1. DI conference – 28 May 2008 (Pre-)SIEF in practice Jack Wille - Cefic

2. DI conference – 28 May 2008 - page 2 SIEFreach Agenda: –Introduction / Background –System overview The overall process Data transfer from ECHA REACH-IT system into SIEFreach Setup company structure / User accounts –How work inside a SIEF –Payment of fees –Beyond the SIEF: Joint Submission

3. DI conference – 28 May 2008 - page 3 SIEF IT system project - Background The obligation to share animal study data in SIEFs (Substance Information Exchange Fora) and Submission of a Joint Registration: –is industry’s responsibility –the European Agency (ECHA) will not be involved –therefore industry has to find a solution Cefic initiative: IT platform giving service to all industry, providing for: –Collaboration of companies in SIEF formation & sharing of data, identification of data gaps, cost sharing, etc. –Secure communication inside and between SIEFs Benefits for companies of a SIEF IT platform: –Consistent processes and procedures –No need for individual solutions (reducing complexity) –Reduced investment and lower operational cost per company What if not such a system…….: –Multiple other (independent) SIEF IT systems by industry sector, for consortia, etc. –Email communication for SIEF communication less efficient / more time consuming

4. DI conference – 28 May 2008 - page 4 SIEF IT system Project – Timing –Project kick-off (Requirements Definition)31 July 2007 –Start Build-phase 8 Jan. 2008 –User Acceptance test-121 May 2008 Test-1 with ECHA REACH-IT system22-23 May 2008 –User Acceptance Test – 216-20 June 2008 –Implementation: Release 1.0Early July 2008 Release 2.0 (Invoicing, reporting)August 2008 Release 3.0 (Splitting / Merging SIEFs)1 Dec. 2008

5. DI conference – 28 May 2008 - page 5 Central IUCLID5 database Pre- Registration Registration SIEFreach ECHA Industry (Joint) Dossier Preparation SIEF IT system project Pre-Registration data IUCLID5 system ECHA Pre-SIEF data is the source for SIEF REACH-IT system

6. DI conference – 28 May 2008 - page 6 SIEFreach – Key components A common system for SIEF participants (consistency) Used across different industries (chemical, cosmetics, paper, etc.) Based on ECHA Pre-SIEF data: –Enable Pre-SIEF / SIEF discussions using collaboration tool features Free access area vs. ‘paid’ area Predefined roles / privileges: –SIEF Formation Facilitator, SFF, Lead Registrant –Legal Entity Group Administrator –Legal Entity User (one primary user per LE / Substance) –Invited Expert –Data Holder

7. DI conference – 28 May 2008 - page 7 SIEFreach – IT Infrastructure Robust, scalable system configuration (servers, database, network) IT Service Provider: IBM Sub-systems designed under ‘umbrella’ of Portal software Redundant installation to limit system downtime (max. 24 h.) (Disaster recovery site) Service Desk to resolve problems 3 main sub-systems: –Legal Entity / User Management –SIEF collaboration / processing (based on Lotus QuickR software) –Invoicing (fee collection)

8. DI conference – 28 May 2008 - page 8 SIEF IT system – Company launched Dedicated company established (ReachLink) Shareholders: Cefic + National Federations: –Germany – VCI –France – UIC –Italy – Federchimica –UK – CIA –Spain – FEIQUE ReachLink owns and manages the system Management Board (Shareholder representatives) User Committee and Steering Committee Managing Director hired Marketing / Communication campaign started 2H-May 2008

9. DI conference – 28 May 2008 - page 9 SIEF IT System Benefits: –Streamlined transparent communication between parties –Consistent processes and procedures –Tracking of all discussions / decisions during SIEF life time –Designed in collaboration with major players in the Chemical Industry –ECHA pre-SIEF data is the basis for the SIEF –No need for individual solutions (reducing complexity) –Lower operational cost per company –Controlled access & Secured communication –Guaranteed platform till at least 2018

10. DI conference – 28 May 2008 - page 10 SIEFreach Agenda: –Introduction / Background –System overview The overall process Data transfer from ECHA REACH-IT system into SIEFreach Setup company structure / User accounts –How work inside a SIEF –Payment of fees –Beyond the SIEF: Joint Submission

11. DI conference – 28 May 2008 - page 11 Registration SIEF IT system Agency Industry (Joint Submission) Dossier Preparation Pre-Registration / SIEF / Registration process IUCLID5 ECHA Pre-SIEF data is the basis for SIEF-IT system Other source (e.g. Excel) Plug-in XML conversion 1 3 2 Pre-SIEF SIEF Data Holders Pre- Registrants Data Holder Submission Procedure Registrants Early Registrants Cefic / Concawe developed standard based on Excel – free of charge for all companies

12. DI conference – 28 May 2008 - page 12 This slide is copied from ECHA presentation 15 Feb. 2008 Pre-SIEF web page (ECHA REACH-IT system)

13. DI conference – 28 May 2008 - page 13 Export to SIEF-IT system Pre-SIEF data are the basis for SIEF-IT system SIEF participants Read- across Data Holders Designation of SFF Sameness LR Designation Classification & Labeling Cost sharing Testing proposals Dashboard ECHA Pages (cannot be updated) Data Availability Data Holder pages Data gaps SIEF Member Pages Substance description After 1-1-2009 Company Available data (studies) Free access ECHA REACH-IT system – Pre-SIEF SIEF-IT system Data export from Pre-SIEF (ECHA REACH-IT system) to SIEF-IT system

14. DI conference – 28 May 2008 - page 14 SIEFreach – Information Folders SIEF participants Read- across Data Holders -Designation of SFF -Sameness -LR Designation -Classification & Labeling -Cost sharing -Testing proposals -SIEF Status page ECHA Pages (cannot be updated) -Data Availability Data Holder pages -Data gaps SIEF Pages Pre- SIEF data Substance description After 1-1-2009 -Company Available data (studies) Free access Note: Consider a SIEF as a set of ‘Information pages’ on relevant topics

15. DI conference – 28 May 2008 - page 15 SIEFreach - SIEF Page composition 4 different Body types, i.e. maintained by: - Synchronisation with ECHA - Maintained by SFF / LR (most pages) - Maintained by SIEF User (Studies pages) - Maintained by Data Holder Threaded discussion: - Any SIEF LE User who has write access Attaching documents: - Any SIEF LE User who has write access SIEF Name, SIEF Nickname, Sub-SIEF Name Body Forum Attachments Header

16. DI conference – 28 May 2008 - page 16 From REACH-IT system to SIEFreach 1. SIEFreach - preparation: –Setup Legal Entity structure and create User Accounts –Legal Entity Group Administrator (First user to sign up for a company): –Creates Legal Entity Group –Creates Legal Entities –Creates User Accounts 2. REACH-IT system - Data transfer: –ECHA Pre-SIEF data is the basis for the SIEF –Pre-Registrants access ECHA Pre-SIEF web page to view pre-registrants, including Potential Registrants, (Early)-Registrants, Data Holders –Data transfer from ECHA system to SIEF IT system triggered by a Pre-SIEF participant 3. SIEFreach - SIEF activation: –‘Handshake’ ECHA data and SIEF LE data –Assigns Users to SIEFs (allocate to SIEF slot)

17. DI conference – 28 May 2008 - page 17 Substance Legal Entity Legal Entity Group 1 2 Legal Entity Legal Entity Legal Entity Substance Legal Entity Legal Entity Legal Entity ECHA REACH-IT system SIEF Substance Legal Entity Legal Entity Substance Legal Entity Legal Entity Legal Entity SIEF 4 SIEFreach system 1 - Setup your company SIEF structure (Legal Entity Group, Legal Entities, Administrator, User Accounts) - Data transfer from ECHA - Handshake / activate in SIEFreach - Allocate Users to SIEF / SIEF Role - Collaborate with other SIEF participants Legal Entity 3 5 Legal Entity Pre-SIEF 1 Pre-SIEF 3 Pre-SIEF 2 Pre-SIEF … 2 3 4 Pre-SIEF Legal Entity Group Admin. (LEGA) User Account SIEF Folder E.g. - Substance Sameness - Studies - Data Gaps - C&L 5 Pre-SIEF data Steps to go through: From REACH-IT system to SIEFreach

18. DI conference – 28 May 2008 - page 18 SIEFreach Agenda: –Introduction / Background –System overview The overall process Data transfer from ECHA REACH-IT system into SIEFreach Setup company structure / User accounts –How work inside a SIEF –Payment of fees –Beyond the SIEF: Joint Submission

