IUCLID 5 Guidance and Support
Contents
1. C IUCLID5 plugins client eu echa iuclid client plugin tccvalidate ui zip Hint In the folder you will already find files like ClientExtensionPointRootPlugin zip eu echa iuclid plugin helpsystemEN zip eu echa iuclid plugin xform zip Copy eu echa iuclid server plugin tccvalidate zip the file into the lt IUCLID5 folder gt plugins server folder C IUCLID5 plugins server eu echa iuclid server plugin tccvalidate zip Hint In the folder you will already find files like ServerExtensionPointRootPlugin zip eu echa iuclid plugin resources zip The plug in will be available after re starting your IUCLID 5 application Tip If the plug in is no longer required the files can be removed from the folders The plug in will disappear from the IUCLID 5 application 2 2 Distributed installation You will find the sub folders on your IUCLID 5 application server l5clientPlug ins remotePlugins folder for the client side plug ins WEB INF classes plugins folder for the server side plug ins To install the plug in you need to copy the above mentioned client and server side zip files into the appropriate folders see examples below in the table July 2012 v1 5 5 20 IUCLID 5 Technical Completeness Check plug in User Manual Copy eu echa iuclid client plugin tccvalidate ui zip the file lt IUCLID5 WebApp folder gt i5clientPlugins remotePlugins folder Sample C Program Files apache tomcat webapps2. i a IUCLID 5 Guidance and Support IUCLID 5 Technical Completeness Check Plug in User Manual PTE Ae DMPP THUE a ee AE ECHA EUROPEAN CHEMICALS ENC Y IUCLID 5 a icals Agency in associatio Ju ly 2012 v1 5 the Organisation for Economic Co operation and Development IUCLID 5 Technical Completeness Check plug in User Manual Table of contents 1 Principle of the Technical Completeness Check TCC plug in ccccceeeceeeeeeeeeeeeeeeeeeeeeeeeaeeeeeees 3 Tti Technical completeness CHECK 55 ie eaewestel ends vate a a e A 3 LZ BUSINESS TUNES COCK aaan a a ientuianend 3 123 SUDSTANCE deny CHCCK anonn a a AO 3 2 Adding the plug in to your local IUCLID 5 installation cece cecccceeceeeeeeeeeeeeeeeeaeeeeeeesaeeeeeeenaaees 4 2 1 Workstation stand alone Installation ccccccccssscceecessceeceeeeeecceeeceeceeceeseeeeeseeeeeessaeeeessaeeees 4 22 DIStHIDUTES INSTA ANON ecscncacaiecuel ces tenac sens ta hacteclial a oaeuianiel cules 5 3 Launching the TCC plug in cccccccccccccccceeseeceeeceeseeceeeeseeeceesceaeseceeesseaseceeeseaeeeesseaeeeeeesaaeeeessssaaaes 7 Ae MISMO E CHT CG ONG NN ein a O a O ete 8 4 1 STEP 1 select the dossier SUDStance ssnin a E E 8 4 1 1 Checking dossiers all supported dossier templates ccccceeeeeeeeeeeeeeeeeeeeeeeeaeneeeeeeeas 8 4 1 2 Checking substance datasets for registration PPORD inquiry seeeeeeeeeeeee
3. Transported 1000 tonnes On site AND Transported 1 1000 tonnes On site AND Transported 1000 tonnes 2 es lt Back Next gt Cancel Define dossier options Figure 9 Selection of tonnage band for an individual registration July 2012 v1 5 10 20 IUCLID 5 Technical Completeness Check plug in User Manual 4 2 2 Lead of a joint submission If you are preparing the lead dossier for a joint submission select the radio button Yes under the heading Joint submission The heading Role in the joint submission will appear Set the radio button to Lead registrant of a joint submission and then select the tonnage band s for your dossier using the picklists Registration dossier and Intermediates gt Technical completeness check The European Chemical Agency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Check TOC of a dossier or a substance dataset according to Article 9 3 or 20 2 of the RESCH Regulation Joint Submission O No Role in the Joint submission O Member of ajoint submission 9 Lead registrant of ajoint submission The lead registrant should select here belowthe dossier type that refers to the joint submission dossier In general only ane dossier type must be selected either in the picklist Registration dossier or inthe picklist Intermediate In exceptional case where the registrant would like to submit a c
4. forthe correct execution of certain TCC and business rules joint Submission C No Yes Role in the Joint submission 9 Member of ajaint submission Tonnage band of the joint submission Registration dossier above 1000 tonnes Tonnage band of the member Tonnage band standard registrations Between 100 te 1000 tonnes year On site isolated intermediate tonnage band Transported isolated intermediate tonnage band Provided by lead Guidance on safe use Chemical Safety Report Is a Safety data sheet required for this substance The substance js classified under the CLP regulation is PBT rw Pb or is on the candidate list G Yes No ia Lead registrant of ajoint submission In general only one dossier type must be selected either in the picklist Registration dossier or in the picklist Intermediate In exceptional case where the registrant would like to submit a combined dossier which would cover a standard registration as well as an intermediate use then an item in both picklists must be selected Registration dossier 7 intermediates e2 le Back Mext gt i Cancel Define dossier options Figure 12 Indication of whether a safety data sheet is needed joint submission member registration After having completed Step 2 of the TCC wizard the Next button becomes active Clicking on the Next button will run the TCC rules according to the selected parameters and display the resul
5. the dossier header However this information can only be checked for dossiers since a substance dataset does not contain a dossier header Therefore even if your substance dataset is considered complete by the plug in it is very important that you check also the dossier you have generated from the substance dataset to verify that the dossier header is also complete Note Please keep in mind that this plug in has been designed to validate the technical completeness of REACH registration dossiers and PPORDs In addition the REACH templates for Inquiry Downstream user report and Notification of substance in article and the CLP templates for CLP notification and CLP alternative name request are supported for a partial business rules check The plug in also supports the business rules check for the following dossier types submitted by Authorities Substance Evaluation REACH Annex XV Restriction REACH Annex XV SVHC and CLP Regulation CLH dossier If the validation is started on a dossier created with another dossier template the process aborts with an error similar to the one shown below p IUCLID 5 You hawe selected a dossier created with dossier template COMPLETE Only dossiers created with REACH specific templates are supposed ta be checked and submitted please click Back and select another dossier The user must also define if the dossier is for a phase in or for a non phase in substance If the user wants to claim a fee w
6. which the substance dataset or dossier is prepared 4 3 3 TCC results table The rows highlighted in yellow in the TCC results table indicate the sections of the dossier substance that gave rise to the failure warning or in the case of a BR SID failure the failing section and the number of the rule amp A Filter Show all T with typ Failure description Er Section 1 2 Composition Degree of purity is not complete At least one value and Fae TCE failure Composition t aunit must be prowided Section 1 2 Composition Information about the concentration for one or more Pe TCE failure Composition 2 constituents is not complete At least one value anda Constituent 2 Unit must be provided Figure 14 Yellow rows of the TCC results table The rows in grey or white indicate the fields of the dossier substance that need to be filled in to correct the failure warning S amp Filter Show all with typ REJ Section 1 2 Composition Degree of purity is not complete At least one value and i0 TCE failure Composition 2 a Unit must be provided Section 1 2 Composition Information about the concentration for one or more Pe TCE failure Composition 2 constituents is not complete At least one value anda Constituent 2 Unit must be provided Figure 15 Grey white rows of the TCC results table July 2012 v1 5 16 20 IUCLID 5 Technical Completeness Check plug in User Manual A right mous
7. 18 20 IUCLID 5 Technical Completeness Check plug in User Manual If the plug in is up to date the following status is displayed Fw Current plugin is upto date Figure 18 Message for plug in up to date If a newer TCC plug in is available for update the following status is displayed 4 Mew plugin available Figure 19 Message when new plug in is available In this latter case the new TCC plug in should be downloaded from the IUCLID 5 website the previous one needs to be removed and the new one installed In step 3 of the TCC plug in wizard below the TCC results table the version information for the TCC engine the Business rules the Completeness check rules and the Substance identity rules are displayed In order to verify that you are using the latest version of the TCC plug in you may compare these version numbers with the ones listed on the download page of the TCC plug in on the IUCLID 5 homepage TCO engine version 6 06 Business rules version 2 2 8 Completeness rules version 2 2 7 Substance identity rules versionj1 1 2 9 2 8 8 Finish J Cancel TCE result Figure 20 TCC version information July 2012 v1 5 19 20 European Chemicals Agency IUCLID 5 Support Technical Completeness Check plug in Manual July 2012 v 1 5 http iuclid eu
8. C amp L July 2012 v1 5 11 20 IUCLID 5 Technical Completeness Check plug in User Manual p Technical completeness check Ed The European Chemical Agency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Check TCC of a dossier or a substance dataset according to Article 9 3 or 20 2 of the RESCH Regulation joint Submission C No ires Role in the Joint submission Member of ajoint submission Tonnage band of the joint submission Registration dossier above LOO0 tonnes Tonnage band of the member Tonnage band standard registrations Between 100 to LO00 tonnes ear On site isolated intermediate tonnage band Transported isolated intermediate tonnage band Provided by lead v Guidance on safe use w Chemical Safety Report Lead registrant of ajoint submission In general only one dossier type must be selected either in the picklist Registration dossier orin the picklist Intermediate In exceptional case where the registrant would like ta submit a combined dossier which would cover a standard registration as well at an intermediate use then an item in both picklists must be selected Registration dossier Intermediates 2 lt pack Next gt finish Cancel Define dossier options n l aa r Figure 11 Selection of tonnage band for a joint submission member registration Note IUCLID 5 4 offers the possibility to claim confid
