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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. Outline. Introduction
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
Outline • Introduction • Applications • Legislative review • Risk assessment • Public dialogue • Conclusion
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
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.”
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
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
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
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.
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
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
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
Beliefs Frame Cognition, informational asymmetry, and ethics Object Object description to one’s self Choice
Public dialogue Registration opens 1st week of July: http://ec.europa.eu/health/ph_risk/events_risk_en.htm
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!
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
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