How to do a registration as a member of a joint
Contents
1. REACHIT 5 5 perormed Syene LEOX REACH cu rt already ceste user n the 52 appeaton Insta latest version of the plugin avalabie the ECHA Create substance dataset and fin a necessary sections Create JS REACHIT proving JS name and geting secu taken on he syst Transat hs Bo he MR acess REACHLT and conum membership he JS wi tha dala proved he LR JA messe are te Mane LR Message Bor stg nate section 1 5 n UCLID S win he JS name ota can get he infomalon fom te Message Box Create dossier he dose REACH Fistraion bove 1000 tonnes a an Create donor he dose tempe REACH Fgistraion member of a doi Submission Ter ine general ease or intermediates fun TOC ool lo ec or dnl wb acepten REACH _REACHIT Ext he dossier into a 16z in your PC Submit a new Relation Submission indeaing name of Ie JI A message wil rive o he LR Message Box indicating pelniny submission number perome Business Rules vaaton Technica Completeness hack nd cris tat a takes has bab pad BR and payment of and imus gia for he LR dossier A message o he LR sad the MIs message Boxes he U2. European Chemicals Agency Practical guide 4 How to do a registration as a member of a joint submission LEGAL NOTICE This document provides practical and technical advice explaining how companies iar REACH clgatons However users ara reminded thal the text of the REACH Regulation and any related EU legislation are the only authentic legal references and thal the Information inthis document does not constitute egal advice The European Chemicals Agency does ot accept any with regard to he contants of this document Document History Version Comment T ISIUSTZUTU veran Practical guide 9 How to do a registration as member of joint submission Reference ECHA 10 8 12 EN ISBN 13 978 92 9217 380 7 ISSN 1831 6727 Publ date 261052010 Language European Chemicals Agency 2010 Cover page European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form Source European Chemicals Agency http lecha europa eu and provided writen nolfication is given to the ECHA Communication Unit publications loch europa ou This document wil be avaliable in the following 22 languages Bulgarian Czech Danish Dutch English Estonian Finnish French German Greek Hungarian Latvian Lithuanian Maltese Polish Portuguese Romanian Slovakian Slovenian Spanish and Swedish If you have questions or c
3. HHHH Figure 5 Seis of steps for registration dossier to reach the end of the process When the last stop is succeeded this moans that the dossier has successfully reached the fend of the registration process passed the TCC the appropriate fee has been paid etc A message arrives the internal message box indicating i Select Detalls Read Subject Fee Yor Reference number assignee Px142273 C5 Reference number has been assnedto your submission Submisen numer P1432720 Suomen exte 1 04 2010 10 14 Regstaten eger Reference number 01 541006540845 000 Reference aue 164 010 10 14 Figure 57 Message REACH indicating the issue of the registration number Finally will send you a confirmation of the registration number via your account 42 Attachment 1 Full registration submission process for the Lead Registrant LR and the Member Registrant MR Step by Step The following table describes the overall registration process that the LR and the MRS wil follow in order successfully submit a registration dossier via 2 0 Note that you wil mot find full delall of some ofthese steps in the practical guide as the scope ofthis document is to highlight what need to do in order to fll thelr obligations IT system where sep to este aes Egueucs 2 qo Pigeons 5
4. Select the View option to check what data you have in your dossier Please see the Data Submission Manual 4 How to pass Business Rule Verification Enforce Rules htpiiocha europa euhelp help docs on a window informs you about the success of the creation When pressing the View dossier button the dossier wil be displayed LIED Figure 36 View dossier 2 4 Technical Completeness Check Tool on the dossier Run the TCC tool again except this time select the dossier o run Figure 37 TOC icok seed documento rum You can search by for example dossier date Select and Assign the dossier ig ee Figure SE TEC Wook Select query res ype Dossr are errors failures you will need to go to the substance dataset to correct them create new dossier and run the TCC tool again When more fallures aro displayed you should get the following warning message where you can then select Finish Congratulations Your dossier is now ready lo export Figure 3S TOC task Final TCC warning 2 5 Exporting Export from IUCLID 5 is possible for dossiers substances endpoints legal entes and all other data objects IUCLID 5 also makes It easy to filer information before exporting using the export wizard To export one can allematively use the manu entry Export in Fla or use the short key The export wizard
5. acing in agreement with the other assenting registrants shall first submit the joint submission lead dossier to ECHA European Chemical Agency Including substance classification and labeling study summaries robust study summaries and testing proposals Subsequently other registrants of that substance member registrants must individually submit their member registration dossier including as sat in Annex VI of REACH the information on their own identity part 1 the identi of thelr substance part 2 information the manufacture and use s of he substance part 3 and exposure information part The registrants may decide whether to submit guidance on safe use and a chemical safety report CSR individually or jointly Le aspect of the registration dossier I is crcl for both lead and member to have a clear understanding on who is providing which information If the member has to submit ts own CSR preparations need to start in due time 1 2 Goal of this document This practical guide acts as a supporting material for the workshop on Joint Submission member registrants organised for HelpNet REACH and CLP Helpdesk Network The workshop is series of webinars targeted to member registrants Iis available at Bil echa europa euinewshwebinars en asp Polenta regstants might be or representation The four webinar sessions ofthis workshop are Session 1 Dossier preparation by a
6. IUCLID 5 2 Data requirements in IUCLID IUCLID sections be filled in for member dossiers gt Section 1 General information Section 3 Manufacture use and exposure IUCLID sections to be left empty for member dossiers except in case of an opt out Section 2 Classification and labeling Sections 4 5 6 and 7 Endpoint sections IUCLID sections which can be submitted jointly only inthe lead dossier or separately in the ead dossier and in the member dossiers Section 11 Guidance on safe use Section 13 Chemical Safety Report CSR 1 Assessor review if he guidance on safe use the CSR and the assessor review are submitted separately then this nat considered as an opt out Information is considered as it is provided in IUCLID Section 2 or in IUCLID sections 4 to 7 Whether the registrant wants to opt out and for which information requirements this needs to be indicated In IUCLID 5 during the dossier creation process The consequences of an opt out are that the dossier wil be prittised for evaluation and that hero is no Joint Submission discount foc the fee In this chapter you wil learn how to Crealo a substance dataset Attach documents lo a substance Use the Technical Completeness Check tool to check that the substance dataset is complete Create a dossier Use the Technical Completeness Check tool again o ensure that the dossier header Informa
