"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