Product Safety Governance Philippe Martin, MBA, DEA, MS, PhD European Commission Directorate General for Health and Consumers philippe.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

IRGC (2007, Fig. 1, p. 23; www.irgc.org)

IRGC (2007, Fig. 1, p. 23; www.irgc.org) FP6 & FP7 safety research 2004 “Mapping Nano Risks” SCENHIR SCCS EFSA EMA IRGC (2007, Fig. 1, p. 23; www.irgc.org)

IRGC (2007, Fig. 1, p. 23; www.irgc.org) 2006-2010 Action Plan IRGC (2007, Fig. 1, p. 23; www.irgc.org)

IRGC (2007, Fig. 1, p. 23; www.irgc.org) Nano Safety for Success Dialogues Public consultations FP7 projects

IRGC (2007, Fig. 1, p. 23; www.irgc.org) 2008 Review 2nd (forthcoming) review Inventory JRC database Definition Int’l Regulators’ Meetings Transatlantic Economic Council IRGC (2007, Fig. 1, p. 23; www.irgc.org)

Products, claims, and regulation

Substances (= REACH)

Consumer Products

Cosmetics

Food and feed Safety research Requests Scientific advice Risk assessment Review Amendments Food contact materials Cosmetics Food Information to Consumers

Medicines & Medical Devices

The definition and what it means

1 nm < < 100 nm 100 nm < < <

What risk managers learn from risk assessors

Exposure Lack of high quality exposure and dosimetry data Problems in replicating actual exposure conditions Insufficient knowledge to allow predictions Ecotoxic effects demonstrated Need for validated tests

Detection: Size, mass, contrast Haystack in Buhtan: Flicker/Copyright free Ag NPs in meat: Courtesy Q. Chaudury

Hazard NPs can promote or retard protein assembly NP translocation to the brain NPs penetrate subcellular compartments CNTs can cause inflammatory reactions

Risk assessment “Smaller” Does not necessarily mean “more toxic” Can be different Is not predictable Requires specific safety assessment “Case-by-case” (for now) Guidelines

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