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ECHA - REACH-IT Industry User Manual: Part 06 Dossier Submission

1. ag mst cat ag mst clits vender HH sane tif ty My Recent edip Smet met dih gt met met ett wah eee a Documents ES qt E cist ag mst cists orden wi same LIER tty a r E 5 wah ghia aian i gt tele Access code fo Desktop eg mst cat ages d amp wapite it ec AE clit et ST jn Deep ranija h toluene reg lead 10 100 init iSz Pog DS hae ap nda wih b Se ry tag tts a r For the submissic tit a rr If you have an ac Large file acces th Pith tat th rr a t t ts t t tty TET ately gt 6 at eee Fist tatty rr an tis tot ih ted otb oet th My Computer my File name toluene reg lead 1 0 1 00 init 152 My Network Files of type All Files Only one i5z file can be selected Now select the file dossier you want to submit and click on lt Open gt You will see the link to your locally stored i5z file appear in the lt File name gt field Figure 18 Figure 18 Link to locally stored i5z file in lt File name gt data field step 3 Home gt Submit Dossier Intro gt Submit External Dossier Regular registration dossier submission Please pick here using the Browse button the file which contains your dossier your file should have been created using IUCLID 5 and have the extension i5z File name kisera AA A ya Te ess T lisri s fsi Dossiers 1 2 Browse Enter the text shown cfn5 2 Can t read the text below Try another PERS lt For t
2. Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 9 Table 1 Overview of dossier types supported by REACH IT Submission Classification and Labelling C amp L notification Yes Yes Inquiry notification Yes No NO Substance maremote Yves Downstream verre tM 2 2 Submission parameters Process and Product Oriented Research and Yes Yes Development PPORD notification In addition to the dossier type the applicant must specify other parameters of the submission listed in Table 2 The submission parameters are discussed below and more information is provided for each parameter Table 2 Submission parameters to be specified Dossier type Submission parameters O C O cD J O am JJ c gt O Reason for submitting DU report Exception for CSR Purchase order Registration a Registration of on site isolated intermediate Registration of transported isolated intermediate PPORD notification C amp L notification Inquiry notification Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 10 REACH IT Industry User Manual Version 2 0 wssn Ye ly Permatasari y YY resoan YY e e mens e ery sesse YY Create substance identity Y smsa eoo d mee Check Poysuombsontee e v n WW
3. s ssssssssss2us2 sssuusuuuunununnunnnnnnnnnnnnnn 40 Restart manufacture confirmation MESSAGE ssssss2222222222222222u220u20uu20uun0unnnnnnnn 41 Restart manufacture internal MeSSage sssssss22 2 22252225220uu202220u220u20uu20uun0unnnnnnnn 41 Table of Tables Table 1 Table 2 Table 3 Table 4 Overview of dossier types supported by REACH If sssssss22222222222 2 2 5 9 Submission parameters to be specified ssnsss22222522252222220222u220u220222022202200 2 nn 9 Submission steps versus submitted dossier tYP sssssss2222222222222225u22222022202 5 10 SUUCEUre referenc NUMDEN siisieiisiseissivitsnisdcueneniswiidcsiistnewnewivs a 15 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu REACH IT Industry User Manual Version 2 0 1 Introduction The Industry User Manual IUM is the reference manual that describes to industry users how they can submit and view data within REACH IT As REACH IT evolves additional and updated parts of this IUM will be released and made available via the ECHA website Prior to using this Part 6 Dossier submission it is strongly recommended that the user reads Part 1 Getting started with REACH IT where the following topics are discussed in more detail e structure of this IUM e conventions used in terms of icons text buttons links e background information on REACH IT a
4. Dossier submission Release date July 2012 11 Submission step C amp L notification article notification Downstream user w c e E ed a 5 a notification notification Substance in Inquiry Overall completeness Y Y check Step occurs Y yes N no given during the inquiry process not during submission 2 3 1 Virus scan The submitted dossier file is scanned for known viruses Only virus free dossier files will proceed to the next step 2 3 2 File format validation The file format validation is verification that the submitted dossier file is of the appropriate format 15z file format and is compliant with the XML schema used by UCLID 5 2 3 3 Check XML structure This verification ensures that the submitted dossier file does not contain attachments for which the format is not supported recognised by REACH IT Only after that step can REACH IT proceed with the actual validation of the submission This step consists only in a warning in case your dossier contains unsupported file types However your dossier will never be rejected at this step and will continue to be processed If the format of the file sent is not supported and or recognised by REACH IT your dossier is still processed but the following message is sent to your REACH IT message box Your dossier contained unsupported attachment file type s Please note Your dossier is still being processed During further pr
