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Safe Nanotechnology
                           EC Industrial Research



    Georgios Katalagarianakis
    EC, Research DG
    Industrial Technologies Directorate
    G4 Nanoscience - Nanotechnology

OEAW, Vienna, 24/9/2009                             1
summary

      The EU project portfolio and RTD
       investment
      The problem
      The next steps
      RTD policy making




OEAW, Vienna, 24/9/2009                   2
The EC research
      Lisbon strategy for growth and Jobs…

      FP7 - the 7th Framework Programme for
       Research of the EC (2007 – 2013)
       ”Building the Europe of knowledge”

      NMP - Theme 4 “Nanosciences,
       nanotechnologies, Materials, and new
       Production technologies”
       - Industrial research programme




OEAW, Vienna, 24/9/2009                        3
NMP aims at
                          Industrial Transformation
     In the globalised economy,
     EU industry should focus on creating products
       with more added-value

     especially by moving from:
       – Individual to system competitiveness
       – Resource-based to knowledge-based economies
       – Macro → micro → nano
       – Mono-disciplinarity → interdisciplinarity →
         convergence

                   Nanoechnology action plan 2004-2009
OEAW, Vienna, 24/9/2009                                  4
FP6 - NMP PROJECTS

     •     ON SAFETY OF NANOPARTICLES:
           •    CELLNANOTOX: Cellular Interaction and Toxicology with Engineered Nanoparticles
           •    DIPNA: Development of an Integrated Platform for Nanoparticle Analysis to verify their possible
                toxicity and eco-toxicity
           •    NANOINTERACT: Development of a platform and toolkit for understanding interactions
                between nanoparticles and the living world
           •    NANOSH: Inflammatory and genotoxic effects of engineered nanomaterials
           •    NANOCAP: Nanotechnology Capacity Building NGOs (FP6-SOCIETY)
           •    IMPART: Improving the understanding of the impact of nanoparticles on human health and the
                environment
           •    PARTICLE-RISK: Risk Assessment of Exposure to Particles (FP6-NEST)

     •     SAFETY OF PROCESSES
           •    NANOSAFE2: Safe production and use of nanomaterials
           •    SAPHIR: Controlled Production Of High Tech Multifunctional Products And Their Recycling

     •     STANDARDISATION AND METROLOGY:
           •    NANO-STRAND: Standardization related to Research and Development for Nanotechnologies
           •    NANOTRANSPORT: The Behaviour of Aerosols Released to Ambient Air from Nanoparticle
                Manufacturing - A Pre-normative Study



OEAW, Vienna, 24/9/2009                                                                                           5
Impact on Health and the Environment
                     FP7-NMP, 1st year, 2007, topics
      NMP-2007-1.3-1      Specific, easy-to-use portable devices for measurement and analysis
      Large RTD           NANODEVICE: Novel Concepts, Methods, and Technologies for the Production of
      Projects            Portable, Easy-to-Use Devices for the Measurement and Analysis of Airborne
                          Engineered Nanoparticles in Workplace Air
      NMP-2007-1.3-2      Risk assessment of engineered nanoparticles on health and the environment
      Small RTD           NANOMMUNE: Comprehensive assessment of hazardous effects of engineered
      projects                nanomaterials on the immune system
                          NANORETOX: The Reactivity and Toxicity of Engineered Nanoparticles: Risks to the
                              Environment and Human Health
                          NEURONANO: Do nanoparticles induce neurodegenerative diseases? Understanding
                              the origin of reactive oxidative species and protein aggregation and mis-folding
                              phenomena in the presence of nanoparticles
      NMP-2007-1.3-3      Scientific review on the data and studies on the potential impact on health,
      Coordination            safety and the environment of engineered nanoparticles
                          ENRHES: Engineered Nanoparticles: Review of Health and Environmental Safety
      NMP-2007-1.3-4      Creation of a critical and commented database on the health, safety and
      Coordination            environmental impact of nanoparticles
                          NHECD

