1. http://echa.europa.eu1 Post Pre-Registration Christel Musset Directorate Registration & IT tools SIEF Management Brussels, 30 January 2009

2. http://echa.europa.eu2 Content 1.State of play of pre-registration / pre-SIEF 2.Next steps

3. http://echa.europa.eu3 Principle of pre-registration Pre-registration: option for potential registrants of phase-in substances, to benefit from extended deadlines for registration 1 June to 1 December 2008: phase-in substances already manufactured / imported / placed on the market After 1 December 2008: “late” pre-registration for phase-in substances manufactured / imported / placed on the market for the 1 st time When omitted, companies can no longer manufacture, import or place on the market phase-in substances or preparations containing those substances until they have registered them

4. http://echa.europa.eu4 Pre-registration state-of-play at the end of the pre-registration period: –more than 65,000 companies from all 27 MS + EAA –more than 2,700,000 pre-registrations received –more than 150,000 different substances pre-registered Complete EC inventory 17,000 identified by CAS numbers 9,500 identified by chemical names 14,500 multi-constituent substances 1105 pre-registrations submitted through back-up procedure on 1 December 2008

5. http://echa.europa.eu5 Legal entities signed up total = 65655 (01.12.2008)

6. http://echa.europa.eu6 Pre-registration state of play Legal entities signed up in REACH-IT: –Expected companies (manufacturers, importers, distributors, OR, consultants, etc… –But also: testing system (blocked in Dec 08) foreign or non-existing address (blocked in Dec 08) high number of legal entities: OR not yet representing a non-EU company??? ~ 20% of companies have not pre-registered –company size (35% of companies are micro-sized)

7. http://echa.europa.eu7 Pre-registration total = 2,750,464 (12.12.2008)

8. http://echa.europa.eu8 in the last weeks of pre-registration, ECHA received a very high number of users Pre-registration: pattern

9. http://echa.europa.eu9 Bulk pre-registrations / day Pre-registration: pattern

10. http://echa.europa.eu10 Pre-registration experiences Substances pre-registered: –high number of pre-registrations by some companies Purpose? Secure business, double pre-registration… –CAS n° does not correspond to chemical name Corrected with the support of CAS: correct CAS names in the list of pre-registered substances published on ECHA web site Wrong CAS names provided by companies transferred into the synonym list –substances having EINECS n° pre-registered using only CAS number or chemical name  duplicate pre-SIEF Check ongoing with CAS for substances with only chemical names

11. http://echa.europa.eu11 Pre-registration experiences Substances pre-registered: –preparations (and alloys) pre-registered as multi- constituent substances ??? –use of non-English chemical names translations done as far as possible –poor identification of substances: especially for pigments (orange 79, yellow 104) –polymers pre-registered –articles pre-registered

12. http://echa.europa.eu12 Pre-registration experiences pre-SIEF size

13. http://echa.europa.eu13 List of pre-registered substances published on 19 December 2008 Since 5 January: –Using REACH-IT First-time manufacturers or importers can pre-register (art. 28.6) Data holders may indicate that they have data on pre- registered substances (art. 28.5) –ECHA-CHEM (web forms on ECHA web site) Third parties may submit information on pre-registered substances (art 41.6) DU can notify ECHA of their interest in not listed substances Steps after 1 December 2008

14. http://echa.europa.eu14 Next steps

15. http://echa.europa.eu15 Challenges for industry –Some SIEFs have more than 1000 participants CEFIC initiative for organising the SIEFs –Feedback from associations Companies using the system for proposing services SIEF Formation Facilitators blocked by companies –Access to REACH-IT problematic System overloaded by users performing complex searches and downloading enormous amount of data → system slow and unstable Pre-SIEFs

16. http://echa.europa.eu16 Challenges for industry –SIEF facilitators – low percentage of pre-SIEFs Pre-SIEFs

17. http://echa.europa.eu17 Challenges for ECHA –List of pre-registered substances Corrections were suggested to companies during pre- registration (9,000 emails) – very few feedback from companies → quality of the list? → data sharing issue? (wrong / duplicate pre-SIEFs) → SIEF is industry responsibility… ECHA’s role? Pre-SIEFs

18. http://echa.europa.eu18 Challenges for ECHA –REACH-IT Scalability of the system: need for substantial performance improvement → 1 st Improvement: January 26 → Next planned for 2 nd week of February → will continue in the next months to ensure performance and stability for the 2010 peak –Registrations and C&L notifications expected to follow the same pattern as pre-registrations: high peak in the last 3 months System needed to regulate the flow of submissions and ensure registrants meet the deadline Pre-SIEFs

19. http://echa.europa.eu19 Challenges for ECHA –Workload in 2010 Commission estimations in 2003: 25.000 registrations in 2010 Real number of dossiers? Feedback necessary from industry on the number and size of SIEFs –Quality of dossiers Essential to have high quality dossiers to ensure maximum throughput of submissions Technical completeness check module to be released as an plug-in to IUCLID 5 in Autumn 2009 User manuals and guidance Pre-SIEFs

20. http://echa.europa.eu20 Thank you for your attention