DG JRC – the European Commission’s Research Based Policy Support Organisation

1. Part 1 DG JRC – the European Commission’s Research Based Policy Support Organisation ECB/Croatia Chemical InfoDays Zagreb, Croatia 11-13 December, 2006 http://www.jrc.ec.europa.eu

2. Research Based Policy Support - DG JRC – Robust Science for Policy Making • As a Directorate General (DG) of the European Commission, DG JRC provides scientific and technical support to Community policy making

3. Court of Justice SANCO RTD JRC SG. RELEX ENTR ENV ... ... ... ... …. ... ... …. IPSC IHCP IRMM IPTS IES The EU Institutions Committee of the Regions Court of Auditors The Council of Ministers The European Parliament Economic and Social Committee European Commission (the ‘College’: 25 Commissioners)

4. The Mission of the Joint Research Centre … is to provide customer-drivenscientific and technicalsupport for the conception, development, implementation and monitoring of EU policies. As a service of the European Commission, the JRC functions as a reference centre of science and technology for the Union. Close to the policy-making process, it serves the common interest of the Member States, while being independent of special interests, whether private or national.

5. Implementing the Mission … in implementing its mission, DG JRC… ….. depends on intensive networking withpublic and private institutions in the Member States and beyond……. DG JRC is involved in over 250 networksand collaborative projects

6. 7 Institutes in 5 Member States • IRMM – Geel, BELGIUM • - Institute for Reference Materials and Measurements • IE – Petten, The NETHERLANDS • Institute for Energy ITU – Karlsruhe, GERMANY - Institute for Transuranium elements IPSC - IHCP – IES, Ispra ITALY - Institute for the Protection and the Security of the Citizen - Institute for Health and Consumer Protection - Institute for Environment and Sustainability • IPTS – Seville, SPAIN • - Institute for Prospective Technological Studies Total staff: > 2600 people Structure of DG JRC

7. Sub-alpine lake in Northern Italy: Lago Maggiore WHERE ARE WE? • Second largest lake in Italy • Altitude 194 m above s.l • Length 66 km (IT + CH) • Width max. 10 km • Width med. 3.9 km • Area 212.5 km² • Volume 37.5 km³ • Coastline 170 km • Max. depth 370 m • Avg. depth 176 m • Water RT ~ 4 Years Ispra Site

8. The Ispra site • Third biggest Commission site after Brussels and Luxemburg • 160 hectares • 36 km of roads • 6 km perimeters of fencing • 140 heated buildings • 1600 staff : • 1000 core staff • 600 visiting staff • + 200 staff of external organizations / contractors • + 200 daily visitors

9. DG JRC Work Programme 2003-2006 Budget Breakdown (M€) Institutional budget for 4 years FP6 EC Programme (M€) 760 Euratom Programme (M€) 290 Total DG JRC (M€) 1050 • Complemented by competitive earnings (10-15%): • funded work from other Commission services • third party work • participation in FP6 Indirect Actions

10. DG JRC Work Programme 2003-2006 Food, Chemicals, and Health(food safety & quality, food chain & consumer protection, GMOs, chemical products, alternative testing methods, biomedical technologies, health & environment) Environment and Sustainability(air, water & soil quality, land resources, sustainability issues, climate change, ecosystem monitoring, energy technologies) Nuclear Safety and Security(waste treatment & storage, nuclear non-proliferation, reactor safety, radiation monitoring, basic actinide research) S&T Foresight(technology & techno-economic foresight, statistical methods for analysis of economic indicators) Reference Materials and Measurements(reference materials & methods, certified reference materials, radionuclide metrology, neutron data measurements) Public Security and Antifraud(antifraud technologies, cybersecurity, technological & natural emergencies, humanitarian aid)

11. DG JRC contribution to ERA • DG JRC ERA Action Plan • 11 Actions & 19 targets • Accompanying ERA Implementation Plan • via DG JRC work programme • strategic participation in Indirect Actions Realising objectives and delivering high-quality results via strong partnerships with public and private organisations in the Member States and Candidate Countries

12. DG JRC contribution to ERA • Common scientific reference systems • identify & provide reference materials and measurements • Networking • strategic collaborations via e.g. flagship NoE, links with high-quality network partners • Training and mobility of researchers • promotion of research training opportunities, increase mobility of research staff • Broadening access to infrastructures • increased awareness, hosting of researchers • Support to Enlargement + Integration

13. DG JRC and Enlargement • Strategic Objectives: • To help the new Member States (EU+10) and the Candidate Countries in dealing faster and efficiently with the “EU acquis” in areas of DG JRC competence • To contribute to the development of the “European Research Area” • Main Target: • To achieve full working involvement between the Candidate Countries, the EU-10 Member States and DG JRC, consistent with the level enjoyed by the EU-15 Member States

14. Working for the DG JRC • DG JRC Staff • Policy of attracting bright and able scientists • Multi-national skills and talents • Scientific and cultural diversity • Interested in working with DG JRC? • Email: JRC-recruitment@ec.europa.eu • Web: http://www.jrc.ec.europa.eu

15. Institute of Health and Consumer Protection DG Joint Research Centre

16. The DG Joint Research Centre (JRC) and its Institute for Health and Consumer Protection (IHCP) The Joint Research Centre (JRC) is the European Union’s scientific and technical research laboratory and an integral part of the European Commission. The JRC provides the scientific and technical know-how to support EU policies.