7. Task Panel You can also start by selecting it from the main menu Plugins then TCC tool Figure 25 Plugins Main Menu E Select your substance datasat to be checked by selecting the Accept the defaults for Select query result type as Substance and Select query as Find substances Under Chemical name wile methanoic and select Figure 28 Substance dataset as query resul type for TCC Accept the defaults select Next E Figure 27 TOO Step 1 For Joint Submission select Yes and for Role in the Joint submission select 2 Member o a joint submission Select Tonnage band of tho joint submission In our example we entered 100 1000 tonnes Select the Tonnage band of the member In our example we entered 1 10 tonnes In our example the lead registrant provided the Guidance on safe use and the Chemical safety report on behalf of no members so we accept the default values Select Next Lane Figure 28 TCC Step 2 are displayed Correct the errors by double cicking on them Your substance dataset is opened automaticaly Figure 28 TCC Step 3 Correct the error inthe substance dataset When you click on the refresh button two blue arrows your substance dataset is checked 23 again and the warningiailure message wil disappea
8. button Analytical results used to characterise the substance must be provided in the repeating blocks under Results of analysis as an attachment by clicking on the paper button or in the Remarks field RTE Wear Figure 14 1 4 Analytical information 13 2 1 6 Section 1 5 of IUCLID Joint submission JS The information of the Joint Submission is completely derived from and any information in Section 1 5 is nol taken inlo account Section 1 5 can be used for your own administrative purposes but It is important to note that the consistency of any information in this Section of IUCLID will not be verified against the information derived from REACH IT For secon 15 Joint submission got the Query result and Tree View area on the lt hand side soe Secon 7 8 or submission and double ick ont open Select CTRL o go o edi f yo are ron edt made aea in Data area on he right hand of the screen select he green sign to open The Jon submission he Jont submission name 8 0 e IS for formi acid Registrant ames are not required Save select tho menu or CTRLS dert submission Figure 15 Secton 1 5 Joint submission 2 1 7 Section 1 6 of IUCLID Sponsors Secon 1 does not need to be filed in by member registr
9. member registrant Session 2 Dossier creation In IUCLID 5 2 by a member registrant Session 3 CSR overview of requirements and tools Session 4 Submission of member registration dossier via REACH IT The goal of this document is to explain to the member registrants how to do a registration as member of joint submission if the endpoint data is provided by the lead registrant Firstly a member registrant needs to compile all the necessary data to bo included in the registration dossier and to obtain the information on the Joint Submission Object from the lead registrant Secondarly the member registrant needs lo complete the substance dataset and to creato a registration dossier in IUCLID 5 Thirdly after creating the registration dossier to access or create a account confirm participation in the jolnt submission and submit the registalon dossier via REACHAT This document outlines the basic steps for preparing a registration dossier in IUCLID 5 2 and the submission ofthe dossier via REACHAT 20 Itis assumed that the lead registrant covers all the necessary Information In his Joint Submission dossier Consequently opting fom submission of certain data by the member registrant is not covered by this practical quide 1 3 Prerequisites IUCLID 5 2 and the Technical Completeness Check TCC plug in need to be installed and the Legal Entity must be imported Instructions on how to insallUC
10. of reaction e g flid bed reaction the system in which the Substance is processed openiciosed continuous batchwlse durallon and frequency of processing maximum capacity per time unit pressure and temperature during processing Solvents used processing efficiency I no information is available a justification needs lo be enlered in this field e g Fluid bed reaction Substance processed in closed system No further information available due 1o Figure 17 Secton 3 1 Technological process 15 2 1 10 Section 3 2 of IUCLID Estimated quantities Select section 3 2 Estimated quantities in the Query result and Tree View area on the left hand side and double click on order 1o open it in tha Data area on the right hand side of tho screen select the green to expand i Manufacturersimporters of a substance and producers of have to give information on their tonnage manufactured imported andlor used in articles per year that is subject to registration REACH Annex VI point 3 1 and also an indication of the tonnage used for their own use s REACH Annex VI point 3 3 This corresponds to section 3 2 of JUCLID Estimated quantiles and the fields tonnage and year need lo be completed Enter for instance 2009 for Year and 20000 for Total tonnage Select OK Save Figure 18 Secton 3 2 Estimated quanties 16 2 1 11 Section 3 3 of I
11. of the joint submission that you want to jon Aloken is categorised block of text and i serves o confirm membership of a Joint Submission by ite members PTET TORT ro Dee a en Beli ees Figure 43 REACHAT Joint submission membership confirmation wizard One of tho most common errors made is entering an incorrect joint submission name or token sting In order to avoid that copy pasting the information provided by the lead registrant is recommended Otherwise the following error message will appear Figure 44 error message when entering the wrong Join submission information Important information about token management issues is available in the attachments of this document If the combination of and token Is correct you will move to the second step whore a contact person needs lo be identified If the REACH IT account does not yet have a contact person Identified you need to Select an existing one or to create a new by clicking create new contact information a Serena Figure 45 contacts information lab You wil beable to move to the last stop Validation validate the data entered by clicking Next Once all data is verfiod as a member registrant you need to confirm the membership by clicking the button Confirm membership as iis shown in the following figure and the
12. the data panel gt The Section ree of your substance dataset is displayed in the navigation part of the scroon to sae the complete trea view press 7 and select Expand from the pop up menu Figure 3 since iemiheatien Figure 3 Section tree and Expand Toopen the it of dossier types press lt Select REACH Registration member of a joint submission general case from the up menu You will notice that sections 1 and 3 are highlighted in red whereas other sections are green These colour codes are guidelines indicating in red the mandatory sections that need tobe fled in by member registrants rrospective of what sections have been filed the substance dataset the dossier wizard wil display the relevant sections for the dossier template which was chosen in red and all other sections will be displayed in green Indicate a third party in section 1 1 only if one has been appointed E Figure 4 Third party representative legal entity in lUCLID Section 1 1 Tho Liga Ei used fortis example sila E Indicate your role in the supply chain Role in the supply chain ole nag EER ERE ERTIES Figure S Role n the supply chain 2 1 2 Assign a new reference substance to your substance dataset section 1 1 of IUCLID In section 1 of the substance dataset Information on the substance is s
13. will appear This wizard has diferent number of slaps to be performed depending on the kind of data being exported Substances require the highest number of slaps other data will have a wizard with some steps missing Accept the default export without annotations Choose a name and a location for the export Select Finish The export fla is successfully created The fle can now be uploaded into hpJ echa ouropa oulreactit_ en asp 3 SUBMIT THE DOSSIER VIA REACH IT In this chapter you wil learn how to Sign up in Confirm membership in the joint submission Submit the member registration dossier and pay the registration fee 3 1 Sign up in REACH IT 3 1 1 Sign up Sign up in the Portal at lips reach iLecha ouropa eui folowing the link Sign up as a company In case you already nave KEACHHIT account follow the link login and jump to chapter 3 1 3 of this document What can you do ca scary Se SOS faite Figure 40 REAGHIT Portal welcome page For more information about the diferent roles and how to sign up in read question 7 ofthe Technical Aspects REACH IT FAQ available on the ECHA website at hip lecha europa eu reachilreachit faq en asp A Terms and Conditions page wil appear and after having read the full text and agreed with it click acce
14. 52 Dossier creation wizard step 6 Selecting tonnage band 47 Token and Joint Submission name management For security reasons only five attempts at entering the correct combination of token and joint submission name are permitted If the maximum number of attempls is reached the token Is blocked and those member registrants who might be sill working on confirming their membership wil not be able to do The lead registrant would then have to generate a new token and distributa It soon as possible to all those member registrants that have not yet confirmed their membership AS member registrant you need to pay attention to the Sequence of characters for both the joint submission name and the token provided by the lead registrant It Is recommended to copy paste the data received from the lead registrant Also remember that the token has an expiry date of 30 days after it was issued You need to remember to click on the Related to a submission check box in order to submit the dossier as part of a joint submission specifying the appropriate joint submission name otherwise the submission wil fal Dossier management You need to be sure that the dossier has been created in IUCLID 5 2 and not in other previous Versions of the application as REACH IT 2 0 only accepts dossiers created within IUCLID 52 You need to ensure that the dossier template that was used in IUCLID 5 2 when creating the registration dossier i
15. CH purposes can also be prepared in IUCLID 5 e g dossiers CAL notifications nolficalions of substances articles DU reports and Annex XV dossiers Comprehensive information about dossier creation is available in Data Submission Manual 4 z locha europa eu docireachiihow pass business verification pd On the IUCLID Task Panel s Update from Substance Figure 31 Substance NewlUpdale Allavalable substances are displayed select your substance e g melhanoic acid Right click on a substance in the query results list From the pop up menu select Creato dossier Figure 32 Star create dossier wizard The dossier creation wizard is displayed Slep 1 Select the corresponding dossier template For the our example select REACH Registration member of a joint submission general case from the list then press the Next gt button Figure 33 Choose dossier ype Note The dossier template selection determines which IUCLID 5 sections and endpoint studies wil be of your dossier Stop 2 Define tho filers Every item that matches these fiters will be taken into account for the dossier The Select al button allows you to select possible tems at once Press the Nex button Stop 3 Soo tho stato ful partial of ll documents taken into account for the dossier creation AL this stage it is possible
16. LID 5 are Included in the installation package and instructions for installing the TCC plugin can be found under the Get SupportIDocumentation section of the IUCLID 5 website echa europa eu The user must have the necessary rights to Import and export data which implies that the user can also creato and update substances otc A lead registrant must have been appointed for the particular substance that member registrant is about to register The lead registrant must have Created a Joint Submission Object JSO and distributed the joint submission information name and token to all member registrants in the SIEF this happens outside the REACH IT environment Ths apples to version 52 of IUCLID Toughul he document is to as LUCLID S b Submited the joint submission dossier The dossier must have successfully reached the end of the submission process and a registration number must have been assigned to the registration dossier For more up to date and detailed information on the information requirements please read the Guidance on data sharing section 8 and the Guidance on information requirements and chemical safety assessment avatable on tho ECHA website at hiiauidanceecha europa eulguidance en him crn nga erdt REACH 21 teow emer et ea soon ae e lend regata o rocas 2 PREPARE YOUR REGISTRATION DOSSIER IN
17. R doaser has reached the end afte Tegistaton pe Sibi Regksbaton Subniasn ndicatng the name ot te I5 he Mi eaesponding t a submission 1 A message wil are to me MR Message Box dicatng number Business Rules valdalon Technical Completeness hack nd cris ai e iudices has ECHA confms BR and payment of and iussa fre 11 messege o he LR the Mite message Boxes the dossier has reached the end ot tha raion process Attachment 2 Avoiding REACH IT account problems If you have the role of Organisation Manager of your Company and you could not remember your password ECHA highly recommends you to use the Forgot your User ID or password link availabe in the Login page before tha account gets blocked See next figure Figure 58 Login screen in REACHAT Request lost password Ves ces inem Figure 59 Request lost password screen M you an Organisation Manager and you block your account please go o the ECHA website at hito echa europa eulabouticontact orm en asp and select the web form indicating thal your account s blocked and identifying your userlD so hat can be unblocked aware that unblocking an account always triggers the reset of the password system will always send an e mail with the new password v
