1. Product Safety Governance
Philippe Martin, MBA, DEA, MS, PhD
European Commission
Directorate General for Health and Consumers
philippe.martin (at) ec.europa.eu
Risk Governance of Manufactured Nanoparticles
Brussels, 21 Nov 2011, – 18.00

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

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

6. 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;

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

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

9. 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;

10. Products, claims, and regulation

11. Substances (= REACH)

12. Consumer Products

13. Cosmetics

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

15. Medicines & Medical Devices

16. The definition and what it means

17. 1 nm < < 100 nm
100 nm < < <

22. What risk managers learn from risk assessors

23. 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

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

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

26. 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

27. 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