9. C in REACH IT These messages are flagged with the 1 icon TCC warnings A TCC warning is not an indication of that your dossier will fail the TCC but it indicates that some information that should normally be in your registration dossier is lacking Therefore you are advised to correct the issue that raised the warning message since it could have implications for the compliance of your dossier ary BR failures A BR failure in the plug in is associated with a BR step failure in REACH IT If you submit a dossier without correcting the issue mentioned in the message your dossier will fail the business rules check during the submission process BR warnings A BR warning does not directly translate into a BR step failure in REACH IT but it indicates that some information that should normally be in your dossier is missing Therefore you are advised to correct the issue that raised the warning message since it could have implications for the compliance of your dossier July 2012 v1 5 15 20 IUCLID 5 Technical Completeness Check plug in User Manual uf SID failures A SID failure informs you of substance identity deficiencies detected by the plug in You are therefore highly advised to correct any SID failure displayed al SID warnings A SID warning displays important recommendations on the substance identity information to be reported You are highly recommended to address any SID warning which is relevant for the substance for
10. aiver this must also be indicated By default the settings of the plug in are for a phase in substance with no fee waiving claimed In addition to check that the relevant Regulatory programme identifiers are entered in IUCLID 5 section 1 3 the user should indicate the update status of the dossier to be submitted Note the fee waiver can only be claimed in the case stated in REACH Article 74 2 July 2012 v1 5 9 20 IUCLID 5 Technical Completeness Check plug in User Manual Phase in definition not applicable to PPORD notifications gt Phase in substance Non phase in substance Fee waiving not applicable to PPORD notifications O Yes 8 No Submission update indicate reason for submission update if applicable ls the submission an update C Spontaneous update Figure 8 Selection of phase in definition fee waiving and update status Once all the necessary definitions are done the user can proceed to the next step by clicking on the Next button If you select Registration dossier templates you will be directed to step 2 where further parameters need to be specified If you select PPORD notification or Substance identity check you will be directed directly to step 3 where the results of the check are displayed 4 2 STEP 2 select the template only for registration substance datasets In this step the user has to define which template should be used for the TCC i e the tonnag
11. ance dataset without losing the settings defined for the TCC check gt In the Query window of your list of dossiers or substances g ie Mawi E ation Query results b Section tree ery I Oper sa Print E Export A Create dossier a Add to folder Run Tcc at Delete Delete Figure 4 Run TCC option In the Substance or Dossier menu right click the name of the substance dataset or dossier in the Query window and select Run TCC This is a convenient way to launch the completeness check of the substance dataset or the dossier right after modifying creating it without having to search for it Furthermore since the completeness check can be launched from the same location where dossier creation in the case of a substance dataset or dossier export in the case of a finished dossier takes place the possibility of checking the incorrect substance dossier is reduced July 2012 v1 5 7 20 IUCLID 5 Technical Completeness Check plug in User Manual 4 Using the TCC plug in This section explains how to use the TCC plug in to check the completeness of a dossier or a substance dataset Depending on the dossier type the dossier content is assessed through business rules checks technical completeness checks or substance identity checks or their combinations Click on fis in the Task pane to go Home if you are not already there Start the TCC wiza
