"Informational needs and the regulatory frame for consumer applications: The EU Commission's view"

1. Draft "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 ENTR ENV SANCO EMPL

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. Beliefs Frame Cognition, informational asymmetry, and ethics Object Object description to one’s self Choice

18. Public dialogue Registration opens 1st week of July: 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&format=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 • FAQs: http://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 • Scientific Committee on Consumer Products (SCCP) opinion on nanomaterials in cosmetics: http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.htm • 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 • 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

21. Coordinates Philippe Martin, PhD Principal Administrator European CommissionDirectorate-General for Health and ConsumersB232 2/12, B-1049 Brussels, Belgium +32-2-29-93669 (phone) +32-2-29-57332 (fax) philippe.martin (at) ec.europa.eu