Nano-EHS activity and strategy in the EU

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1 Nano-EHS activity and strategy in the EU European Commission Directorate-General for Research and Georgios Katalagarianakis Disclaimer: This presentation is not legally binding and does not represent any commitment on behalf of the European Commission

2 Horizon 2020 The vision Current situation The strategy

3 EU research and innovation strategy Horizon 2020: 3 interlinked priorities 1.) Smart growth: developing an economy based on knowledge and innovation Flagship initiative: Union 2.) Sustainable growth: promoting a more efficient, greener and more competitive economy 3.) Inclusive growth: fostering a high-employment economy delivering social and territorial cohesion Research/ 3

4 Union A cornerstone of Europe 2020 strategy Globalisation of knowledge production and innovation capacities Impact of the crisis on public and private finance, survival of innovative SMEs Major challenges to address with reduced means emergency! Key measures of Union Getting good ideas to market Access to finance Single innovation market Openness and creative potential

5 LEADERSHIP IN ENABLING AND INDUSTRIAL TECHNOLOGIES KEY ENABLING TECHNOLOGIES Nanotechnology Advanced Materials Advanced Manufacturing Systems Biotechnology Photonics Microand nanoelectronics ICT Space

6 The vision Research/

7 NANOTECHNOLOGY the three main axis Enabling Programme Components: non application specific R&D, TRLs 1-4 Next generation nanomaterials, -devices and -systems Safe development and application Societal dimension Synthesis and manufacturing Capacity enhancing techniques Cross KET application focus areas: Application specific R&D&I with important nanotechnology contribution, TRLs 5-8 Nanoenabled surfaces Nanostructures and composites Nanotechnology innovation showcases: Applications uniquely enabled by nanotechnology, TRLs 5-8 Nanomedicine Environmental technologies

8 The current situation Research/

9 Impact on Health and the Environment FP7-NMP, 1st year, 2007, Projects launched in NMP Large RTD Projects NMP Small RTD projects NMP 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 NMP Coordination Creation of a critical and commented database on the health, safety and environmental impact of nanoparticles NHECD NMP Coordination HEALTH Small RTD projects 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

10 Impact on Health and the Environment FP7-NMP: Topics addressed in 2008 Projects launched in 2009 NMP Large RTD Projects NMP 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, Bio-imaging 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

11 Impact on Health and the Environment FP7-NMP: Topics addressed in 2009 Projects launched in 2010 NMP ENV Small RTD projects 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') 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 Coordination Exposure scenaria to nanoparticles NANEX: Development of Exposure Scenarios, for Manufactured Nanomaterials KBBE Small RTD projects Analytical tools for characterisation of nano-particles in the food Matrix NanoLyse: Nanoparticles in food: analytical methods for detection and characterisation

12 Impact on Health and the Environment FP7-NMP: Topics addressed in 2010 Projects launched in 2011 NMP Large RTD projects NMP Small RTD projects Coordinated call with USA Reference methods for managing the risk of engineered nanoparticles MARINA: Managing Risks of Nanoparticles NANOVALID: Development of reference methods for hazard identification, risk assessment and LCA of engineered nanomaterials Modelling toxicity behaviour of engineered nanoparticles ModNanoTox: Modelling nanoparticle toxicity: principles, methods, novel approaches NanoTransKinetics: Modelling the basis and kinetics of nanoparticle cellular interaction and transport NMP Coordination INFRA Infrastructures ERA-NET on nanotechnologies, including nanotoxicology SIINN: Safe Implementation of Innovative Nanoscience and Nanotechnology Research Infrastructures for processing, analysis and characterisation (physico-chemical properties, health and environmental impact) of engineered nanomaterials, nanoparticles and nanostructures QNano: A pan-european infrastructure for quality in nanomaterials safety testing