      NMP-2007-1.3-5      Coordination in studying the environmental, safety and health impact of
      Coordination        engineered nanoparticles and nanotechnology based materials and products
                          NANOIMPACTNET: The European Network on the Health and Environmental
                          Impact of Nanomaterials
    HEALTH-2007-          Alternative testing strategies for the assessment of the toxicological profile
    1.3-4                 of nanoparticles used in medical diagnostics
    Small RTD             NANOTEST: Development of methodology for alternative testing strategies for the
    projects
OEAW, Vienna, 24/9/2009   assessment of the toxicological profile of nanoparticles used in medical diagnostics   6
Impact on Health and the Environment
                   FP7-NMP: Topics addressed in 2008


     NMP-2008-1.3-1       Validation, adaptation and/or development of risk assessment
     Large RTD Projects   methodology for engineered nano-particles
                          No proposals selected
     NMP-2008-1.3-2       Impact of engineered nanoparticles on health and the environment
     Coordination
                          ENNSATOX: Engineered Nanoparticle Impact on Aquatic Environments:
                          Structure, Activity and Toxicology
                          ENPRA: Risk Assessment Of Engineered Nanoparticles
                          HINAMOX: Health Impact of Engineered Metal and Metal Oxide Nanoparticles:
                          Response, Bioimaging and Distribution at Cellular and Body Level
                          INLIVETOX: Intestinal, Liver and Endothelial Nanoparticle Toxicity Development
                          and evaluation of a novel tool for high-throughput data generation
                          NEPHH: Nanomaterials Related Environmental Pollution And Health
                          Hazards Throughout Their Life Cycle




OEAW, Vienna, 24/9/2009                                                                                    7
Impact on Health and the Environment
                           FP7-NMP: Topics addressed in 2009
                            Submissions deadline 31/3/2009

     NMP-2008-1.3-1         Activities towards the development of appropriate solutions for the use,
     Small RTD projects     recycling and/or final treatment of nanotechnology-based products
                            (Joint call with Theme 6: 'Environment - Climate Change')
                            Four proposals selected for negotiation:
                            NANOPOLYTOX: Toxicological impact of nanomaterials derived from processing,
                            weathering and recycling of polymer nanocomposites used in various industrial
                            applications
                            NANOHOUSE: Life Cycle of Nanoparticle-based Products used in House Coating
                            NanoFATE: Nanoparticle Fate Assessment and Toxicity in the Environment
                            NanoSustain: Development of sustainable solutions for nanotechnology-based
                            products based on hazard characterization and LCA
     NMP-2008-1.3-2         Exposure scenaria to nanoparticles
     Coordination           One proposal selected for negotiation
                            NANEX: Development of Exposure Scenarios, for Manufactured Nanomaterials
     KBBE-2009-2-4-1        Analytical tools for characterisation of nano-particles in the food Matrix
     Small RTD projects     One proposal selected for negotiation

                            NanoLyse: Nanoparticles in food: analytical methods for detection and
                            characterisation


OEAW, Vienna, 24/9/2009                                                                                     8
EU RTD investment

        FP 6: About € 25 million
        FP7, 1st year: About € 25 million
        FP7, 2nd year: € 13.75 million
        FP7, 3rd year: Estimated after
         negotiation € 11 million

      Total: € 75 million EU funding



OEAW, Vienna, 24/9/2009                       9
The challenges for Nano
      Next technological revolution
      Massive investment
      New materials, properties, products
      Huge impact for medicine, energy,
       water, food, etc.
      But …

                New potential risks to manage


OEAW, Vienna, 24/9/2009                             10
Problem dimensions
      Emerging
      Global
      Crucial
      Several industrial sectors involved
      Unclear framework in standards,
       experience, inspection, …
      Generic legislation exists



OEAW, Vienna, 24/9/2009                        11
Knowledge gaps
        Background level
        Measurement methods
        Metrics
        Biological impact
        Exposure data
        Risk assessment underpinning data
        …

