1. Turning our REACH expertise into practical help for industry 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 WHO? WHAT? WHEN? HOW? STEPWISE APPROACH AND THE COST IS? REACH 2013 REGISTRATION DEADLINE UPDATES AND EVALUATION TEST PLANS? AUTHORISATION? SUPPLY CHAIN INFORMATION REACH 2010 DOSSIERS CLP MIXTURES 2015

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

5. DEADLINE DETERMINATION REMEMBER : NO REGISTRATION = NO MARKET ! YEARLY VOLUME PER LE (LEGAL ENTITY) YEARLY VOLUME = AVERAGE OF LAST 3 YEARS STARTING TO COUNT FROM 2007 HIGHEST RECORDED VOLUME TO BE TAKEN

6. 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 …

7. 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

8. 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 …

9. REGISTRATION: OPTIONS SUMMARY Co registrant remaining in the SIEF BUY A LOA AND JOIN THE JOINT SUBMISSION 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 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

10. OTHER REACH ONGOING DUTIES 2010 REGISTERED DOSSIERS CLP DUTIESDU’s DUTIES

11. 2010 SUBMITTED DOSSIERS Around 4000 dossiers have been submitted to ECHA for the 2010 deadline ARE WE DONE NOW ? NO!

12. 2010 SUBMITTED DOSSIERS/ THE STORY IS NOT YET ENDING Test plan(s) : wait ECHA approval Dossier evaluation by ECHA ( at least 5% ) Voluntary When new information’s are becoming available Updates of the dossiersAuthorization ( if applicable ) Supply chain communication

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

14. 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)

15. Turning our REACH expertise into practical help for industry THANK YOU! www.reachcentrum.eu info@reachcentrum.eu