13 Impact on Health and the Environment FP7-NMP: Topics addressed in 2011 Projects to be launched in 2012 NMP RTD projects for SMEs NMP Small RTD projects NMP Coordination New methods for measuring, detection and identification of nanoparticles in products and/or the environment INSTANT: Innovative Sensor for the fast Analysis of Nanoparticles in Selected Target Products SMART-NANO: Sensitive Measurement, detection, and identification of engineered nanoparticles in complex matrices NANODETECTOR: Ultrasensitive plasmonic detection of single nanoparticles Worker protection and exposure risk management strategies for nanomaterial production, use and disposal SANOWORK: "Safe Nano Worker Exposure Scenarios" NANOMICEX: "Mitigation of risk and control of exposure in nanotechnology based inks and pigments" SCAFFOLD: "Innovative strategies, methods and tools for occupational risks management of manufactured nanomaterials (MNMs) in the construction industry" Intelligent testing strategies for nanomaterials impact and exposure towards regulation and clustering of materials ITS-NANO: INTELLIGENT TESTING STRATEGY FOR ENGINEERED NANOMATERIALS

14 Impact on Health and the Environment Topics addressed in 2012 (to be launched in 2013) NMP Large RTD projects NMP Small RTD projects NMP Large RTD projects NMP Support Action Systematic investigations of the mechanisms and effects of engineered nanomaterial interactions with living systems and/or the environment NanoMile: "Engineered nanomaterial mechanisms of interactions with living systems and the environment: a universal framework for safe nanotechnology" NanoSolutions: "Biological Foundation for the Safety Classification of Engineered Nanomaterials (ENM): Systems Biology Approaches to Understand Interactions of ENM with Living Organisms and the Environment" Modelling toxicity behaviour of engineered nanoparticles MODERN: "MODeling the EnviRonmental and human health effects of Nanomaterials" NanoPuzzles: "Modelling properties, interactions, toxicity and environmental behaviour of engineered nanoparticles" PreNanotox: "Predictive toxicology of engineered nanoparticles" MembraneNanoPart: "Modelling the mechanisms of nanoparticle-lipid interactions and nanoparticle effects on cell membrane structure and function" Mod-ENP-Tox: "Modeling Assays Platform "MAP" for hazard ranking of engineered nanoparticles" Regulatory testing of nanomaterials NANoREG: A common European approach to the regulatory testing of nanomaterials Support for standardisation needs NanoStairs: Establishing a process and a platform to support standardization for nanotechnologies implementing the STAIR approach

15 Food packaging Projects under negotiation (to be launched in 2013) Nanobarrier DIBBIOPACK The overall concept of NanoBarrier is to develop a new nanotechnology platform based on inorganicorganic hybrid polymers, microfibrillated cellulose, nanocapsules with controlled permeability and additive technology and combine this with resource-efficient processing technologies to realize safe and extended shelf-life and multifunctional biopolymer food packaging solutions. These solutions based on CO2 neutral and renewable resources, should work as an enabling technology for innovative companies to stimulate to further consumption growth of fish and seafood and environmental conscious packaging solutions for meat and dairy products; food sectors of major social, economic and health impact in the European region. The project aims on the development of new bio-based materials specially adapted to the development of a wide range of containers or packages (films made by extrusion laminating, trays or lids developed by injection moulding and bottles performed through extrusion blow moulding technologies) and the improvement of thermal, mechanical and barrier properties of these packages through nanotechnology based innovative coatings. The project targets operational integration of different intelligent technologies or smart devices to provide to the packaging value chain more information about the products and the processes, increase safety and quality of products through supply chain and improve the shelf-life of the packaged products.

16 EU RTD investment in nanosafety research FP6: About 31 M (13 projects completed) FP7: 2007: 25 M 2008: 14 M 2009: 14 M 2010: 29 M 2011: 21 M 2012: 35 M 2013: 30 M (estimated) Total FP7: 171M EU funding ~50 projects Member States efforts to add Research/

17 The NMP Nanosafety Cluster To maximise synergies between projects A European projects and researchers forum Open to voluntary participation About 30 EU and national projects Vision document and Strategic Research Agenda preparation launched International cooperation is a key issue A projects compendium published yearly; 2012 version available Integrating in the Technology Platform NanoFutures

