Transcript Slide 1

The European Commission’s approach
to Nano Safety
Nicholas Deliyanakis
European Commission
Research DG
Industrial Technologies
Conference on Nano-Safety, Ljubljana, 22-24 April 2009
EC Integrated Strategy
for Nanotechnology:
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Research
Infrastructures
Human Resources
Industrial Innovation
Societal Issues
Outreach, Ethics, Code of Conduct
 Safety & Regulation
 International Cooperation
In both Research and Policy
Communications on Strategy, Action Plan & Implementation:
COM(2004)338
of 12/05/04
COM(2005)243
of 07/06/05
COM(2007)505
of 06/09/07
(2009)…
Implementation:
 N&N in FP6: ~1.4 Billion € in 550 projects (not
only from NMP)
 EC accounts for ~1/3 of public funding in EU
 600 M€ in 2007, first year of FP7
 Similar amount expected in 2008
 Support for Infrastructures and Human
Resources in nanotechnology (generic/specific)
 Increasing industrial participation & patents
 Funded R&D: Topics gradually moving from
“enabling” science to industrial applications and
systems
Implementation –pt II:
 Staying in tune with society: Information and
dialogue
 “Code of Conduct for Responsible N&N
Research”, Feb 08
 Work on safety and regulatory issues (several
DGs)
 Increasing investment in safety R&D
 “Regulatory Review”, Jun 08
 International cooperation –in research and policy,
e.g.
 Coordinated call with Russia, 2009
 International dialogue, OECD, ISO etc
Regulatory Challenge:
Is the regulatory framework sufficient?
 Regulatory Review: COM(2008)366, 17/06/08
 Accompanying Staff Working Document
SEC(2008)2036
Relevant EU legislation
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Chemicals (REACH)
Worker Protection
Products (Specific and General regulations)
Environmental protection (IPPC, Seveso II, Water,
Waste directives)
Regulatory Challenge:
Is the regulatory framework sufficient?
o Overall, it can be concluded that current
legislation covers to a large extent risks in relation
to nanomaterials and that risks can be dealt with
under the current legislative framework.
o However, current legislation may have to be
modified in the light of new information becoming
available, for example as regards thresholds used
in some legislation.
Currently this is the subject of debate (e.g. EP)
o Specific legislation
o Labelling
Safety Challenge:
 SCENIHR opinions -latest in January 2009:
The methodology for both exposure estimations and
hazard identification needs to be further developed,
validated, and standardised. ref: SCENIHR opinions
 R&D to address safety gaps:
 Effects on human health
 Environmental effects, life-cycle
 Exposure assessment
 Test equipment
 EC invested 28M€ up to 2006,
>20M€ since 2007; work of JRC
Organisational Challenges:
 Global strategy
 International coordination of effort
 Work of OECD WPMN
 Unpublished or proprietary data
 Standardisation
 Regulatory changes, where appropriate
R&D projects on Safety
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SAFETY OF NANOPARTICLES:
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SAFETY OF PROCESSES
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CELLNANOTOX: Cellular Interaction and Toxicology with Engineered Nanoparticles
DIPNA: Development of an Integrated Platform for Nanoparticle Analysis to verify their possible
toxicity and eco-toxicity
NANOINTERACT: Development of a platform and toolkit for understanding interactions
between nanoparticles and the living world
NANOSH: Inflammatory and genotoxic effects of engineered nanomaterials
NANOCAP: Nanotechnology Capacity Building NGOs (FP6-SOCIETY)
IMPART: Improving the understanding of the impact of nanoparticles on human health and the
environment
PARTICLE-RISK: Risk Assessment of Exposure to Particles (FP6-NEST)
NANOSAFE2: Safe production and use of nanomaterials
SAPHIR: Controlled Production Of High Tech Multifunctional Products And Their Recycling
STANDARDISATION AND METROLOGY:
