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
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
<strong>Data</strong> <strong>Submission</strong> <strong>Manual</strong><br />
Version Changes<br />
3.1 02/2013<br />
The following paragraphs have been updated:<br />
Chapter 4.3.2 – Clarifications on how <strong>to</strong> report the <strong>to</strong>nnage for<br />
registrants of intermediates.<br />
Chapter 4.3.5 – Clarifications on how <strong>to</strong> report uses within a joint<br />
submission. New figure added <strong>to</strong> illustrate the use of the field “Use<br />
coverage in CSR”.<br />
Chapter 4.3.7 – Clarifications and instructions added on waste<br />
management. New figure added <strong>to</strong> illustrate the migration of<br />
information in IUCLID 5.4.<br />
Chapter 4.4 – Clarifications on filling in the Purpose flag field for<br />
adaptions of the standard testing regime.<br />
Chapter 4.6 – Added instructions and a figure on how <strong>to</strong> report on<br />
waste from production and use.<br />
Chapter 5.1 – Information on the new <strong>to</strong>ol included in the TCC<br />
plug-in: the Dossier Quality Assistant.<br />
Annex 5 Instructions on how <strong>to</strong> report uses in IUCLID 5.4 for lead,<br />
member and individual registrants.<br />
3.0 07/2012<br />
Document updated for the <strong>ECHA</strong> New Visual Identity and <strong>to</strong> reflect<br />
changes brought about by IUCLID 5.4.<br />
2.9 Included advice in line with DSM12 <strong>to</strong> include statement<br />
"unknown" if affected organs are unknown.<br />
2.8 04/2011<br />
Document updated <strong>to</strong> reflect the changes introduced by the 2nd<br />
ATP <strong>to</strong> the CLP Regulation. <strong>How</strong> <strong>to</strong> report C&L within a joint<br />
submission: clarification on best practice <strong>to</strong> follow in case a<br />
member has a different C&L than the lead and does not intend <strong>to</strong><br />
opt-out (Chapter 4.2).<br />
A new chapter (Chapter 5, "Technical Completeness Check") has<br />
been added <strong>to</strong> explain the importance of running the TCC plug-in<br />
<strong>to</strong>ol <strong>to</strong> check the <strong>complete</strong>ness of the substance dataset and the<br />
final dossier.<br />
2.7 12/2010:<br />
Document updated <strong>to</strong> reflect the changes introduced by the<br />
amendment of the REACH Regulation foreseen in Article 58 of the<br />
CLP Regulation. This amendment entered in<strong>to</strong> force on 1<br />
December 2010:<br />
P 24-34. Requirements for classification and labelling have been<br />
updated.<br />
P 87-88. Annex 3. Text on the fee for confidentiality claims on the<br />
Version: 3.1 2