12. ce of section 1 1 Note The UUID of the reference substances is indicated in the Information pane of IUCLID 5 B B B Tee result Figure 13 TCC results display the numbering corresponds with the following subsections 4 3 1 TCC results toolbar Refresh the TCC result only for substance datasets 4 Export the result list as xml All the TCC results are exported in a XML file Print the TCC result Ei Copy the TCC results could be pasted to Excel Word Navigate to the document in the dossier 3 If you select any row and press this button it will open the dossier which was checked at the corresponding section Navigate to the document in the substance dataset ka If you select any row and press this button it will open the substance which was checked or the one that was used to create your dossier at the corresponding section This option is not available if you were checking a dossier but the substance dataset that was used to generate that dossier is not in your IUCLID 5 database July 2012 v1 5 14 20 IUCLID 5 Technical Completeness Check plug in User Manual Tip A double click on any row of the TCC results table has the same effect than clicking on the navigation buttons z and Asa consequence a double click on a specific row will directly open the substance dossier at the corresponding section 4 3 2 Filtering the results table Show all All result items are displayed with
13. e band of the registration dossier if it is part of a joint submission and if it covers intermediate uses or not After these parameters are defined the Next button becomes active 4 2 1 Individual registration If you are preparing a dossier that is not part of a joint submission select the radio button No under the heading Joint submission and then use the picklists Registration dossier and Intermediates to indicate the relevant tonnage band In the exceptional case of preparing a combined dossier i e a registration dossier that covers both the use of a substance as an intermediate as well as non intermediate use select the appropriate tonnage bands from both picklists A Technical completeness check The European Chemical Agency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Check TOC of a dossier or a substance dataset according to Article 9 3 or 20 2 of the REACH Regulation Joint Submission No C Yes In general only one dossier type must be selected either in the picklist Registration dossier or in the picklist Intermediate In exceptional case where the registrant would like to submit a combined dossier which would cover a standard registration as well as an intermediate use then an item in both picklists must be selected Registration dossier Intermediates 10 100 tonnes not applicable On site Transported 1 1000 tonnes
14. e click on the results table opens the following menu Print table The whole TCC result table will be printed Copy table The whole TCC result table will be copied in the windows clipboard and can be pasted in Excel or Word for instance Go to referenced This option will open the dossier that was checked with the plug in document dossier data Go to referenced This option will open the substance dataset that was checked with the document raw data plug in if available in your IUCLID 5 database Tip At step 3 of the TCC plug in results table if you are running the TCC on a substance dataset it is possible to interactively correct modify the dataset while keeping the TCC results table open After obtaining the TCC results table in step 3 Click on the toggle button a to hide the TCC plug in window or move the plug in window aside by dragging with the mouse Correct the indicated failure in the substance dataset Click on the save button b in the IUCLID 5 toolbar Click on the toggle button to show the TCC plug in window if you had hidden it Click on the refresh button of the TCC plug in window to see if the failure description is still present Specific cases where failures indicated by the TCC plug in may be disregarded There are cases where a ICC failure is listed in the TCC result table even if the dossier may be technically complete These TCC failures do not mean that the dossier will necessa
15. ential the information contained in the Safety Data Sheet SDS such as the registration number the legal entity and the outcome of the PBT assessment These confidentiality claims will be charged and invoiced for all substances that require a SDS As before a business rule will check that all chargeable claims are supported by a justification To determine whether the substance being registered requires a SDS or not for joint submission member registrations that lack information on classification and or PBT assessment some input by the user may be needed This information is indicated with the radio buttons that appear under the new heading Is a safety data sheet required for this substance in Step 2 of the TCC wizard Figure 12 The input is only asked when the substance dataset or dossier contains confidentiality claims on the safety data sheet information and the member dossier does not contain enough information to determine whether a SDS is required for the substance to be registered More information on the dissemination and confidentiality claims of SDS information can be found in the FAQ document Questions and answers on dissemination and confidentiality claims of Safety Data Sheet information in IUCLID 5 4 available at htip echa europa eu support faqs July 2012 v1 5 12 20 IUCLID 5 Technical Completeness Check plug in User Manual E Technical completeness check The information requested in this step is needed