     Knowledge gaps not necessarily RTD related

OEAW, Vienna, 24/9/2009                           12
Organisational gaps

      No global strategy, good intentions
      Many funding sources, coordination needed
      Many research projects, plethora of results
      Unpublished or proprietary data
      Data comparison and verification
      Focus on nanoparticles toxicity and
       ecotoxicity, not (adequately) on
       process/product safety
      Specific legislation
      Standardisation


OEAW, Vienna, 24/9/2009                              13
The future priorities

     Technical areas in risk management:
      Detection, measurement, marking
      Characterisation
      Exposure control
      Safe processes in production and use
      Safe handling and transport
      Equipment
      Hazard identification and risk
       assessment, Life Cycle Impact

OEAW, Vienna, 24/9/2009                           14
EU RTD policy bodies in Nano
      High Level Experts Group of MS and FP7-AS
        – Meetings 19/2/2009, 1/6/2009, next 26/11/2009
        – Safety chosen as priority area
      NANOFUTURES technology platform
        – A research stakeholders forum
        – Synergy across other technology platforms
        – MINAM working group partnership (600 organisations)
          used as basis
        – Some work done in ETP Industrial Safety, and other
          groups (nanosafe, nanocare, …)
      Ad-hoc Industrial Group
        – Has met several times since october 2008
        – Fixing industry objectives (mainly non-safety)
      An industrial group on safety
        – Has met in June and September, 2009


OEAW, Vienna, 24/9/2009                                         15
Discussion
        How to manage industrial safety in the nano-industry?
                • Safety at work; occupational diseases
                • Environmental safety; secondary exposure
                • Consumer safety; product safety
          –   Can RTD and legislation go hand in hand?
          –   Can RTD needs be anticipated/planned?
          –   How to address EU-MS authorities, industry collaboration
          –   How to join efforts

        EU RTD is breakthrough-innovation oriented; it cannot be used for
         routine work but can establish foundations
          – Data collection, management, RA, LCA
          – Standardisation
          – Market surveillance, …

        OECD Working Party on Manufactured Nanomaterials

        A mechanism to map and control progress?



OEAW, Vienna, 24/9/2009                                                      16
The next steps in RTD
      A projects cluster on Nano-Safety
          – Meetings 26/2/2009, 1/4, 28-29/4, 24-25/8,
                • Next: 8-9 october
          – Synergy, projects mapping, data, test protocols, results
            verification and validation, material characterisation, research
            roadmapping
          – Mainly nano-toxicity at present
      Infrastructure/competences integration               (call now open;
         proposal in preparation)
        Modelling/simulation (NMP call open, jointly with USA)
        Risk management (NMP call open)
        ERANET (NMP call open)
        Joint Programming (call open)
        Risk monitoring
        Risk reduction
        International cooperation
        RTD support to Standardisation

OEAW, Vienna, 24/9/2009                                                        17
priority topics discussion


        Rationale:
        Based on what is needed by 2016. 6 topics to be proposed
         up to 2013 – 2 per year
        Topics should have sufficient scope as to be meaningful,
         without being too large (focus will be on large projects).
        Complementary to the existing ~30 projects (FP6 and FP7)
         in the cluster (€75M funding) and the expected (€25M)
        Considering needs of industry, employment, environment,
         consumer safety & work conditions
        Considering other RTD programmes, coordination
        Strengthening international cooperation
        Research projects must be innovation driven.
        Next call to be published in July 2010 with closing date Dec
         2010 and projects starting late 2011 onwards


OEAW, Vienna, 24/9/2009                                                 18
2011-2013 RTD topics
                             Innovation driven
        Worker protection and exposure risk management
         strategies for nanomaterial production, use and disposal
        New methods and strategies for measurement, detection
         and identification of nanoparticles in products and/or in
         the environment
        Understanding pathogenic mechanisms of nanomaterials
         interacting with living systems from unicellular species to
         humans
        Systematic investigation of effects of nanomaterial
         properties, functionalisation or surface coatings on the
         mode of action, bioaccumulation / biopersistence and/or
         human /environmental exposure for (future) modelling
        New methods & approaches for dealing with large scale
         (accidental) exposures to nanoparticles: Remediation of
         polluted environments and treatment of acute toxicity
         following heavy exposure
        Intelligent testing strategies for nanomaterials impact and
         exposure – towards regulation and clustering of materials