17. The Institute for Health and Consumer Protection The mission of the IHCP is to provide scientific support to the development and implementation of EU policies related to health and consumer protection. The IHCP carries out research to improve the understanding of potential health risks posed by • chemicals • genetically modified organisms • contaminants released from food contact materials and consumer products. http://ihcp.jrc.cec.eu.int

18. Working Areas of IHCP • Chemicals • Environment & Health • GMOs • Alternatve Testing Methods • In Vitro • In silico • Bio-Sensors • Nano-toxicology

19. IHCP Scientific Units Development and validation of methods for detection, identification and quantification of GMOs. B&GMOs Unit(Biotechnology & GMOs) Guy VAN DEN EEDE BMS Unit(Biomedical Materials and Systems) Hermann STAMM Development of methods and materials to ensure safety, quality and reliability of medical devices and biomedical systems (development and application of (bio)sensors). ECB Unit(European Chemicals Bureau) Steven EISENREICH Integrated Risk Assessment, C&L/GHS, biocides, testing methods, QSARs/ITS, REACH, Nano-Toxicology, ECVAM Unit (Validation of Alternative Methods) Thomas HARTUNG Reduction of animal testing by looking for alternatives with in vitro techniques. PCE Unit(Physical & Chemical Exposure) Dimitrios KOTZIAS Evaluation and quantification of human exposure and risk assessments from environmental stressors.

20. Examples of Achievements • Support to EU Chemical Policy (REACH ), risk assessment reports for priority chemicals, QSARs • REACH Implementation Projects, Tools for IND and ECHA, MS • ENGL: The European Network of GMOs laboratories (74 EU official laboratories) • First EC Community Reference Laboratories: CRL on GM food and feed. New CRL on contact materials in 2006 • Validated alternative methods for in vitro tests • Application of biosensors for toxicological • endpoint detection

21. End of Part 1 DG JRC – the European Commission’s Research Based Policy Support Organisation ECB/Croatia Chemical InfoDays Zagreb, Croatia 11-13 December, 2006 http://www.jrc.ec.europa.eu

22. Part 2 The European Chemicals Bureau provides technical and scientific support for implementation of certain EU legislation on dangerous chemicals and the preparation for REACH

23. European Chemicals Bureau

24. Established in 1993 THE EUROPEAN CHEMICALS BUREAU Commission communication to the Council and the European Parliament(93/C 1/02) Statement • The Commission wishes to inform the Council and the Parliament that it has established, within the Joint Research Centre (JRC), Environment Institute, at Ispra, a special unit THE EUROPEAN CHEMICALS BUREAUdedicated to undertaking certain of the scientific/technical tasks required of the Commission in the context of certain pieces of Community legislation relating to the control of chemicals.

25. Short description of the work to be carried out by the European Chemicals Bureau • Directive 67/548/EEC (as amended for the seventh time by Directive 92/32/EEC) on the classification, packaging and labelling of dangerous substances: • - scientific and technical support activities associated with the adaptation of Annexes I to IX to the Directive to scientific and technical progress, • - scientific and technical support activities associated with the implementation of the new chemicals notification scheme (Articles 17, 18 and 21 of the Directive), • - scientific issues related to the Commission Directive on the risk assessment of new chemicals including the development and updating of scientific guidance documents, • - technical competence for the European inventory of existing commercial chemical substances (EINECS). • Council Regulation on the evaluation and control of existing chemical substances (to be adopted by the Council in March 1993): • - collection of data submitted by industry (Articles 3 and 4), • - to establish and maintain the European chemicals information data-base (Euclid) and to ensure the dissemination of information on existing chemicals within the Commission to the Member States and to the general public (Articles 6 and 17), • - scientific and technical support activities related to the preparation of lists of priority chemicals and the drawing up of agreed risk assessments on these priority chemicals (Articles 8 and 11 of the Regulation). • Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals: • - scientific and technical support activities related to the implementation of the Regulation and in particular the provision of up-to-date scientific and technical information on banned or restricted chemicals.

