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REACH-IT Industry User Manual
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Table of Figures
Figure 1: Flow diagram...........................................................................................................8
Figure 2: Starting an online dossier creation..........................................................................9
Figure 3: Dossier type.............................................................................................................9
Figure 4: Selecting a new or an existing dossier.....................................................................10
Figure 5: Naming new dossier................................................................................................10
Figure 6: Continue/finish the creation of a dossier.................................................................11
Figure 7: Inquiry type.............................................................................................................11
Figure 8: Specification of the registration number..................................................................12
Figure 9: Specification of the foreseen tonnage band.............................................................13
Figure 10 : Substance type.....................................................................................................14
Figure 11 : Substance identity................................................................................................15
Figure 12 : Degree of purity....................................................................................................16
Figure 13 : EC inventory .........................................................................................................16
Figure 14 : EC inventory search..............................................................................................16
Figure 15 : CAS information....................................................................................................17
Figure 16 : IUPAC information................................................................................................17
Figure 17 : Typical concentration............................................................................................17
Figure 18 : Molecular formula.................................................................................................17
Figure 19 : Molecular weight range........................................................................................18
Figure 20 : SMILES notation...................................................................................................18
Figure 21 : Structural formula................................................................................................18
Figure 22 : Remarks section...................................................................................................18
Figure 23 : Add Impurity… and Add additive… .......................................................................19
Figure 24 : Add substance impurity........................................................................................19
Figure 25 : Substance composition of multi-constituent substance........................................20
Figure 26 : Adding main constituents.....................................................................................20
Figure 27 : Concentration range.............................................................................................21
Figure 28 : Naming of multi-constituent substance................................................................23
Figure 29 : Edit name of a multi-constituent substance..........................................................23
Figure 30 : Substance identity of UVCB substance..................................................................25
Figure 31 : Substance name field............................................................................................26
Figure 32 : Description field....................................................................................................26
Figure 33 : Substance composition of UVCB substance...........................................................27
Figure 34 : Add constituents of a UVCB substance..................................................................28
Figure 35 : Analytical information...........................................................................................29
Figure 36 : Production sites....................................................................................................31
Figure 37 : Create a production site........................................................................................31
Figure 38 : Select production site...........................................................................................32
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Part 11 - Online dossier creation and submission for inquiries
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Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Figure 39 : Selected production site.......................................................................................33
Figure 40 : Information requirements....................................................................................34
Figure 41 : Defining information requirements.......................................................................34
Figure 42 : Selecting information requirements......................................................................35
Figure 43 : Studies selected....................................................................................................35
Figure 44: Create a new contact.............................................................................................37
Figure 45: Select a contact.....................................................................................................37
Figure 46 : Selecting a Third Party Representative.................................................................38
Figure 47 : Adding a new Third Party Representative.............................................................39
Figure 48 : Appointing a Third Party Representative..............................................................39
Figure 49 : Validation of inquiry dossier.................................................................................40
Figure 50 : Verification...........................................................................................................41
Figure 51 : Successful messages............................................................................................41
Figure 52: Message box..........................................................................................................42
Figure 53: Message for accepted inquiry.................................................................................42
Figure 54: Annotation for accepted inquiry.............................................................................43
Figure 55: Searching with submission number.......................................................................44
Figure 56: Search result .........................................................................................................44
Figure 57: Dossier UUID link..................................................................................................45
Figure 58: Submission Report tab...........................................................................................45
Figure 59: .i5z file download...................................................................................................46
Figure 60: Dialogue window...................................................................................................46
Figure 61: Message for a rejected inquiry...............................................................................48
Figure 62: Annotation for a rejected inquiry...........................................................................49
Figure 63: Warning message in case no impurity has been specified for a mono-constituent.50
Figure 64: Warning message in case CAS information is incomplete......................................50
Figure 65: Error message if a mandatory field is not filled in..................................................51
Figure 66: Error message if a mandatory field is not filled in (2)............................................51
Figure 67: Error message in case of incorrect range specification..........................................52
Figure 68: Error message in case of incorrect value specification...........................................52
Figure 69: Error message in case of wrong CAS number format.............................................53
Figure 70: Error message if a registration number does not belong to your company ............53
Figure 71: Error message in case of role combination not allowed.........................................53
Figure 72: Error message if the dossier name specified already exists...................................54
Figure 73: Error message in case the declaration is not acknowledged..................................54
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REACH-IT Industry User Manual
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Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
1.