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NANO-STRAND: Standardization related to Research and Development for Nanotechnologies
NANOTRANSPORT: The Behaviour of Aerosols Released to Ambient Air from Nanoparticle
Manufacturing - A Pre-normative Study
FP7-NMP: Topics addressed in 2007
NMP-2007-1.3-1
Large RTD
Projects
Specific, easy-to-use portable devices for measurement and analysis
NANODEVICE: Novel Concepts, Methods, and Technologies for the Production of
Portable, Easy-to-Use Devices for the Measurement and Analysis of Airborne
Engineered Nanoparticles in Workplace Air
NMP-2007-1.3-2
Small RTD
projects
Risk assessment of engineered nanoparticles on health and the environment
NANOMMUNE: Comprehensive assessment of hazardous effects of engineered
nanomaterials on the immune system
NANORETOX: The Reactivity and Toxicity of Engineered Nanoparticles: Risks to the
Environment and Human Health
NEURONANO: Do nanoparticles induce neurodegenerative diseases? Understanding
the origin of reactive oxidative species and protein aggregation and mis-folding
phenomena in the presence of nanoparticles
NMP-2007-1.3-3
Support
Scientific review on the data and studies on the potential impact on health, safety and
the environment of engineered nanoparticles
ENRHES: Engineered Nanoparticles: Review of Health and Environmental Safety
NMP-2007-1.3-4
Support
Creation of a critical and commented database on the health, safety and
environmental impact of nanoparticles
NHECD
NMP-2007-1.3-5
Coordination
Coordination in studying the environmental, safety and health impact of engineered
nanoparticles and nanotechnology based materials and products
NANOIMPACTNET: The European Network on the Health and Environmental
Impact of Nanomaterials
HEALTH-20071.3-4
Small RTD
projects
Alternative testing strategies for the assessment of the toxicological profile of
nanoparticles used in medical diagnostics
NANOTEST: Development of methodology for alternative testing strategies for the
assessment of the toxicological profile of nanoparticles used in medical diagnostics
FP7-NMP: Topics addressed in 2008
NMP-2008-1.3-1
Large RTD Projects
Validation, adaptation and/or development of risk assessment methodology for
engineered nano-particles
No proposals selected
NMP-2008-1.3-2
Small RTD Projects
Impact of engineered nanoparticles on health and the environment
ENNSATOX: Engineered Nanoparticle Impact on Aquatic Environments:
Structure, Activity and Toxicology
ENPRA: Risk Assessment Of Engineered Nanoparticles
HINAMOX: Health Impact of Engineered Metal and Metal Oxide Nanoparticles:
Response, Bioimaging and Distribution at Cellular and Body Level
INLIVETOX: Intestinal, Liver and Endothelial Nanoparticle Toxicity Development
and evaluation of a novel tool for high-throughput data generation
NEPHH: Nanomaterials Related Environmental Pollution And Health
Hazards Throughout Their Life Cycle
FP7-NMP: Topics addressed in 2009
NMP-2009-1.3-1
Small RTD projects
Activities towards the development of appropriate solutions for the use,
recycling and/or final treatment of nanotechnology-based products
(Joint call with Theme 6: 'Environment - including Climate Change')
NMP-2009-1.3-2
Support
Exposure scenarios to nanoparticles
The next steps
• A project cluster on Nano-Toxicology
– First meeting 26/02/2009; next 01/04, 2829/04
– Synergy, projects mapping, data, test protocols,
results verification and validation, material
characterisation, research roadmaps
– Towards a RTD stakeholders’ forum
• Competence and Infrastructure Integration
• Modelling/simulation (planned joint call EU-USA)
• Risk detection and monitoring
• Risk reduction
• International cooperation
• Standardisation
EC Nanotechnology
Information
• Commission Nanotechnology
homepages (with FAQs):
ec.europa.eu/nanotechnology
cordis.europa.eu/nanotechnology
• CORDIS – Information on
(NMP) Calls:
cordis.europa.eu/fp7/dc
• Industrial Technologies
website:
ec.europa.eu/research/industrial_tech
nologies/