4th ECHA Stakeholder Day 19th May 2010 Review Amanda Foulkes University of Hull

1. 4th ECHA Stakeholder Day19th May 2010ReviewAmanda FoulkesUniversity of Hull

2. Topics Classification & Labelling Notification Chemical Safety Reports & CHESAR Registration & Evaluation feedback Dissemination

3. The Prize Why are we here? We are leading the way in the ‘quest’ for safer chemicals: Protect human health Protect the environment Encourage competitiveness and innovation Promote a more positive image of chemicals

4. Challenges for 2010

5. Link to ECHA C&L web-pages where you see this sign

6. C&L Notification 2010 registrants – notification included in registration Notification by 3rd January 2011 2013 & 2018 registrants Substances under 1 tonne Substances used in research / PPORD Millions of notifications expected Range of IT tools available CLP pages of ECHA website updated Do it early!!!!!

7. C&L – who notifies? Single manufacturers or importers Group of Manufacturers or importers OR’s not entitled to notify under CLP....but If OR has registered substance, importers do not need to notify; If OR is an importer, he can notify on behalf of a “group of manufacturers or importers”

8. C&L notification by SIEF members SIEF members with registration deadlines after Dec 2010 have to notify “I agree” button in on-line tool can be used to agree with lead registrant SIEF members can notify as a group through a nominated “group leader”

9. C&L notification tools Several tools for different companies/situations IUCLID 5.2 XML creation and Excel tool for bulk file creation On-line creation in REACH-IT for single submissions Submission is always through REACH-IT: Bulk or single submissions Individuals or groups of M/I Need to create group in REACH-IT All tools are compatible with each other and are accessible from the CLP and REACH-IT web pages

10. C&L notification  IUCLID 5.2 Use “CLP notification” template Most powerful tool Enables submission of substances with different compositions and classifications Allows attachments for supporting evidence Data submission Manual Part 12 ...for guidance

11. C&L notification  Bulk submission Bulk submission using XML file: Map form existing data bases, or Excel tool for data compilation User friendly Available in all 22 official EU languages “Button” to create XML export file Can’t accommodate multi-compositions/different classifications Can’t add attachments

12. C&L notification REACH-IT On-line C&L notification Create single submissions directly in REACH-IT Checks for previous submissions “I agree” button available / automatic data entry Can only be used for single composition/classifications Simple and easy to use Lots of inbuilt “tool tips” and links to guidance Search and export facilities (all submission modes) View submitted C&L Export pdf or XLM type files of own/group submissions

13. CSRs - recap

14. Exposure Scenarios Two types: Exposure scenarios for CSR Exposure scenarios for eSDS Extract from CSR Phrased so customers can understand May be several for different target groups/uses Contain recommended risk management measures Advice to downstream users on how to determine if they are working safely

15. CSR Submission CSR is submitted with Registration Dossier fro all substance at 10 tonnes or above Don’t assume Lead Registrant will do this for you Lead Registrant should communicate if they intend to prepare a joint CSR Member registrant supports joint CSR by: Providing all necessary information Identifying which uses and exposure scenarios are relevant to him Communicating openly if they intend to submit a separate complementary part of the CSR to meet their specific needs

16. CSA Guidance Recently updated: Use descriptor system (R.12) Exposure scenario format(Part D and F) Exposure estimation for workers (R.14) Exposure estimation for consumers (R.15) Exposure estimation for the environment (R.16) DNEL derivation from human data (R.8)

17. CSA Guidance Q1 / 2011: “Strictly controlled conditions” and “no release” (R.5) Exposure assessment for waste life stage (R.18) Scope of exposure assessment (B)

18. Chemical Safety Assessment and Reporting Tool Main principals of the guidance into an IT tool Guides users through CSA process Generates CSR in an efficient way Harmonised structure Facilitates easy updating and transfer of information IUCLID 5 plug-in Extends previous plug-in to include CSA process Ensures information in CSR & technical dossier “match” NOT COMPULSORY!!!

