Experiences with registrations - 5 years on the road

1. Experiences with registrations- 5 years on the road On the REACH Road 23 November 2011 Kevin PollardECHA – Dossier Submission and Dissemination

2. Content • Summary of the Registration Statistics • Feedback from ECHA on preparing for the registration submission process http://echa.europa.eu http://echa.europa.eu

3. Registration: outcome of the 1st deadline • Phase-in substances • over 1000 tonnes per annum (tpa) • Substances very toxic to aquatic environment (R50/53) over 100 tpa • CMRs over 1 tpa http://echa.europa.eu

4. Registration - Dossiers http://echa.europa.eu

5. Registration - Dossiers http://echa.europa.eu

6. Registration - Substances http://echa.europa.eu

7. Registration - Substances http://echa.europa.eu

8. http://echa.europa.eu

9. http://echa.europa.eu

10. Outcome • Successful management of the deadline • ca. 25 000 dossiers corresponding to 4300 substances • Majority of large companies: 86 % • Submission by Only Representatives: 19 % • Joint Registrations: 94 % • 25% substances with intermediate use only • Major co-operation effort • Excellent commitment by industry • Close cooperation between key players to narrow down uncertainties & clarify open questions (Directors’ Contact Group) http://echa.europa.eu

11. Some analysis • Overall number of registrations in line with expectations • Number of substances registered is lower than announced by industry in April 2010 surveys • Gap of 1500 substances • Analysis done to evaluate market impact • Explanations found for majority of substances: later registration, better understanding of REACH obligations (e.g. exemptions), merge/split of SIEFs, etc. • Results should be communicated to give certainty to Downstream users http://echa.europa.eu

12. Lessons learnt • Data Sharing • Pre-registration managed successfully but failed to meet its aims • Due to millions of pre-registrations, no clear picture of real intentions to register; no market certainty for downstream users • Despite challenges in SIEF formation, 94 % joint registrations • Challenges on data & cost sharing for smaller players or non EU manufacturers • Recommendations • Market surveys for next deadline; Encourage companies to de-activate pre-registration if no intention to register in 2013 • Start SIEF work for 2013 deadline early enough; Encourage early nomination of Lead Registrants • Increase transparency, promote best practices and fairness http://echa.europa.eu

13. Lessons learnt • Registration • Stability of legal interpretations & guidance is fundamental • Availability & stability of IT tools • Helped industry to pass the registration process • 98 % success rate for dossier completeness checks in Nov 2010 • Still challenge for newcomers, time needed to know the tools • Active communication and intensive dialogue • Helped raising awareness & addressing concerns • Recommendations • Tools and Guidance stabilised well ahead of the deadline, e.g. 1 year earlier for certain tools • Continuation of the DCG until September 2013 to address concerns http://echa.europa.eu

14. Content Summary of the Registration Statistics Feedback from ECHA on preparing for the registration submission process http://echa.europa.eu http://echa.europa.eu

15. 2011 2012 2013 2 Finally: Less than 2 years to the next deadline! • Phase-in substances over 100 tonnes per annum • Preparations should be underway! • Non EU manufacturers: make sure that your Only Representative gets ready http://echa.europa.eu

16. Important to know • Check if your substance is already registered on ECHA website or with Industry organisations • Less data requirements than for 2010 deadline: cost sharing only for data needed for your tonnage band • If your substance is not registered: • Create/join the SIEF immediately and start discussion on substance sameness and data sharing • Refer to Industry organisations to get advice on advice, model agreements and standard letters to manage the SIEF • Nominate/find the Lead registrant and make sure that he is known from ECHA to benefit from special services and create transparency for other market players http://echa.europa.eu

17. 31 Dec 2011 31 May 2012 31 Dec 2012 31 Mar 2013 Start to Prepare 31 May 2013 Deadline Substance ID Data sharing Hazard Data Late Pre-registration DU request for identified uses Chemical Safety Assessment Lead Submission Member Submission Countdown: optimal situation http://echa.europa.eu

18. More information: • ECHA website: http://echa.europa.eu/ • Basic and detailed explanations on REACH and CLP • Guidance documents and other supporting documentation • Formats and Tools for registration and notification • Entry to the Helpdesk • News and Events; e.g. info on Stakeholder days http://echa.europa.eu

19. 2010 Lead Registrants • You hold obligations to the next registrants wishing to register the same substance as you • You remain Lead of the joint submission beyond 1 June 2018 • Inform (pre-)SIEF members of your existence • Ensure that data sharing conditions are fair, transparent and non discriminatory • Newcomers only required to share costs of data needed for their tonnage band: Annex 10 not required • You will need to distribute the tokens to new registrants • Document your communications with the SIEF http://echa.europa.eu

20. 2013 Registrants • Is your substance already registered? • ECHA website: • http://apps.echa.europa.eu/registered/registered-sub.aspx • Some substances may not appear on the list, if the registrant has requested confidentiality on the name • Verify within SIEF or industry associations • Contact the Lead Registrant • Verify whether you have the same substance • Start data sharing negotiations • Ask for your token to join the “joint submission” http://echa.europa.eu

21. 2013 Registrants • Your substance is not registered yet • Some 2013 SIEFs already exist, the Lead may have been nominated already • Verify on ECHA website or with industry associations • If not, start the process of SIEF formation • Verify whether a SIEF Formation Facilitator (SFF) exists for your substance in REACH-IT (nb. some poor experiences in this area) • If not, contact pre-SIEF members to identify those registering in 2013 http://echa.europa.eu

22. New SIEFs • Verify substance sameness before forming the SIEF • Nominate a Lead Registrant • Collect data needed for Annexes 6-9 • target end 2011 • Inform your downstream users • their uses must be known to you before 30 May 2012 • Prepare Chemical Safety Assessment • target end 2012 http://echa.europa.eu

23. New Leads • Nominate yourselves to ECHA to benefit from special services, e.g. webinars https://comments.echa.europa.eu/Comments/LeadRegistrantNomination.aspx • Inform the supply chain that your SIEF is functioning and your substance will be registered http://echa.europa.eu

24. Practical recommendations • Make sure you are aware of all tools and guidance available • Some tools are critical to the success of your submission: IUCLID 5, Technical completeness check, fee calculator, & dissemination tools (http://www.iuclid.eu/) • Use Chesar for your chemical safety assessment and your CSR (http://chesar.echa.europa.eu/) • Dossier submission (http://echa.europa.eu/reachit_en.asp) • Data submission manuals (http://echa.europa.eu/reachit/dsm_en.asp) • Understanding of the dossier processing by ECHA (http://echa.europa.eu/reachit/dossier_processing_en.asp) http://echa.europa.eu

25. Thank you for your attention! http://echa.europa.eu http://echa.europa.eu