Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 105
11.3 How to prepare a dossier
a) Lead Registrant of a joint submission
(http://www.echa.europa.eu/web/guest/joint-submission-lead)
Please note that during the process you need to prepare the Joint Submission in REACH-IT and
manage the security tokens. Industry User Manual – Part 7: Joint Submission, helps you by
providing step-by-step instructions.
Collect all data needed according to the highest tonnage band within the joint
submission (REACH Annexes VI-X)
Agree with the rest of registrants whether the following information will be submitted
jointly or separately: (i) the chemical safety report, (ii) the guidance on safe use and
(iii) an indication that information included in the dossier has been reviewed by an
assessor
It is important to carefully read the relevant Data Submission Manuals during the
creation of your substance dataset and your final dossier. Special attention should be
given to:
o Data Submission Manual 4: How to Pass Business Rule Verification (“Enforce
Rules”);
o Data Submission Manual 5: How to complete a Technical Dossier for Registrations
and PPORD Notifications;
o Data Submission Manual 18: How to report the substance identity in IUCLID 5 for
registration under REACH.
As the lead registrant you may need to prepare a joint chemical safety report (CSR)
and/or an individual CSR (if relevant). For detailed instructions please refer to Data
Submission Manual 19: How to submit a Chemical Safety Report as part of a joint
submission . Other relevant links:
o
o
Chesar tool – Software to support the chemical safety assessment and generate the
chemical safety report.
CSR Template – Document structured according to the format specified in Annex I
of REACH.
o CSR plug-in – Plug-in for IUCLID that generates the chemical safety report.
When your substance dataset is complete (i.e. the relevant IUCLID 5 fields have
been filled in with the necessary information), create the final dossier following the
instructions as prompted by the IUCLID 5 ‘Dossier Creation wizard’. When the dossier
has been created it is then ready to be exported to your computer
Before submitting your dossier to ECHA, you are advised to run the following
IUCLID 5 plug-ins on your substance dataset and on the final dossier (plug-ins are
available at the IUCLID 5 website – “Download” section):
o IUCLID 5 TCC plug-in: checks the technical completeness of the substance dataset
and dossier
o IUCLID 5 Fee Calculation plug-in: calculates the fee payable on the successful
submission of your dossier
o
IUCLID 5 Dissemination plug-in: simulates which information from your dossier
ECHA will make available over the internet
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