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The NANoREG Project A common European approach to the regulatory testing of nanomaterials

The NANoREG Project A common European approach to the regulatory testing of nanomaterials. NANoREG at a Glance. Agenda. Introduction Overview approaches Objectives Workflow Partners Results/Impact. Introduction. Ongoing international initiatives: OECD WPMN.

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The NANoREG Project A common European approach to the regulatory testing of nanomaterials

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  1. The NANoREG ProjectA common European approach to the regulatory testing of nanomaterials

  2. NANoREG at a Glance Agenda • Introduction • Overview approaches • Objectives • Workflow • Partners • Results/Impact NANoREG general pressentation

  3. Introduction Ongoing international initiatives: OECD WPMN • Searching for common instruments to regulate nanomaterials • Main players: EU, US, Japan, Korea, Canada, Australia • Sponsorship project running to 2015 • Aims include: grouping the main risks of nanomaterials • Aim: find common denominator for implementing guidelines • Aim: Develop or modify SPSF procedures or technical guidelines The OECD WPMN approach is based on research into the material based effects of nanomaterials NANoREG general pressentation

  4. Introduction NANoREG – the other side of the coin • A H2020 project, before H2020 even kicks off, combining all the aspects of societal needs, innovation, exploitation & industry • 61 partners from 14 EU states, 50 M €, 42 months • 20 M € in-vivo, 25 M € in-vitro, 5 M € safe by design • NANoREG approach is to look at the overal methodology • Value Chain Studies central in NANoREG strategy • Aim is grouping of nanomaterials based on phys-chem and tox rather than risk based (OECD WPMN) • Structured to deliver answers on regulatory questions coming from the member states NANoREG general pressentation

  5. Introduction NANoREG – expected results and impact • Will contribute to a safe and controlled market entrance of new nanomaterials and nanomaterial based products • Help fill the gaps and shortcomings in current evaluation methods for new materials • Include risk analysis at the drawing board stage – promote Safe by Design • Support an EU wide integrated risk policy • Aim: find common denominator for implementing guidelines • Aim: Develop or modify SPSF procedures or technical guidelines Grouping, regulating, and risk management NANoREG general pressentation

  6. Introduction NANoREG – international position • Already forms the EU contribution to the EU-US axis on global regulation of nanomaterials • Strong interest shown by several OECD countries to participate on the basis of their own financial support – Japan, Korea, Australia, Canada, Turkey • Strong interest shown by several other countries to join on an own cost basis, now under evaluation – China, Russia, Brazil • Links to other organisations (ECHA, OECD, ISO, etc) • Links to ongoing projects and initiatives based on areas of common interest NANoREG general pressentation

  7. National Mirrors of the NANoREG consortium NANoREG’s unique approach • Collaboration • between: • regulation & legislation authorities and • Industry with • experts from science NANoREG general pressentation 7

  8. Industry Focus of the European Approach 1 2 NANoREG general pressentation 8

  9. The NANoREG Approach NANoREG general pressentation 9

  10. NANoREG Partners A collaboration between 60 partners from 14 European countries 11 are EU member states (NL, DE, FR, ES, IT, DK, SE, FI, UK, IR, PT) 3 are associated states (TR, CH, NO), and JRC NANoREG general pressentation 10

  11. Overall objectives 1. Providing legislators with a set of tools for risk assessment and decision making instruments for the short to medium term, by gathering data and performing pilot risk assessment, including exposure monitoring and control, for a selected number of nanomaterials used in products; 2. Developing for the long term, new testing strategies adapted to a high number of nanomaterials where many factors can affect their environmental and health impact. 3. Establishing a close collaboration among authorities and industry with regard to the knowledge required for appropriate risk management, and create the basis for common approaches, mutually acceptable datasets and risk management practices. NANoREG general pressentation 11

  12. NANoREG’s European/global workflow NANoREG general pressentation 12

  13. From Questions to Answers NANoREG’s Workflow NANoREG general pressentation 13

  14. NANoREG’s Value Chain Approach Bidirectional information flow and risk communication Generative route, hazard and exposure Materials Use R&D ManufactureProcessing Recycling/Waste treatment Value chain only indicative Market control, probes for exposure Work place inspections NANoREG general pressentation 14

  15. Working Groups and Value Chain Projects (VCP) key elements of NANoREG NANoREG’s Open Architecture for Industry participation WP1 Task 1.3 WP2 WP3 WP4 WP5 WP6 Working Group/ VCP 1 Working Group/ VCP 2 Working Group/ VCP 3 Industry participation also fromoutside the NANoREG consortium Working Group/ VCP 4 Working Group/ VCP n NANoREG general pressentation 15

  16. NANoREG’s Organisational Structure General Assembly (Chair Coordinator) Industry Consultation Committee Global (EU-US) Community of Research Coordinator Scientific and Regulatory Advisory DG Research and Innovation National Advisory Board Management Committee (Chair Coordinator) IPR Advisory Committee WP1 Scientific answers to regulatory issues WP2 Synthesis, supplying and characterization WP5 Regulatory risk assessment and testing WP6 Keeping pace with Innovation WP7 Liaisons, dissemination, exploitation, communication WP8 Project Management WP3 Exposure through life cycle analysis WP4 Biokinetics and toxicity testing in vivo Working Group 1: Solution strategies answering regulatory demands Working Group 2 Carbon Nano Tubes Value Chain Projects defined by WP 1 NANoREG general pressentation 16

  17. National Advisors National Coordinators NANoREG’s National Organizations NANoREG general pressentation 17

  18. National Tasks National Workshop Country 1 National Workshop Country n National Workshop Country 2 National Workshop Country 3 Consolidation the questions and needs within WP 7 and transfer to WP 1, Task 1 and 3 Development of the solution strategy for the Questions and needs (WP1, Task 1.1) (if appropriate WS with national regulators and legislators) Approval of the proposed VCPs and WP2 - WP4 activities by the Management Board Start R&D work and other activities to answer the questions and providing solutions (WP2 – WP4) Elaboration of the Questions and Needs NANoREG general pressentation 18

  19. Consolidated answers by WP 1, Task 1.3 Transfer of NANoREG results from R&D, test and case studies to the national regulation and legislation authorities with experts of the NANoREG WPs (Tasks 7.2 and 7.3) Organization of national seminars with NANoREG general information for Industry, the public, NGOs, etc. (Tasks 7.3, 7.4 and 7.2) National Workshop Country 1 National Workshop Country 2 National Workshop Country 3 National Workshop Country n National Tasks Result transfer NANoREG general pressentation 19

  20. Results • Safe Products and Processes • Safe by Design Processes • Answers to regulatory questions • Tool Box • Test guidelines • Standard Operation Procedures (SOPs) • Reference materials NANoREG general pressentation 20

  21. Thank you for your attention. NANoREG general pressentation

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