Guidance on registration - ECHA - Europa

108
<strong>Guidance</strong> on registration
Version 2.0 May 2012
c) Individual registration
(http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/registration)
Potential registrants of the same substance have to share data and submit information
jointly. However, there might be situations where only one company intends to register
a particular substance. In this situation, an individual registration (not linked to any
joint submission) should be prepared and submitted to ECHA. It will always be possible
to create a joint submission at a later stage in case of a second company intending to
register the same substance
Collect all data needed according to your tonnage band (REACH Annexes VI-X)
It is important to carefully read the relevant Data Submission Manuals during the
creation of your substance dataset and the 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 an individual registrant you may need to prepare a chemical safety report (CSR). For
detailed instructions please refer to:
o
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.
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, 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
o
o
IUCLID 5 TCC plug-in: checks the technical completeness of the substance dataset
and dossier
IUCLID 5 Fee Calculation plug-in: calculates the fee payable on the successful
submission of your dossier
IUCLID 5 Dissemination plug-in: simulates which information from your dossier
ECHA will make available over the internet
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu