IUCLID 5 Plugin
Contents
1. Please ensure that you use the plug in onthe final dossier and correct all reported Technical Completeness Check and Business Rules failures before submitting your information ta ECHA Using the tool on the final dossier is vital for you to avoid failures 43 1 Business Rules 2 Dossier Quality Assistant Technical Completeness Check 2 a iz T amp SS 432 Filter 5howall w with type failure warning Failure description ma BE GHS Lh Meither a Hazard category and a Hazard statement io TZE failure nor a Reason for no classification is given for Acute toxicity oral Identification The substance is specified as a mona constituent in F ER failure section 1 1 The first composition block of section 1 2 is expected to contain a single reference substance that has the same UUID than the reference substance of section 1 1 Note The UUID of the reference substances is indicated in the Information pane of IUCLID 5 TCC engine version 7 00 Business rules version 2 2 10 Completeness rules version 2 2 8 S a B H Results Figure 11 TCC plug in results display the numbering corresponds with the following subsections 4 3 1 BR TCC tab and Dossier Quality Assistant tab From the TCC plug in version 5 4 3 onwards the results window is split into two separate parts tabs When entering the results window the tab that is opened by default is the one containing the results of the Busi2. echa europa eu web quest support dossier submission tools reach it data Scbmiecione industry user manuals e Guidance documents http echa europa eu quidance documents guidance on reach e Practical guides 2 4 http echa europa eu en practical quides February 2013 v1 6 4 24 IUCLID 5 Technical Completeness Check plug in User Manual 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 Note For the plug in to work properly both of the zip files must be copied into their respective folders it is not enough to copy only the client side zip file Copy eu echa iuclid client plugin tccvalidate ui zip the file lt IUCLID5 folder gt plugins client C IUCLID5
3. IUCLID 5 Guidance and Support IUCLID 5 Technical Completeness Check Plug in User Manual ena i ny meee SADALA t gt imant HTE SANA WAL JEDIN CHEDMITOL INF ve DOTADOS ECHA EUROPEAN CHEMICALS AGENCY ped by the Eur OECD IUC opean Chemicals Agency the Organisation for Economic Co operation and Development ation with February 2013 v1 6 IUCLID 5 Technical Completeness Check plug in User Manual Table of contents 1 Principle of the Technical Completeness Check TCC plug in 2 0 ee eccceeeeeeeeeeeeeeeees 3 1 1 Technical Completeness Check niie a a a a 3 1 2 BUSINESS PUES CHEEK srra e idea aticuaeadhaanodans Given balsas AEN 3 1 3 Dossier Quality ASSISCANE cc ccccccccesseceeeceeeseeeeeceseseceeeeeseesceeesaaeeeceeeseeaeeeesesaeaeeeeeesanes 4 2 Adding the plug in to your local IUCLID 5 installation eeccceeeceeeeeeeeeeeeeeeeeeeas 5 2 1 Workstation stand alone installation 2 0 eecceccaeeceeceeeeeeeaeeceeeneeceeeaeeeaeeneeseeneeens 5 2 2 Distributed Metalla OM ianen a a auana eens anaes 6 3 Lanning the TCC iG sii iirc aaa ily A A 8 Cra Checking multiple dossiers substance datasets ce eccceeecceceeseeeeeeseeeeeeneeeeeeneess 8 3 2 Checking a substance dataset or dossier you are working ON ccccceeeeeeeeeeeeeeeees 9 4 Using the FCG PIG AI eena a e a hubamwtadawemndloanqantatonnantanties 10 4 1 Checking dossiers all supported dossier templates ecccccceseeeeee
4. TCC messages appear only for registration and PPORD 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 Substance Identity warnings appear for registration and inquiry dossiers and Substance datasets Dossier Quality warnings appear for registration dossiers and substance datasets s ICC failure 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 TCC in REACH IT These messages are flagged with the 3 icon TCC warning A TCC warning is not an indication of that your dossier will fail the Technical Completeness Check but it suggests 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 ae BR failure A BR failure in the plug in is associated with a Business Rules step failure at ECHA 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 warning A BR warning does not directly translate into a Business Rules step failure at ECHA but it indicates that
