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A PRACTICAL GUIDE FOR THE 2013 REGISTRATION AND OTHER REACH ONGOING DUTIES

A PRACTICAL GUIDE FOR THE 2013 REGISTRATION AND OTHER REACH ONGOING DUTIES. On the REACH road Warsaw , Poland 24 November 2011. Yvan Bisschops. AGENDA. REACH 2013 REGISTRATION DEADLINE. WHO? WHAT? WHEN? HOW? STEPWISE APPROACH AND THE COST IS?. REACH 2010 DOSSIERS.

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A PRACTICAL GUIDE FOR THE 2013 REGISTRATION AND OTHER REACH ONGOING DUTIES

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  1. A PRACTICAL GUIDE FOR THE 2013 REGISTRATION AND OTHER REACH ONGOING DUTIES On the REACH road Warsaw, Poland 24 November 2011 Yvan Bisschops

  2. AGENDA REACH 2013 REGISTRATION DEADLINE • WHO? WHAT? WHEN? • HOW? STEPWISE APPROACH • AND THE COST IS? REACH 2010 DOSSIERS • UPDATES AND EVALUATION • TEST PLANS? AUTHORISATION? • SUPPLY CHAIN INFORMATION CLP MIXTURES 2015

  3. REGISTRATION: WHO? AND WHAT? WHO HAS REACH REGISTRATION OBLIGATIONS? • EU PRODUCERS / IMPORTERS / O.R.’s • NOT THE DU’S NOR THE DISTRIBUTORS WHAT HAS TO BE REGISTERED? • SUBSTANCES FALLING UNDER REACH • NOT THE MIXTURES NOR SUBSTANCES UNDER OTHER REGULATIONS (FOOD)

  4. DEADLINE DETERMINATION • REMEMBER : NO REGISTRATION = NO MARKET !

  5. REGISTERING IN 2013? HOW? STEP 1 : CHECK IF SUBSTANCE REGISTERED IN 2010 => IF YES , CONTACT THE LR OR/AND CHECK REACH-IT AND BUY A LoA => IF NO, GO TO STEP 2 STEP 2 : CHECK SIEF ACTIVITY IN REACH-IT => IF SIEF ACTIVE (LR/SLT/CONSORTIUM), THEN OR JOIN OR WAIT FOR LoA => IF SIEF NOT ACTIVE, THEN INVESTIGATE => WORST CASE SCENARIO: “ORPHAN” STEP 3 FURTHER INVESTIGATIONS =>CHECK “SIMILAR” SUBSTANCES (OTHER CAS) =>CHECK IF SOME SIEF MEMBERS WOULD BE WILLING TO WORK ON THE 2013 DOSSIER …

  6. REGISTERING IN 2013? HOW? STEP 4 LR IN STAND ALONE? => MAKE UP YOUR MIND (BUSINESS DECISION)… => IF NEEDED SEEK HELP & SUPPORT STEP 5 LR JOBS IN A NUTSHELL => SIEF COMMUNICATION => MAKING THE DOSSIER (IUCLID) => BUILDING THE ES (IF NEEDED) => JOINT SUBMISSION => GIVING ACCESS TO THE JS VIA THE LoA => UPDATING THE DOSSIER

  7. AND THE COST IS? BASICALLY TWO TYPE OF COSTS: DATA COSTS (EXISTING & NEW STUDIES) NON DATA COSTS (MANAGEMENT COSTS) LIKE SIEF COMMUNICATION / LITTERATURE SEARCH / IUCLID / CSR …

  8. REGISTRATION: OPTIONS SUMMARY BUY A LOA AND JOIN THE JOINT SUBMISSION • Co registrant remaining in the SIEF • As a working member of a consortium or a SLT • As the LR in a consortium or a SLT • As a LR in standalone position PARTICIPATE TO THE DOSSIER WORK

  9. OTHER REACH ONGOING DUTIES

  10. 2010 SUBMITTED DOSSIERS Around 4000 dossiers have been submitted to ECHA for the 2010 deadline ARE WE DONE NOW ? NO!

  11. 2010 SUBMITTED DOSSIERS/ THE STORY IS NOT YET ENDING

  12. THE CHALLENGES FOR DU’S Under CLP Under REACH • Implementation for MIXTURES … ( 2015! ) • Are your uses covered? • Supplychain information duties • Extended SDS

  13. DU’s CHECKLIST • Ensure substance has been (pre) registered • Upon receipt of an eSDS: • review ES and check if your use(s) are covered • check if your conditions comply with the ES • implement (if needed ) the recommended RMM • If use or conditions are not covered : • make use & conditions known to your supplier • assess whether additional measures are needed such as «own chemical assessment» ,informing ECHA , test plan … • Further downstream communication (RMM ; eSDS) • Establish management of change system (updates)

  14. THANK YOU! www.reachcentrum.eu info@reachcentrum.eu

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