19. DI conference – 28 May 2008 - page 19 Pre- SIEF Administrative Tasks SIEF Status Page - User Admin - Security - Assign Lead Registrant SIEF Formation Cost sharing C&L Subst. Id. Card Data Exchange Maintain Information Pages SFF* responsibility Lead Registrant responsibility * SFF = SIEF Formation Facilitator Prepare Joint Submission Administrative Tasks SIEF Status Page Joint Submission Member Submission - Discussion Forum - Collaboration Tool - SIEF changes Registration SIEF IT system - Overview Potential Registrants ‘Invited Users Page’ SIEF System boundary SIEF system changes SIEF Database

20. DI conference – 28 May 2008 - page 20 SIEFreach – System overview SIEF updates Updates at ECHA system during / after Pre-Registration phase, e.g.: –Name, Address, Contact person –Cancel Pre-registration (inactivate in system – no physical delete) –Late Pre-Registrant –Add Read-across Substances –Add Data Holder Synchronisation with SIEF by ‘ refresh’, triggered by an active SIEF User In addition, SIEF updates will be possible in SIEF IT system, e.g.: –Splitting / Merging of SIEFs

21. DI conference – 28 May 2008 - page 21 SIEFreach – screenshot-1

22. DI conference – 28 May 2008 - page 22 SIEFreach – screenshot-2

23. DI conference – 28 May 2008 - page 23 SIEFreach Agenda: –Introduction / Background –System overview The overall process Data transfer from ECHA REACH-IT system into SIEFreach Setup company structure / User accounts –How work inside a SIEF –Payment of fees –Beyond the SIEF: Joint Submission

24. DI conference – 28 May 2008 - page 24 Fee Payment: –Payment options: Credit card (CC) orders and Purchase Order (PO) / Sales Order (SO) / Invoice process –Legal Entity Group Admin (LEGA) is contact for PO / Invoice –LEGA sends Purchase order for SIEF participations by Legal Entities –After payment, credit amount is stored at LEG level –For each SIEF participation, credit amount will be deducted –Reporting will provide details on spent amount per Legal Entity SIEFreach – Invoicing process

25. DI conference – 28 May 2008 - page 25 SIEFreach – Fee payment Fee payment to be paid in order to cover the cost for the system ‘One time fee’ for each SIEF participation for 11 yrs.: Base fee: 300 € by SIEF / by Legal Entity / Substance Payment required to obtain access to SIEF (However, a ‘non paying area’ is available to view limited information) Payment mode: –Credit card (for one SIEF): direct access –Purchase order / Invoicing: Pay in advance for multiple substances (Credit amount managed by the system) ‘Early birds’ – PO before 1 July 2008 (tbc): Discount if Purchase Order >= 3000€ Discount for SMEs will be reviewed by end 2008 User RoleBase Fees Pre-registrant Additional person for a Legal Entity /SIEF 300 € 150 € Registrant Additional person for a Legal Entity /SIEF 300 € 150 € Invited Expert150 € Data Holder150 €

26. DI conference – 28 May 2008 - page 26 SIEFreach Agenda: –Introduction / Background –System overview The overall process Data transfer from ECHA REACH-IT system into SIEFreach Setup company structure / User accounts –How work inside a SIEF –Payment of fees –Beyond the SIEF: Joint Submission

27. DI conference – 28 May 2008 - page 27 Registration SIEF IT system Agency Industry (Joint Submission) Dossier Preparation Pre-Registration / SIEF / Registration process IUCLID5 ECHA Pre-SIEF data is the basis for SIEF-IT system Other source (e.g. Excel) Plug-in XML conversion 1 3 2 SIEF Data Holders Pre- Registrants Data Holder Submission Procedure Registrants Early Registrants

28. DI conference – 28 May 2008 - page 28 SIEF IT system project After SIEF: Registration (Joint Submission): –Lead Registrant (LR) submits Registration Dossier first –Receives ‘Joint Submission token’ (ticket number) –LR distributes JS token to other JS members –JS members submit their registration dossier –Dossiers are processed at ECHA (using REACH-IT Workflow system)

29. DI conference – 28 May 2008 - page 29 Thank you