Challenges of Regulation and Risk Assessment of Nanomaterials

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Challenges of Regulation and Risk Assessment of Nanomaterials, a Joint JRC – ENPRA Workshop organized in the frame of the JRC Enlargement and Integration Action 1. INTRODUCTION The Joint JRC Nano event and 2 nd ENPRA Workshop on Challenges of Regulation and Risk Assessment of Nanomaterials, held in Somma Lombardo the 10-12 May 2011, intended to present the last findings of European research projects in the nanosafety field, with particular emphasis on the ENPRA project results. The main goal was to discuss these results having in mind the regulatory needs and experiences in Europe, US, and China. This discussion intended to contribute to building a bridge between researchers, industry, and regulators. Another main goal of the workshop was to promote collaboration among JRC, European Union research groups and researchers in enlargement countries. The early involvement of researchers and regulators of candidate and potential candidate countries into the European nanosafety network is important to foster a fruitful future collaboration and to smooth the implementation of nanosafety-related regulations. The Workshop was organized by the Nanobiosciences Unit of the European Commission's Institute for Health and Consumer Protection of the Joint Research Centre (IHCP/JRC). There were about 80 invited participants, from national (e.g. national chemical agencies, health ministries, environmental agencies, US-EPA, European Commission DG, EU agencies) regulatory bodies, and researchers/regulators participating to international initiatives such as those led by OECD and ISO. Single industries as well as industrial associations (e.g. NIA, pigments associations, cosmetics association, etc.) were also represented, as well as researchers from universities and national institutes (e.g. China, Netherlands, UK). The final agenda and the full participants list are included as annexes to this document. A link to the presentations can be found at: http://ihcp.jrc.ec.europa.eu/events_workshops/joint-jrc-nano-enpra-2011/program/presentations The workshop was arranged in sessions. The first day was devoted to regulatory development and implementation. It was followed by one and a half days for the presentation and discussion of scientific results on characterization, exposure, and effects. To allow enough time for discussion, a ‘podium discussion’ was organized at the end of each session, where the speakers and the audience were involved in an open dialogue about the session topic. The presentations content and the discussion results are reported in the next chapters, followed by the abstracts of the presentations. 4
2. REGULATORY DEVELOPMENTS 2.1. Summary record One objective of the ENPRA project is to provide results which contribute to nanomaterials' safety within the EU (as well as globally). In order to focus and maximize the impact of their work, ENPRA partners, as well as other scientists and stakeholders attending the annual workshops, need to have a clear view of the regulatory landscape in which their work will be considered, and need to be acquainted of recent developments in the regulatory framework. Thus, the first session of this 2 nd ENPRA workshop was devoted to present and update on the state of the art and developments in the legislation and regulatory context in the EU and the world in relation to nanomaterials. A. Kobe from DG Environment set the scene by presenting an EU perspective of nanomaterials in the regulatory framework. He made a review of the past and recent EU developments starting from the Commission Communication 'Towards a European Strategy for Nanotechnology' (2004) with some emphasis on the Communication on 'Regulatory Aspects' (2008). He also explained the conclusions from the Competent Authorities Sub-group on Nanomaterials regarding REACH and the Classification and Labelling regulation. He summarised the Resolution of the European Parliament on Regulatory aspects of Nanomaterials and explained the status of expected key deliverables by the Commission during 2011, i.e. Finalisation of the REACH Implementation Projects on Nanomaterials (RIP-oN) concerning Substance Identity, Information Requirements and Chemical Safety Assessment; the 2nd regulatory review of nanomaterials; the review concerning 'Nanomaterials in REACH registration dossiers and adequacy of available information'; a report on nanomaterial types and uses on the market and the definition of the term 'nanomaterial'. He also touched on the very important work going on in parallel in the research sphere and in international organisations such as OECD Working party on Manufactured Nanomaterials (WPMN). B. Quinn from ECHA presented work following a request by the Commission with regard to the compilation of an inventory based on nanomaterials in REACH registrations & CLP notifications. She explained that in the context of REACH, nanomaterials can be considered as substances on their own or as forms of substances. The results will be a part of the Commission response to the European Parliament on Regulatory Aspects of Nanomaterials. After explaining the approach for screening the large database of registrations and notifications currently held at ECHA, the presenter explained that this work will give an indication of how registrants and notifiers have identified nanomaterials in their dossiers and consequently applied REACH and CLP. Furthermore, it will show how registrations or notifications of nanomaterials can be found in the database. In addition this screening will also be used to identify 50-60 registration dossiers that include information on nanomaterials for a JRC-ENV project for assessing the adequacy of information included on nanomaterials in a selected number of REACH registration dossiers. Detailed results of these activities should be available towards the end of 2011. There is concern regarding nanomaterials in food and feed that depends on their particular intrinsic characteristics, the lack of in vivo toxicity data and in vitro validated tests and the limited practical experience on risk assessment in this area. Furthermore, there are many uncertainties are associated with measurement of nanomaterials in various matrices, limited experience with testing nanomaterials, a lack of information on long term oral exposure, and there is the possibility that bioaccumulating and persistent nanomaterials end up in the food/feed chain. D. Carlander presented the Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain prepared by the EFSA scientific committee, following a 2009 request by the 5
Page 1 and 2: Challenges of Regulation and Risk A
Page 3: TABLE OF CONTENTS 1. INTRODUCTION .
Page 7 and 8: into risk assessments and risk mana
Page 9 and 10: Nanomaterials in the Regulatory Dev
Page 11 and 12: Guidance on the risk assessment of
Page 13 and 14: Current Progress of activity and ef
Page 15 and 16: of the Sponsorship programme and pr
Page 17 and 18: exposure using new metrics and to d
Page 19 and 20: and risks would increase the probab
Page 21 and 22: OECD Working Party on Manufactured
Page 23 and 24: REACH Implementation Project on Nan
Page 25 and 26: Industry experience with conducting
Page 27 and 28: Health, Safety, and Environment: As
Page 29 and 30: 4. CHARACTERISATION AND DETECTION O
Page 31 and 32: 4.2. Abstracts 31
Page 33 and 34: Primary and secondary characterizat
Page 35 and 36: 5. EXPOSURE ASSESSMENT 5.1. Summary
Page 39 and 40: Application and adaptation of expos
Page 41 and 42: areas. The final remark was that th
Page 45 and 46: Integrating test strategy for ecoto
Page 47 and 48: Ageing and Toxicity of real NM in a
Page 49 and 50: The bioavailability and trophic tra
Page 51 and 52: 7. HUMAN TOXICITY 7.1. Summary reco
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Variation in acute toxicity for 9 e
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In conclusion, the in vitro hepatoc
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Acknowledgements The editors would
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24 FURUNO Shoko Association (NIA) A
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76 VOM BROCKE Jochen German Federal
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05. NANEX: development of Exposure
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European Commission JRC 67654- Join
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The mission of the JRC is to provid
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Challenges of Regulation and Risk Assessment of Nanomaterials

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