OEAW, Vienna, 24/9/2009                                                19
Information on
                          Nanotechnology in EC




  • Commission Nanotechnologies homepage
     http://cordis.europa.eu/nanotechnology/
       http://ec.europa.eu/nanotechnology/index_en.html




OEAW, Vienna, 24/9/2009                                   20

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Safe Nanotechnology EC Industrial Research

  • 1. Safe Nanotechnology EC Industrial Research Georgios Katalagarianakis EC, Research DG Industrial Technologies Directorate G4 Nanoscience - Nanotechnology OEAW, Vienna, 24/9/2009 1
  • 2. summary  The EU project portfolio and RTD investment  The problem  The next steps  RTD policy making OEAW, Vienna, 24/9/2009 2
  • 3. The EC research  Lisbon strategy for growth and Jobs…  FP7 - the 7th Framework Programme for Research of the EC (2007 – 2013) ”Building the Europe of knowledge”  NMP - Theme 4 “Nanosciences, nanotechnologies, Materials, and new Production technologies” - Industrial research programme OEAW, Vienna, 24/9/2009 3
  • 4. NMP aims at Industrial Transformation In the globalised economy, EU industry should focus on creating products with more added-value especially by moving from: – Individual to system competitiveness – Resource-based to knowledge-based economies – Macro → micro → nano – Mono-disciplinarity → interdisciplinarity → convergence Nanoechnology action plan 2004-2009 OEAW, Vienna, 24/9/2009 4
  • 5. FP6 - NMP PROJECTS • ON SAFETY OF NANOPARTICLES: • CELLNANOTOX: Cellular Interaction and Toxicology with Engineered Nanoparticles • DIPNA: Development of an Integrated Platform for Nanoparticle Analysis to verify their possible toxicity and eco-toxicity • NANOINTERACT: Development of a platform and toolkit for understanding interactions between nanoparticles and the living world • NANOSH: Inflammatory and genotoxic effects of engineered nanomaterials • NANOCAP: Nanotechnology Capacity Building NGOs (FP6-SOCIETY) • IMPART: Improving the understanding of the impact of nanoparticles on human health and the environment • PARTICLE-RISK: Risk Assessment of Exposure to Particles (FP6-NEST) • SAFETY OF PROCESSES • NANOSAFE2: Safe production and use of nanomaterials • SAPHIR: Controlled Production Of High Tech Multifunctional Products And Their Recycling • STANDARDISATION AND METROLOGY: • NANO-STRAND: Standardization related to Research and Development for Nanotechnologies • NANOTRANSPORT: The Behaviour of Aerosols Released to Ambient Air from Nanoparticle Manufacturing - A Pre-normative Study OEAW, Vienna, 24/9/2009 5
  • 6. Impact on Health and the Environment FP7-NMP, 1st year, 2007, topics NMP-2007-1.3-1 Specific, easy-to-use portable devices for measurement and analysis Large RTD NANODEVICE: Novel Concepts, Methods, and Technologies for the Production of Projects Portable, Easy-to-Use Devices for the Measurement and Analysis of Airborne Engineered Nanoparticles in Workplace Air NMP-2007-1.3-2 Risk assessment of engineered nanoparticles on health and the environment Small RTD NANOMMUNE: Comprehensive assessment of hazardous effects of engineered projects nanomaterials on the immune system NANORETOX: The Reactivity and Toxicity of Engineered Nanoparticles: Risks to the Environment and Human Health NEURONANO: Do nanoparticles induce neurodegenerative diseases? Understanding the origin of reactive oxidative species and protein aggregation and mis-folding phenomena in the presence of nanoparticles NMP-2007-1.3-3 Scientific review on the data and studies on the potential impact on health, Coordination safety and the environment of engineered nanoparticles ENRHES: Engineered Nanoparticles: Review of Health and Environmental Safety NMP-2007-1.3-4 Creation of a critical and commented database on the health, safety and Coordination environmental impact of nanoparticles NHECD NMP-2007-1.3-5 Coordination in studying the environmental, safety and health impact of Coordination engineered nanoparticles and nanotechnology based materials and products NANOIMPACTNET: The European Network on the Health and Environmental Impact of Nanomaterials HEALTH-2007- Alternative testing strategies for the assessment of the toxicological profile 1.3-4 of nanoparticles used in medical diagnostics Small RTD NANOTEST: Development of methodology for alternative testing strategies for the projects OEAW, Vienna, 24/9/2009 assessment of the toxicological profile of nanoparticles used in medical diagnostics 6