16. eres 8 4 2 STEP 2 select the template only for registration substance datasets ccceeceseeeeeeeeees 10 4 2 1 INEIVIGUIAL TEGIStPAUION cxsssart sgictiontwacenstaan oneviasTomn san doaseineedualettendaatcyermitanadabendederineerionad 10 AZ 2 SAC Of a ONE SUDIMISSION seriea a cancel caren atenc a a Di 11 4 2 3 Member of a joint submission ccccccccceeeceeecaeeeeeeeeaeeeeeeeesaeeseeeeesaaeeeeessseaeeeeeessaeeeeeeeas 11 4 3 STEP 3 Interpretation of the TCC results table 00 0 ccecscceccceseeeeeeeeeeeeeeeesseeeeeeeeesaeeseeeeeeas 13 4 3 1 TEO FESS TOC DAN aches dca eee et ee est TN ta dae ca a TB dat dense 14 432 Piltenngthe results tablari eile ariel et data a a uc dada etek 15 AG WGC FESUMS HAD ec scs Recreate a a a aaa aaa oe 16 44 TGC Version Onn allOM sige testa cheated aden a ateseiet e t a a a 18 Table of figures Foure 1 TCC MIU GSM P UI OC as setae aa tc eh eae ee cate ch aaa Dace cal a ican Pest ask a acca disc cue ah aan ap Macctsah nye 7 Figure 22 TCC plug in Via MENU ATEM 222226562 moea a a E E A E EES 7 Figure 82 1C GC 1OOGIE DUNO a iseen er e Ea e eea e e E Ee e RA 7 Figure aA RUN TGC OPUON seara eoaceatee es cance Ge teciatede ental a dec wsauauetetet a caciaunteacencnc oan anetas ones ieseeieten 7 Figure 5 Entry field Select document tO CHECK ccccccceeseecceceeeceeeseeeeeeeeceaeeeeeeeeeseeeeeeeeeeeeseeeeeeeeeeessssaeaeeeeeeeeaags 8 Figure 6 QUE Y SOlE CIO Ise sessies sedis rec
17. i5server idclientPlugins remotePlugins eu echa iuclid client plugin tccvalidate ui zip Hint In the folder you will already find files like ClientExtensionPointRootPlugin zip eu echa iuclid plugin helpsystemEN zip u echa iuclid plugin xform zip Copy eu echa iuclid server plugin tccvalidate zip the file lt IUCLID5 WebApp folder gt WEB INF classes plugins folder Sample C Program Files apache tomcat webapps i5server WEB INF classes plugins eu echa iuclid server plugin tccvalidate zip Hint In the folder you will already find files like ServerExtensionPointRootPlugin zip u echa iuclid plugin resources zip The plug in will be available after re starting your IUCLID 5 application as well as your server e g TOMCAT Tip If the plug in is no longer required the files can be removed from the folders The plug in will disappear from the IUCLID 5 application July 2012 v1 5 6 20 IUCLID 5 Technical Completeness Check plug in User Manual 3 Launching the TCC plug in After the installation of the plug in the new functionality is available in IUCLID 5 gt In the task pane in the part Plug ins Figure 1 TCC plug in run button gt In the main menu of IUCLID 5 Plugins Figure 2 TCC plug in via menu item gt In the toolbar 2 a Figure 3 TCC toggle button A click on this toggle button in the toolbar hides or displays the TCC window e g it allows the user to modify a subst
18. iers substance datasets do not correspond to a specific type of submission and therefore the user needs to select which rules need to be applied for the TCC If the substance has to be checked in order to create a PPORD notification dossier select the radio button PPORD notification Similarly if the substance dataset will be used for the preparation of an inquiry dossier select the radio button Substance identity check for inquiry notification Otherwise leave the box Registration dossier templates selected selection done by default and when you press the Next button you will be directed to a new screen where you can select the type of registration dossier you would like to perform the TCC on see Step 2 below July 2012 v1 5 8 20 IUCLID 5 Technical Completeness Check plug in User Manual Select document to check a Test substance f boron f borane f 7440 42 67 PPORD notification a Registration dossier templates substance identity check for inguiry notification Figure 7 Radio button for dossier type A Important note A IUCLID 5 dossier consists of two parts a substance dataset and the so called dossier header The dossier header has to be generated during the dossier creation process and it contains certain relevant information about the dossier such as the tonnage band covered by the registration The Technical Completeness Check also verifies the presence of certain information in
19. ion of substances in IUCLID 5 please refer to Data Submission Manual 18 How to report the substance identity in IUCLID 5 for registration under REACH available at http echa europa eu web quest support dossier submission tools reach it data submission industry user manuals and Guidance for identification and naming of substances under REACH and CLP available at http echa europa eu quidance documents quidance on reach 2 Adding the plug in to your local IUCLID 5 installation The plug in is based on a server side and a client side ZIP file called e eu echa iuclid client plugin tccvalidate ui zip e eu echa iuclid server plugin tccvalidate zip The installation of the plug in depends on your IUCLID 5 installation e workstation stand alone version or e distributed version 2 1 Workstation stand alone installation If you have installed the IUCLID 5 stand alone software in the folder C IUCLID5 You will find the sub folders C IUCLID5 plugins client folder for the client side plug ins C IUCLID5 plugins server folder for the server side plug ins To install the plug in you need to copy the above mentioned client and server side zip files into the appropriate folders see examples below in the table July 2012 v1 5 4 20 IUCLID 5 Technical Completeness Check plug in User Manual Copy eu echa iuclid client plugin tccvalidate ui zip the file into the lt IUCLID5 folder gt plugins client folder
20. lfils all the relevant legal requirements Please refer to Data Submission Manual 5 How to complete a technical dossier for registrations and PPORD notifications for detailed information on how to fill in the minimum requirements in IUCLID 5 The manual is available at http echa europa eu web quest support dossier submission tools reach it data submission industry user manuals 1 2 Business rules check The TCC plug in incorporates several of the business rules BR checked at ECHA The following REACH dossier types are supported for business rules check Registration Downstream user report PPORD Substance in article and Inquiry notification In addition the business rules check is available for the dossier types CLP notification and CLP alternative name request From version 5 4 0 onwards the TCC plug in also supports the business rules check for dossiers submitted by Authorities namely Substance Evaluation dossiers REACH Annex XV proposals restriction and SVHC and CLP Annex VI CLH proposals Note As some of the business rules depend on information that is stored within the REACH IT database the plug in cannot simulate all the business rules checked at ECHA For further information on the business rule check please refer to Data Submission Manual 4 How to Pass Business Rule Verification Enforce Rules available at user manuals 1 3 Substance identity check The TCC plug in also features a
21. module for improved check of inquiry dossiers The so called substance identity SID check has been designed to assist companies in the preparation of inquiry dossiers It enables potential registrants to identify which fields in IUCLID should be filled in or deserve particular attention The SID check together with the inquiry business rules is automatically executed when the TCC plug in is run on a dossier built on the inquiry template Similarly the SID check and the inquiry BR check can also be carried out on a substance dataset by selecting the option Substance identity check in the TCC wizard July 2012 v1 5 3 20 IUCLID 5 Technical Completeness Check plug in User Manual Note The substance identity check carried out by the plug in does not provide an assessment of the adequacy of the information reported The use of this tool is without prejudice to the expert assessment carried out by ECHA to establish the adequacy of the information required under Annex VI section 2 of the REACH Regulation This responsibility lies with the submitter of the inquiry Please refer to Data Submission Manual 2 How to prepare and submit an inquiry dossier for information on how to fill in the minimum requirements for an inquiry dossier in IUCLID 5 The manual is available at http echa europa eu web quest support dossier submission tools reach it data submission industry user manuals For further information on the descript
22. ombined dossier which would cover a standard registration as well as an intermediate use then an item in both picklists must be selected Registration dossier Intermediates 10 100 tonnes not applicable BBE lt Back ii Next gt Cancel Define dossier options Figure 10 Selection of tonnage band for a joint submission lead registration 4 2 3 Member of a joint submission Select the radio button Yes under the heading Joint submission Set the radio button for block Role in the joint submission to Member of a joint submission and then select the tonnage band s for your dossier using the picklists Registration dossier and Intermediates For a correct outcome of the TCC tool you should also indicate if the Chemical Safety Report and Guidance on safe use are provided by the lead registrant on your behalf or if they are included in your dossier Please note also that you should make a selection in the picklist Tonnage band of the joint submission Note For the endpoint sections section 4 to 8 of IUCLID 5 a dossier for a member of a joint submission should normally contain only endpoint study records for those endpoints for which the member opts out from the joint submission In the same manner the member dossier should not contain any Classification and Labelling information IUCLID 5 sections 2 1 and 2 2 unless the member indicates that they are opting out for the
23. on e R 8 Figure 7 Radio button for dossier type cccccseeeccccceseeececcceeeeeeecseuueceeseeaseeeeessueeeessaaeeeessaueeeesseaeeeeeesaageeessssageeess 9 Figure 8 Selection of phase in definition fee waiving and Update StatuS cccceeeecececsseseeeeeeeeeeeeeeesaeeeeeeesaeees 10 Figure 9 Selection of tonnage band for an individual registration ccccccccssseeececeeeeeeeeeseeeeeeeeseeeseeessaeeeeeeenaeees 10 Figure 10 Selection of tonnage band for a joint submission lead registration cceeceeeeeeeeeeeeeeeeeeeeeeeaeeseeeeeess 11 Figure 11 Selection of tonnage band for a joint submission Member reQistration ccccccccesseeeeeeeeeeeeeeeeeeeeees 12 Figure 12 Indication of whether a safety data sheet is needed joint submission member registration 13 Figure 13 EGC results CIS Ol ayaa oases ee lea el seal ih le det le ana ay heuer eee stu calh ae hace ck 14 Figure 14 Yellowrows of the TCC results table sosirea weedeat ance ect iors ee 16 Figure 15 Grey white rows of the TCC results table cccccccccccsesseeeeeceeeeeeeesseeeeeeeeseeeeeeeesaaeseeeeseeeseeessaeeeeeessaaees 16 Figure 16 Message for failed version CNECK cccccccccsseeccceeeeeceeeecceueceeseeuseecsaeeseaseeeseaseessaueeesseeeessueeesseneeessass 18 FIGUKe 17 INtemet CONNECTION COMMOULAN OM siec uc cette cider e e hse tetci od taser noted a a tans 18 Figure 16 gt Wessade for OlUG si UO TO Cale armecacecct ne