18. UCLID Sites As specified in point 1 1 3 of REACH Annex VI the locaton of the registrants production and own use site s must be provided as appropriate lt Select section 3 3 Stes in the Query result and Tree View area on tho left hand sido and double click itin order to i nthe Data area on the right hand side of the screen select the green to expand it From the menu on top left hand side select Fil then Now and then Site asked to save select Save Enter a sile name for example testsitename Select Next Assign the appropriate legal entity from the drop down list Select Finish Ensure that your site has an Address Postal code Town and County The minimum data required is the townlity and county where the sila is located However we suggest you to enter information for each For example Address Annankatu 18 Postal code 00121 Town Helsink Country Finland Save Please note that in case of an importer no information is required in this section however ifa sito is provided the same requirement apples ses nega Other IT system identifiers cms Dem Contact address n Fra Ei x Figure 19 Secton 3 3 tes 17 Select the back arrow on the top left hand sido of the screen to go back to your substance Select CTRL to go into edit modo Select the ink in the Da
19. ald for 5 days only to the mall address spacified in the REACH IT account During the frst login the new password wil have to be changed the e mail address specified in your REACH IT account is correct and you do not receive new password please note that your e mall management system might be fitering all as incoming e mails from the domain echa europa eu and considering them as SPAM Contact your System Administrator in order to confirm that you have no restrictions lo receive e mails rom our domain and the functionally again Ifyou are not an Organisation Manager and your REACH IT account is blocked please remember that your Organisation Manager able to unblock your account for you Find out who is the responsible person within your organisation and he she wil be able to unblock it Remember that the CAPTCHA used to confirm the login does not affect the number of attempts lo login therefore itis not a cause of blocking an account Under no circumstances should you send your REACH IT account password via e mail If there is any problem with it the password can be reset but we advise you not to send it to anyone including the European Chemicals Agency Attachment 3 Considerations for member registrants in order to avoid business rules problems in REACH IT 2 0 Substance identification It is important for both the lead registrant and the member registrants to fully agree on the substance I
20. ants 2 1 8 Section 1 7 of IUCLID Suppliers Ifyou are an Orly Representative Lo box Only representative was liked in IUCLID 5 Section 1 1 Identification you are advised to fil in section 1 7 Iis suggested to attach 14 clear documentation of your appointment as the Only Representative e g copy of the appointment letter which was sent to importers in the field Assignment from non EU manufacturer In this case you are also advised to indicate tho list of importers names Covered by the registration in the Other importers This information in Section 1 7 for Only Representatives is advised but not mandatory Figure 16 Secton 17 Suppers 2 1 9 Section 3 1 of IUCLID Technological process Following the requirement of point 3 2 of Annex VI of REACH if the box Manufacturer is licked in section 1 1 Identfication then information must be provided in the field Methods of manufacture In the Query result and Tree View area on the left hand side expand the Section 3 Manufacture use and exposure Select section 3 1 Technological process and double click on order to open it inthe Data area on the right hand side of tho screen select the green to expand i Describe the technological process used for manufacture of the substance or the production of the ar cles in which the substance is being used It might include of the type
21. ap aslacing te submission ype Figure 51 Submiting a registration vie REACH T Second providing registration information Figure 52 Submiting a registration via REACH T Third step select the dossier fe and submit 4 Figure 53 Submiting a registration REACH T Fourth step confrming submission information Figure 54 Submiting registration va REACH T Issung the Pralminary submission number BBBERUREHRRESROEDESNSSUNSEENNSNSBZaISGazdSII Figure 55 REACHIT intemal message confirming the submission Figure 56 Series of steps for registration dossier reach the end ia process Figure 57 Message in REACH indicating the issue of the registration number Figure 58 Login screen REACHT Figure 59 Request lost password screen Figure 60 IUCLID 52 Dossier creation wizard stop Seeing taanage 42 42 47 1 INTRODUCTION 1 1 Background The REACH Regulation 1907 2008 stipulates that when a substance is intended to bo manulaclurediimperted by one more manufactarer mpertr in quantities above metic tonne per year per legal enti the substance needs to be registered there are more manufacturersimporters the registration needs to be submited jointly Article 11 of the REACH Regulation those potenti registrants of the same substance form a SIEF Substance Information Exchange Forum 29 of the REACH Regulation registrant lead registrant
22. as A message indicating that the submission has been successful wil arrive in the member registrant internal message box and a direct Ink to Download the submission report wil be available The registrant may prefer to click on Go to the dossier in order to how the dossier is progressing metas Resa sunject Creston tote expire Date ves m i your la unger examination ty cur T Your doover le under by systems to enoure that void dossier Flowing ms Sucreseta cordon orti tas you receve Config your suns oni Fd Vx 0 cate subicere message Figure 55 REACHIT intemal message confirming the submission Downloading the submission report wil produce pdf fle with tho current status of the submission at that exact moment For consultation purposes only users may prefer to sea the status of the submission ive by clicking on Go to the dossier link instead This wil not generato a fle and tho data willbe displayed on the screen By pressing F5 users can refresh the pago to check tho status The dossier goes through the diferent steps ofthe registration process As member registrant you have to pay the fee according to the registration you are submiting and only when tho payment has been confiemed by ECHA the registration process wil continue
