Guidance on registration - ECHA - Europa
Guidance on registration - ECHA - Europa
Guidance on registration - ECHA - Europa
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106<br />
<str<strong>on</strong>g>Guidance</str<strong>on</strong>g> <strong>on</strong> registrati<strong>on</strong><br />
Versi<strong>on</strong> 2.0 May 2012<br />
b) Member of a joint submissi<strong>on</strong><br />
(http://echa.europa.eu/web/guest/joint-submissi<strong>on</strong>-member)<br />
Please note that during the process you need to c<strong>on</strong>firm membership in the Joint Submissi<strong>on</strong><br />
created by the Lead in REACH-IT. Industry User Manual - Part 7: Joint Submissi<strong>on</strong>, helps you<br />
by providing step-by-step instructi<strong>on</strong>s.<br />
<br />
<br />
<br />
<br />
<br />
<br />
Collect all data needed according to your t<strong>on</strong>nage band in c<strong>on</strong>sultati<strong>on</strong> with your Lead<br />
Registrant (REACH Annexes VI-X).<br />
Some of the informati<strong>on</strong> may be submitted by the Lead <strong>on</strong> your behalf after agreement<br />
(i.e. chemical safety report, guidance <strong>on</strong> safe use and an indicati<strong>on</strong> that informati<strong>on</strong><br />
included in the dossier has been reviewed by an assessor)<br />
It is important to carefully read the relevant Data Submissi<strong>on</strong> Manuals during the<br />
creati<strong>on</strong> of your substance dataset/dossier. Special attenti<strong>on</strong> should be given to:<br />
o<br />
o<br />
o<br />
Data Submissi<strong>on</strong> Manual 4: How to Pass Business Rule Verificati<strong>on</strong> ("Enforce<br />
Rules");<br />
Data Submissi<strong>on</strong> Manual 5: How to complete a Technical Dossier for Registrati<strong>on</strong>s<br />
and PPORD Notificati<strong>on</strong>s;<br />
Data Submissi<strong>on</strong> Manual 18: How to report the substance identity in IUCLID 5 for<br />
registrati<strong>on</strong> under REACH.<br />
If a chemical safety report (CSR) is relevant for your registrati<strong>on</strong>, it may be partly or<br />
fully covered in a joint CSR submitted by the lead registrant <strong>on</strong> your behalf. For detailed<br />
instructi<strong>on</strong>s, please refer to Data Submissi<strong>on</strong> Manual 19: How to submit a Chemical<br />
Safety Report as part of a joint submissi<strong>on</strong> . Other relevant links:<br />
o<br />
o<br />
o<br />
Chesar tool – Software to support the chemical safety assessment and generate the<br />
chemical safety report.<br />
CSR Template – Document structured according to the format specified in Annex I<br />
of REACH.<br />
CSR plug-in – Plug-in for IUCLID that generates the chemical safety report.<br />
When your substance dataset is complete (i.e. the relevant IUCLID 5 fields have been<br />
filled in with the necessary informati<strong>on</strong>), create the final dossier following the<br />
instructi<strong>on</strong>s as prompted by the IUCLID 5 ‘Dossier Creati<strong>on</strong> wizard’. When the dossier<br />
has been created it is then ready to be exported to your computer<br />
Before submitting your dossier as a member of a joint submissi<strong>on</strong> to <strong>ECHA</strong>, you are<br />
advised to run the following IUCLID 5 plug-ins <strong>on</strong> your substance dataset and <strong>on</strong> the<br />
final dossier (plug-ins are available at the IUCLID 5 website – “Download” secti<strong>on</strong>):<br />
o<br />
o<br />
o<br />
IUCLID 5 TCC plug-in: checks the technical completeness of the substance dataset<br />
and dossier as a member (however, it is worth noting that ultimately the<br />
completeness of your dossier is dependant <strong>on</strong> the completeness of the lead<br />
registrant dossier).<br />
IUCLID 5 Fee Calculati<strong>on</strong> plug-in: calculates the fee payable <strong>on</strong> the successful<br />
submissi<strong>on</strong> of your dossier<br />
IUCLID 5 Disseminati<strong>on</strong> plug-in: simulates which informati<strong>on</strong> from your dossier<br />
<strong>ECHA</strong> will make available over the internet<br />
Member registrants are str<strong>on</strong>gly advised to take into c<strong>on</strong>siderati<strong>on</strong> the "Practical guide 9: How<br />
to do a registrati<strong>on</strong> as a member of a joint submissi<strong>on</strong>" available <strong>on</strong> the <strong>ECHA</strong> website. This<br />
document outlines the basic steps for preparing a registrati<strong>on</strong> dossier in IUCLID 5 and the<br />
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu