment of Nanomaterials

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<strong>Challenges</strong> <strong>of</strong> <strong>Regulation</strong> <strong>and</strong> <strong>Risk</strong> <strong>Assessment</strong> <strong>of</strong><br />

<strong>Nanomaterials</strong>,<br />

a Joint JRC – ENPRA Workshop organized in the frame <strong>of</strong> the<br />

JRC Enlargement <strong>and</strong> Integration Action<br />

1. INTRODUCTION<br />

The Joint JRC Nano event <strong>and</strong> 2 nd ENPRA Workshop on <strong>Challenges</strong> <strong>of</strong> <strong>Regulation</strong> <strong>and</strong> <strong>Risk</strong> <strong>Assessment</strong><br />

<strong>of</strong> <strong>Nanomaterials</strong>, held in Somma Lombardo the 10-12 May 2011, intended to present the last<br />

findings <strong>of</strong> European research projects in the nanosafety field, with particular emphasis on the ENPRA<br />

project results. The main goal was to discuss these results having in mind the regulatory needs <strong>and</strong><br />

experiences in Europe, US, <strong>and</strong> China. This discussion intended to contribute to building a bridge<br />

between researchers, industry, <strong>and</strong> regulators. Another main goal <strong>of</strong> the workshop was to promote<br />

collaboration among JRC, European Union research groups <strong>and</strong> researchers in enlargement countries.<br />

The early involvement <strong>of</strong> researchers <strong>and</strong> regulators <strong>of</strong> c<strong>and</strong>idate <strong>and</strong> potential c<strong>and</strong>idate countries<br />

into the European nanosafety network is important to foster a fruitful future collaboration <strong>and</strong> to<br />

smooth the implementation <strong>of</strong> nanosafety-related regulations.<br />

The Workshop was organized by the Nanobiosciences Unit <strong>of</strong> the European Commission's Institute<br />

for Health <strong>and</strong> Consumer Protection <strong>of</strong> the Joint Research Centre (IHCP/JRC). There were about 80<br />

invited participants, from national (e.g. national chemical agencies, health ministries, environmental<br />

agencies, US-EPA, European Commission DG, EU agencies) regulatory bodies, <strong>and</strong><br />

researchers/regulators participating to international initiatives such as those led by OECD <strong>and</strong> ISO.<br />

Single industries as well as industrial associations (e.g. NIA, pigments associations, cosmetics<br />

association, etc.) were also represented, as well as researchers from universities <strong>and</strong> national<br />

institutes (e.g. China, Netherl<strong>and</strong>s, UK). The final agenda <strong>and</strong> the full participants list are included as<br />

annexes to this document. A link to the presentations can be found at:<br />

http://ihcp.jrc.ec.europa.eu/events_workshops/joint-jrc-nano-enpra-2011/program/presentations<br />

The workshop was arranged in sessions. The first day was devoted to regulatory development <strong>and</strong><br />

implementation. It was followed by one <strong>and</strong> a half days for the presentation <strong>and</strong> discussion <strong>of</strong><br />

scientific results on characterization, exposure, <strong>and</strong> effects. To allow enough time for discussion, a<br />

‘podium discussion’ was organized at the end <strong>of</strong> each session, where the speakers <strong>and</strong> the audience<br />

were involved in an open dialogue about the session topic.<br />

The presentations content <strong>and</strong> the discussion results are reported in the next chapters, followed by<br />

the abstracts <strong>of</strong> the presentations.<br />

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