A common European approach to the regulatory testing of nanomaterials
The NANoREG Project
A common European approach to the
regulatory testing of nanomaterials
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NANoREG at a Glance
A common European approach to the regulatory testing of nanomaterials
Agenda
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Introduction
Overview approaches
Objectives
Workflow
Partners
Results/Impact
NANoREG general pressentation
Introduction
A common European approach to the regulatory testing of nanomaterials
Ongoing international initiatives: OECD WPMN
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Searching for common instruments to regulate nanomaterials
Main players: EU, US, Japan, Korea, Canada, Australia
Sponsorship project running to 2015
Aims include: grouping the main risks of nanomaterials
Aim: find common denominator for implementing guidelines
Aim: Develop or modify SPSF procedures or technical guidelines
The OECD WPMN approach is based on research into
the material based effects of nanomaterials
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NANoREG general pressentation
Introduction
A common European approach to the regulatory testing of nanomaterials
NANoREG – the other side of the coin
 A H2020 project, before H2020 even kicks off, combining all the
aspects of societal needs, innovation, exploitation & industry
 61 partners from 14 EU states, 50 M €, 42 months
 20 M € in-vivo, 25 M € in-vitro, 5 M € safe by design
 NANoREG approach is to look at the overal methodology
 Value Chain Studies central in NANoREG strategy
 Aim is grouping of nanomaterials based on phys-chem and tox
rather than risk based (OECD WPMN)
 Structured to deliver answers on regulatory questions coming
from the member states
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NANoREG general pressentation
Introduction
A common European approach to the regulatory testing of nanomaterials
NANoREG – expected results and impact
 Will contribute to a safe and controlled market entrance of new
nanomaterials and nanomaterial based products
 Help fill the gaps and shortcomings in current evaluation
methods for new materials
 Include risk analysis at the drawing board stage – promote Safe
by Design
 Support an EU wide integrated risk policy
 Aim: find common denominator for implementing guidelines
 Aim: Develop or modify SPSF procedures or technical guidelines
Grouping, regulating, and risk management
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NANoREG general pressentation
Introduction
A common European approach to the regulatory testing of nanomaterials
NANoREG – international position
 Already forms the EU contribution to the EU-US axis on global
regulation of nanomaterials
 Strong interest shown by several OECD countries to participate
on the basis of their own financial support – Japan, Korea,
Australia, Canada, Turkey
 Strong interest shown by several other countries to join on an
own cost basis, now under evaluation – China, Russia, Brazil
 Links to other organisations (ECHA, OECD, ISO, etc)
 Links to ongoing projects and initiatives based on areas of
common interest
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NANoREG general pressentation
NANoREG’s unique approach
A common European approach to the regulatory testing of nanomaterials
Collaboration
between:
- regulation &
legislation
National
authorities
Mirrors
and of the
-NANoREG
Industry with
-consortium
experts from
science
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NANoREG general pressentation
Industry Focus of the European Approach
A common European approach to the regulatory testing of nanomaterials
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2
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NANoREG general pressentation
The NANoREG Approach
A common European approach to the regulatory testing of nanomaterials
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NANoREG general pressentation
NANoREG Partners
A common European approach to the regulatory testing of nanomaterials
A collaboration between
60 partners from
14 European countries
11 are EU member states
(NL, DE, FR, ES, IT, DK, SE,
FI, UK, IR, PT)
3 are associated states
(TR, CH, NO), and
JRC
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NANoREG general pressentation
Overall objectives
A common European approach to the regulatory testing of nanomaterials
1. Providing legislators with a set of tools for risk
assessment and decision making instruments for the short
to medium term, by gathering data and performing pilot
risk assessment, including exposure monitoring and
control, for a selected number of nanomaterials used in
products;
2. Developing for the long term, new testing strategies
adapted to a high number of nanomaterials where many
factors can affect their environmental and health impact.
3. Establishing a close collaboration among authorities and
industry with regard to the knowledge required for
appropriate risk management, and create the basis for
common approaches, mutually acceptable datasets and
risk management practices.
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NANoREG general pressentation
NANoREG’s European/global workflow
A common European approach to the regulatory testing of nanomaterials
OECD
ISO
CEN
CARACAL
SRA
ICSU
ECHA
…….