26. The European Chemicals Bureau – 2006  2007 SUPCHEM Support to Chemicals Legislation RefineRisk Integrated Risk Assessment of Chemicals GlobCHEM Global Chemical Data Management and Harmonization CompuTERM Computational Toxicology and Environmental Risk Modelling

27. Actions in FP6 year 2006 1311 Assessment of Chemicals New and Existing Chemicals Biocides, Classification and Labeling, Testing Methods Export/Import Legal basis Directive 67/548/EEC Class + Label, Notification, Testing Methods Directive 93/67/EEC Risk Assessment New Substances Directive 98/8/EC Biocidal Products Regulation 2455/92 Export/Import

28. Actions in FP6 2006 • 1313 REACH • Support to future chemicals legislation and the adoption and Implementation process of the REACH legislation • ECB delivers technical and scientific support to REACH implementation – overall coordinator of TGD preparation • Refocusing of current activities to prepare for REACH • General support on request (from DG ENV and ENTR) • RIP projects – Technical Guidance for IND, MS and ECHA

29. Actions in FP6 2006 1314REACH-IT & Informatics (new in 2006) Chemical databases, IT for registration, workflow for dossiers, global portal for sharing data

30. Actions in FP6 2006 1321 Computational Toxicology (QSARs) Development, validation and implementation of (Q)SARs and other estimation methods for the assessment of chemicals

31. Additional tasks within the current legislation • Support to the EU policies on traded chemicals • European Customs Inventory of Chemical Substances (ECICS database) 2. PBTs, POPs, Implementation of protocols (UN agreement) existing substances, PPP, Biocides 3.Export/Import Implementation of the Rotterdam Convention/Customs Controls on Hazardous Materials

32. Research Activities • Risk Assessment Methodologies • Human Health • Environmental Health (Aquatic inland/marine and terrestrial) • Endocrine disruptors • (Q)SAR development, • OSIRIS - Optimized Strategies for Risk Assessment of Chemicals based on Intelligent Testing, • Coordinated by UFZ • 10M Euros over 4 years • JRC-ECB and JRC-ECVAM are participants

33. ECB Now (1) • ECB today is the focal point for collecting and disseminating information on new and existing chemicals in the EU • ECB provides scientific and technical support to the conception, development, implementation and monitoring of EU policies on dangerous chemicals; risk assessments • ECB provides scientific support to key chemical questions at interface between science & policy • Example: DecaBDE (and its substitutes)

34. ECB Now (2) • development and harmonization of test methods (EU, international-OECD) • classification and labeling of substances • management of scientifically-sound risk assessment of chemical substances in EU • notification of new substances • authorization of biocides (Biocidal Products Directive) • information exchange on import and export of dangerous substances; Customs-relevant tools • scientific, technical and coordinating support to the development and harmonization of test methods and (Q)SAR models

35. ECB Now (3) • hosts the major EU databases such as EISIS, EINECS, IUCLID4, EDEXIM, and NCD • hosts, develops and applies the EUSES and EURAM models on environmental risk assessment and prioritization of chemicals, resp. • ECB Web Page hits > 5000-6000 hits a day • REACH, RIPs, IT tools • support to the conception and development of the new regulation • coordination, scientific development, TGDs • tools for industry (e.g., IUCLID5) • ECHA & development of its central information system (REACH-IT) • training • dissemination of information and practice

36. ECB 2007+ (4) • Focus on Integrated Risk Assessment • Science, science-policy interface, harmonization • REACH/ECHA Support/Training, Agency recruits, and others esp. in CC • Global Harmonised System (GHS) for Classification of Dangerous Chemicals • Data management systems: Further Development and Application (IUCLID5, EU database on intrinsic properties of nanoparticles, biocides) • Nanotoxicology (risk assessment, intrinsic properties, data management, science-policy interface, nano-toxicology) • (Q)SARs (toolbox, decision support system, regulatory acceptance, EDCs) • Test methods (Harmonized at EU and OECD levels); ITS • Environmental Quality Standards (PS in WFD) GOAL: to be at the nexus of Integrated Risk Assessment of Chemicals in the EU

37. The European Chemicals Bureau - WP 2007 SUPCHEM Support to Chemicals Legislation RefineRisk Integrated Risk Assessment of Chemicals GlobCHEM Global Chemical Data Management and Harmonization CompuTERM Computational Toxicology and Environmental Risk Modelling

38. Support to Enlargement and Integration • Strategic Objectives: • To help the AC / CC in dealing faster with the “EU acquis” in areas of JRC competence • To contribute to the development of the “European Research Area” • Main Target: • To achieve full working involvement between the AC/CCs and the JRC, consistent with the level enjoyed by EU Member States • Actions: Training • IUCLID and EUSES • Current Chemical Policy • QSARs • REACH (New Chemicals Policy)

39. What now for ECB? Classification & Labeling New Chemicals/ Existing Chemcials Support to REACH Implementation TGD via RIPs IUCLID5 Current Activities Chemical Databases Biocides Import-Export Risk Assessment of Chemicals & Test Methods Computational Toxicology (QSARs) http://ecb.jrc.it Training on New Chemical Policy

40. ECHA European Chemicals Agency EiF – May 2007 EiO – May 2008 Classification & Labeling New Chemicals/ Existing Chemicals Future Activities Chemical Databases Support to REACH Implementation ECHA, COM Biocides Import-Export http://ecb.jrc.it Integrated Risk Assessment Methodology Nano-Toxicology IUCLID5+ GHS (Q)SARs Chemical Risk Assessment & Test Methods ITS - Computational Toxicology (QSARs) Training on New Chemical Policy

41. ECB Website: http://ecb.jrc.it Thank you for your attention!