a practical guide for the 2013 registration and other reach ongoing duties
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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
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
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?
DEADLINE DETERMINATION
REMEMBER : NO REGISTRATION = NO MARKET !
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 …
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
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 …
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
OTHER REACH ONGOING DUTIES
2010 SUBMITTED DOSSIERS
Around 4000 dossiers have been submitted to
ECHA for the 2010 deadline
ARE WE DONE NOW ?
NO!
2010 SUBMITTED DOSSIERS/ THE STORY IS NOT YET ENDING
THE CHALLENGES FOR DU’S
Under CLP
•Implementation for MIXTURES … ( 2015! )
Under REACH
•Are your uses covered?
•Supply chain information duties
•Extended SDS
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)
Turning our REACH expertise into practical help for industry
THANK YOU!www.reachcentrum
.eu info@reachcentrum
.eu