5. need for extra caution on specific topics February 2013 v1 6 18 24 IUCLID 5 Technical Completeness Check plug in User Manual You are recommended to consider all Substance Identity warnings and address the reported inconsistencies before submitting your dossier to ECHA Note that in certain situations it may be justifiable to ignore the warnings This should be decided after consulting the warning message and the relevant guidance documents 4 3 4 TCC plug in results table The rows highlighted in yellow in the TCC plug in results table indicate the sections of the dossier substance that gave rise to the failure warning or in the case of BR Dossier Quality Substance Identity rules the section and the number of the rule ars ster rowa with Failure description Ep Section 1 2 Composition Degree of purity is not complete At least one value and Foe TCE failure Composition 2 a Unit must be provided Section 1 2 Composition Information about the concentration for one or more i TCE failure Composition 2 constituents is not complete At least one value and a Constituent iz Unit must be provided Figure 12 Yellow rows of the TCC plug in results table The rows in grey or white describe in more detail the fields of the dossier substance that need to be filled or modified in to correct the failure warning 4 amp Filter Show all with typ ox Composition Degree of purity is not complete At least
6. 1 can be used at any point to hide or display the TCC plug in window without losing the its settings or result 3 2 Checking a substance dataset or dossier you are working on If you are working on a substance dataset and want to interactively check the TCC BR Quality rules while entering the data the most convenient way to do this may be to while in the Substance menu right click the name of the relevant substance dataset in the Query window and select Run TCC The plug in window can be kept open and refreshed while entering editing the data see Tip in chapter 4 3 4 for instructions on refreshing fet Navigation m Query results Folders Section tree ery O O amp Test su p Open a Print 4 Export E Create dossier a Add to folder Fe Run TC at Delete Delete Figure 4 Run TCC option on a substance dataset Similarly if you finished creating a new dossier and want to run the TCC plug in on it you can in the Dossier menu right click the name of the dossier in the Query window and select Run TCC This is a convenient way to launch the plug in on the dossier right after creating it without having to search for it Furthermore since the plug in can be launched from the same location where dossier creation or dossier export takes place the possibility of checking the incorrect dossier is reduced February 2013 v1 6 9 24 IUCLID 5 Technical C
7. 6 Selection of phase in definition fee waiving and Update StatuS ccccccceeeeececeeseeeeeeeeeeeeeesseeeeeeeesaaees 11 Figure 7 Selection of tonnage band for an individual registration ccccccecsseeeeeeceeeeeeeeseeeeceeesaeeeeeeesaeeeeeesaeees 12 Figure 8 Selection of tonnage band for a joint submission lead registration ccseeeeeeeeeeeeeeeeeeeeeeeeeesaeeeeeeeess 13 Figure 9 Selection of tonnage band for a joint submission member registration ccccccceseeeeeeeeeeeeeeeeeeeeeeeees 14 Figure 10 Indication of whether a safety data sheet is needed joint submission member registration 15 Figure 112 FCC plug in reSultS GIS Play enean esata temcaccisddnedatectacsupshduedadecd ded E A E 16 Figure 12 Yellow rows of the TCC plug in results table ccccccceccccccceeceeeeeeeeeeeeeeeeeeeeeeeessseeeseeeeeeessaeaeeeeeees 19 Figure 13 Grey white rows of the TCC plug in results table ccccccccseeeeceeeeeeeeeeeceeeeeeeeeeeeeeeeessaeeeeeessaeeseeeesaaees 19 Figure 14 Message for failed Version Check isserrat e aaiae eieaa aaiae aeraithe iinei 21 Figure 15 Internet connection configuration cccceeccccseeeecceeeeeeseeeeceeeeecaeeeeeseeeessaceeessaeeeessueeessaeeeessaeeeesneeesaess 22 Figure 16 Message for plug in up to dat s x vecieseticcsck ve esssediececstoceaucetddiw ans cdieed eameneli hearse 22 Figure 17 Message when new plug in IS available ccccseeccccse
8. 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 C amp L February 2013 v1 6 13 24 IUCLID 5 Technical Completeness Check plug in User Manual Technical completeness check 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 2025 of the REACH Regulation joint Submission C3 No Yes Role in the Joint submiss ton 9 Member of a joint submission Tonnage band of the joint submission Registration dossier above 1000 tonnes Tonnage band of the member Tonnage band standard registration Between 100 to 1000 tonnes year On site isolated intermediate tonnage
9. band Transported isolated intermediate tonnage band Provided by lead Guidance on safe use Chemical Safety Report 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 ta 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 a B B lt Back i Next gt Cancel Define dossier options Figure 9 Selection of tonnage band for a joint submission member registration Note IUCLID 5 4 offers the possibility to claim confidential 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 Ste