5. Substance in article notification Downstream user report M Mandatory submission parameter O optional parameter NR parameter not relevant for that dossier type Purchase order field where a company specific purchase order number may be entered by the applicant This value will appear on the invoice related to that submission in order to facilitate its treatment by the billing organisation Declaration this is an acknowledgement that the information submitted is correct and the company size is calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance is appropriate for registration notification under Regulation EC No 1907 2006 2 3 Data Submission process Once the dossier is submitted its subsequent processing by REACH IT is executed in a series of steps The different submission steps are listed below Table 3 in relation to the type of submitted dossier Table 3 Submission steps versus submitted dossier type Submission step c O 0 UV v 5 D AS re o ow amp aad _ u Ges UW e Q y RN ae es Pag 6 G C ra a U U 9 Ww _ num mm G J j A e753 5 92 oc cl icli ol asa Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06
6. TES Is it a joint submission Mo Status of the dossier Complete Substance Reference Number substance Mame alpha 2 cdichloro 4 nitrotoluene Request submitted file The lt Request submitted file gt button gives you the option to request the file that was uploaded during the submission process You must provide a justification with your request The justified request is sent to a dossier manager in ECHA Figure 31 Request submitted file page Home gt Submitted Dossiers gt Dossier Details gt Request Submitted File Details Submission Report Accounting Annotations A justification is needed for requesting the file submitted Fields marked WEN an sfensk are mandaton Hovering aver g 7 sign displays helo information Request submitted file Justification Send request Cancel You will receive a response in your REACH IT Message box If your request is approved you will be able to download the file to your local system 3 2 2 2 Submission Report tab The dossier Submission Report tab shows the status of a submission at the time of consultation It displays submitted substance and dossier information as well as completed tasks Click on lt Download submission report gt Figure 32 to save this report as a PDF document Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 34 REACH IT Industry User Manual Version 2 0 Figure 32 D
7. 3 Dossier submission failures A submission failure is always communicated via an internal message in your REACH IT Message box Click on the link lt Show gt and the message details will be displayed Figure 36 for example the dossier fails a business rule is technically incomplete Technical Completeness Check or the file format is invalid see chapter 2 3 3 An explanation for the dossier failure is given in the message The information provided in the message is only a Summary For more details you can lt Download submission report gt in pdf format or you can lt Go to dossier gt to consult the complete dossier information Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 cy Figure 36 Internal message with dossier submission failure details Home gt iMessages This intemal Message box is dedicated to ie raceplion of messages sent by REACH IT ECHA lo ihe user You will nol rece Private Or professional emal account However if yOu wani to receive alens when a Message ls recelved in this intemal mes The list below displays ihe intemal messages Mat were sant io you ine last 20 days To view all intemal messages click her Message box folder F Usertolder Organisation folder Roletolder Deleted messages Select Details Read ri THide Yes Decision made by the Agency GY12757 7 03
8. 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 21 Figure 7 Specific submission parameters for a PPORD notification step 2 Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below process as for the initial submission The new dossier submitted as an update must also contain all the previously su side markad th an actaorick aro man Fieiads markea ifle Asters are dal Submission type Purchase order The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Declaration Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 Proceed Purchase Order Where needed fill in with the appropriate reference to be used by ECHA Declaration Tick the checkbox related to the statement agreement 3 1 2 4 Submitting an Inquiry notification Select Inquiry notification as the Submission type Figure 8 Figure 8 Specific submission parameters for an inquiry notification step 2 Registration notification submission Here you can begi