18 DATABASE(S) EU research NANOSAFETY WG1 MATERIALS ENP Synthesis, Dispersion & Characterisation WG2 HAZARD SG1 Toxicology SG2 Ecotoxicology WG3 EXPOSURE Products / LCA (embedded ENP) Fate & behaviour Workplace & Environmental exposure Detection tools WG4 WG5 RISK Workplace Consumer Environment Assessment Appraisal Control & Reduction WG6 MODELLING SG1 Standardisation / Regul. Bodies / Intern. coop WG7 DISSEMINATION SG2 Industry/NGOs/ NanoFutures SG3 Workshops & Conferences / Website

19 NMP Call 7, Work Programme 2013 NMP Safety in nanoscale production and products (Large) NMP Nanomaterials safety assessment: Ontology, database(s) for modelling and risk assessment (Small, max 1 project) NMP Development of a systematic framework for naming and assessing safety of the next generations of nanomaterials being developed for industrial applications (Large, max one project, max funding 7M ) NMP Development of methods and standards supporting the implementation of the Commission recommendation for a definition of nanomaterial (Large, max one project, max funding 7M )

20 The strategy Research/

21 A snapshot on RTD level Materials characterisation well advanced for most common nanomaterials; difficulties with variations, stability, changing environment, ageing Hazards mostly understood; difficulties with quantification, combination, long term, special cases Eco-toxicity has taken some delay. Exposure monitoring advances fast to cover lost field. Unclear metrics (number, mass, surface), release from matrix, fate Life-Cycle Analysis progresses well. Faster progress needed for risk evaluation and risk communication Some progress marked for risk reduction

22 A snapshot on innovation and regulatory level -Materials characterisation data insufficient to underpin Risk Assessment -Hazards quantification not standardised, combined hazards unclear -Exposure monitoring and metrics reliability is low. -In-situ characterisation technologies needed -Life-Cycle Analysis data inadequate -Criteria for Risk evaluation/acceptance needed -Costs-Benefits Analysis just starting and for very few applications -Risk communication not really up to challenges -Few best practice guides published -International cooperation -

23 Regulatory testing; the NANOREG project Building on on-going work Necessary to secure innovation on nanotechnologies Aiming at providing the necessary mass of data on materials and their behaviour Input to the OECD-WPMN A joint action supported by public funding from EU ( 10M ) Public funding or contribution of resources from MS and FP7-associated states Private funding or contribution of resources from industry or other stakeholders Total project size close to 50M Laboratories working in network Consortium agreement on results communication compulsory International cooperation to be encouraged

24 A snapshot on market level -Laboratories networks and certification? -Benchmarking performances and practices? -Regulation and implementation mechanism? -Skills of experts and standardisation? -Safety management services market? -Mitigation measures assessment? -Risk perception and transparency?

25 Which nano-ehs strategy for Europe? A European Technology platform is the policy instrument Nanosafetycluster is the safety pillar of nanofutures Complemented by national platforms A vision document sets the goals to reach (what will be the safety requirements in 10 years?) A strategic research agenda, updated every 4-5 years, provides the strategy Implementation plan to follow Attention is due to the European situation International cooperation Standardisation and education are key elements

26 EU-US cooperation on nanosafety Framework: Science and Technology Cooperation Agreement Communities of Research launched: CoR-1: Exposure through the Life Cycle, with Material Characterization CoR-2: Ecotoxicity Testing and Extrapolation towards QSARs, with Material CoR-3: Predictive Modeling for Health, with Material Characterization CoR-4: Risks Assessment CoR-5 Databases and Ontologies CoR-6: Risk Management Risk Control

27 MEMBERS CSA Working Group Associations SMEs Industries Universities Scientists... ObservatoryNANO ProNano NanoCom Nano2Market MINAM 2.0 Nano-TV REGULATION NETWORKING COMMUNICATION STANDARDIZATION SAFETY RESEARCH SKILLS AND EDUCATION RESEARCH / TECHNOLOGY INDUSTRIAL SAFETY STRATEGY INDUSTRIALIZATION/ nano-manufacturing TECH TRANSFER and INNOVATION FINANCING NANOfutures as Nano-Hub ETP NANOfutures CSA 3 27

28 Useful links Union ec.europa.eu/research/innovation-union Horizon 2020 ec.europa.eu/research/horizon2020 Industrial technologies ec.europa.eu/research/industrial_technologies FP7 calls ec.europa.eu/research/participants/portal/page/fp7_calls