10. iSclientPlugins remotePlugins eu echa iuclid client plugin tccvalidate ui zip In the folder you will already find files like ClientExtensionPointRootPlugin zip eu echa iuclid plugin helpsystemEN zip eu echa iuclid plugin xform zip February 2013 v1 6 6 24 IUCLID 5 Technical Completeness Check plug in User Manual Copy eu echa iuclid server plugin tccvalidate zip the file lt IUCLID5 WebApp folder gt WEB INF classes plugins C Program Files apache tomcat webapps i5server WEB INF classes plugins eu echa iuclid server plugin tccvalidate zip 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 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 February 2013 v1 6 7 24 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 This can be confirmed by the appearance of a new icon in the Plugins section of the home view of IUCLID Figure 1 The plug in can be launched from a variety of locations according to preference and way of working 3 1 Checking multiple dossiers substance datasets If the
11. 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 Oneng the dossier as incomplete The manual iS available at Submissions industry user manuals Similarly for this type of dossier any warnings issued by the Dossier Quality Assistant concerning sections outside the information requirements indicated in Annex 4 of Data Submission Manual 5 may be disregarded Note As stated in section 1 the check performed 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 Plug in 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 defi
12. one value and 8 TCE failure Composition 2 a Unit must be provided Section 1 2 Composition Information about the concentration for one or more BEY TCE failure Composition 2 constituents is not complete At least one value anda Constituent 2 Unit must be provided Figure 13 Grey white rows of the TCC plug in results table A right mouse 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 document dossier plug in data Go to referenced This option will open the substance dataset that was checked document raw data with the plug in if available in your IUCLID 5 database February 2013 v1 6 19 24 IUCLID 5 Technical Completeness Check plug in User Manual Tip At step 3 of the TCC plug in results table if you are running the plug in 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 Ee 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 tog
13. purpose is to run the plug in on a set of dossiers or substance datasets in the IUCLID application the following approach may be adopted Launch the plug in from any of the three locations shown in Figure 1 from left to right the TCC tool icon in the Plugins section of the home view the Plugins tab in the main menu the TCC toggle button in the toolbar a5 IWCLID 5 4 1 H Fee Calculation EEI Dissemination tool E CSR tool Administration zE Example Company 1 Example city Finla Figure 1 Launching the TCC plug in from the home view of IUCLID After launching the TCC plug in the first step in the wizard is to choose the document to be checked by clicking on the Icon Select document to check BOE Figure 2 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 dataset Note that while the rules for the document types registration PPORD and inquiry can be checked in both dossier and substance dataset mode the remaining supported document types can only be checked as dossiers Please refer to Annex I of this manual for more details E Query Select query result type a substance 7 Select query Substance Figure 3 Query selection February 2013 v1 6 8 24 IUCLID 5 Technical Completeness Check plug in User Manual Note that the TCC toggle button in the toolbar rightmost option in Figure
14. supported by the plug in see Annex I only a Business Rules check is performed 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 have selected a dossier created with dossier template COMPLETE Only dossiers created with REACH specific templates are supposed to be checked and submitted please click Back and select another dossier February 2013 v1 6 10 24 IUCLID 5 Technical Completeness Check plug in User Manual 4 2 Checking substance datasets for registration PPORD inquiry 4 2 1 Step 1 select dossier type Unlike dossiers substance datasets do not correspond to a specific type of submission and therefore the user needs to select against which rules the dataset should be checked e If the substance has to be checked in or
15. table has the same effect as clicking on the navigation buttons and As a consequence a double click on a specific row will directly open the substance dossier at the corresponding section 4 3 3 Filtering the results table Show all Business Rules Only TCC rules Technical Completeness Check tab Only Business rules Dossier Quality Only Dossier Assistant tab Quality rules Only Substance Identity rules failure warning failure February 2013 v1 6 All result items are displayed without filtering Only results with the level TCC failure lt 4 and TCC warning E are displayed in the results table Only results with the level BR failure 4 and BR warning are displayed in the results table Only results with the level Dossier Quality warning E are displayed in the results table Only results with the Substance Identity warning E are displayed in the results table Both failures and warnings are displayed in the results table Only the failures are displayed in the results table not the warnings 17 24 IUCLID 5 Technical Completeness Check plug in User Manual 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 TCC warnings and TCC failures BR warnings and BR failures Dossier Quality warnings and Substance Identity warnings