9. case you want to display the whole list of dossiers submitted by your organisation click search without entering any search criterion above Search Search results Submission number Substance name Type Submission date Reference number Update Joint submission Dossier status RX120540 22 alpha 2 dichloro 4 nitrotoluene Registration 08 09 2008 Yes No Complete In the column Submission number if you click on the link lt Dossier Details gt page and its four tabs opens lt Details gt lt Submission Report gt lt Accounting gt and lt Annotations gt Figure 30 Figure 28 and Figure 29 also show a link lt Advanced search gt Details on this function are given in Part 9 Advanced Search of the Industry User Manual available on the ECHA website Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 33 3 2 2 Dossiers information pages 3 2 2 1 Details tab A summary of key dossier information related to the dossier type the submission and the substance is provided in the lt Details gt tab Figure 30 and Figure 31 Figure 30 Dossier details page Home gt Submitted Dossiers gt Dossier Details Details Submission Report Accounting Annotations Dossier Dossier type Registration Submission oubmission Number Ral 2040 22 Submission Date 0809 2006 Is the submission an update
10. dossiers for the processes in the drop down menu shown below process as for the initial submission The new dossier submitted as an update must also contain all the previously su Fields marked with an asterisk are mandatory Submission type Classification and Labelling C amp L notification Quantity Notified Quantity notified Select Quantity Year Proceed When completed Figure 9 click on lt Proceed gt you will then be asked to specify if you submit the C amp L notification on your own or on behalf of a group of Manufacturers and or Importers group of MI Figure 10 Figure 10 Specify if the submission is on behalf of a group You are connected as HomoSapiens on behalf of superOupercCrib Prefere Home gt Submit Dossier Intro gt Select group of Manufacturer svimporter s Company Group of Manufacturer s Importer s Pre registration f the notifier of this C amp L notification is a group of Manufacturer syIlmporter si you shall select it from the list below and click an next Pre SIEF lf you do not notify this C amp L as a group of Manufacturer s lmporter s click on next a Mote that if wou are submitting a notification on behalf of a group of Manufacturer simporter s without being yourself a Manufacturer importer Phase in Information YOU are only entitled to submit the group notification if you are able to document that you have been mandated to act on behalf and in the name the manufactur
11. eu REACH IT Industry User Manual Version 2 0 Figure 28 shows the example of a search for complete update registration dossiers having a Submission number containing the number 120 Figure 28 Search combination for submissions Home gt Submitted Dossiers Search Internal Search Dossiers Submitted by your Organisation Lise fhe sign as wildeard for your search criteria Dassier type Registration Substance Mame Dossier name Submission Number Submission Date fee dc mm yyyy To f dd mmiyyyy Reference Number Is it an Update Yes Is it a Joint submission w Status of the Dossier Complete Advanced Search In case you want to display the whole list of dossiers submitted by your organisation click search without entering any search criterion above Search Then click on lt Search gt The submission s matching the search criteria is are displayed in lt Search results gt at the bottom of the screen Figure 29 Figure 29 Search results for submissions Home gt Submitted Dossiers Search UGUENL Search Dossiers Submitted by your Organisation Use fhe sign as wildcard for your search criteria Dossier type Registration v Substance Name Dossier name Submission Number 120 submission Date From damma yyy To Gilt dimm Reference Number Is it an Update Yes Is it a Joint Submission v status of the Dossier Complete Advanced Search In
