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Introduction to IUCLID5 and REACH-IT: Chemical Information Submission in EU

Learn about IUCLID5, the IT system for REACH-compliant dossiers, and REACH-IT for electronic chemical data submission in the EU. Understand the transition from IUCLID4 to IUCLID5 and the use of DES/SNIF format for new substances. Explore the benefits of IUCLID5 deployment, data reusability, and IT tool accessibility. Discover the abstraction layers in IUCLID5 and essential features for substance identification. Get insights on tools, user roles, data migration, and substance inventories for compliance with EU regulations.

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Introduction to IUCLID5 and REACH-IT: Chemical Information Submission in EU

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  1. Christel Musset European Commission DG JRCEuropean Chemicals Bureau IUCLID5 and REACH-IT Croatia- JRC-ECB InfoDays December 11-13, 2006

  2. Contents • Electronic submissionof chemical information in the EU: current situation • IUCLID5 and the REACH context • Introduction to IUCLID5 • REACH-IT

  3. Contents • Electronic submissionof chemical information in the EU: current situation • IUCLID5 and the REACH context • Introduction to IUCLID5 • REACH-IT

  4. e-Submission in EU: current situation • IUCLIDis the data entry tool for: • Existing substances (793/93/EEC): data collection and evaluation within the EU Risk Assessment programme • Biocides (98/8/EC): notification of active substances • OECD HPV chemicals programme since 1999 • DES (SNIF format) is the data entry tool for: • New substances (67/548/EECand amendments): compilation and exchange of summary data on new notified substances • The file created is in the SNIF format

  5. IUCLID • Used by: • Industry: for capturing and storing data on chemical substances and preparing dossiersfor the Authorities (ca. 500 installed companies) • Authorities: for viewing and evaluating the submitted information (ECB, Member States Competent Authorities, OECD, US-EPA, ...) • ECB: IUCLID database contains 37,000 dossiers ca. 10,500 different substances (~ 2,700 HPV) • non-confidential information published on ECB website (ESIS)

  6. IUCLID • 1st reporting tool: HEDSET(no windows version available – no local database to archive the data) • Current version: IUCLID4 (windows version, oracle database)

  7. DES / SNIF format • Used by: • Industry: for notifying information on new substances to the Member States Competent Authorities (single file for each substance, no database for storage) • Member States Competent Authorities: for viewing and evaluating the submitted information • ECB: New Chemical database containing the reviewed SNIF files sent by the Competent Authorities • 7,000 dossiers for about 4,500 different substances

  8. Contents • Electronic submissionof chemical information in the EU: current situation • IUCLID5 and the REACH context • Introduction to IUCLID5 • REACH-IT

  9. REACH context • the REACH proposal(Art. 110)specifies: • “The Agency shall specify formats and make them free of charge, and software packages and make them available on its website for any submissions to the Agency” • “For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID” • Unique system for new and existing substances • One single IT tool for industry: IUCLID5 • However SNIF to be used until Entry into operation June 2008

  10. IUCLID5 • IUCLID5 is the IT system (software & database) • designed toprepare REACH-compliant registration dossiers to be submitted to the European Chemicals Agency • it will be made available to Industry free of charge

  11. Why IUCLID5? • Full re-design of IUCLID4: • New requirements for REACH • New technology, improved user interface • Standard exchange format (XML format) for interfacing with other IT systems • Key new feature: Data structure for reporting hazard properties harmonised and agreed at international level (OECD project) Data entered once in IUCLID5 can be re-used for REACH, OECD, Biocides, and other international programmes!

  12. IUCLID5 Deployment • Flexibility in distribution: • stand-alone version • open source software(Tomcat: application server, PostgreSQL: database engine) • distributed version (network) • open source software • or commercial system software(BEA: application server, Oracle: database engine) • depending on the organisation/company policy

  13. Timeline Business model Roll out Analysis & Design Build IUCLID 5 Review Last changes COMMproposal Council draft text Final text Entry intoForce

  14. Contents • Electronic submissionof chemical information in the EU: current situation • IUCLID5 and the REACH context • Introduction to IUCLID5 • REACH-IT

  15. Abstraction layers Multiple data layers in IUCLID 5 raw data layer ENTERING dossier layer FREEZING / SUBMITTING annotation layer COMMENTING XML layer EXCHANGING

  16. High-level view on data model EC Inventory (read only) Reference Substance Substance (data set) Legal entity (owner) Endpoint study record Site

  17. Important features • Administration of users roles & privileges • Harmonised data format (OECD templates) • Grouping of substances in categories • Mixtures (preparations) • C&L according to 67/548/EEC and GHS • Endpoint summaries (interface with Exposure calculation tools) • IUCLID4 to IUCLID5 migration tool

  18. IUCLID5 home page

  19. Tools and administration

  20. Tools and administration • Several users per organisation; one user may be assigned to several organisations (test houses) • Import files if in the “correct format” • Migration tool from IUCLID4 to IUCLID5

  21. Inventories for substance identification

  22. Inventories for substance identification

  23. Tasks panel: day to day work

  24. Tasks panel: day to day work

  25. Substance dataset: step 1, selection of a substance

  26. Tree view: Organisation in sections

  27. Endpoint (OECD harmonised template format)

  28. Different views on data

  29. Colour code to indicate optional or required sections

  30. Dossier creation

  31. Documents table to add/remove items in the dossier

  32. Dossier creation

  33. Contents • Electronic submissionof chemical information in the EU: current situation • IUCLID5 and the REACH context • Introduction to IUCLID5 • REACH-IT

  34. REACH-IT is… • Central IT system of the European Chemicals Agency for managing the REACH processes • It will be used by: • Agency stafffor day to day work, e.g. dossier compliance • Member States Competent Authorities for consultation,follow-up of dossiers, substance evaluation, etc. • Industry for submission of information to the Agency and consultation; • Public (dissemination website)

  35. REACH-IT Main modules • Web portal for data entry, submission and consultation (e.g. tracking the status of a dossier) • Workflow system to follow the REACH processes(pre-registration / registration, evaluation, authorisation, etc.) • Invoicing system • Dissemination website (publication of non confidential information coming from the registration dossiers)

  36. REACH-IT is…

  37. From IUCLID5 to REACH-IT • The dossier prepared in IUCLID5 is exported and submitted to the Agency web site

  38. Dossier follow-up Substance name Registration number Submission date • The user may consult the Agency website to get an overview of his submitted dossiers

  39. Timeline Business model Roll out Analysis & Design Build IUCLID 5 A&D 2 Build A&D 1 REACH-IT Review Last changes Entry intoForce COMMproposal Final text Council draft text

  40. Further information • http://ecb.jrc.it/REACH-IT-INFORMATICS/

  41. Thank you for your attention

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