iuclid: run the tcc tool plug-in - boron consortium · member of a joint submission : run plug-in...
TRANSCRIPT
IUCLID: Run the TCC Tool plug-in
April 2013
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Boron Consortium
Disclaimer & guidance version• Disclaimer:
The Boron Consortium and Boron Consortium Services Ltd. do not make any representations or warranties in relation to the content of this guidance document. In particular, the Boron Consortium and Boron Consortium Services Ltd. do not make any representations or warranties regarding the accuracy, timeliness or completeness of its content. The Boron Consortium and Boron Consortium Services Ltd. will not be responsible for any loss or damage caused by relying on the content contained in this document.
• Guidance versions– Version 1 - April 2010 : “IUCLID: Run the TCC Tool plug-in ”, developed by R. CHRISTOPHE
(ArcelorMittal, Corporate Health & Safety) for the first REACH registration deadline– Version 2 – January 2013: “IUCLID: Run the TCC Tool plug-in ”. Minor update of the guidance– Version 3 – May 2013: “IUCLID: Run the TCC Tool plug-in ”. Minor update of the guidance to include
information on the use of the Dossier Quality Assistant.
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Content
• TCC plug-in overview……………………………………………………… slide 3• Business Rules and Technical Completeness Check…………………..slide 4• Dossier Quality Assistant ………..………..………..………..…………… slide 20
2Boron Consortium
Since February 2013, a ‘Dossier Quality Assistant’ has been incorporated in the TCC plug-in to help registrants to identify potential inconsistencies in their registration dossier. Note that it does not introduce any changes to the current TCC rules or affect the outcome of the Technical Completeness Check performed on registration dossiers.
It is strongly recommended to use the Technical Completeness Check (TCC) plug-in on the substance dataset and then again, on the final version of your dossier.
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TCC plug-in overview
3Boron Consortium
1) Are there any Business Rules
and TCC failures on your
IUCLID substance and
dossier ?
2) Assess the quality of your
IUCLID substance and
dossier
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Boron Consortium 4
Run plug-in TCC Tool - IUCLID
To run TCC Tool:
1. In the main menu of IUCLID
or
1. In the toolbar
or
1. On the task panel, in the part “Plug-ins”
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Boron Consortium 5
Run plug-in TCC Tool - IUCLID
If the plug-in is not updated, enter the correct proxy configuration
Message when new plug-in available
In this case the new TCC plug-in has to be downloaded from the IUCLID website (the
previous one needs to be removed and the new one
installed).
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Boron Consortium 6
Run plug-in TCC Tool - IUCLID
=>Choose the document used for the TCC by clicking on the icon
It will be possible to select either a dossier or a substance (the TCC plug-in can be used to check the completeness of dossiers or of substance data sets).
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Boron Consortium 7
Run plug-in TCC Tool - IUCLID
=> e.g. type “mill*” to find all substances named “mill scale”
=>Click on SEARCH
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Run plug-in TCC Tool - IUCLID
=>Assign the substance to be checked
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Boron Consortium 9
Run plug-in TCC Tool - IUCLID
-Select your case:
PPORD notification or other dossier template
Phase-in definition
Fee waiving
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Boron Consortium 10
Run plug-in TCC Tool - IUCLID
Select YES in Joint submission
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Run plug-in TCC Tool - IUCLID
Select Member of a Joint Submission
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Run plug-in TCC Tool - IUCLID
Select the joint submission tonnage band
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Boron Consortium 13
Run plug-in TCC Tool - IUCLID
Select your tonnage band
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Run plug-in TCC Tool - IUCLID
1.Check if “Guidance on safe use” and “Chemical Safety Report” boxes are ticked
If so, these documents will be submitted by the Lead Registrant
2.Click on NEXT
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Boron Consortium 15
Run plug-in TCC Tool - IUCLID
Wait
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Run plug-in TCC Tool - IUCLID
The rows in yellow or white indicate the fields of the dossier / substance that need to be filled in to correct the failure / warning.
Example : error in chapter 1.5:
Double click on the item to open the chapter concerned and correct the error
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Boron Consortium 17
Run plug-in TCC Tool - IUCLID
1.Correct the error
2. Click on save
3.Click on refresh
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Boron Consortium 18
Run plug-in TCC Tool - IUCLID
After the screen refreshes, the error disappears
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Run plug-in TCC Tool - IUCLID
After all corrections, a message will indicate that your dossier is considered as complete for the indicate tonnage band.
But ECHA could make additional checks
=>Click on FINISH
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Dossier Quality Assistant
20Boron Consortium
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Dossier Quality Assistant• The ‘Dossier Quality Assistant’ helps registrants to detect potential inconsistencies
in their registration dossiers.
• Examples of warning highlighted by the Dossier Quality Assistant:– Substance identity warning:
• The composition range (with min, max and unit) is missing in the IUCLID section 1.2
• Inconsistencies between the purity of the substance and the sum of the maximum amounts of impurities
– Dossier quality warning:• The detail of the tonnage is not reported in the IUCLID section 3.2 (note that 0
should be reported when the requested tonnage is not relevant to your registration dossier.
21Boron Consortium
• Note that the ‘Dossier Quality Assistant’ does not have an impact on ECHA Business Rules. However, the corrections of the identified shortcomings may avoid further updates of your registration dossier.