12. manufacture internal message Message box folder F User folder Organisation folder Role folder Deleted messages Previous 1 10 of46 4 Next 10 Select All Select None Select Details Read Subject Creation Date Expire Date Recipient i WHide Yes Restarted manufacture for registration 01 2114082176 48 0000 22 03 2010 15 37 Party LEA Manufacture has been restarted for registration 01 21140821 76 48 0000 after a restart manufacture claim performed by party Manufacture ceased for registration 01 21140821 76 48 0000 22 03 2010 15 22 Party LEA Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu EUROPEAN CHEMICALS AGENCY ANNANKATU 18 P O BOX 400 FI 00121 HELSINKI FINLAND ECHA EUROPA EU
13. the user concerning the corresponding dossier 2 5 2 Reference number A reference number has been coined as a more general designation than registration number or notification number and represents a unique number which is generated by REACH IT and given to a substance and a company after dossiers of certain types are successfully submitted for the first time Such a reference number is generated at the submission of e A registration dossier the registration number as per REACH Article 20 3 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 15 e A PPORD notification the PPORD notification number as per REACH Article 9 3 e A C amp L notification the C amp L notification number e An inquiry the inquiry number e A pre registration the pre registration number e A substance in articles notification the substance in articles notification number e A downstream user report the downstream user report number The reference number is only issued once at the end of the initial and successful submission process The reference number is a unique number generated per dossier type per substance and per company This number will be unique for every company and every substance The structure of the reference number will be lt TYPE gt lt BASE NUMBER gt lt CHECKSUM gt lt INDEX NUMBER gt Table 4 shows th
14. 2222522222222225u22052202220uu20uu20ununuunnnnnnnnnnnnnnnnnnnnnnnnnn 17 SLEA UDM SON encase sanvscesnvuswrawesnecescesonsaced ses EAE NE EER 17 3 1 1 Step 1 starting a dossier sUbMISSION ssssssssrerrsrrsrrrrrrrsrrsrrrrnerrerrrrrrrrrrsrrrrsrrerrrrerrerrerern 17 3 1 2 Step z Selecting a dossier CY DS sesasec ssid evedesserneuandsencasecceadeaedoeeiasis wind wa EARE 18 3 1 2 1 Submitting a Registration dossier ccc ccccc cece eee nee nen e EERE EEE SEED EEE SEEDS rnrn ESSE SESE E SEEDS EEE ESSERE EEE EES 19 3 1 2 2 Submitting a Registration dossier of an on site transported isolated intermediate cccccce cece eeeeeeeeeeees 19 321 215 SUBMITUNG PPORD NOUTICATION ers A A A T EE NESE ee 20 Jiz A SUDMILUING aly LNGUIlyY ROLTICAL OMe ctecatuaiiessenraennnlanutiadeiaasaneer E E A 21 cee SUDMIRNG aC EL NORCO i ne ee arene Tn ee en ne Tt nr ee 21 3 1 2 6 Submitting a notification Of substance IN ALTICIE cece cece eee een EE eden EEE E EE Ee dS DEE EEE SESSA EEE G SEES EEE EES 22 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu REACH IT Industry User Manual Version 2 0 3 12 7 SUBMITTING a downstream USEF report ec ecsenseswennenaviansanaraneurnaaenaaieaeaawainenasdedddededidididedede ideas AA 23 3 1 3 Step 3 Uploading a dosSier fil ccc eee r een e eee e een EE 25 3 1 4 Step 4 Confirming Dossier submission ccc cece cece eee eee e
15. 3 2 3 4 The results of the checks are reported in real time in the submission report which can be consulted online or downloaded Part B Technical Completeness Check TCC and part C Invoicing When the dossier passed the virus plus xml checks and BR validation the dossier undergoes a Completeness Check CC that consisting of a technical completeness check TCC part B and if applicable an invoicing process part C Invoicing and TCC does not apply for all Submitted dossiers for example inquiries The invoice is sent to the registrant via a REACH IT message More details on the process are provided in the chapters 2 3 9 3 2 2 3 and 2 3 8 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 7 Part D End of process Once the dossier is considered by ECHA technically complete and the fee has been paid within the due date the registrant will receive the positive decision together with the reference number e g registration number in case of registration dossiers More details are provided in chapter 2 3 10 In case the dossier fails the technical completeness check for the first time the registrant has to submit a dossier update within the given deadline In case the dossier fails the technical completeness check for the second time or the fee is not paid within the extended payment due date the dossier wo
