A PRACTICAL GUIDE FOR THE 2013 REGISTRATION AND OTHER REACH ONGOING DUTIES
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Transcript of A PRACTICAL GUIDE FOR THE 2013 REGISTRATION AND OTHER REACH ONGOING DUTIES
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Turning our REACH expertise into practical help for industry
A PRACTICAL GUIDE FOR THE 2013
REGISTRATION AND OTHER REACH ONGOING DUTIES
On the REACH roadWarsaw, Poland24 November 2011
Yvan Bisschops
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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
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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?
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DEADLINE DETERMINATION
REMEMBER : NO REGISTRATION = NO MARKET !
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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 …
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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
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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 …
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REGISTRATION: OPTIONS SUMMARY
•Co registrant remaining in the SIEF
•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
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OTHER REACH ONGOING DUTIES
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2010 SUBMITTED DOSSIERS
Around 4000 dossiers have been submitted to
ECHA for the 2010 deadline
ARE WE DONE NOW ?
NO!
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2010 SUBMITTED DOSSIERS/ THE STORY IS NOT YET ENDING
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THE CHALLENGES FOR DU’S
Under CLP
•Implementation for MIXTURES … ( 2015! )
Under REACH
•Are your uses covered?
•Supply chain information duties
•Extended SDS
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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)
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Turning our REACH expertise into practical help for industry
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.eu info@reachcentrum
.eu