Data Submission Manual 5: How to complete a - ECHA - Europa
Data Submission Manual 5: How to complete a - ECHA - Europa
Data Submission Manual 5: How to complete a - ECHA - Europa
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<strong>Data</strong> <strong>Submission</strong> <strong>Manual</strong><br />
The IUCLID 5 sections 2, 4, 5, 6 and 7 (the C&L and the endpoints sections) of the lead<br />
registrant dossier should be <strong>complete</strong>.<br />
The IUCLID 5 sections 2.1, 2.2, 4, 5, 6 and 7 (the C&L and the endpoints sections) of the<br />
member dossier should be empty. If information is submitted in a member dossier in one<br />
of these sections then this information will be considered as an opt-out. The<br />
study/information opted out will be checked for <strong>complete</strong>ness in the member dossier.<br />
Moreover, some specific rules for dossiers of members of a joint submission are<br />
described in IUCLID 5 section 2 "Classification & Labelling and PBT assessment",<br />
IUCLID 5 section 11 "Guidance on safe use" and IUCLID 5 section 13 "Assessment<br />
Reports" of this manual.<br />
For detailed information on how <strong>to</strong> fill in the IUCLID 5 dossier header please<br />
read <strong>Data</strong> <strong>Submission</strong> <strong>Manual</strong> 4 "<strong>How</strong> <strong>to</strong> Pass Business Rules Verification"<br />
available at: http://echa.europa.eu/web/guest/support/dossier-submission<strong>to</strong>ols.<br />
3.2. Special rules for isolated intermediate dossiers<br />
For dossiers of isolated intermediates the sections 1.4 "Analytical information", 3.1<br />
"Technological process", 3.4 "Information on mixtures", 3.6 "Uses advised against" and<br />
13 "Assessment Reports" will not be checked for <strong>complete</strong>ness. In addition, section 3.2<br />
"Estimated quantities" will not be checked for <strong>complete</strong>ness, however it is recommended<br />
<strong>to</strong> fill in the field "Year", at least one of the "Total <strong>to</strong>nnage" fields and as much as<br />
possible the fields under "Details on <strong>to</strong>nnages".<br />
The registrants of isolated intermediates have <strong>to</strong> provide information on risk<br />
management measures and their efficiency (REACH Article 17 and 18). This information<br />
must be entered in section 11 "Guidance on safe use" (chapter 4.5).<br />
For dossiers of intermediates, the registrant must agree <strong>to</strong> comply with Article 17 for onsite<br />
isolated intermediates or with Article 18 for transported isolated intermediates by<br />
selecting the tickbox "Production and use under strictly controlled conditions" in the<br />
IUCLID 5 dossier header.<br />
In addition, for transported isolated intermediates at least one of the two following<br />
tickboxes must be selected: "Registrant confirms that the intermediate is used in<br />
accordance with the conditions set out in Article 18(4)" or "Registrant has received<br />
confirmation from the users that the intermediate is used in accordance with the<br />
conditions set out in Article 18(4)". These tickboxes must be indicated during dossier<br />
creation.<br />
3.3. Special rules for PPORD dossiers<br />
For PPORD notifications the sections 2 "Classification & Labelling and PBT assessment",<br />
3.1 "Technological process", 3.2 "Estimated quantities", 3.4 "Information on mixtures",<br />
3.5 "Life Cycle description", 3.6 "Uses advised against", 3.7 "Exposure Scenarios,<br />
exposure and risk assessment", 11 "Guidance on safe use" and 13 "Assessment Reports"<br />
will not be checked for <strong>complete</strong>ness. <strong>How</strong>ever, section 1.8 "Recipients" and section 1.9<br />
"PPORD" will be checked for <strong>complete</strong>ness.<br />
Version: 3.1 14
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