16. are displayed see Figure 18 Similarly when accessing the Dossier Quality Assistant tab the version information for the Dossier Quality rules and the Substance Identity rules are shown 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 TCC engine version 7 00 Business rules version 2 2 10 Completeness rules version 2 2 8 Finish Cancel Figure 18 TCC and Business rules version information amp Note If you are uncertain about how to enter the required information in the correct format in your IUCLID 5 dossier or how to run the TCC plug in please contact the ECHA Helpdesk at http echa europa eu web guest contact ECHA will then provide you with specific advice on how to proceed February 2013 v1 6 22 24 Annex I Summary of contents of TCC plug in per dossier type Available modules Dossier Applicable to Regulation Dossier type Quality substance Assistant datasets Registration O x x x k PPORD m n a a Inquiry REACH Downstream user report Substance in article en o a CLP CLP notification CLP CLP alternative name ee eee Substance evaluation X J o y REACH auth Annex VI CLH CLP auth proposal European Chemicals Agency IUCLID 5 Support Technical Completeness Check plug in Manual February 2013 v 1 6 h
17. bstance 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 fulfils 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 op The manual is available at http echa europa eu web guest support dossier submission tools reach it data submission industry user manuals 1 2 Business rules check The TCC plug in also 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 doss
18. der to create a PPORD notification dossier select the radio button PPORD notification When clicking Next you will be directed directly to step 3 where the results of the check are displayed e If the substance dataset will be used for the preparation of an inquiry dossier select the radio button Substance identity check for inquiry notification When clicking Next you will be directed directly to step 3 where the results of the check are displayed e Otherwise leave the box Registration dossier templates selected selection done by default When clicking Next you will be directed to a new screen where you can select the type of registration dossier you would like to perform the Technical Completeness Check on see Step 2 in the next chapter Select document to check a Test substance f boron borane 440 42 0 fF PPORD notification a Registration dossier templates 7 substance identity check for inguiry notification Figure 5 Radio button for dossier type 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 waiver this must also be indicated in Step 2 of the wizard note that a fee waiver can only be claimed in the case stated in REACH Article 74 2 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 iden
19. e Data reported as Quality warnings registration The Dossier Quality Assistant runs automatically when users launch the TCC plug in version 5 4 3 or above on their substance dataset or dossier The results are shown in a separate screen and have no impact on the outcome of the Technical Completeness Check However registrants are encouraged to analyse the results obtained from the Assistant and revise their dossiers as appropriate The warnings given by the Dossier Quality Assistant can refer to that conflicting data have been provided that data have been entered in an unexpected manner or they can just be reminders highlighting the need for extra caution on a particular topic Note that in certain situations it may be justifiable to ignore the warnings This should be decided after consulting the warning message and the relevant guidance documents Note The Dossier Quality Assistant does not affect the outcome of the Technical Completeness Check performed by ECHA It is a tool which helps registrants to avoid common data inconsistency issues and thereby improve the quality of their dossiers Note The use of the Dossier Quality Assistant is without prejudice to the expert assessment carried out by ECHA to establish the adequacy of the information required under the REACH Regulation For further information on the preparation of inquiry and registration dossiers please refer to e Data submission manuals 2 4 5 18 http
