JOINT RESEARCH CENTRE EUROPEAN COMMISSION European Information System Risks from chemicals released from consumer products/articles EIS- ChemRisks on behalf of the European Commission, DG SANCO D. Papameletiou, P. Hakkinen, D. Schwela and A. Zenié Physical and Chemical Exposure Unit IHCP, JRC, Ispra 13 th Annual Conference of the International Society for Exposure Analysis, ISEA 2003, Stresa, Italy 21. September 2003

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Rationale Human exposure data related to chemicals released from consumer products/articles are highly complex and substantially missing or difficult to access and use: –a major bottleneck in the risk assessment process in the EU and elsewhere Implementation of the General Product Safety Directive (2001/95/EC) and of the relevant sections of the New Chemicals Policy (REACH): –there is a clear need to build knowledge and to develop EU-wide infrastructure, methods and tools

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS - ChemRisks Objectives To design, prototype and implement a toolbox on exposure assessment To apply transparent peer review and validation procedures To become a reference system To network all relevant institutions/stakeholders To harmonise/develop tools To produce guidance documents To support the GPSD and REACH

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Novelty of Approach An integrated reference system on: Exposure Scenarios Exposure Factors Exposure data – measured & modeled Health data europa.eu.int/comm/consumers/cons_safe/ news/eis_plan_052003_en.pdf

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Milestones Concept & Prototype Development (2003) Feasibility & User Requirements Study (2003) Pilot operation (2004) Long-term operation

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks The Team Pertti Hakkinen Vittorio Reina Demosthenes Papameletiou Dieter Schwela Alex Zenié

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Net The European Exposure Network a Network of Networks: focal points - thematic/geographic networks Level 1: National Authorities (Public Health, Consumer Protection, Statistics, etc) Level 2: Industries (Chemical Producers & Downstream Users) Level 3: Academia, R&D, International Organisations, NGOs facilitate science - based consensus/validation structured and transparent information exchange/sharing review a) user requirements b) data availability/quality develop and adopt harmonised/common tools

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Information Exchange and Communication Tools EIS-ChemRisks web-system –Intranet –Communication to the public Inventory & analysis study for the harmonisation of key data sources in the EU on human exposure data to chemicals

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks European Exposure Factors and Scenarios –Concept and prototype development (2003) Comparative study of key existing systems Evaluation of the data situation in the EU System specifications –Pilot Operation (2004)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Exposure Scenarios Default scenarios? Consensus scenarios? Guidance for scenario building: the template approach: – Transparent use of stakeholder information: Product Factors Human Factors Boundary conditions –Transparent use of appropriate exposure models/algorithms (TGD…..) and reference exposure factors and data (EIS-ChemRisks) Peer review – Sectorial workshops – Scientific Committees

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Exposure Data Data on chemical emissions (migration/release) from consumer products, chemical substances by type of exposure (inhalation, ingestion and dermal uptakes) –Scenario driven approach –Measured data: by surveying testing methods and analysing testing reports –Modeled data by using data derived from harmonised consumer exposure models

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks surveying testing methods and reports Determination of chemicals in Products/Articles Determination of chemicals emissions/release from products/articles –Stucture of EIS-ChemRisks data base: Characterisation: method description, chemical substances, scenario, validation status, accredited testing institutes, testing reports Peer review of reference exposure data Specification of R&D needs beyond EIS - ChemRisks: ChemTest: network of testing laboratories and implentation of R&D projects(FP6 ………FP7

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Use of modeling data on exposure to chemicals released from products/articles Task Force Inventory of consumer exposure models Intercomparison Harmonisation Validation Activity will start in Contact person: Stelios Kephalopoulos

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Sectorial Workshops tattoo/piercing colours and materials (May 2003) clothing/textiles (June 2003) toys (October 2003), personal hygiene products (January 2004), computer devices (April 2004) automotive components (June 2004)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- ChemRisks Work-programme for the product/articles-specific sectoral workshops Task Force Regulatory Review Health Effects Review Inventory "Chemicals in Product Review of the availability of test methods and of modeling tools Exposure assessment toolbox: Exposure Factors and Scenarios Platform Conference

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS- CHEMRISKS Health Data Inventory of data sources Product specific health data reviews European biomarkers study and workshop Report (2004) Workshop (2004)

JOINT RESEARCH CENTRE EUROPEAN COMMISSION EIS-ChemRisks the way ahead….. 1.Testing and improving the concept development 2.EIS-ChemRisks Net 3.Pilot phase 4.Chem-Test 5.Support to GPSD, Rapex, REACH……...