turning our reach expertise into practical help for industry a practical guide for the 2013...

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

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