Transcript Nanotechnology - NanoImpactNet

Nanotechnologies –
research needs from an
EU policy and regulatory
perspective
NanoImpactNet, Lausanne, 10-12 March 2010
Eva Hellsten, DG Environment, European Commission
Disclaimer: This presentation is not legally binding and does not represent any commitment on behalf of the European Commission
EU nanotech policy development
~ 2000 - Lisbon Agenda; growth, jobs, competiveness.
Nanotech benefits and applications - contribution to economic
growth and welfare
~ 2004 – risk debate started – knowledge gaps, ethical and regulatory
issues.
Nanotech risk research and “integrated, safe and responsible”
development
~ 2010 – economic crisis and “grand challenges” – climate, energy,
resources….
Nanotech and sustainability – need to analyse safe solutions with
nanotechnology, predictive modelling of risks and benefits
R&D funding of Nanotech in FPs
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FP4 1994-1998
120 M€
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FP5 1998-2002
280 M€
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FP6 2002-2006
1300 M€
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FP7 2007-2013
~ 3400 M€
HSE funding: 2003-06 ~ 25 M€; 2007-08 ~ 50 M€
Two interlinked objectives in
health, safety and environment
 regulation - in place, implemented
and enforced
 scientific knowledge gaps filled
To make risk legislation work….
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Regulatory framework itself –
definitions, scope and requirements
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Implementation – supported by
technical guidance, standards etc.
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Enforcement – legal certainty
Example REACH registration
 Nanomaterials covered by “substance
definition” – included in REACH
 Information requirements - in REACH
annexes, e.g. toxicity tests depending on
volume
 Chemical safety assessment > 10 tpa
 Hazard assessment
 PBT/vPvB assessment
 Exposure assessment
 Risk characterisation and risk management
Some critical scientific issues in
REACH to consider
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Are information requirements for different tonnage
triggers sufficient for nanomaterials?
New tests required? Modified test guidelines?
Validation of test methods. Predictability of in vitro
tests
Exposure measurement and assessment
methods?
Definition issues. E.g. nano form versus
“traditional” form
Not only REACH to address nanomaterials
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Chemicals and chemical products:
 Industrial chemicals – REACH
 Pharmaceuticals, Pesticides, Biocides
 Medical devices, Cosmetics, Food additives and
packages
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Worker protection
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Environment protection: air, water, IPPC, Seveso, waste
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Horizontal - environment and product liability, product
safety
Regulatory Review, 2008
Commission conclusions regulatory review
Environmental and health risks of nanomaterials in principle covered by EU
regulatory frameworks
Did not exclude regulatory changes in light
of new evidence or results of R&D
Implementation of the legal frameworks
remains difficult due to:
 Scientific knowledge gaps
 Fast evolving market for products
Risk paradigm for legislation
Hazards
(eco)toxicity
tests
Exposures
fate, transport
exposure
assessment
Scientific uncertainty
Risk assessment
Proportionality
principle
Precautionary
principle
Risk management
What have we learned?
Test and measurement of hazards and exposures are
more complex for nanomaterials compared with
ordinary chemicals
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High & unspecific background, artefact formation
pose challenges for analysis
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Careful characterisation of test samples and
experimental set up to ensure reproducibility and
repeatability in test systems
Validated and internationally harmonised methods to
ensure legal certainty and avoid trade problems
For NMs specific considerations
Hazards
charaterization, standards,
reference materials,
(eco)toxicity tests
metrics, dosimetry,
fate, transport
validation
Scientific uncertainty
Exposures
exposure
assessment
Risk assessment
Proportionality
principle
Precautionary
principle
Risk management
Progress – in which areas?
Research 2005-2009
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Characterisation, standards, reference materials
Analysis and measurement, exposure in working environment
Interaction with biological systems
Translocation in the body, transport across the food chain
Certain toxic effects of some NMs observed in vitro or in vivo
Case by case assessments
See further, opinions of Scientific Committees and
Commission final implementation report of Action Plan
(Staff Working Document 2009)
Progress - work to obtain
international harmonisation
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OECD WPMN Sponsorship programme,
internationally harmonised test
methods, test guidelines alternative
test methods, exposure assessment
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ISO/CEN international standards,
nomenclature, methods
Research priorities from a regulatory
perspective – Staff Working Doc 2009
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Validation and harmonisation of methodologies
(characterisation, hazards, exposures), reference
materials
Fundamental phenomena, biological interactions
Further work on test methods and test guidelines
Long term toxicity, transport, fate and behaviour
Exposure throughout life cycle
Predictive methods – models using in vivo, in
vitro, in silicio results - for priority setting
Need for an efficient transfer of research
results and dialogues between
researchers and regulators
Looking ahead
How can nanomaterials be used
in a sustainable and safe manner
to address “grand challenges”?
Millennium Development Goals – where
nanotechnology can contribute
 Energy production, storage and conversion
 Water treatment and remediation
 Environment and health monitoring
 Health – diagnosis, screening, drug delivery
 Soil and polluted sites remediation
 Food safety, agricultural productivity
Source: “Innovation: applying knowledge in development”, UN
OECD conference on environmental benefits – fostering a safe and
sustainable development of nanotechnology, July 2009
Different forms of nanomaterials
Used in many sectors + lifecycle perspective
Material
processing
Manufacture
Distribution
Use
Recovery
Reuse
Recycle
Raw material
Waste
Need for a broader view on life cycle for
applications based on nanotechnology
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From extraction to disposal/recycling of the nanomaterial - or
of all components of the application
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Positive and negative impacts on environment and health (e.g.
energy savings versus toxicity, or depletion of rare minerals)
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Geographical, societal or economic impacts
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Comparison with conventional technologies
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For various stages of development of applications - in
particular at early innovation stages – predict benefits and risks
The challenge in policy
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Create good conditions for innovation and development of
applications, contributing to sustainable growth
AND AT THE SAME TIME
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Ensure that potential risks to environment and human
health are identified and managed - at the earliest stage
possible
“Scientific investigation and assessment of
possible health or environmental risks
associated with nanotechnology need to
accompany R&D and technological progress.”
On “integrated, safe and responsible”
Towards a European Strategy for
Nanotechnology (2004)
Publications http://ec.europa.eu/nanotechnology
 Towards a European Strategy for Nanotechnology
(2004) and the Nanotechnology Action Plan for
Europe 2005-2009
 Mid-term Implementation Report (2007)
 Code of Conduct for Research (2008)
 Regulatory review (2008)
 Action Plan final Implementation report (2009)