  • 7. Impact on Health and the Environment FP7-NMP: Topics addressed in 2008 NMP-2008-1.3-1 Validation, adaptation and/or development of risk assessment Large RTD Projects methodology for engineered nano-particles No proposals selected NMP-2008-1.3-2 Impact of engineered nanoparticles on health and the environment Coordination ENNSATOX: Engineered Nanoparticle Impact on Aquatic Environments: Structure, Activity and Toxicology ENPRA: Risk Assessment Of Engineered Nanoparticles HINAMOX: Health Impact of Engineered Metal and Metal Oxide Nanoparticles: Response, Bioimaging and Distribution at Cellular and Body Level INLIVETOX: Intestinal, Liver and Endothelial Nanoparticle Toxicity Development and evaluation of a novel tool for high-throughput data generation NEPHH: Nanomaterials Related Environmental Pollution And Health Hazards Throughout Their Life Cycle OEAW, Vienna, 24/9/2009 7
  • 8. Impact on Health and the Environment FP7-NMP: Topics addressed in 2009 Submissions deadline 31/3/2009 NMP-2008-1.3-1 Activities towards the development of appropriate solutions for the use, Small RTD projects recycling and/or final treatment of nanotechnology-based products (Joint call with Theme 6: 'Environment - Climate Change') Four proposals selected for negotiation: NANOPOLYTOX: Toxicological impact of nanomaterials derived from processing, weathering and recycling of polymer nanocomposites used in various industrial applications NANOHOUSE: Life Cycle of Nanoparticle-based Products used in House Coating NanoFATE: Nanoparticle Fate Assessment and Toxicity in the Environment NanoSustain: Development of sustainable solutions for nanotechnology-based products based on hazard characterization and LCA NMP-2008-1.3-2 Exposure scenaria to nanoparticles Coordination One proposal selected for negotiation NANEX: Development of Exposure Scenarios, for Manufactured Nanomaterials KBBE-2009-2-4-1 Analytical tools for characterisation of nano-particles in the food Matrix Small RTD projects One proposal selected for negotiation NanoLyse: Nanoparticles in food: analytical methods for detection and characterisation OEAW, Vienna, 24/9/2009 8
  • 9. EU RTD investment  FP 6: About € 25 million  FP7, 1st year: About € 25 million  FP7, 2nd year: € 13.75 million  FP7, 3rd year: Estimated after negotiation € 11 million  Total: € 75 million EU funding OEAW, Vienna, 24/9/2009 9
  • 10. The challenges for Nano  Next technological revolution  Massive investment  New materials, properties, products  Huge impact for medicine, energy, water, food, etc.  But … New potential risks to manage OEAW, Vienna, 24/9/2009 10
  • 11. Problem dimensions  Emerging  Global  Crucial  Several industrial sectors involved  Unclear framework in standards, experience, inspection, …  Generic legislation exists OEAW, Vienna, 24/9/2009 11
  • 12. Knowledge gaps  Background level  Measurement methods  Metrics  Biological impact  Exposure data  Risk assessment underpinning data  … Knowledge gaps not necessarily RTD related OEAW, Vienna, 24/9/2009 12
  • 13. Organisational gaps  No global strategy, good intentions  Many funding sources, coordination needed  Many research projects, plethora of results  Unpublished or proprietary data  Data comparison and verification  Focus on nanoparticles toxicity and ecotoxicity, not (adequately) on process/product safety  Specific legislation  Standardisation OEAW, Vienna, 24/9/2009 13