INTRODUCTION
The Industry User Manual (IUM) serves as the reference manual for all REACH-IT
functionalities, which are or will be available to the Industry. This IUM is meant for any
Industry user, who needs to use REACH-IT to submit or consult data.
As more functionality becomes available, additional or updated parts of this IUM will be
released and made available on the ECHA website (http://echa.europa.eu/
).
Part 11 of the Industry User Manual (IUM) covers online inquiry dossier creation and
submission via REACH-IT, whereas the “Data Submission Manual Part 2” (also available on the
ECHA website) covers inquiry dossier creation in IUCLID 5 and submission of IUCLID 5 dossier
via REACH-IT (i5z-files). Additional sources for support are also given at
http://www.echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/data-
submission-industry-user-manuals
.
Prior to using this “Part 11 - Online dossier creation and submission for inquiries”, it is strongly
recommended that the user reads “Part 1 – Getting started with REACH-IT”, where the
following topics are discussed in more detail:
conventions used, in terms of icons, text, buttons, links, …
background information on REACH-IT and its link to the IUCLID 5 website and application
definitions of parties, users, message box, contacts, legal entity object, …
Each subsequent part of this IUM will therefore provide step-by-step instructions to perform
the required tasks of REACH submission of data.
2.
GENERAL CONCEPT OF INQUIRY
2.1
Legal requirements
Inquiry is the process by which every potential registrant of a non-phase-in substance (or a
phase-in substance which has not been pre-registered) shall inquire from ECHA whether a
registration has already been submitted for the same substance. This is done according to the
Article 26 requirements.
Also before submitting an update of a registration, due to a tonnage band increase, a
registrant is obliged to inform ECHA of the additional information he would require to
comply with the information requirements for the new tonnage band (Article 12(2)). In order
to inform ECHA of the additional information required, the registrant shall submit an inquiry to
ECHA.
If additional information is not required, there is no need to submit an inquiry to request
additional data.
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Part 11 - Online dossier creation and submission for inquiries
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Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
There are two options to prepare and submit an inquiry:
•
The information can be entered directly online in the REACH-IT system following a step-
by-step procedure which includes a final validation and submission at the end of the
procedure. The following step-by step instructions describe how to use the REACH-IT
online tool.
•
The inquiry dossier can be prepared with the IUCLID 5 software and the dossier can
then be submitted via REACH-IT. To prepare inquiry dossier with IUCLID, you can find
the instructions in the “Data Submission Manual Part 2” available on the ECHA website
at: http://www.echa.europa.eu/web/guest/support/dossier-submission-tools/reach-
it/data-submission-industry-user-manuals
.
In order to correctly identify the substance, we recommend that, before preparing and
submitting the inquiry dossier, the inquirer familiarises themselves with the “Guidance for
identification and naming of substances under REACH and CLP” available at
http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach
.
2.2
Overview
Figure 1 provides an overview of the online dossier creation process prior to submitting an
inquiry.
At the end of the “online dossier creation” wizard, and after submission of your dossier, you
will receive:
•
a submission number;
•
a submission report;
•
a IUCLID 5 substance dataset of the online dossier you have created and submitted.
You can import this IUCLID 5 substance dataset into your IUCLID 5 database and use it as a
base of the registration dossier.
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REACH-IT Industry User Manual
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Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Figure 1: Flow diagram
Within the online dossier creation process you always have the possibility to save the current
state of creation of your online dossier (choose “Save and Close”) and to continue to work on
the dossier later if needed (see section 3.3.2 of this manual).
Your dossier is also saved automatically by REACH-IT when you move between the different
screens.
3.
STEP BY STEP INSTRUCTIONS
3.1
Starting an online dossier
To start the online dossier creation, go to the menu option <Online Dossier> on the left-hand
side of the REACH-IT screen, and click on the sub-menu <Online dossier creation and
submission> (Figure 2).
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Part 11 - Online dossier creation and submission for inquiries
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Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Figure 2: Starting an online dossier creation
3.2
Select a dossier type (Step 1)
The dossier selection page opens (Figure 3).
To select the dossier type, click on
and select the option <Inquiry> from the drop down list.
Figure 3: Dossier type
Click on <Next >>> to proceed.
3.3
Select whether to create a new online dossier or continue with an
existing one (Step 2)
Select whether you want to create a new dossier or continue to work on an existing inquiry
dossier that you have not yet submitted (Figure 4).
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REACH-IT Industry User Manual
Version 2.1
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Figure 4: Selecting a new or an existing dossier
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