D
F
NL
BE
I
UK
CH
National Advisors
NANoREG
Coordinator
Global
Advisory Board
Working
Groups
(WGs)
Industry
Consultation
Committee
NANoREG
TOOL BOX
IPR
Advisory
Board
National
Coordinators
Regulatory
Advisory
Board
Knowledge Base (Workpackages 2, 3 and 4)
Supporting Workpackages (1, 5 and 6)
NANoREG Consortium
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NANoREG general pressentation
IUCLID data structure/endpoints
CEN and ISO Standards
OHTs (OECD Harmonized Templates)
Global and European Harmonizing, Standardisation and Regulation Institutions
Data platform
Integrated in
NANOhub
NANoREG’s Workflow
A common European approach to the regulatory testing of nanomaterials
From Questions to Answers
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NANoREG general pressentation
NANoREG’s Value Chain Approach
A common European approach to the regulatory testing of nanomaterials
Bidirectional
Generative
Value chain
only indicative
R&D
information
route, hazard
Materials
flow and risk
communication
and exposure
Manufacture
Processing
Use
Market control, probes for exposure
Work place inspections
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NANoREG general pressentation
Recycling/
Waste treatment
NANoREG’s Open Architecture for Industry participation
A common European approach to the regulatory testing of nanomaterials
Working Groups and Value Chain Projects (VCP) key elements of NANoREG
Industry participation also from
outside the NANoREG consortium
WP1
Task 1.3
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WP2
WP3
WP4
Working Group/
VCP 1
Working Group/
VCP 2
Working Group/
VCP 3
Working Group/
VCP 4
Working Group/
VCP n
NANoREG general pressentation
WP5
WP6
NANoREG’s Organisational Structure
A common European approach to the regulatory testing of nanomaterials
General Assembly
(Chair Coordinator)
Industry
Consultation Committee
Global (EU-US)
Community of Research
Scientific and
Regulatory Advisory
Coordinator
DG Research and
Innovation
National Advisory Board
Management
Committee
IPR
Advisory Committee
(Chair Coordinator)
WP1
Scientific
answers to
regulatory
issues
WP2
Synthesis,
supplying
and
characterization
WP3
Exposure
through
life cycle
analysis
WP4
Biokinetics
and toxicity
testing in vivo
WP5
Regulatory
risk
assessment
and testing
WP6
Keeping
pace with
Innovation
Working Group 1: Solution strategies answering regulatory demands
Working Group 2 Carbon Nano Tubes
Value Chain Projects defined by WP 1
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NANoREG general pressentation
WP7
Liaisons,
dissemination,
exploitation,
communication
WP8
Project
Management
NANoREG’s National Organizations
A common European approach to the regulatory testing of nanomaterials
National Advisors
National Coordinators
Strategic level
National
Coordinators
coordinatorsNC
National Advisory
National
Strategic
Board NAB
Advisory Board
OECD
ISO
CEN
ECHA
SRA
ICSU
Workpackage 7,
5, Task 7.2
5.2
Global Harmonizing,
Standardisation
and Regulation Institutions
NANoREG Coordinator
National
Advisors
advisors
NA
Operational level
National
Liaisons
National
Cluster
National
Co-financing
National
Events
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NANoREG general pressentation
National Tasks
A common European approach to the regulatory testing of nanomaterials
Elaboration of the Questions and Needs
National
Workshop
Country 1
National
Workshop
Country 2
National
Workshop
Country 3
Consolidation the questions and needs within WP 7
and transfer to WP 1, Task 1 and 3
Development of the solution strategy for the
Questions and needs (WP1, Task 1.1)
(if appropriate WS with national regulators and legislators)
Approval of the proposed VCPs and WP2 - WP4 activities
by the Management Board
Start R&D work and other activities to answer the questions
and providing solutions (WP2 – WP4)
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NANoREG general pressentation
National
Workshop
Country n
National Tasks
A common European approach to the regulatory testing of nanomaterials
Result transfer
Consolidated answers by WP 1, Task 1.3
Organization of national
seminars with NANoREG
general information for
Industry, the public, NGOs, etc.
(Tasks 7.3, 7.4 and 7.2)
National
Workshop
Country 1
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Transfer of NANoREG results from
R&D, test and case studies
to the national regulation
and legislation authorities
with experts of the NANoREG WPs
(Tasks 7.2 and 7.3)
National
Workshop
Country 2
NANoREG general pressentation
National
Workshop
Country 3
National
Workshop
Country n
Results
A common European approach to the regulatory testing of nanomaterials
 Safe Products and Processes
 Safe by Design Processes
 Answers to regulatory questions
 Tool Box
 Test guidelines
 Standard Operation Procedures (SOPs)
 Reference materials
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NANoREG general pressentation
A common European approach to the regulatory testing of nanomaterials
Thank you for your attention.
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NANoREG general pressentation