1. Nanotechnologies – research needs from an EU policy and regulatory perspective NanoImpactNet, Lausanne, 10-12 March 2010 Eva Hellsten, DG Environment, European Commission Disclaimer: This presentation is not legally binding and does not represent any commitment on behalf of the European Commission

2. EU nanotech policy development ~ 2000 - Lisbon Agenda; growth, jobs, competiveness. Nanotech benefits and applications - contribution to economic growth and welfare ~ 2004 – risk debate started – knowledge gaps, ethical and regulatory issues. Nanotech risk research and “integrated, safe and responsible” development ~ 2010 – economic crisis and “grand challenges” – climate, energy, resources…. Nanotech and sustainability – need to analyse safe solutions with nanotechnology, predictive modelling of risks and benefits

3. R&D funding of Nanotech in FPs FP4 1994-1998 120 M€ FP5 1998-2002 280 M€ FP6 2002-2006 1300 M€ FP7 2007-2013 ~ 3400 M€ HSE funding: 2003-06 ~ 25 M€; 2007-08 ~ 50 M€

4. Two interlinked objectives in health, safety and environment  regulation - in place, implemented and enforced  scientific knowledge gaps filled

5. To make risk legislation work…. Regulatory framework itself – definitions, scope and requirements Implementation – supported by technical guidance, standards etc. Enforcement – legal certainty

6. Example REACH registration Nanomaterials covered by “substance definition” – included in REACH Information requirements - in REACH annexes, e.g. toxicity tests depending on volume Chemical safety assessment > 10 tpa  Hazard assessment  PBT/vPvB assessment  Exposure assessment  Risk characterisation and risk management

7. Some critical scientific issues in REACH to consider Are information requirements for different tonnage triggers sufficient for nanomaterials? New tests required? Modified test guidelines? Validation of test methods. Predictability of in vitro tests Exposure measurement and assessment methods? Definition issues. E.g. nano form versus “traditional” form

8. Not only REACH to address nanomaterials Chemicals and chemical products: Chemicals and chemical products:  Industrial chemicals – REACH  Pharmaceuticals, Pesticides, Biocides  Medical devices, Cosmetics, Food additives and packages Worker protection Worker protection Environment protection: air, water, IPPC, Seveso, waste Environment protection: air, water, IPPC, Seveso, waste Horizontal - environment and product liability, product safety Horizontal - environment and product liability, product safety Regulatory Review, 2008

9. Commission conclusions - regulatory review Environmental and health risks of nano- materials in principle covered by EU regulatory frameworks Did not exclude regulatory changes in light of new evidence or results of R&D Implementation of the legal frameworks remains difficult due to:  Scientific knowledge gaps  Fast evolving market for products

10. Risk paradigm for legislation Risk assessment (eco)toxicity tests exposure assessment Risk management Scientific uncertainty HazardsExposures fate, transport Precautionary principle Proportionality principle

11. What have we learned? Test and measurement of hazards and exposures are more complex for nanomaterials compared with ordinary chemicals High & unspecific background, artefact formation pose challenges for analysis Careful characterisation of test samples and experimental set up to ensure reproducibility and repeatability in test systems Validated and internationally harmonised methods to ensure legal certainty and avoid trade problems

12. For NMs specific considerations Risk assessment (eco)toxicity tests fate, transport exposure assessment Risk management Hazards Exposures charaterization, standards, reference materials, metrics, dosimetry, validation Scientific uncertainty Precautionary principle Proportionality principle

13. Progress – in which areas? Research 2005-2009  Characterisation, standards, reference materials  Analysis and measurement, exposure in working environment  Interaction with biological systems  Translocation in the body, transport across the food chain  Certain toxic effects of some NMs observed in vitro or in vivo  Case by case assessments See further, opinions of Scientific Committees and Commission final implementation report of Action Plan (Staff Working Document 2009)

14. Progress - work to obtain international harmonisation OECD WPMN Sponsorship programme, internationally harmonised test methods, test guidelines alternative test methods, exposure assessment ISO/CEN international standards, nomenclature, methods

15. Research priorities from a regulatory perspective – Staff Working Doc 2009 Validation and harmonisation of methodologies (characterisation, hazards, exposures), reference materials Fundamental phenomena, biological interactions Further work on test methods and test guidelines Long term toxicity, transport, fate and behaviour Exposure throughout life cycle Predictive methods – models using in vivo, in vitro, in silicio results - for priority setting

16. Need for an efficient transfer of research results and dialogues between researchers and regulators

17. Looking ahead How can nanomaterials be used in a sustainable and safe manner to address “grand challenges”?

18. Millennium Development Goals – where nanotechnology can contribute l Energy production, storage and conversion l Water treatment and remediation l Environment and health monitoring l Health – diagnosis, screening, drug delivery l Soil and polluted sites remediation l Food safety, agricultural productivity Source: “Innovation: applying knowledge in development”, UN OECD conference on environmental benefits – fostering a safe and sustainable development of nanotechnology, July 2009

19. Used in many sectors + lifecycle perspective Material processing ManufactureUse Recovery Distribution Reuse Recycle WasteRaw material Different forms of nanomaterials

20. Need for a broader view on life cycle for applications based on nanotechnology  From extraction to disposal/recycling of the nanomaterial - or of all components of the application  Positive and negative impacts on environment and health (e.g. energy savings versus toxicity, or depletion of rare minerals)  Geographical, societal or economic impacts  Comparison with conventional technologies  For various stages of development of applications - in particular at early innovation stages – predict benefits and risks

21. The challenge in policy Create good conditions for innovation and development of applications, contributing to sustainable growth AND AT THE SAME TIME Ensure that potential risks to environment and human health are identified and managed - at the earliest stage possible.

22. On “integrated, safe and responsible” Towards a European Strategy for Nanotechnology (2004) “Scientific investigation and assessment of possible health or environmental risks associated with nanotechnology need to accompany R&D and technological progress.”

23. Publications http://ec.europa.eu/nanotechnology Towards a European Strategy for Nanotechnology (2004) and the Nanotechnology Action Plan for Europe 2005-2009 Towards a European Strategy for Nanotechnology (2004) and the Nanotechnology Action Plan for Europe 2005-2009  Mid-term Implementation Report (2007) Code of Conduct for Research (2008) Code of Conduct for Research (2008) Regulatory review (2008) Regulatory review (2008) Action Plan final Implementation report (2009) Action Plan final Implementation report (2009)