Safe Nanotechnology EU Industrial Research

(1)

1 CIAA, Brussels, 23 March 2010

Safe Nanotechnology

EU Industrial Research

Georgios Katalagarianakis

EC, Research DG

Industrial Technologies Directorate

G4 Nanoscience - Nanotechnology

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2 CIAA, Brussels, 23 March 2010

summary



Policy; Towards a second Action

Plan 2010-2015



The Objectives



Building on existing work in safety



RTD policy making and

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3 CIAA, Brussels, 23 March 2010

First Nanotechnology Ac2on Plan

Conclusions of the Second Implementa2on report 2007-‐2009(i)

Progress has been achieved in most areas. Future emphasis is on:



Deepening the research eﬀorts and roadmaps for key

nanotechnology sectors, to enhance innova2on,

compe22veness and safety. Life-‐cycle approaches should be

taken into account.



Developing infrastructures and the educa2onal system further,

consistent with the mul2disciplinary character of

nanotechnology.



Strengthening the mechanisms available for industrial

innova2on, stressing the concept of open innova2on and

facilita2ng technology transfer.

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4 CIAA, Brussels, 23 March 2010

First Nanotechnology Ac2on Plan 2005-‐2009

Conclusions of the Second Implementa2on report 2007-‐2009 (II)



Implemen2ng a more direct, focused and con2nuous societal

dialogue; and monitoring public opinion and the issues related

to consumer, environmental and worker protec2on.



Con2nuing to review the adequacy of regula2on, building

where possible on interna2onal developments.



Surveying the market for products of nanotechnology, including

safety aspects.



Stepping up the research eﬀort on safety assessment

throughout the product life-‐cycle, including the further

development and valida2on of nanomaterial characterisa2on

and test methods.

The Commission is considering proposing

a new Nanotechnology Ac7on Plan 2010-‐2015

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5 CIAA, Brussels, 23 March 2010

Leveraging

European Investment

in Nanotechnologies R&D and Innova2on

Value

crea2on

underpinnin

g

Sustainable

socio-‐

economic

developme

nt

resul2ng

in

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6 CIAA, Brussels, 23 March 2010

1. barriers

for business growth need to be iden2ﬁed and removed

2. real innova:on

needs must guide R&D output

3. fragmenta:on in R&D and Innova:on

eﬀorts has to be eliminated

4. market fragmenta:on

for Nano-‐based Innova2ons has to be combated

5. opportuni:es

for European leadership must be iden2ﬁed and seized

6. Strategic role of Nanotechnology in

recovery

from the economic downturn

must be ra2onalised

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7 CIAA, Brussels, 23 March 2010

The Options



Policy option 1: Continuation without

a new Action Plan

–

build on the momentum

–

Funding of R&D will continue

–

regulatory review and an inventory of nanomaterials by

2011

–

review of the Code of Conduct and monitoring every two

years

–

Coordination of “bottom-up” initiatives with Member

States and other stakeholders pursued through existing

mechanisms

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8 CIAA, Brussels, 23 March 2010

The Options



Policy option 2: Action Plan with

emphasis on coherence

–

a new strategic action plan continuing the integrated,

safe and responsible development of nanotechnology

policy

–

fundamentally strengthening the coherence of various

EU and national policies

–

major effort of coordination is needed in selected key

areas for innovation

–

technology roadmaps; risk governance; building of

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9 CIAA, Brussels, 23 March 2010

The Options



Policy option 3: A new structure for

innovation

–

strong additional mechanism of

coordination with the Member States

and industry

–

set up a structure with the remit of

developing and implementing innovation

policy

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10 CIAA, Brussels, 23 March 2010

most fundamental

criteria



Innovation

–

Strengthening of supply side measures;

–

Enhancing of the uptake and commercialisation of R&D results;

–

New demand-side policies meeting integrated research and innovation

needs;

–

Introduction of nanotechnology applications with societal benefits in

the market



Strengthening of the integrated, safe

and responsible approach

–

Increased investment in the EHS aspects of nanotechnology

–

A stable and predictable legal framework

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11 CIAA, Brussels, 23 March 2010

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12 CIAA, Brussels, 23 March 2010

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

Coordination 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

Coordination 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-2007-1.3 -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

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13 CIAA, Brussels, 23 March 2010

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

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14 CIAA, Brussels, 23 March 2010