20. e appropriate tonnage bands from both picklists p Technical completeness check The European Chemical Agency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Check ITOO of a dossier or a substance dataset according to Article 93 or 20f25 of the REACH Regulation Joint Submission Mo 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 hot applicable not applicable On site Transported 1 1000 tonnes Transported 1000 tonnes On site AND Transported 1 1000 tonnes On site AND Transported 1000 tonnes 2 2 8 aon J Define dossier options Figure 7 Selection of tonnage band for an individual registration February 2013 v1 6 12 24 IUCLID 5 Technical Completeness Check plug in User Manual 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 doss
21. eeeeeeeeeeeees 10 4 2 Checking substance datasets for registration PPORD inquiry ceeeeeeeee 11 AQ coleo 12 Select dossier TV OC muniri nan el essay aad dee lees r 11 4 2 2 Step 2 select the tonnage bands only for registration substance datasets 12 4 3 Interpretation of the TCC plug in results table 0 0 ec ccccceeeeeceeeeesseeeeeeeaseeeeeeeas 16 4 3 1 BR TCC tab and Dossier Quality Assistant tab 0 0 ccccccccsecseseeeeeeeeeeeeeeeseeeeeeeeeesaaeeeenens 16 AS2 TCC plug in results toolbar cie eve sth ee ian ae ee tds 17 433 SEUCKIAG TAG KOSUIS table nea a salah itd Marii tla basi aaa Ie dao a 17 ASA TEC Pug are Suis Tabii a r a aes went oe cease wae 19 4A PLUG versionin or mato sencics nan descccglsatvat ss atecedacsndestter a a 21 Annex I Summary of contents of TCC plug in per dossier typPe ce eeeccceeceeeeeeeeeeeeeees 23 Table of figures Figure 1 Launching the TCC plug in from the home view of IUCLID 2 0 ccccccceeeeeeeeeeeeeeseeeeeeeeeeeesaeeeeeeeeseaas 8 Figure 2 Entry field Sel ct document to check senccis ic seed cen maA A 8 Roure DUCHY SCIOCTOM aie cco saeco acide tro E cata ccessenma ence osbadeecouniada mea ceseepadecuseursaetee 8 Figure 4 Run TCC option on a Substance dataset ccccccccccseeceeceeeeeeseeeeesseeeeseeeeeeseueeesseseeeseeeeesaeeeesseeeeesaeeees 9 Figure Radio b tton TOF dossier TV DG assets te a ea eth ete eS ae ote eae lt EaR 11 Figure
22. gle 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 a failure indicated by the TCC plug in may be disregarded There are certain cases where a TCC 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 necessarily fail the Technical Completeness Check 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 the plug in does not detect any failures warnings for one or several of the modules in the dossier or the substance dataset this is reported by the following disclaimer messages TCC registration PPORD 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 dossie
23. ier using the picklists Registration dossier and Intermediates A Technical completeness check The European Chemical Agency ECHA has developed this plug in to assist legal entities in verifying the Technical Completeness Check TCO of a dossier or a substance dataset according to Article 93 or 2025 of the REACH Regulation Joint Submission O No fres Role in the Joint submission O Member of ajoint submission 9 Lead registrant of ajoint submission The lead registrant should select here below the 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 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 riot applicable B B B lt Back Mext gt Define dossier options Figure 8 Selection of tonnage band for a joint submission lead registration Member of a joint submission Select the radio button Yes under the heading Joint submission Set the radio button for the 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
24. iers 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 February 2013 v1 6 3 24 IUCLID 5 Technical Completeness Check plug in User Manual For further information on the business rule check please refer to Data Submission ane 4 How to Pass Business Rule Verification Enforce Rules available at Sbmiscione industry user manuals 1 3 Dossier Quality Assistant From version 5 4 3 onwards the TCC plug in contains a new feature This so called Dossier Quality Assistant has been designed to assist companies in the preparation of registration and inquiry dossiers It contains rules of the type warning that highlight some of the most common inconsistencies found in registration and inquiry dossiers While the rule set will be extended in the future at present the Dossier Quality Assistant module focuses on the following areas in the IUCLID substance dataset and dossier Sections 1 1 and 1 2 reported as Substance Identity warnings registration and inquiry Section 3 2 reported as Quality warnings registration standard tonnage Section 3 5 reported as Quality warnings registration intermediate Endpoint study records Administrativ
