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 Strategyfor Nanotechnology:

Research Infrastructures Human Resources Industrial Innovation Societal Issues

Outreach, Ethics, Code of Conduct

Safety & Regulation International Cooperation

In both Research and Policy

COM(2004)338COM(2004)338of 12/05/04of 12/05/04

COM(2005)243COM(2005)243of 07/06/05of 07/06/05

COM(2007)505COM(2007)505of 06/09/07of 06/09/07

Communications on Strategy, Action Plan & Implementation:

(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 EU600 M€ in 2007, first year of FP7Similar amount expected in 2008

Support for Infrastructures and Human Resources in nanotechnology (generic/specific)

Increasing industrial participation & patentsFunded 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, 17/06/08Accompanying Staff Working Document

SEC(2008)2036

Relevant EU legislationo Chemicals (REACH)o Worker Protectiono Products (Specific and General regulations)o 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 healthEnvironmental effects, life-cycleExposure assessmentTest equipmentEC 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

• SAFETY OF NANOPARTICLES:SAFETY OF NANOPARTICLES: • 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)

• SAFETY OF PROCESSESSAFETY OF PROCESSES• NANOSAFE2: Safe production and use of nanomaterials • SAPHIR: Controlled Production Of High Tech Multifunctional Products And Their Recycling

• STANDARDISATION AND METROLOGY:STANDARDISATION AND METROLOGY:• 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 inFP7-NMP: Topics addressed in 20072007NMP-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-2007-1.3-2Small RTD projects

Risk assessment of engineered nanoparticles on health and the environmentNANOMMUNE: Comprehensive assessment of hazardous effects of engineered

nanomaterials on the immune systemNANORETOX: The Reactivity and Toxicity of Engineered Nanoparticles: Risks to the

Environment and Human HealthNEURONANO: 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-2007-1.3-3Support

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-2007-1.3-4Support

Creation of a critical and commented database on the health, safety and environmental impact of nanoparticles

NHECD

NMP-2007-1.3-5Coordination

Coordination in studying the environmental, safety and health impact of engineered nanoparticles and nanotechnology based materials and productsNANOIMPACTNET: The European Network on the Health and EnvironmentalImpact of Nanomaterials

HEALTH-2007-1.3-4Small RTD projects

Alternative testing strategies for the assessment of the toxicological profile of nanoparticles used in medical diagnosticsNANOTEST: Development of methodology for alternative testing strategies for the assessment of the toxicological profile of nanoparticles used in medical diagnostics

FP7-NMP: Topics addressed inFP7-NMP: Topics addressed in 20082008

NMP-2008-1.3-1Large RTD Projects

Validation, adaptation and/or development of risk assessment methodology for engineered nano-particlesNo proposals selected

NMP-2008-1.3-2Small 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 LevelINLIVETOX: Intestinal, Liver and Endothelial Nanoparticle Toxicity Development and evaluation of a novel tool for high-throughput data generation NEPHH: Nanomaterials Related Environmental Pollution And HealthHazards Throughout Their Life Cycle

FP7-NMP: Topics addressed inFP7-NMP: Topics addressed in 20092009

NMP-2009-1.3-1Small 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-2009-1.3-2Support

Exposure scenarios to nanoparticles

The next steps

• A project cluster on Nano-Toxicology– First meeting 26/02/2009; next 01/04, 28-29/04– 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 EC Nanotechnology InformationInformation

• Commission Nanotechnology homepages (with FAQs):ec.europa.eu/nanotechnologycordis.europa.eu/nanotechnology

• CORDIS – Information on (NMP) Calls: cordis.europa.eu/fp7/dc

• Industrial Technologies website:ec.europa.eu/research/industrial_technologies/