24. out filtering R ha Only results with the level TCC failure 1 and TCC warning a are displayed in the results table Only Only results with the level BR failure 5 and BR warning E are displayed in Business the results table rules RE Only results with the level SID failure 0 and SID warning are displayed in the results table Identity rules failure Both failures and warnings are displayed in the results table warning failure Only the failures are displayed in the results table not the warnings When the TCC plug in is run on a dossier or substance dataset there are six types of messages that can be displayed depending on the dossier template selected Technical Completeness Check warnings and Technical Completeness Check failures Business Rules warnings and Business Rules failures Substance Identity Check warnings and Substance Identity Check failures TCC messages appear only for registration and PPORD dossiers or substance datasets SID messages appear only for inquiry dossiers or substance datasets BR messages appear for all dossier types supported by the plug in as well as for substance datasets of the type registration PPORD notification or inquiry a TCC failures TCC failure messages correspond to the Technical Completeness Check carried out at ECHA If you submit your dossier without correcting the issues mentioned in the TCC failure messages your dossier will fail the TC
25. rd as described above 4 1 STEP 1 select the dossier substance The first step in the wizard is to choose the document to be checked by clicking on the H icon Select document to check Figure 5 Entry field Select document to check This will open a query window where 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 datasets Select query result type o Substance Select query A Substance Figure 6 Query selection 4 1 1 Checking dossiers all supported dossier templates When the TCC plug in is launched on a dossier it will by default perform a check according to the dossier template used For dossiers built on the templates REACH Registration and REACH PPORD this means that both a technical completeness check and a business rules check are performed Similarly for dossiers built on the template REACH Inquiry both a substance identity check and a business rules check are carried out For the remaining templates supported by the plug in see section 1 only a business rules check is performed When running the technical completeness check on a REACH Registration dossier the plug in furthermore uses the tonnage band information from the dossier template and header and applies the appropriate technical completeness rule set 4 1 2 Checking substance datasets for registration PPORD inquiry Unlike doss
26. rformed by the TCC plug in does not cover all of the verifications carried out on a dossier submitted to ECHA It is the responsibility of the submitter to ensure that the dossier fulfils the appropriate data requirements and to monitor the outcome of the submission process in REACH IT 4 4 TCC version information When launching the TCC plug in in step 1 there is a plug in version checker at the bottom of the plug in window The version checker verifies the version of the currently installed TCC plug in and displays a warning message if a newer version is available on the IUCLID 5 website To get the version checker working an internet access needs to be established In case a proxy server is necessary for the internet access this can be defined by pressing the plug in checker button ey Version check failed Press to configure Figure 16 Message for failed version check Afterwards a configuration popup window will appear where you will be able to define if necessary a proxy hostname and a port The vendor URL is the URL from the IUCLID 5 website which is used for the online check The definitions are stored for each user on the server To reset the default value for the vendor URL just press Reset to default URL below the vendor URL input field AE Internet connection configuration Werdor URL Reset to default URL HTTP Proxy Proxy Lser Password Figure 17 Internet connection configuration July 2012 v1 5
