Safety Assessment of Nanomaterials at the Joint Research Centre

Transcription

1 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Safety Assessment of Nanomaterials at the Joint Research Centre Hermann Stamm Institute for Health and Consumer Protection Joint Research Centre, Ispra * The views expressed in this presentation are personal and may not necessarily reflect those of the European Commission

2 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Research-Based Policy Support JRC - Robust Science for Policy Making As a Directorate-General of the European Commission, the JRC provides customer-driven scientific and technical support to Community policy making Supporting citizen s security, health and environmental protection, safety of food and chemicals, alternative energies, nuclear safety, econometrics, prospective technologies

3 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Our Structure: 7 Institutes in 5 Member States IHCP - Ispra, Italy Institute for Health and Consumer Protection IES - Ispra, Italy Institute for Environment and Sustainability IPSC - Ispra, Italy Institute for the Protection and Security of the Citizen IRMM - Geel, Belgium Institute for Reference Materials and Measurements IE - Petten, The Netherlands Institute for Energy ITU - Karlsruhe, Germany Institute for Transuranium Elements IPTS - Seville, Spain Institute for Prospective Technological Studies

4 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Nanomaterials (NM) Safety Assessment Assessment Methodology Substance identification Information requirements Test methods and testing strategies Safety and risk assessment REACH Implementation Projects on Nano (RIPoN) Steering group: ENV, ENTR, ECHA, JRC Provide Implementation Tools Information Platform: NAPIRAhub Test Assessment Methods Nanomaterials for testing: Repository Provide data for safety assessment Data evaluation reports for nanosafety Databases for safety assessment

5 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March JRC Nanotechnology Policy Support European Commission Testing and guidelines (OECD) Member states Standardization Committees (ISO, CEN) EFSA Working Group on Nanotechnology Collaboration on nanotechnology related issues with ECHA

6 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March EU Regulation Nanotechnology Relevance Horizontal Legislation 1. Chemicals Legislation (REACH) Product Legislation 2. Safety Worker aspects Protection regarding nanotechnologies Plant are Protection in principle Products covered. 3. Environmental Legislation Integrated Pollution Prevention and Control Major-accidents, Seveso II Directive Water Waste General Safety of Consumer Products Biocides Need for modification? New Approach Legislation Cosmetic Products Aerosol Dispensers Medicinal Products Cars Food Legislation

7 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Requirements Definition of Nanomaterials for Regulatory Purposes A single definition broadly applicable in EU legislation and policies Legally clear and unambiguous, i.e. enforceable In line with other approaches world-wide Questions concerning the key elements of a definition What is a material (in the context of nanomaterial)? What is the nanoscale and which size range should it encompass? Should other properties which are the consequence of the material being at the nanoscale be included?

8 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March OECD Working Party for Manufactured Nanomaterials In 2006, the OECD established the Working Party on Manufactured Nanomaterials (WPMN). Objective: To promote international co-operation in human health and environmental safety related aspects of manufactured nanomaterials (MNs), in order to assist in the development of rigorous safety evaluation of nanomaterials.

9 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Work Area 1 Characterisation, Definition, Terminology and Standards OECD Working Party on Manufactured Nanomaterials (WPMN) Work Area 2 Testing Methods and Risk Assessment Project 3: Sponsorship Programme: Nanomaterial Measurement and Testing OECD WPMN Project 5: Voluntary Schemes and Regulatory Programmes Work Area 3 Information sharing, Co - operation and Dissemination Project 1 and 2: Nanosafety Projects Database Project 4: Manufactured Nanomaterials and Test Guidelines Project 6: Risk Assessment Project 7: Alternative Test methods and Testing Strategies Project 8: Exposure Measurements

10 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Nanomaterials Safety Assessment Assessment Methodology Substance identification Information requirements Test methods and testing strategies Safety and risk assessment Provide Implementation Tools Information Platform: NAPIRAhub Test Assessment Methods Nanomaterials for testing: Repository Provide data for safety assessment Data evaluation reports for nanosafety Databases for safety assessment

11 3RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23rd March 2010 Understanding the biological response Size and Shape Size distribution Shape State of Dispersion Agglomeration/Aggregation Physical and Chemical Properties Chemical composition Crystalline phase and crystallite le c i t size r a op s Solubility Nan c i t s i r Impurities haracte C Surface Area and Porosity Surface Properties Surface composition Catalytic properties Surface charge Reactivity Adsorption/desorption of molecules Lipophilicity/hydrophilicity 11 EFFECT Translocation from GI-tract to target organs Protein binding Cellular uptake Accumulation and retention Toxicity Cell/tissue response

12 12 3RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23rd March 2010 Nanotoxicology Systems Response In vivo Engineered Nanomaterials Biol. Response, pathogenicity In vitro Kinetics/ADE In vivo Uptake Accumulation Tissue and Cell Responses

13 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Nanomaterials tested at JRC

14 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Characterisation Techniques Size Morphology Concentration, Purity Proteins Interaction Uptake, Protein Interaction Particle-by-particle size distribution analysis Dynamic Light Scattering Scanning Electron Microscope Inductively Coupled Plasma Mass Spectrometry Fast Protein Liquid Chromatography Surface Plasmon Resonance 24 nm

15 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March In vitro toxicological profile NR CFE MTT Micronucleus test Cytocotoxicity Interaction with cells Inflammation Oxidative Stress NPs STEM analysis Cell transformation assay Genotoxicity Cancerogeneous Potential

16 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Result: Dose-Effect Relationship Unexposed cells 10µM Cytotoxicity Colony Forming Efficiency test in Balb/3T3 Cobalt nanoparticles (80 nm) 30µM 50µM Inhibitory Concentration 50% (IC50) 70µM 100µM Cell viability (%) Concentration (µm)

17 Repository: NM for testing 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March

18 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March IT Platform - NAPIRAhub NAPIRAhub is a comprehensive IT platform dedicated to the management of information on nanomaterials, relevant for safety/risk assessment. FEATURES Built on proven technology (IUCLID 5). Stores information/data structured in accordance with OECD and ISO guidelines and harmonised templates. Facilitates exchange and merging of datasets. Tracks changes to ensure traceability and reliability. Extensive search capabilities. Supplied free-of-charge by JRC, with support (

19 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Nanotechnology at IHCP Nanobiotechnology NM properties NM test method adaptation Innovative nano-applications Nanosafety and Regulatory Methods Nanosafety of substances and products Test methods- regulatory issues Radiotracers NM radiolabelling NM radioactivation Assay Technologies High Throughput assays and automation Repository: Nanomaterials for testing In vitro Methods Optimisation Test Method Optimization Test Method Validation

20 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March NANOMATERIALS SAFETY RESEARCH at JRC Methodology Test methods for nanomaterials (NM) Advanced characterisation methods Assay automation for High Throughput (HTS) Implementation tools Repository: Nanomaterial for testing NAPIRAhub information platform Validation for test methods Data for safety assessment Research projects FP6, FP7 ACT-ECO CELL-NANO-TOX INTELTEX CAREMAN BIOMONAR NANOIMPACTNET NEURONANO ENRHES NANORETOX NANOTHER PepChipOmics NHECD NANEX ENPRA

21 3 RD CIAA NANOTECHNOLOGY DIAOLOGUE MEETING, Brussels, 23 rd March Joint Research Centre (JRC) Robust science for policy making Thank you for your attention Web: Contact: