"Informational needs and the regulatory frame for consumer applications: The EU Commission's view"
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"Informational needs and the regulatory frame for
consumer applications: The EU Commission's view"
Philippe MartinEuropean Commission
Directorate-General for Health and Consumersphilippe.martin (at) ec.europa.eu
CEFIC, Brussels, Tuesday, 24 June 2008
Outline
IntroductionApplicationsLegislative reviewRisk assessmentPublic dialogueConclusion
Working definition of nanoscale“A feature characterised by dimensions of the
order of 100 nm or less” (SCENIHR, 2007)But,
size limits somewhat arbitraryno conflict with meaning of existing wordscertain physico-chemical properties to have major impact on behaviourincreased production requires consideration of potential new words and definitionsmay 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 rangehierarchical etymological approach based on consideration of physical, chemical and biological fundamentals
Legislative review adoptedCommissioner 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.”
Targeted drug delivery systems
Diagnostics
Regenerative medicine
Diseases of the nervous system
EU LegislationIndustrial new and existing chemicals (REACH)Pharmaceuticals, Pesticides, BiocidesMedical devices, Cosmetics, Food additives and packages Worker protection Air, Water, IPPC, Seveso, WasteEnvironment 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 gapsMarket surveillanceExposure, hazard, and risk assessment
Data generation: excellence, independence, transparency
Risk assessmentSCENIHR & 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-responseDe novo, case-by-case RA & new data
EFSA mandateRisksHazardsGuidance
Issues relating to sources and type of NPs
naturally produced vs. engineered NPsNPs in matrix vs. free, insoluble NPsclassical physics + quantum mechanicsincreased surface to volume ratiosize, shape, number, surface areasurface chemistry, charge, topographychemical composition and stabilitysolubility, vapor pressure, etc.
Issues Relating to Exposureroutes of exposure to NPsincreasing levels of exposuremechanisms and kineticssampling, detection, measurement, and characterisation of NPsvalidity of current environmental exposure modelsbackground data on the current and historic exposure levelsadditive effects of simultaneous exposure
Issues Relating to Hazard Assessment
insufficiency of scientific informationphysico-chemical changes of NPstranslocation of NPsinteraction with living matterfate, distribution, and persistenceextrapolation of data from non-nano
Issues Relating to the Risk Assessment Strategies
Include size, shape, surface area, # and ζExisting methods may be adequateNew testing methods may be neededCase-by-case approach
different exposure levelsnot all NPs exhibit higher toxicity than bulk formulationsmethodological uncertainties do not allow for extrapolation between NPsinsufficient toxicological data on NPs
Cognition, informational asymmetry, and ethics
Object ChoiceObject
descriptionto one’s self
Beliefs Frame
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 understandingRisk assessment: To perform de novo, case-by-case RA using substance specific dataImplementation of regulation: To fulfill legal obligations and secure pre-market approvalPublic dialogue: To have an informed exchange
Thank you!
Links on nanoLegislative 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=YESFAQs: http://ec.europa.eu/nanotechnology/faq/faq_en.cfm
Scientific OpinionsScientific 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.htmScientific Committee on Consumer Products (SCCP) opinion on nanomaterials in cosmetics: http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.htmEuropean 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
CoordinatesPhilippe Martin, PhDPrincipal AdministratorEuropean Commission Directorate-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