1. "Informational needs and the regulatory frame for consumer applications: The EU Commission's view" Philippe Martin European Commission Directorate-General for Health and Consumers philippe.martin (at) ec.europa.eu CEFIC, Brussels, Tuesday, 24 June 2008

2. Outline Introduction Applications Legislative review Risk assessment Public dialogue Conclusion

3. Working definition of nanoscale “A feature characterised by dimensions of the order of 100 nm or less” (SCENIHR, 2007) But, size limits somewhat arbitrary no conflict with meaning of existing words certain physico-chemical properties to have major impact on behaviour increased production requires consideration of potential new words and definitions may be necessary to distinguish between different sizes of NPs and molecules for a variety of reasons - does not imply greater toxicological, public health, or environmental health concern associated with any one size range hierarchical etymological approach based on consideration of physical, chemical and biological fundamentals

4. Legislative review adopted Commissioner Androulla Vassiliou responsible for Health said: “In today’s Europe, nanotechnologies must be developed in a safe, integrated and responsible way, involving all stakeholders so that new applications can result in real benefits for EU citizens in the area of health.”

5. Targeted drug delivery systems

6. Diagnostics

7. Regenerative medicine

8. Diseases of the nervous system

10. EU Legislation Industrial new and existing chemicals (REACH) Pharmaceuticals, Pesticides, Biocides Medical devices, Cosmetics, Food additives and packages Worker protection Air, Water, IPPC, Seveso, Waste Environment Liability, Product liability, Product safety ENTRENVSANCOEMPL

11. Legislative review [COM(2008)366] “Current legislation covers in principle the potential health and environmental risks in relation to nanomaterials” Associated informational needs: Scientific knowledge gaps Market surveillance Exposure, hazard, and risk assessment Data generation: excellence, independence, transparency

12. Risk assessment SCENIHR & SCCP scientific opinions Possible limits to adequacy of RA methods (cf., esp., percutaneous penetration, inhalation and ingestion, in vitro toxicology, ecotoxicology, environmental fate and effects) Dose metrics & dose-response De novo, case-by-case RA & new data EFSA mandate Risks Hazards Guidance

13. Issues relating to sources and type of NPs naturally produced vs. engineered NPs NPs in matrix vs. free, insoluble NPs classical physics + quantum mechanics increased surface to volume ratio size, shape, number, surface area surface chemistry, charge, topography chemical composition and stability solubility, vapor pressure, etc.

14. Issues Relating to Exposure routes of exposure to NPs increasing levels of exposure mechanisms and kinetics sampling, detection, measurement, and characterisation of NPs validity of current environmental exposure models background data on the current and historic exposure levels additive effects of simultaneous exposure

15. Issues Relating to Hazard Assessment insufficiency of scientific information physico-chemical changes of NPs translocation of NPs interaction with living matter fate, distribution, and persistence extrapolation of data from non- nano

16. Issues Relating to the Risk Assessment Strategies Include size, shape, surface area, # and ζ Existing methods may be adequate New testing methods may be needed Case-by-case approach different exposure levels not all NPs exhibit higher toxicity than bulk formulations methodological uncertainties do not allow for extrapolation between NPs insufficient toxicological data on NPs

17. Cognition, informational asymmetry, and ethics ObjectChoice Object description to one’s self BeliefsFrame

18. Public dialogue Registration opens 1st week of July: http://ec.europa.eu/health/ph_risk/ events_risk_en.htm http://ec.europa.eu/health/ph_risk/ events_risk_en.htm

19. Conclusion: Who provides what information to whom for which purpose? Science: To advance understanding Risk assessment: To perform de novo, case-by- case RA using substance specific data Implementation of regulation: To fulfill legal obligations and secure pre-market approval Public dialogue: To have an informed exchange Thank you!

20. Links on nano Legislative review Press Release on Public Dialogue: http://www.europa.eu/rapid/pressReleasesAction.do?reference=IP/08/947&fo rmat=HTML&aged=0&language=EN&guiLanguage=en Communication (2008)366: http://www.cc.cec/home/dgserv/sg/sgvista/i/sgv2/repo/repo.cfm?institution= COMM&doc_to_browse=COM/2008/0366&refresh_session=YES http://www.cc.cec/home/dgserv/sg/sgvista/i/sgv2/repo/repo.cfm?institution= COMM&doc_to_browse=COM/2008/0366&refresh_session=YES FAQs: http://ec.europa.eu/nanotechnology/faq/faq_en.cfmhttp://ec.europa.eu/nanotechnology/faq/faq_en.cfm Scientific Opinions Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) opinions on nanotechnologies http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_opinions_ en.htm http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_opinions_ en.htm Scientific Committee on Consumer Products (SCCP) opinion on nanomaterials in cosmetics: http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.ht m http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.ht m European Food Safety Authority (EFSA) information about risk assessment in the field of food and feed: http://www.efsa.europa.eu/EFSA/KeyTopics/efsa_locale- 1178620753812_Nanotechnology.htm http://www.efsa.europa.eu/EFSA/KeyTopics/efsa_locale- 1178620753812_Nanotechnology.htm 2nd Annual Nanotechnology Safety for Success Dialogue Workshop in Brussels, Belgium, on 2-3 October 2008: http://ec.europa.eu/health/ph_risk/events_risk_en.htm http://ec.europa.eu/health/ph_risk/events_risk_en.htm

21. Coordinates Philippe Martin, PhD Principal Administrator European Commission Directorate-General for Health and Consumers B232 2/12, B-1049 Brussels, Belgium +32-2-29-93669 (phone) +32-2-29-57332 (fax) philippe.martin (at) ec.europa.eu