1. Risk Assessment in Nanosafety - Tools for Now and the Future,
Professor Keld Alstrup Jensen, Ph.D., cand.scient.

2. Principal Risk Assessment and Risk Management
Communication and Consulting
Monitoring and Review
Establishing the context
Risk Identification
Risk Analysis
Risk Evaluation
Risk Treatment
ISO/IS/31000 (2009)

3. ”Current” situation – Example REACH risk assessment approach
REACH Tier 1 estimates
ECETOC TRA
EMKG EXPO Tool
ConsExpo
(Risk of Derm)
Stoffenmanager
Advanced REACH Tool …
No official OELs available - NM limits values are just slowly emerging (+grouping issues)
No proper emission potentials for NM in tools
No default exposure scenarios in the tools
Lack of product categories for nanoproducts
Gaps in application domains
Need for suitable
data and “validation” of existing or new nano-specific
Risk Assessment and – Management approaches
Reliable risk assessments with REACH model is either
impossible or should be done with GREAT care!

4. From Risk Assessment to Emerging Risk Management and Governance
Emerging Risk Management Framework [CEN Workshop Agreement (2013)]
Ability to ID a new risk
Applicable data or methods and tools
Applicable data
knowledge
Knowledge Applicable methods, tools, data
In the stage-gate innovation funnel, knowledge increases along the funnel and where Env. and Health Safety (EHS) by industry is normally first considered very late during innovation, then regulation and insurance (risk transfer). If the materal or product fails, this late assessment can result in great losses. Idea is to add EHS assessments in the gates of the Cooper-like stage-gate innovation funnel model.
Different?; Unsafe?
Regulation? …
Methods, Measurement,
Read-across, Grouping, ..
Efficacy of RMM,
“risk-knowledge”,..
Methods, Systems,
Data-bases,..

5. Substance identification and grouping:
Substance identification and grouping: Essential for ID of new risks in REACH

6. Substance identification and grouping:
Substance identification and grouping: Essential for ID of new risks in REACH

7. “Standards” takes leaders, time, cost:
“Standards” takes leaders, time, cost: Leveraging on national and EU research results
NANODEVICE
ENPRA
DK NANOKEM
DK NSC 1
NANOGENOTOX
NANOREG
SUN
DK NSC 2
NANODEFINE
caLIBRAte (RA)
NANOFASE
ACEnano
PATROLS
GOV4NANO
Malta initiative
Modified from Jukka Ahtiainen og Mar Gonzales (OECD HQ, Paris)

8. From Emerging Risk Management to Nano-risk (innovation) Governance+
Emerging Risk Management Framework [CEN Workshop Agreement (2013)]
Idea
screen
Gate 1
Scoping
Screen
Gate 2
Go to development
Gate 3
Go to test
Gate 4
Go to Launch
Gate 5
Post-Launch
review
Gate 6
Discovery
and ideas
Stage 1
business case
Build
Research and
development
and Validation
Testing
Launch
Horizon Scanning/ Monitoring
Cooper Stage-Gate® Idea to launch model
In the stage-gate innovation funnel, knowledge increases along the funnel and where Env. and Health Safety (EHS) by industry is normally first considered very late during innovation, then regulation and insurance (risk transfer). If the materal or product fails, this late assessment can result in great losses. Idea is to add EHS assessments in the gates of the Cooper-like stage-gate innovation funnel model.

9. From Emerging Risk Management to Nano-risk (innovation) Governance
Building and maintainence of confidence in the risk assessment for trustworthy
risk communication and governance
Idea
screen
Gate 1
Scoping
Screen
Gate 2
Go to development
Gate 3
Go to test
Gate 4
Go to Launch
Gate 5
Post-Launch
review
Gate 6
Discovery
and ideas
Stage 1
business case
Build
Research and
development
and Validation
Testing
Launch
Horizon Scanning/ Monitoring
Cooper Stage-Gate® Idea to launch model
ERM
ERM
ERMF
ERM
(E)RM
(E)RM
Quantitative predictive / Test Data Driven
Qualitative / Semiquantitative predictive

10. In line with stakeholder opinions!
Unpublished caLIBRAte results

11. Do we already have the nano-specific Risk Assessment tools?
Common for all!
Often restricted to specific application domains
Users often have challenges in finding input data
Limited use and low general knowledge about them
NOT VALIDATED

12. Performance testing for validation: Ongoing work
MDL
Risk of Derm
NanoQSAR Env. Hazard model

13. Future steps: Include new approach
Future steps: Include new approach methodologies (NAMs) MN Risk Assessment
Nymark et al. Applicability of new approach methodologies to innovation and safety assessment of nanomaterials. In preparation

14. Further development in NMBP-13 and NMBP14 projects
H2020 NANOREG2
Further development in NMBP-13 and NMBP14 projects

15. Far Future: We may reach >90% Predictive “Chemical” Risk Assessment
Technical and safety information level
Understanding Physics, Exposure Environment, Biology
Validated material test methods
Computing Chemical Safety
Further Research and Methods standardization
Data
Further Research and Methods standardization
Data

16. Thank you for your attention
Webpage:
See also:
Thank you for your attention