1. The European Commission’s approach to Nano Safety Nicholas Deliyanakis European Commission Research DG Industrial Technologies Conference on Nano-Safety, Ljubljana, 22-24 April 2009

2. EC Integrated Strategy for Nanotechnology: lResearch lInfrastructures lHuman Resources lIndustrial Innovation lSocietal Issues èOutreach, Ethics, Code of Conduct lSafety & Regulation lInternational Cooperation èIn both Research and Policy COM(2004)338 of 12/05/04 of 12/05/04 COM(2005)243 of 07/06/05 of 07/06/05 COM(2007)505 of 06/09/07 of 06/09/07 Communications on Strategy, Action Plan & Implementation: (2009)…

3. Implementation: lN&N in FP6: ~1.4 Billion € in 550 projects (not only from NMP)  EC accounts for ~1/3 of public funding in EU  600 M€ in 2007, first year of FP7  Similar amount expected in 2008 lSupport for Infrastructures and Human Resources in nanotechnology (generic/specific) lIncreasing industrial participation & patents  Funded R&D: Topics gradually moving from “enabling” science to industrial applications and systems

4. Implementation –pt II: lStaying in tune with society: Information and dialogue  “Code of Conduct for Responsible N&N Research”, Feb 08 lWork on safety and regulatory issues (several DGs)  Increasing investment in safety R&D  “Regulatory Review”, Jun 08 lInternational cooperation –in research and policy, e.g.  Coordinated call with Russia, 2009  International dialogue, OECD, ISO etc

5. Regulatory Challenge: Is the regulatory framework sufficient?  Regulatory Review: COM(2008)366, 17/06/08COM(2008)366  Accompanying Staff Working Document SEC(2008)2036 SEC(2008)2036 Relevant EU legislation oChemicals (REACH) oWorker Protection oProducts (Specific and General regulations) oEnvironmental protection (IPPC, Seveso II, Water, Waste directives)

6. Regulatory Challenge: Is the regulatory framework sufficient? oOverall, it can be concluded that current legislation covers to a large extent risks in relation to nanomaterials and that risks can be dealt with under the current legislative framework. oHowever, current legislation may have to be modified in the light of new information becoming available, for example as regards thresholds used in some legislation. Currently this is the subject of debate (e.g. EP) oSpecific legislation oLabelling

7. Safety Challenge: lSCENIHR opinions -latest in January 2009: The methodology for both exposure estimations and hazard identification needs to be further developed, validated, and standardised. ref: SCENIHR opinionsSCENIHR opinions lR&D to address safety gaps:  Effects on human health  Environmental effects, life-cycle  Exposure assessment  Test equipment  EC invested 28M€ up to 2006, >20M€ since 2007; work of JRC

8. Organisational Challenges: lGlobal strategy lInternational coordination of effort  Work of OECD WPMN lUnpublished or proprietary data lStandardisation lRegulatory changes, where appropriate

9. R&D projects on Safety SAFETY OF NANOPARTICLES: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 PROCESSESSAFETY OF PROCESSES NANOSAFE2: Safe production and use of nanomaterials SAPHIR: Controlled Production Of High Tech Multifunctional Products And Their Recycling STANDARDISATION AND METROLOGY: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

10. FP7-NMP: Topics addressed in 2007 NMP-2007-1.3-1 Large RTD Projects 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 NMP-2007-1.3-2 Small RTD projects 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 NMP-2007-1.3-3 Support 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-2007-1.3-4 Support Creation of a critical and commented database on the health, safety and environmental impact of nanoparticles NHECD NMP-2007-1.3-5 Coordination 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 HEALTH-2007- 1.3-4 Small RTD projects 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

11. FP7-NMP: Topics addressed in 2008 NMP-2008-1.3-1 Large RTD Projects Validation, adaptation and/or development of risk assessment methodology for engineered nano-particles No proposals selected NMP-2008-1.3-2 Small RTD Projects 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

12. FP7-NMP: Topics addressed in 2009 NMP-2009-1.3-1 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 - including Climate Change') NMP-2009-1.3-2 Support Exposure scenarios to nanoparticles

13. The next steps A project cluster on Nano-Toxicology –First meeting 26/02/2009; next 01/04, 28- 29/04 –Synergy, projects mapping, data, test protocols, results verification and validation, material characterisation, research roadmaps –Towards a RTD stakeholders’ forum Competence and Infrastructure Integration Modelling/simulation (planned joint call EU-USA) Risk detection and monitoring Risk reduction International cooperation Standardisation

14. EC Nanotechnology Information Commission Nanotechnology homepages (with FAQs): ec.europa.eu/nanotechnology cordis.europa.eu/nanotechnology CORDIS – Information on (NMP) Calls : cordis.europa.eu/fp7/dc cordis.europa.eu/fp7/dc Industrial Technologies website: ec.europa.eu/research/industrial_tech nologies/