25. mission 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 a e2 B8 lt Back Next gt Cancel Define dossier options Figure 10 Indication of whether a safety data sheet is needed joint submission member registration After having completed Step 2 of the TCC plug in wizard the Next button becomes active Clicking on the Next button will run the TCC rules according to the selected parameters and display the results in Step 3 February 2013 v1 6 15 24 IUCLID 5 Technical Completeness Check plug in User Manual 4 3 Interpretation of the TCC plug in results table In step 3 of the TCC plug in wizard the outcome of the performed check s is displayed Figure 11 The different parts of the results display are further described in the following subsections While the screenshots used in this chapter illustrate the case of a dossier type checked with Technical Completeness Check rules Business Rules and Dossier Quality Assistant rules the interpretation of the results as described below is also valid for dossier types which are only checked by some of the modules Technical completeness check
26. ned by pressing the plug in checker button ay Version check failed Press to configure Figure 14 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 February 2013 v1 6 21 24 IUCLID 5 Technical Completeness Check plug in User Manual p internet connection configuration wendor URL Reset to default URL HT TP Proxy Proxy LUser Password Figure 15 Internet connection configuration If the plug in is up to date the following status is displayed Current plugin is up to date Figure 16 Message for plug in up to date If a newer TCC plug in is available for update the following status is displayed Mew plugin available Figure 17 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 Business Rules and Technical Completeness Check results table the version information for the TCC engine the Business rules and the Completeness check rules
27. ness Rules and Technical Completeness Check By clicking on the second tab header the Dossier Quality Assistant results can be displayed In the tab headers numbers are displayed in brackets They indicate the number of messages displayed for each rule type with red pointing to a message of the type failure and yellow pointing to a message of the type warning February 2013 v1 6 16 24 4 3 2 TCC IUCLID 5 Technical Completeness Check plug in User Manual plug in results toolbar Refresh the plug in result only for substance datasets Export the result list as xml All the plug in results are exported in a XML file Print the plug in result Copy the plug in results can be pasted to Excel Word Navigate to the document in the dossier only for dossiers If you select any row and press this button it will open the corresponding section in the dossier which was checked Navigate to the document in the substance dataset If you select any row in the results table and press this button it will open the substance which was checked if the results are from a substance dataset or the substance dataset that was used to create your dossier if the results are from a 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 Tip A double click on any row of the plug in results
28. ompleteness Check plug in User Manual 4 Using the TCC plug in This section explains how to use the TCC plug in to check 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 and Quality checks or their combinations Annex I of this manual summarises which checks are available for each dossier type Launch the TCC plug in as described in Chapter 3 4 1 Checking dossiers all supported dossier templates When the TCC plug in is launched on a dossier it will by default perform the check s corresponding to the dossier template used These are summarised in the table in Annex I of this manual e For dossiers created with any of the REACH Registration templates the plug in performs a Technical Completeness Check according to the tonnage band information from the dossier template and header In the same screen the outcome of the Business Rules check is automatically reported In addition for these dossier templates the quality check in the Dossier Quality Assistant tab is launched e For dossiers created with the template REACH PPORD the plug in carries out a Technical Completeness Check and a Business Rules check e For dossiers created with the template REACH Inquiry a Business Rules check is performed In addition the quality check in the Dossier Quality Assistant is launched e For the remaining templates
