Safe Nanotechnology EU Industrial Research Georgios Katalagarianakis EC, Research DG Industrial Technologies Directorate G4 Nanoscience - Nanotechnology 1
summary Policy; Towards a second Action Plan 2010-2015 The Objectives Building on existing work in safety RTD policy making and implementation 2
First Nanotechnology Ac2on Plan Conclusions of the Second Implementa2on report 2007-2009(i) Progress has been achieved in most areas. Future emphasis is on: Deepening the research efforts and roadmaps for key nanotechnology sectors, to enhance innova2on, compe22veness and safety. Life- cycle approaches should be taken into account. Developing infrastructures and the educa2onal system further, consistent with the mul2disciplinary character of nanotechnology. Strengthening the mechanisms available for industrial innova2on, stressing the concept of open innova2on and facilita2ng technology transfer. 3
First Nanotechnology Ac2on Plan 2005-2009 Conclusions of the Second Implementa2on report 2007-2009 (II) Implemen2ng a more direct, focused and con2nuous societal dialogue; and monitoring public opinion and the issues related to consumer, environmental and worker protec2on. Con2nuing to review the adequacy of regula2on, building where possible on interna2onal developments. Surveying the market for products of nanotechnology, including safety aspects. Stepping up the research effort on safety assessment throughout the product life- cycle, including the further development and valida2on of nanomaterial characterisa2on and test methods. The Commission is considering proposing a new Nanotechnology Ac7on Plan 2010-2015 4
Leveraging European Investment in Nanotechnologies R&D and Innova2on underpinnin g Value crea2on resul2ng in Sustainable socio- economic developme nt 5
1. barriers for business growth need to be iden2fied and removed 2. real innova:on needs must guide R&D output 3. fragmenta:on in R&D and Innova:on efforts has to be eliminated 4. market fragmenta:on for Nano- based Innova2ons has to be combated 5. opportuni:es for European leadership must be iden2fied and seized 6. Strategic role of Nanotechnology in recovery from the economic downturn must be ra2onalised 7. funding mechanisms have to be simplified 6
The Options Policy option 1: Continuation without a new Action Plan build on the momentum Funding of R&D will continue regulatory review and an inventory of nanomaterials by 2011 review of the Code of Conduct and monitoring every two years Coordination of bottom-up initiatives with Member States and other stakeholders pursued through existing mechanisms 7
The Options Policy option 2: Action Plan with emphasis on coherence a new strategic action plan continuing the integrated, safe and responsible development of nanotechnology policy fundamentally strengthening the coherence of various EU and national policies major effort of coordination is needed in selected key areas for innovation technology roadmaps; risk governance; building of trust; and improved coordination with policy area 8
The Options Policy option 3: A new structure for innovation strong additional mechanism of coordination with the Member States and industry set up a structure with the remit of developing and implementing innovation policy 9
Innovation Strengthening of supply side measures; most fundamental criteria Enhancing of the uptake and commercialisation of R&D results; New demand-side policies meeting integrated research and innovation needs; Introduction of nanotechnology applications with societal benefits in the market Strengthening of the integrated, safe and responsible approach Increased investment in the EHS aspects of nanotechnology A stable and predictable legal framework Rapid uptake of research findings in the regulatory process 10
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NMP-2007-1.3-1 Large RTD Projects NMP-2007-1.3-2 Small RTD projects NMP-2007-1.3-3 Coordination NMP-2007-1.3-4 Coordination Specific, easy-to-use portable devices for measurement and analysis NANODEVICE: Novel Concepts, Methods, and Technologies for the Production of Portable, Easy-to-Use Devices for the Measurement and Analysis of Airborne Engineered Nanoparticles in Workplace Air Risk assessment of engineered nanoparticles on health and the environment NANOMMUNE: Comprehensive assessment of hazardous effects of engineered 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 Scientific review on the data and studies on the potential impact on health, safety and the environment of engineered nanoparticles ENRHES: Engineered Nanoparticles: Review of Health and Environmental Safety Creation of a critical and commented database on the health, safety and environmental impact of nanoparticles NHECD NMP-2007-1.3-5 Coordination HEALTH-2007-1.3-4 Small RTD CIAA, projects Brussels, 23 March 2010 Coordination in studying the environmental, safety and health impact of engineered nanoparticles and nanotechnology based materials and products NANOIMPACTNET: The European Network on the Health and Environmental Impact of Nanomaterials Alternative testing strategies for the assessment of the toxicological profile of nanoparticles used in medical diagnostics NANOTEST: Development of methodology for alternative testing strategies for the assessment of the toxicological profile of nanoparticles used in medical diagnostics 12
NMP-2008-1.3-1 Large RTD Projects NMP-2008-1.3-2 Small RTD projects Validation, adaptation and/or development of risk assessment methodology for engineered nano-particles No proposals selected Impact of engineered nanoparticles on health and the environment 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 13
NMP-2008-1.3-1 Small RTD projects NMP-2008-1.3-2 Coordination Activities towards the development of appropriate solutions for the use, 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 Exposure scenaria to nanoparticles NANEX: Development of Exposure Scenarios, for Manufactured Nanomaterials KBBE-2009-2-4-1 Small RTD projects Analytical tools for characterisation of nano-particles in the food Matrix NanoLyse: Nanoparticles in food: analytical methods for detection and characterisation 14
EU RTD investment FP 6: About 25 million FP7, 1st year: About 25 million FP7, 2 nd year: 13.75 million FP7, 3rd year: 11 million Total: 75 million EU funding, NMP Plus 7 million from other programmes A projects compendium prepared 15
2010 Calls closed Infrastructure integration (proposal submitted) Modelling/simulation (NMP call closed, jointly with USA) Risk management (NMP call closed) ERANET (proposal submitted) 16
Nano-Risk Management System elements Risk assessment 1. Develop models for predicting potential impact of nanomaterials 2. Develop and validate methods to evaluate toxicity Risk monitoring 1. Instruments for assessing exposure to nanomaterials in air and water (number, surface area, mass) 2. Monitoring accidental hazards Risk understanding / risk evaluation Acceptable/unacceptable risks, Exposure limits Impact evaluation over entire life cycle Risk Communication Dialog and transparency Risk perception Risk mitigation Proactive risk management Safe processes and safe handling Priority: Develop strategic programmes that enable risk-focussed research 17
Knowledge gaps Background level Measurement methods Metrics Biological impact Exposure data Risk assessment underpinning data Knowledge gaps not necessarily RTD related 18
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 19
EU RTD policy bodies in Nano High Level Experts Group of MS and FP7-AS Established in February 2009 Safety chosen as priority area NANOFUTURES technology platform A research stakeholders forum Synergy across other technology platforms Launch of preparation phase in June 2010 The nanosafety cluster Established in February 2009 An industrial group on safety Established in June 2009 20
Discussion points 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, certification OECD Working Party on Manufactured Nanomaterials Sponsorship programme A mechanism to map and control progress? 21
2011 RTD call topics Innovation driven New methods and strategies for measurement, detection and identification of nanoparticles in products and/or in the environment (SME targeted) Worker protection and exposure risk management strategies for nanomaterial production, use and disposal (small) Intelligent testing strategies for nanomaterials impact and exposure towards regulation and clustering of materials (CSA) 22
THANK YOU 23