23. d click on Submit dossier validation page will appear in order for you to confirm the submission after verifying the data that wil be submitted as shown in the following figure Click on the Confirm Submission button CAPTCHA is a type of chalenge response est used in computing to ensure thatthe response is not generated by computer It usually consists ofan mage with some text im that tha user needs io tex eld lo validate a request E Gare Gesner p Peery rc Figure 53 Submating registration via Fourth step confirming submission information new page will confem that the submission of the dossier has been successtu A preliminary submission number is given and a direc link to the internal REACH IT message box is given Figure 54 Submsiting a registration via Issuing the Pralminary submission number Tis is new feature of 20 when submitting a dossier users wil first get preliminary submission number Once the dossier successfully passes the business rules 40 will confirm this submission number which wil be the same one and tho submission will receive atime stamp You can find further information about the post submission process on the ECHA website at Bililecha europa ou reachiipostsubmission en
24. dentification and also on the way to indicato it in IUCLID 5 and REACI IT Users need to pay special altention to the IUPAC name as It has to be written In the exactly same way The submission wil fall f there is even the slightest difference between the substance identification in the IUCLID 5 dossier and the substance Identification of Ine joint submission in REACHHT Tonnage Band Member registrants to ensure that the tonnage band that they aro indicating in the IUCLID 52 dossier is equal to or lower than the tonnage indicated by the lead registrant in Joint submission otherwise tho member registrants submission wil fal Only if you as a member registrant indicate an opt out your dossier can the tonnage be higher than the ono specified by the lead registrant and in this case the submission wil not fall One of he changes in IUCLID 5 2 and REACH IT 2 0 is that the tonnage Is now only indicated in IUCLID 82 step 6 of tho dossier creation wizard In tho previous version of REACH IT 1 5 member registrants needed to select again the tonnage during the registration submission process in From 2 0 onwards this selection of the lonnage band is performed in IUCLID 5 2 only Note thatthe tonnage to be selected in the pick lists framed in red below should be the one of the member registrant and nol the tonnage band of the ont submission Figure 60 IUCLID
25. e created in more than one table then of those lines have to be complete e g there Is ono line under Uses by professional workers and one line under Uses by consumer then both lines have to be complete Figure 22 Secton 35 dented uses the Most commen technical functions of the substance section please provide at least one ofthe following places of information a selection is made from the pickist Technical function of substance provided in the free txt fold Remarks Figure 23 Closed system and technical funcion Tick identified uses take place in closed system uses by workers in industrial setings uses by professional workers and uses by consumers take place in a closed system Since in our example we have not Identified Uses advised against or Waste from production and use therefore we will not fl in saclions 36 or 3 7 of IUCLID For detalled information on fling in your substance dataset please have a look at the Data Submission Manual 5 How to complete a technical dossier for registrations and PPORD nalifications Bltplcha europa ewelpihelo does en asp 22 The Technical Completeness Check tool Once you have installed the Technical Completenoss Chock TCC tool and logged into JUCLID 5 again you can start the TCC too by selecting TCC tootrun from the IUCLID 5 Task Panel Figure 24 Plugins
26. entifier EC CAS or IUPAC To easily search among the reference substances stored in your computer you can use T as wildcard all reference substances will be displayed Figure 12 Searching for reference substances wih 2 1 4 Section 1 3 of IUCLID Identifiers To fll in section 1 3 Identifiers in the Query result and Tree View Figure3 area on tha left hand sido selact Section 1 3 Identifiers Click on the edt button or select CTRL E to go into edt mode if you are not in edit mode already In the Data area on the right hand side of the screen select the Add button to add your regulatory program identfier and to select the regulatory program from the pick ist For example indicate your REACH pre registration number or REACH inquiry number Figure 13 Secton 13 deniers Save select Files Save from the menu or CTRL s E 2 1 5 Section 1 4 of IUCLID Analytical information To fil in section 14 Analytical information inthe Query result and Tree View area on the left hand side select section 1 4 Analytica Information Select CTRL E to go into edit made if you are not in edit mode already In the Data area on the right hand side of the screen entar a description of the analytical methods either in the Analytical methods and spectral data field or as an attachment under this field by clicking the paper clip
27. gical process Figure 18 Section 3 2 Estimated quantities Figure 19 Section 33 Sites Figure 20 Produclion sile or Us Figure 21 Secbon 3 Form in the supply chain Figure 22 Secton 3 5 identified uses Figure 23 Closed system and technical function Figure 24 Plugins Task Panel Figure 25 Plugins Main Menu Figure 26 Substance dataset query resul or Figure 27 TCC Step 1 Figure 28 TCC Step 2 Figure 20 TCC Step 3 Figure 30 Figure 31 Substance Figure 32 Start create dossier wizard Figure 33 Choose dossier type Figure 24 Dossier croaton wizard sep 3 Figure 35 Dossier creation wizard sep 4 Figure 36 View dossier Figure 37 TCC took select document io un Figure 38 TCC tol Select query result Dossier Figure 39 TCC tool Final TEC warring Figure 40 Portal welcome page Figure 41 REACHAT signum ward Figure 42 REACHLIT menu to confi membership i doit ubmissan Figure 43 REACH T Jom submission membership wizard Figure 4 error message when entering the wrong Joint submission information Figure 45 REACHAT conlacis information tab Figure 46 Membership confrmaton slap Figure 47 REACH IT message notification confirming mambarship Figure 48 Reviewing Joni submission Figure 49 REACH menu ta submit naw registaion Figure 80 Submiting registration via REACH T Fist sl
28. he section 3 5 Identfled uses In the Query result and Tree View area on the left hand side press CTRL E to go into odit mode and select Add to enter your dala According to Annex VI point 3 5 of the REACH Regulation registrants have to provide brief general description of the identified use s so in the information on uses section ensure that atleast one of the following is provided a complete line for Use by workers in industrial settings is filed in idontfied use name Process category Environmental Release Category and Subsequent service relavani for that oR Ientfied use name Process category and Sector of end use see figure 22 OR complete line for Uses by professional workers is filed In identified use name Process category Environmental Release Category and Subsequent service rolovani for that use oR uso name Process category and Sactor of end us OR complete line for Uses by consumers Identified use name filed n OR selection in tno Justification why no identified uses are reported is filed in NB f Other is selected then the adjacent free text must flied in However if several lines are created in table then all of these lines have to be complete e g if there aro two lines under Usos by professional workers then both lines have to be completo 19 addition if ines ar