29. p 2 of the TCC plug in wizard Figure 10 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 http echa europa eu support faqs February 2013 v1 6 14 24 IUCLID 5 Technical Completeness Check plug in User Manual A Technical completeness check The information requested in this step is needed for the correct execution of certain TCC and business rules Joint Submiss ton O No Yes Role in the Joint submission 9 Member of ajoint submission Tonnage band of the joint submission Registration dossier above 1000 tonnes Tonnage band of the member Tonnage band standard registration Between 100 ta 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 is classified under the CLP regulation is PET vPvB or is on the candidate list Yes No C Lead registrant of ajoint sub
30. plugins client eu echa iuclid client plugin tccvalidate ui zi In the folder you will already find files like ClientExtensionPointRootPlugin zip eu echa iuclid plugin helpsystemEN zip eu echa iuclid plugin xform zip February 2013 v1 6 5 24 IUCLID 5 Technical Completeness Check plug in User Manual Copy eu echa iuclid server plugin tccvalidate zip the file into lt IUCLID5 folder gt plugins server the folder C IUCLID5 plugins server eu echa iuclid server plugin tccvalidate zip 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 i5clientPlug 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 Copy eu echa iuclid client plugin tccvalidate ui zip the file into lt IUCLID5 WebApp folder gt iS5clientPlugins remotePlugins the folder C Program Files apache tomcat webapps i5server
31. rs 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 Dossier Quality registration No quality concerns were detected by the plug in Please note that this tool does not carry out a full assessment of the adequacy of the information provided 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 article 10 17 or 18 of the REACH Regulation February 2013 v1 6 20 24 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
32. secccseeeceeeecceseeceaueeeseuseessaneeecsneeessuseessaneesssaes 22 Figure 18 TCC and Business rules Version information ccccccsseeeccecseeeeeeeeeeeeeeeeesueeeeeeeseaeeeeeesaeeeeeessaaeeeeeesaaess 22 February 2013 v1 6 2 24 IUCLID 5 Technical Completeness Check plug in User Manual 1 Principle of the Technical Completeness Check TCC plug in The aim of the TCC plug in is to assist users in the preparation of IUCLID dossiers e g REACH registration dossiers PPORD notifications so that they can be successfully Submitted to and processed by the European Chemicals Agency The rules included in this plug in allow the users to perform the following checks on their dossiers or substance datasets The Technical Completeness Check TCC The verification of those business rules that do not rely on information from the ECHA databases e g submission history A set of consistency checks to improve dossier quality 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 su
33. 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 Dossier Quality warnings Dossier Quality warnings are only displayed for registration dossiers and substance datasets A Dossier Quality warning contains important recommendations on how to improve the consistency of the selected information The warnings can refer to the fact that conflicting data have been provided that data have been entered in an unexpected manner or they can simply be reminders highlighting the need for extra caution on specific topics You are recommended to consider all Dossier Quality warnings and address the reported inconsistencies before submitting your dossier to ECHA Note that in certain situations it may be justifiable to ignore the warnings This should be decided after consulting the warning message and the relevant guidance documents Fil Substance Identity warnings Substance Identity warnings are only displayed for registration and inquiry dossiers and substance datasets A Substance Identity warning contains important recommendations on how to improve the consistency of the reported substance identity information The warnings can refer to the fact that conflicting data have been provided that data have been entered in an unexpected manner or they can simply be reminders highlighting the
34. tifiers are entered in IUCLID 5 section 1 3 the user should indicate the update status of the dossier to be submitted Phase in definition not applicable to PPORD notifications Phase in substance Non phase in substance Fee waiving not applicable to PPORD notifications i Yes 8 No Submission update indicate reason for submission update if applicable Is the submission an update Fi Spontaneous update Figure 6 Selection of phase in definition fee waiving and update status February 2013 v1 6 11 24 IUCLID 5 Technical Completeness Check plug in User Manual 4 2 2 Step 2 select the tonnage bands only for registration substance datasets In this step the user has to define which template should be used for the Technical Completeness Check i e the tonnage 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 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 th
35. ttp iuclid eu
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