19. CHESAR CHESAR 1.0 supports PBT assessment (not contained in IUCLID file) Use descriptors (R.12) Exposure assessment Built in exposure estimation tools (ECETOC TRA & EUSES) Risk Characterisation Generation of CSR (Chesar 1.1/ early July) Generation of Exposure scenarios (in the future)

20. CHESAR Chesar 1.0 - all functionalities to prepare standard CSA ( except waste life stage) User Manuals (6) available 1st upgrade (Chesar 1.1) planned for early July to include full CSR generation http://chesar.eu/

21. Registration - Feedback 5000 substances/registrations 38,000 registration dossiers Contingency for 25,000 – 75,000 dossiers

22. Registration – Key messages Allow time to learn how to use the tools and the become familiar with the submission process. REACH-IT Manuals / data Submission Manuals/ LR webinars Business Rules Guidance in DSM 4 Use TCC Tool – catches most issues Can resubmit as many times as you like prior to registration deadline Technical Completeness Check Use TCC Tool before submission 3 week response time (until September) Ample time will be given for correcting missing information Only one further attempt at compliance

23. Registration – Key messages Pay Invoice on time Initial 14 days Automatically extended to 44 days Rejected if not paid within extended deadline Don’t wait until the last minute to register Lead Registrants should aim for mid Summer

24. Evaluation - Process

25. Evaluation Compliance Checks 5 % of all dossiers Outcome Formal decision Request for further information Quality Observation letter Shortcomings, inconsistencies or update of whole dossier

26. Evaluation Testing Proposals All dossiers with testing proposals Outcome Formal decision Request or reject performance of test Change conditions of the testing Request additional testing

27. EvaluationDecision Making Process

28. Registration – Key messages Use decision making process to provided extra information 2nd opportunity to complete documentation So far few registrants have used this process constructively Don’t not use process to argue against the decision Substance Identity must be clear and unambiguous Refer to guidance One substance – one registration Ensure justifications for data waiving or use of non-test data need is adequate Refer to guidance Provided sufficient detail e.g. Applicability of (Q)SAR models Build scientific case

29. Evaluation Practical Guides How to report in vitro data How to report Robust Study Summaries How to report Weight of Evidence How to report waiving How to report (Q)SARs How to report read-across and categories http://www.echa.europa.eu/publications-en.asp

30. Evaluation - Intermediates Problems found: Status as an intermediate in question Missing information Inadequate specification of controlled conditions Plausibility of risk management measures Further guidance on ‘strictly controlled conditions’ will be available shortly.

31. Dissemination = Publication of information from registration dossiers on the ECHA website Available to all citizens in the EU http://apps.echa.europa.eu/registered/registered-sub.aspx Or ECHA website>ECHA CHEM> Registered substances 168 substances published so far

32. Registration complete Dossier filtered (filter tool) Leaves only information listed in Art.119 Also filters out Art 119 (2) items that have been flagged as confidential Filtered dossiers sent to Registrants for review Joint dossiers aggregated Dossier disseminated on web It is the responsibility of the registrant: To ensure that information which they wish to be kept confidential is flagged correctly, and To provide an adequate justification Dissemination - Process

33. Dissemination - Tools REACH-IT Data Submission Manual – part 15 Webinar on data-sharing and Dissemination IUCLID plug-in for dissemination (June 2010) Allows registrant to view filtered file before submission. Practical advice being prepared: How to write justifications How ECHA will assess justifications

34. Dissemination Feedback on the dissemination website is welcomed: https://comments.echa.europa.eu/Comments/DisseminationFeedback.aspx

35. Downloads Webstream available until December 2010 Presentations http://echa.europa.eu/news/events/4rd_stakeholders_day_en.asp Webinars Access to previous webinars 2010 schedule http://echa.europa.eu/news/webinars_en.asp

36. Thank you for listening