REACH-IT Stakeholders workshop 7 May Jack Wille - Cefic

Transcription

1 REACH-IT Stakeholders workshop 7 May 2008 SIEF-IT system SIEFreach Jack Wille - Cefic

2 SIEF IT system project Topics: Background SIEF-IT system ( SIEFreach ) overview / status REACH-IT Workshop 7 May page 2

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. communication for SIEF communication less efficient / more time consuming REACH-IT Workshop 7 May page 3

4 SIEFreach Key components A common system for SIEF participants (consistency) Used across different industries (chemical, metal, cosmetics, paper, etc.) Based on ECHA Pre-SIEF data: Enable Pre-SIEF discussions using collaboration tool features Facilitate SIEF 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 REACH-IT Workshop 7 May page 4

5 SIEFreach IT Infrastructure Robust, scalable system configuration (servers, database, network) 3 main sub-systems: Legal Entity / User Management SIEF collaboration / processing (based on Lotus QuickR software) Invoicing (fee collection) 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 REACH-IT Workshop 7 May page 5

6 SIEFreach Company Dedicated company established (ReachLink) Shareholders: Cefic + National Federations: Germany VCI France UIC Italy Federchimica UK CIA Spain - FEIQUE ReachLink owns and manages the system Shareholders pay for development cost; SIEF participants pay for the system operations (pay by SIEF participation) Management Board (Shareholder representatives) User Committee and Steering Committee Managing Director hired Marketing / Communication campaign starting 15 May 2008 REACH-IT Workshop 7 May page 6

7 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) User Role Pre-registrant Additional person for a Legal Entity /SIEF Registrant Additional person for a Legal Entity /SIEF Invited Expert Data Holder Base Fees Early birds PO before 1 July 2008: Discount if Purchase Order >= 3000 Discount for SMEs will be reviewed by end 2008 REACH-IT Workshop 7 May page 7

8 SIEFreach Timing Test system 21 May 2008 Testing with ECHA REACH-IT system tbd Implementation: Release June 2008 Release 2.0 (Invoicing, reporting) 1 August 2008 Release 3.0 (Splitting / Merging SIEFs) 1 Dec REACH-IT Workshop 7 May page 8

9 SIEF IT system project Topics: Background SIEF-IT system ( SIEFreach ) overview / status REACH-IT Workshop 7 May page 9

10 ECHA Pre-SIEF data is the basis for SIEF-IT system Pre-Registration / SIEF / Registration process Pre-SIEF Data Holder Submission Procedure 1 Pre- Registrants Data Holders Early Registrants Registration Registrants Agency Industry 3 2 XML conversion Plug-in SIEF IT system (Joint Submission) Dossier Preparation Other source (e.g. Excel) IUCLID5 SIEF REACH-IT Workshop 7 May page 10

11 From REACH-IT system to SIEFreach 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 REACH-IT system: 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 SIEFreach SIEF activation: Handshake ECHA data and SIEF LE data Assigns Users to SIEFs (allocate to SIEF slot) REACH-IT Workshop 7 May page 11

12 Pre-SIEF web page (ECHA REACH-IT system) This slide is copied from ECHA presentation 15 Feb REACH-IT Workshop 7 May page 12

13 ECHA REACH-IT system Pre-SIEF Data export from Pre-SIEF (ECHA REACH-IT system) to SIEF-IT system Pre-SIEF data are the basis for SIEF-IT system SIEF-IT system Substance description SIEF participants ECHA Pages (cannot be updated) After Data Holders Export to SIEF-IT system Read- across SIEF Member Pages Available data (studies) Company Dashboard Designation of SFF Sameness Data Availability LR Designation Data Holder pages REACH-IT Workshop 7 May page 13 Free access Classification & Labeling Data gaps Cost sharing Testing proposals

14 SIEFreach Information Folders Pre- SIEF data Substance description ECHA Pages (cannot be updated) After SIEF participants Data Holders Read- across Note: Consider a SIEF as a set of Information pages on relevant topics Available data (studies) SIEF Pages -Company -SIEF Status page -Designation of SFF -Sameness -Data Availability -LR Designation Data Holder pages Free access -Classification & Labeling -Data gaps -Cost sharing -Testing proposals REACH-IT Workshop 7 May page 14

15 SIEFreach - SIEF Page composition Header Body SIEF Name, SIEF Nickname, Sub-SIEF Name 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 Forum Threaded discussion: - Any SIEF LE User who has write access Attachments Attaching documents: - Any SIEF LE User who has write access REACH-IT Workshop 7 May page 15

16 SIEF IT system - Overview Pre- SIEF Registration Potential Registrants changes - Discussion Forum - Collaboration Tool - SIEF changes Maintain Information Pages Cost sharing C&L SIEF Subst. Formation Id. Card SIEF system SIEF Database Data Exchange Invited Users Page Prepare Joint Submission Joint Submission Member Submission SIEF System boundary SIEF Status Page SIEF Status Page SFF* responsibility Lead Registrant responsibility - User Admin - Security REACH-IT Workshop 7 May page 16 Administrative Tasks - Assign Lead Registrant Administrative Tasks * SFF = SIEF Formation Facilitator

17 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 SIEF User In addition, SIEF updates will be possible in SIEF IT system, e.g.: Splitting / Merging of SIEFs REACH-IT Workshop 7 May page 17

18 Login Page User Login page REACH-IT Workshop 7 May page 18

19 What has been discussed Ethanol Information Folders List of the Information Folders, click name to access REACH-IT Workshop 7 May page 19

20 Respond to a posting SIEF nr Substance: Ethanol REACH-IT Workshop 7 May page 20

21 SIEFreach Functionalities Functionalities: A free area with access to: substance description overview of the SIEF participants ECHA data read across functionality studies available per participant (if flagged to make available) Sameness discussions Data sharing, data gaps, classification & labelling, etc. Support for cost sharing Progress indicator (SIEF Status Page) Voting and polling capabilities Invited users pages to take discussions off line within a limited group of participants SIEF Status Page will show the progress on the Information Folders Preparation of the joint submission REACH-IT Workshop 7 May page 21

22 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 REACH-IT Workshop 7 May page 22

23 Pre-Registration / SIEF / Registration process ECHA Pre-SIEF data is the basis for SIEF-IT system Data Holder Submission Procedure 1 Pre- Registrants Data Holders Early Registrants Registration Registrants Agency Industry 3 2 XML conversion Plug-in SIEF IT system (Joint Submission) Dossier Preparation Other source (e.g. Excel) IUCLID5 SIEF REACH-IT Workshop 7 May page 23

24 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) REACH-IT Workshop 7 May page 24

25 REACH-IT Workshop 7 May page 25 Thank you