  • 14. The future priorities Technical areas in risk management:  Detection, measurement, marking  Characterisation  Exposure control  Safe processes in production and use  Safe handling and transport  Equipment  Hazard identification and risk assessment, Life Cycle Impact OEAW, Vienna, 24/9/2009 14
  • 15. EU RTD policy bodies in Nano  High Level Experts Group of MS and FP7-AS – Meetings 19/2/2009, 1/6/2009, next 26/11/2009 – Safety chosen as priority area  NANOFUTURES technology platform – A research stakeholders forum – Synergy across other technology platforms – MINAM working group partnership (600 organisations) used as basis – Some work done in ETP Industrial Safety, and other groups (nanosafe, nanocare, …)  Ad-hoc Industrial Group – Has met several times since october 2008 – Fixing industry objectives (mainly non-safety)  An industrial group on safety – Has met in June and September, 2009 OEAW, Vienna, 24/9/2009 15
  • 16. Discussion  How to manage industrial safety in the nano-industry? • Safety at work; occupational diseases • Environmental safety; secondary exposure • Consumer safety; product safety – Can RTD and legislation go hand in hand? – Can RTD needs be anticipated/planned? – How to address EU-MS authorities, industry collaboration – How to join efforts  EU RTD is breakthrough-innovation oriented; it cannot be used for routine work but can establish foundations – Data collection, management, RA, LCA – Standardisation – Market surveillance, …  OECD Working Party on Manufactured Nanomaterials  A mechanism to map and control progress? OEAW, Vienna, 24/9/2009 16
  • 17. The next steps in RTD  A projects cluster on Nano-Safety – Meetings 26/2/2009, 1/4, 28-29/4, 24-25/8, • Next: 8-9 october – Synergy, projects mapping, data, test protocols, results verification and validation, material characterisation, research roadmapping – Mainly nano-toxicity at present  Infrastructure/competences integration (call now open; proposal in preparation)  Modelling/simulation (NMP call open, jointly with USA)  Risk management (NMP call open)  ERANET (NMP call open)  Joint Programming (call open)  Risk monitoring  Risk reduction  International cooperation  RTD support to Standardisation OEAW, Vienna, 24/9/2009 17
  • 18. priority topics discussion  Rationale:  Based on what is needed by 2016. 6 topics to be proposed up to 2013 – 2 per year  Topics should have sufficient scope as to be meaningful, without being too large (focus will be on large projects).  Complementary to the existing ~30 projects (FP6 and FP7) in the cluster (€75M funding) and the expected (€25M)  Considering needs of industry, employment, environment, consumer safety & work conditions  Considering other RTD programmes, coordination  Strengthening international cooperation  Research projects must be innovation driven.  Next call to be published in July 2010 with closing date Dec 2010 and projects starting late 2011 onwards OEAW, Vienna, 24/9/2009 18
  • 19. 2011-2013 RTD topics Innovation driven  Worker protection and exposure risk management strategies for nanomaterial production, use and disposal  New methods and strategies for measurement, detection and identification of nanoparticles in products and/or in the environment  Understanding pathogenic mechanisms of nanomaterials interacting with living systems from unicellular species to humans  Systematic investigation of effects of nanomaterial properties, functionalisation or surface coatings on the mode of action, bioaccumulation / biopersistence and/or human /environmental exposure for (future) modelling  New methods & approaches for dealing with large scale (accidental) exposures to nanoparticles: Remediation of polluted environments and treatment of acute toxicity following heavy exposure  Intelligent testing strategies for nanomaterials impact and exposure – towards regulation and clustering of materials OEAW, Vienna, 24/9/2009 19
  • 20. Information on Nanotechnology in EC • Commission Nanotechnologies homepage http://cordis.europa.eu/nanotechnology/ http://ec.europa.eu/nanotechnology/index_en.html OEAW, Vienna, 24/9/2009 20