Product Safety Governance

Philippe Martin, MBA, DEA, MS, PhDEuropean Commission

Directorate General for Health and Consumersphilippe.martin (at) ec.europa.eu

http://ec.europa.eu/health/index_en.htm#

Risk Governance of Manufactured Nanoparticles Brussels, 21 Nov 2011, 13.30 – 18.00

Outline• Nano risk governance• Products, claims, and regulation• The definition and what it means• What risk managers learn from risk

assessors

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FP6 & FP7 safety research2004 “Mapping Nano Risks”SCENHIRSCCSEFSAEMA

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Nano Safety for Success DialoguesPublic consultationsFP7 projects

2008 Review2nd (forthcoming) reviewInventoryJRC databaseDefinitionInt’l Regulators’ MeetingsTransatlantic Economic Council

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Products, claims, and regulation

Substances (= REACH)

Consumer Products

Cosmetics

Food and feed

Medicines & Medical Devices

The definition and what it means

1 nm < < 100 nm 100 nm < < <

What risk managers learn from risk assessors

Exposure

Detection: Size, mass, contrast

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Risk assessment

Conclusion• Nano innovation potential

confirmed• Product safety framework in place• Guidelines to make it happen• No “sub-prime” risk assessment• S&T challenges to be addressed• Governance & engagement as key