29. into IUCLID 5 needed The LEOX created during the sign up process in will have to be the same as the one used already in IUCLID 5 lo create the Substance and the dossier in which case the user wil import from IUCLID 5 Allematively the LEOX created within REACH IT will have lo be exported and imported into IUCLID 5 in order for both systems to have the same LEOX This LEOX synchronisation is mandatory in order to properly set the identity of the entity performing the registration of the substance For more information about LEOX synchronisation users are invited to read question 15 the Technical Aspects REACH IT FAO avalible on the ECHA website at hiloecha europa eujreachilreachit fag en asp 32 Confirm membership in the Joint Submission a member registrant you need to confirm your membership in the Joint Submission Object USO with the data provided by the lead regisrant and token Therefore once you have the joint submission information details and token you then will be abla to confirm his her membership This is done by logging into REACH IT and going to the menu Joint Submission gt gt Confirm Membership as shown in the following igure Figure 42 REACHT menu to confirm membership Joint submission A wizard to assist in confirming the membership will start In the first step you need to provide the exact name and token
30. ission type that is to be made Figure 50 Submsting registration REACH T First step selecting the submission type this exercise the member registrant needs to select Registration The page wil refresh automatically and he following figure wil be displayed esset sin egrave viden ey mde ret Figure 51 Submating a registration REACHIT Second step providing registration information Click on the Declaration and inthis case the Related to a joint submission box has to be selected Entec the Joint submission name in the appropriate fold Click on the button Proceed ia order to go to tho next step Far and ib trcs sro access coe for large ies Figure St Submating registration via Third stp select the dossier fle and submit You wil have to browse in your computer in order to gat the 82 fle containing the IUCLID 5 2 dossier lo be submitted via Enter the as indicated in the Figure 13 in case the fle is bigger than 20 a special cade is needed upon request To obtain this code the registrant needs to follow the link Request a large flle access code After a few seconds a message containing the code will arrive in the internal REACH IT message box Enter the codo an
31. k Tool on ihe dossier 28 25 Exporting ia SUBMIT THE DOSSIER m 3 1 Sign up in REACHIT 333 88 UP nn Entering 3 1 LEOX synchronisation 32 Confirm membership in the Joint Submission 33 Submit the member registration dossier ATTACHMENT 1 FULL REGISTRATION SUBMISSION PROCESS FOR THE LEAD REGISTRANT LR AND THE MEMBER REGISTRANT MR STEP BY STEP ATTACHMENT 2 AVOIDING REACH IT ACCOUNT PROBLEMS ATTACHMENT 3 CONSIDERATIONS FOR MEMBER REGISTRANTS IN ORDER TO AVOID BUSINESS RULES PROBLEMS IN REACH IT 2 0 ATTACHMENT 4 CONSIDERATIONS FOR MEMBER REGISTRANTS IN ORDER TO AVOID TECHNICAL COMPLETENESS CHECK PROBLEMS IN REACH IT 20 49 TABLE OF FIGURES Figure 1 Substance NewiUpdste Figure 2 Substance creation wizard Figure 3 ee and Expand ai Figure 4 Third party representative legal emily IUGLID Section Figure 5 Role n supply cain Figure Reference substance reato wizard Figure 7 Reference substance Figure amp Search EC name Figure 9 Molecular formula weigh and formula Figure 10 Constituents Figure 11 Search reference substance Figure 12 Searching fr reference substances wih Figure 13 Secton 13 deniers Figure 14 Secton 14 Analytical information Figure 15 Secon 1 5 Joint submission Figure 16 Secon 17 Suppliers Figure 17 3 1 Technolo
32. lo de select the optional 1 2 chapter lo be inserted or omited from tho dossier D Iun Figure 34 Dossier creation wizard step 3 Stop 4 Accept tho default and click Next el of endpoint fields Figure 35 Dossier creation wizard step 4 Step 5 A list of related objects that will be part of your dossier Legal Entity Reference subslance s Endpoints is displayed Select Nex Step amp Enter a comment on your dossier knowing that your dossiar is a ragistration dossier called JS for methanole acid where the information provided by the lead on 27 behalf of the members is Chemical Safety Report Guidance on Safe Use and Review by an assessor Select your tonnage band and select phase in Step 7 wil not be displayed During the creation of a dossier for a member of a joint Submission user has to select which additional information shall be included in the dossier By default section 2 and sections 4 lo 7 are nol pre selected As soon as al least additional information from these sections is selected to be included in the dossier slop 7 will bo displayed in order for the user to provide a mandatory justification for each information selected to be submitted separately opt out If no information from these sections is selected thon step 7 is skipped Stop 8 As we do not want protect our dossier we simply select Finish
33. mission wil fall Each member registrant needs to check the lead registrant s submission in order to confrm that all tho information has been sent and there is nothing missing except for the opt out Iis Important to be in line with what the lead registrant has submitted in order not to fail the submission ofthe registration Please remember to always use the plug in in order to verify that the dossiers are correct and that they wil pass tha in 2 0 This tool simulates the completeness check that wil perform REACH IT It can be downloaded via your IUCLID 5 website account at hitps iucld echa eurapaeul Aller having accepled te lcense agreement and the disclaimer you wil be able lo dawnload a containing the TCC plugin as well as the user manual which wil help you instal Fees and involeing You are reminded that claims for confidentiality or opting out wil increase the fees to be paid to Remember this when making submissions so that there are no surprises when the invelca is received as the ragitraion number Is only provided once the involce has been paid For more information about fees and invoices check the REACH IT FAQs at htp echa europa eulteachivreachit fag enasp For more information about what information from the dossier wil be published on ECHA website consult the Data Submission Manual Part 15 Dissemination How to determine what wil be published o