27. rily fail the TCC but that a manual intervention will be needed from ECHA side in order to verify completeness This is the case for instance with the following TCC failure Dossier header You are a member of a joint submission and your dossier contains an opt out If your tonnage band is higher than the tonnage band of the joint submission ECHA will check that your additional information requirements have been fulfilled If your tonnage band is not higher than the tonnage band of the joint submission then this message can be disregarded When no TCC BR SID failures are found in the dossier or the substance dataset this is reported by the following TCC BR SID warning messages TCC Your dossier substance dataset is considered as complete for the indicated tonnage band However please note that the completeness check performed by ECHA might include additional checks as for instance the relationship with other dossiers e g lead versus member These additional checks could potentially lead to different conclusions from those indicated by this tool The use of the TCC tool is without prejudice to the obligation to submit a dossier that fulfils all relevant legal requirements BR No BR failures were detected by the plug in Please note that some of the business rules can only be checked at dossier level Also note that due to technical reasons the BR check performed by the plug in does not cover all business rules checked at ECHA SID No sub
28. stance identity failures were detected by the plug in Please note that this tool does not provide an assessment of the adequacy of the information reported The use of this tool is without prejudice to the expert assessment carried out by ECHA to establish the adequacy of the information required under Annex VI p 2 of the REACH Regulation July 2012 v1 5 17 20 IUCLID 5 Technical Completeness Check plug in User Manual Note When updating a registration that was previously a notification under Directive 67 548 EEC for another reason than a tonnage band update less information is required than for a standard dossier The minimum information to be provided in this case is described in Annex 4 of Data Submission Manual 5 How to complete a technical dossier for registrations and PPORD notifications The TCC plug in does not offer the possibility to verify the completeness of only these reduced information requirements but will check the full requirements for the selected tonnage band As a consequence the TCC plug in can be used to check the completeness of these dossiers but only the TCC failures warnings related to the information requirements indicated in Annex 4 of Data Submission Manual 5 could be a reason for considering the dossier as incomplete The manual is available at http echa europa eu web quest support dossier submission tools reach it data submission industry user manuals Note As stated in section 1 the check pe
29. ti eters eke eet eeleast E O AO 19 Figure 19 Message when new plug in iS available ccc eeeccecccceeeeeeeceeeeeeeecaeeeeeeeseaeceeeseeeeeeeeseeeeeesessageeeessaaeeees 19 Figure 20 TCC Version IMIOMMAHON ceas aa a 19 July 2012 v1 5 2 20 IUCLID 5 Technical Completeness Check plug in User Manual 1 Principle of the Technical Completeness Check TCC plug in 1 1 Technical completeness check According to the REACH Regulation registration dossiers and PPORD notifications are subject to a completeness check Article 20 2 This completeness check can be divided in two parts the Financial Completeness Check FCC and the Technical Completeness Check TCC The aim of the Technical Completeness Check TCC plug in is to enable registrants and PPORD notifiers to check within their IUCLID 5 installation or database the technical completeness of their dossiers or substance datasets prior a submission to ECHA via REACH IT The plug in also checks that a dossier or substance dataset will be able to pass some of the business rules Note Although the plug in simulates the technical completeness check carried out by ECHA to the largest extent possible it will not be able to capture exhaustively all possible scenarios in which a dossier may be found incomplete e g resulting from different tonnage bands of lead and member dossiers in a joint submission The responsibility remains with the company ensure that their submission fu
30. ts in Step 3 4 3 STEP 3 Interpretation of the TCC results table In step 3 of the TCC wizard the outcome of the performed check is displayed Figure 13 The different parts of the results display are further described in the following subsections While the screenshots are focussed on a dossier type with technical completeness check the interpretation of the results as described below is also valid for dossier types with only SID and or BR check July 2012 v1 5 13 20 IUCLID 5 Technical Completeness Check plug in User Manual Technical completeness check Before you submit your information ta ECHA please ensure that you use the plug in an the final dossier Using the tool on the final dossier is vital for you to avoid failures 43 1 432 Filter Show all Section number Section name Document name Failure description Section 1 2 Composition Degree of purity is not complete At least one value anda Fx TCc failure composition 1 Unit must be provided Section 1 2 Composition Information about the concentration for one or more apy TCC failure Composition 1 constituents is not complete At least one value and a unit Constituent 1 must be provided a RR failure section 1 1 Identification The substance is specified as a mono constituent in F BR failure section 1 1 The first composition black of section 1 2 is expected to contain a single reference substance that has the same UUID than the reference substan
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