NMP-2008-1.3-1

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 - Climate Change') Four proposals selected for negotiation:

NANOPOLYTOX: Toxicological impact of nanomaterials derived from processing, weathering and recycling of polymer nanocomposites used in various industrial applications

NANOHOUSE: Life Cycle of Nanoparticle-based Products used in House Coating NanoFATE: Nanoparticle Fate Assessment and Toxicity in the Environment NanoSustain: Development of sustainable solutions for nanotechnology-based products based on hazard characterization and LCA

NMP-2008-1.3-2

Coordination Exposure scenaria to nanoparticles NANEX: Development of Exposure Scenarios, for Manufactured Nanomaterials

KBBE-2009-2-4-1

Small RTD projects Analytical tools for characterisation of nano-particles in the food Matrix

NanoLyse: Nanoparticles in food: analytical methods for detection and

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15 CIAA, Brussels, 23 March 2010

EU RTD investment



FP 6: About

€

25 million



FP7, 1st year: About

€

25 million



FP7, 2

nd

year:

€

13.75 million



FP7, 3rd year:

€

11 million



Total:

€

75 million EU funding, NMP



Plus

€

7 million from other

programmes

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16 CIAA, Brussels, 23 March 2010

2010 Calls closed



Infrastructure integration

(proposal

submitted)



Modelling/simulation

(NMP call closed,

jointly with USA)



Risk management

(NMP call closed)

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17 CIAA, Brussels, 23 March 2010

Nano-Risk Management

System elements



Risk assessment

1.  Develop models for predicting

potential impact of nanomaterials

2.  Develop and validate methods to

evaluate toxicity

• Risk monitoring

1.  Instruments for assessing exposure

to nanomaterials in air and water (number, surface area, mass)

2.  Monitoring accidental hazards

Risk understanding / risk evaluation

•  Acceptable/unacceptable risks,

•  Exposure limits

•  Impact evaluation over entire life cycle

Risk Communication

•  Dialog and transparency

•  Risk perception

Risk mitigation

•  Proactive risk management

•  Safe processes and safe handling

Priority: Develop strategic programmes that enable risk-focussed research

• Risk monitoring

1.  Instruments for assessing exposure

to nanomaterials in air and water (number, surface area, mass)

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18 CIAA, Brussels, 23 March 2010

Knowledge gaps



Background level



Measurement methods



Metrics



Biological impact



Exposure data



Risk assessment underpinning data



…

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19 CIAA, Brussels, 23 March 2010

Organisational gaps



No global strategy, good intentions



Many funding sources, coordination needed



Many research projects, plethora of results



Unpublished or proprietary data



Data comparison and verification



Focus on nanoparticles toxicity and

ecotoxicity, not (adequately) on process/

product safety



Specific legislation

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20 CIAA, Brussels, 23 March 2010

EU RTD policy bodies in Nano



High Level Experts Group of MS and FP7-AS

–

Established in February 2009

–

Safety chosen as priority area



NANOFUTURES technology platform

–

A research stakeholders forum

–

Synergy across other technology platforms

–

Launch of preparation phase in June 2010



The nanosafety cluster

–

Established in February 2009



An industrial group on safety

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21 CIAA, Brussels, 23 March 2010

Discussion points



How to manage industrial safety in the nano-industry?

• Safety at work; occupational diseases

• Environmental safety; secondary exposure

• Consumer safety; product safety

–

Can RTD and legislation go hand in hand?

–

Can RTD needs be anticipated/planned?

–

How to address EU-MS authorities, industry collaboration

–

How to join efforts



EU RTD is breakthrough-innovation oriented; it cannot be used for

routine work but can establish foundations

–

Data collection, management, RA, LCA, Standardisation

–

Market surveillance, certification



OECD Working Party on Manufactured Nanomaterials

–

Sponsorship programme

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22 CIAA, Brussels, 23 March 2010

2011 RTD call topics

Innovation driven



New methods and strategies for

measurement, detection and identification

of nanoparticles in products and/or in the

environment (SME targeted)



Worker protection and exposure risk

management strategies for nanomaterial

production, use and disposal (small)



Intelligent testing strategies for

nanomaterials impact and exposure –

towards regulation and clustering of

materials (CSA)

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23 CIAA, Brussels, 23 March 2010

Safe Nanotechnology EU Industrial Research

1

CIAA, Brussels, 23 March 2010