34. n an EC inventory entry by pressing the 20 utor The query dialog comes up in nich EC inventory entis can be searched Search lor EC nama e Tormic acid Formic acid is another name for Mathanoe aci E eRe RST Figure amp Search EC name Prass the Assign button in either the CAS number AND name IUPAC name Since the substance in our example is mono constituent substance we need to fll in the Molecular formula Molecular weight and Structural formula import an image well Figure 9 Molecular formula Molecular weight and Structural formula Press button to go back to the Substance save when requested 2 1 3 How to specify the chemical composition in the substance dataset section 1 2 of IUCLID Display the secon ree of he substance by selecting hesacon ree panel on the top left fand de of your sren Figura 3 secon 12 Substance compositor Use tha add uon creata composion Note multipla conposilons can be aided for one substance Fill in the degree of purity in the repeatable block by switching to edit 2 open constituents repeatable block oy pressing the adi buton d Assign a reference substance tothe newly created constituent by pressing the 7 button our example using the Formic acid we search fora the u rence substances present in ha local computer lt Adi a new Conslue
35. n press oc Ec Figure 46 Membership confirmation validation After confirming the membership joint submission both the member registrant and the lead registrant receive a message Figure in their internal message box confirming the new joint submission membership e oes Solet Date Rend subject tenon one Dan Recipient Figure a7 REAGHAT mess contiming membership You can Modify Delete or Leave your participation in a Joint Submission at any timo by accessing your joint submissions in the menu Joint Submission gt gt View Joint Submissions solecing the appropriate one and clicking on the appropriate button Phone Sic mess renes Figure 48 Reviewing Joint submission 3 3 Submit the member registration dossier The member registrant needs submit a new registration in REACH IT concerning the tonnage band as specified in IUCLID 5 and also indicating the name of the joint submission Log into REACHAT and enter the menu Registrationinotification gt gt Submit registrationinotiication as described in the folowing figure Figure 49 menu to submit new registration than select the correct Subm
36. n the ECHA wabsite from the registration dossier at hiliecha europa eu helbihelp docs en asp European Chemicals Agency RO Bax 400 FT00121 Heini hupy echaeuropacu
37. nt by on the add button in the Typical oncenraton and Concentalion range gue 10 Assign a reference substance to the newly created constituent by pressing the 2 button Search for Formic acl among al te reference substances presen in your computer and sas i and Figure 10 Constituents Delino Inpurties and by opening the respective repeatable blocks flowing the same steps as for Constituents linking as many reference substances as necessary Add new impurty by clicking on the add button In the concentatlon and Concentration range Assign a Reference substance o the newly created impurty by pressing the 2 buon Search for impurity n our example water among al reference substances present in your local computer and assign iL 10 Figure 11 Search reference substance water Ifthe reference substance is inactive t appears greyed out in the list and you therefore need to activate before assigning it If his is the case you need to rightclck on the reference substance name and select Active reference substance It your list appears empty deselect show only active values and follow the instructions in the previous point to activate your reference substance Select Assign to assign the active reference substance Impurities 21 should have at least one chemical id
38. o the REACH Regulation in case of opling oul you cannot benefit from the reduced fee applied to joint submissions and the dossier wil be priosed for a compliance check In the event that you are indicating in the dossier header that the lead of tho joint submission is providing on your behalf a Guidance on safe use section 11 of IUCLID or Chemical safety CSR in section 13 of IUCLID then the information in those sections must remain empty The opposite also applies if you do nol indicate that the lead is providing this Information on your behalf the information must be included in your dossier For intermediate dossiers guidance on safe use as specified in point 5 of REACH Annex VI is not required However for these dossiers information on risk management measures should be provided REACH Articles 17 1 and 180 This information should be given in IUCLID section 11 by filing in as a minimum ether the Handing and storage or Ine Exposure controls personal protection field As a consequence even ifthe lead registrant is indicating that he she is submiting the guidance on safe use on your behalf as a member registrant of an intermediate dossier you stil need to include a record in IUCLID section 11 with information on ils risk management measures the event that site is Included in section 3 3 than it has to be identified with at least the following feds Town and Country otherwise the sub
39. omments in relation to this document please send them quote the reference and Issue date using the Infermation request form The information request form be accessed the Contact ECHA page at lip ocha europa eu abouticontact en asp European Chemicals Agency Malling adress Box 400 F 00121 Helsinki Finland Visiting address Annankatu 18 Helsin Finland TABLE OF CONTENTS 1 INTRODUCTION 3 1 Background 12 Goal of this document 1 Prerequisites 2 PREPARE YOUR REGISTRATION DOSSIER IN IUCLID 5 2 21 Substance dataset 2 11 Create a substance and assign a reference substance 2 12 Assign a new reference substance to your substance dataset section 1 1 of 7 2 1 How to spocity the chemical composition in the substance dataset section 12 of IUCLID 10 2 14 Section 1 3 of IUCLID dntifiers 12 21 5 Section 1 4 of UCLID Analytical information 2 1 Section 1 5 of IUCLID Joint submission 45 2 1 7 Section 1 6 of IUCLID Sponsors 2 1 8 Section 1 7 of IUCLID Suppliers 21 9 Section 31 of IUCLID Technological process 15 21 10 Section 3 2 of IUCLID Estimated quantities 16 21 11 Section 3 3 of IUCLID Sites 21 12 ection 34 of IUCLID Form in the supply chain 2 113 Section 3 5 of IUCLID Identified uses E 22 The Technical Completeness Check tool 23 Dossier 24 Technical Completeness Chec
40. pt 3 1 2 Entering information order lo create a REACH IT account the REACH IT Portal offers wizard with several steps User account information Company information Bling information Contacts Validation Figure 41 REACHT sign up wizard Altar the very first step providing User Account information Is created for the User ID selected The QUID format looks ko this company Ug 52 GG Abed aaah 728360120 A this slap the process to create an account is already Initiated for any reason the sign up process cannot be completed now it can be finalised later The system will ask you to finalise the process next lime you try to log in with this account LEOX synchronisation legal entity is ether companylorganisation natural person capable and having the right 1o engage in contracts or commercial transactions In IUCLID a Legal Entity Object LEOX is a specific element to store and manage legal enit information This information includes the the address and other contact detalls the contact person s and legal entity speci identification numbers which may help identifying i in an unambiguous manner such as VAT Value added tax or DUNS Data Universal Numbering System numbers Altar the last step Validation you are invld to export the LEOX created and you wil be to import it
41. r you corrected it For detailed instructons an filing in the different sections of IUCLID 5 correct please referto the Data Submission Manual 5 How to complete a technical dossier for registrations and PPORD notifications hiiplecha eurepa ewhelphnelp docs en asp When your errors are corrected you will receive a final message Select Finis Figure 30 TCC Finish You aro now ready to creato your dossier Information on Business Rules verification can be found in Data Submission Manual 4 europa euelp elo docs on asp while guidance on Technical Completeness Chek is avalabe Submission 5 europa euhelp helo docs on asp 2 2 3 Create Dossier IUCLID 5 enables you to prepare a dossier directly from the substance dataset The level of of the information that wil be part of your dossier strictly depends on the requiremants of the legislation you folowing This technical dossier contains information on the properties uses and classification of a substance as well as guidance safe uso The Information required lo determine the properties of the substances varies according to the tonnage in which the substance is manufactured or imported The higher the tonnage the more information on the intinsic properties of the chemical is required The information requirements are set out in the Annexes VI to XI of REACH Other types of dossiers for REA
42. s the REACH Registration member of a Joint Submission for the general case or for intermediates You need to remember that you cannot submit your member registrant dossiars unt the lead registrant s joint submission dossier has reached the end of the registration process and a registration number has been issued to the lead registrant Otherwise your submission wil falls For further information you can read more about these topics in the Industry User Manual Part 7 Joint Submission document and the Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules that you will find on the ECHA website In the Supporting Documents Section hip lecha europa eulreachilisupo docs en asp Currently ECHA is considering changing this procedure for REACHH T 2 1 in order to alow the member registrant to submit at anyime even before e lead dossier has successfully passed business rules Attachment 4 Considerations for member registrants in order to avoid Technical Completeness Check problems in REACH IT 2 0 Filling in information in IUCLID 5 2 IUCLID 52 sections 2 4 5 6 and 7 CAL and the endpoints sections of your dossier should be empty If information is submitted In a member dossier in one of these sections then this information wil bo considered as an opt out In this case when creating the dossier you will have to enter justification for each opted out section According t
43. ta area on the tight hand side ofthe screen Select your sile lastsitaname and click on OK box Manufacturer in IUCLID section 1 1 Identification is ticked than at least one production sto must be provided here e one site should have the box Production sile ticked Tick Production sile Save Please ba advised that if you are an importer or an only representative you do not need to specify a production site EL EE Figure 20 Production sile or Use s 2 1 12 Section 3 4 of IUCLID Form in the supply chain Select section 3 4 Form in the supply chain area on the lft hand side and double click on Itin order to open it in tha Data area on the right hand side ofthe screen select the green to expand it Under Available as substance tick the box Available as substance Choose one of the three forms substance mixture or article andlor the physical state under which tha substance is made available lo the Downstream User as this is required see Annex VI point 3 4 of the REACH Regulation Tick either the checkbox Available as substance or the checkbox Substance In mixture and give a value to Typical concentration with its or the checkbox Substance in article and give a value in the Tonnage Figure 21 Secton 34 Form in the supply chain 2 1 13 Section 3 5 of IUCLID Identified uses Select t
44. tared One of the most important elements is the identification of the substance In IUCLID 5 the Identification of the substance and its composition is done based on the use of the so called reference substances The reference substances are kept in an inventory in your IUCLID 5 installation outside the normal dataset Tha reference substances contain information CAS number CAS name EC inventory information Le EINECS NLP ELINCS name Information on the structure The idea behind the implementation of reference substances is to prevent re typing the same Information and to enhance consistency of information When defining the identity of the substance in the substance dataset and the compostion of the substance the user does not need to type the dala but specifies the information by making a link to the reference substances 11 ang a relreren suhstarca by psig we E ton 2 Rey dog apr Pras he tont St no rece subtree are sae Figure Reference substance creation wizard Press the Finish button the reference substance is created T Anempty Reference substance section appears sace IDE remm Figure T Rec eno tune by pein 1 asked Data were modified wihout saving Save You might need to select CE or select tho icon 1o go into edi mode Assig
45. tion is complete Export the dossier 2 1 Substance dataset The substance dataset i the central core of the information stored in IUCLID It contains data related to he chemical substance In contrast withthe dossier the substance dataset bo edited at anytime The substance datasat is divided into 14 main sections that are further broken down into subsections This document wil help you understand how to fl in sections 1 and 3 These sections are related 1o the general substance information and the manufacture use and exposure of your substance 2 1 1 Create substance and assign a reference substance For the sake of simplicity of this demonstration the substance used as an example in this documentis a mono constituent substance Information about the difrences to pay attention if the substance is mull constituent substance can be found in Submission 4 tilocha europa eulhelpihelp docs On the IUCLID Task Panel select New under Substance Figure 1 Substance NewUpdate tho namo of your substance e g mothanolc acid Figure 2 Substance creation wizard Select the Next button the substance dataset now bo related to the legal entity assigned to the users Look at the IUCLID line Your user and your legal ently name aro displayed Select the Finish button the substance dataset is created and displayed in
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