16. ECHA EUROPEAN CHEMICALS AGENCY 2 REACH IT Industry User Manual Version 2 0 07 2012 Document in new layout Minor textual revisions Figures and links verified 04 2011 Added new dossier types supported by REACH IT notification of Substance in article downstream user report Screenshots updated 08 2010 References for opt in removed 05 2010 Figure 1 updated 03 2010 Update to REACH IT 2 0 Part 06 Dossier submission Reference ECHA 12 G 22 EN Publ date July 2012 Language EN European Chemicals Agency 2012 Cover page European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form Source European Chemicals Agency http echa europa eu and provided written notification is given to the ECHA Communication Unit publications echa europa eu This document will be available in the following 22 languages Bulgarian Czech Danish Dutch English Estonian Finnish French German Greek Hungarian Italian Latvian Lithuanian Maltese Polish Portuguese Romanian Slovakian Slovenian Spanish and Swedish If you have questions or comments in relation to this document please send them quote the reference and issue date using the information request form The information request form can be accessed via the Contact ECHA page at http echa europa eu about contact_en asp European Chemicals Agency Mailing address P O Box 400 FI 00121 Helsinki
17. Er srrireiie rnin RAER AAAA A 13 2 4 FOUOWING UD ON SUDMISSIONS cccntecotrcecrahens ianh NE NA E EES ENEE AEE aE EE EEE Ei 13 24u L VECEN Gl MES aO are E E a a 13 2 4 2 Dossier information page and submission report s sssssrssrrsrrrrsrrsrrrrerrerrrrrrrrrrnrrerrrrerrerrene 13 2 5 Submission number and reference number ssssssssesssresrsrerrererrererrerrerernrrerrenernererrenernrrerrener 14 291 SUDNI Son NUMO C eei TEESE E E E E EEE EEEE 14 2 5 2 Reference UMNO Si apes cores aneecctasestoreaahae en neqeeaeseanedeouane aniaiaaaneen a Eaa Ana a iaaa ideata aana aa 14 2 6 External versus internal submissions sssssssssssnesssrenrsnerrerrnnererrenenrrrerrenennrrerrerrenennrrerrenan 15 2 7 Initial submission versus Update submisSionS ssssssssrerrerrsrrrrrrrsrrsrrrrerrrrrrrrrrsrrsrrrrerrerrereen 16 Za AU FUD O a r E E E E E E O E EEA 16 2 7 2 Submission of spontaneous updateS ssssssrrsrrsrrrrerrsrrrrrrerrrrrrrrerrerrrrrerrerrrrerrsrerrrrrerrernt 16 2 73 SUDMISSION OF Updates Dy FECQUCSE sisicaerii binni a a A aaa 16 2 9 Cease and restart manufacture caste sicsecateusncacddiecncdtecsenenatnwannawe eeeandaaed E EAEE EEEE 17 2 8 1 Cease manufacture for commercial reasSonS ssssesssrerrsrerrererrererrererrrrerrerrrrererrerenrrrereeren 17 2 8 2 Cease manufacture upon receipt of a draft decision ssssssererrsrrsrrrrerrerrrrrrrrrrsrrerrrrerrerrene 17 3 Step by step dossier SUDMISSION ssssss2 2
18. Figure 19 Dossier upload progress bar step 3 ssssssscccceceeeeesenneeeseeeeeeeeeeeessaaneneneeeeeeeeeeeeaas 27 Figure 20 Confirm dossier submission page step 3 sssss2222222522222222220u222u202220u2202220 2 0 27 Figure 21 Successful dossier upload with preliminary submission number step 4 28 Figure 22 View in message DOX page ssssss222222252222u202225u220u20uu20uun0unnnnnnnnnnnnnnnnnnnnnnnn 28 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 5 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Figure 47 Request access code page ssssss 2 2 2225u2252202u20u220u200u20uunnnnnnnnnnnnnnnnnnnnnnnn n 29 Submission request sent page ssssssss 2225222522252222u202220u220u20uu0nunnnnnnnnnnnnnnnnnnnn 29 Internal REACH IT message regarding Large file one time access code 30 REACH IT search function for dossiers ssssssssssunnnnununnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 31 Submitted dossier Search PAGES ssiirssssrisss nassu a 31 Search combination for submissions sssssssssssuuusnununnnnunnununnnnunnnnnnnnnnnnnnnnnnn 32 S
19. Finland Visiting address Annankatu 18 Helsinki Finland Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 3 Table of Contents 1 N CAUCE OI rcce a a a a ep ta A aa 6 2 General concept of dossier SUDMISSION sssssss2222222252225u202u202u20u220220u20uunuunnnnnnnnnnnnnnnnnnnnn 6 2 1 SUPPO r ed dossier YDG enaa A aeai eA a a AE E A 8 2 2 SUDMISSICON DGFaINClelSescc ccuseanessendedersencsytseaest A E AE a Ea E ns 9 2 3 Data SUDMISSION PDrOCESS serieitonaniie arinn na a aa aa E EED EA iA EENE E 10 2a VIS SC a at eee eas eas angen gee aan santas mes naan ted 11 2 32 FUG TOlinal valda lOM spancarnaadiantenersngnedaeese css bentancsantenipentauanscaenenenenentencogesamaedenenseasenentapantneet 11 2d CHOCK AME SUCU E rarere vertices sanceucsoSoducacdecestusadanaducsspadsaeaketentuerscniesctetodddecewenatusadanadncseu 11 Pre Se Seelam Use ee E E et E EE E E E ee ee ere 11 JD O a T ear E EEE ERE N EE EE 12 2 3 0 Create SUDSTANCE identity sceccccecricncaccduveriedsierendsthaseeansatna E E EE DE E i 12 MeT E eE E ET A EAE E ES E ATT E E ETA E E E E T EET 12 2 3 8 Technical Completeness Check TCC ssssesssrsrrsrrsrrrrerrnrrsrrrrrrrsrrerrrrerrrrrrrrrrsrrerrrrerrerrrreres 13 2 9 9 Vay SUOMMSSION TEE aeeie e a a ESEA 13 2310 Overall completeness CHECK ssasriisrsmasriianininn iaaa E TAN EA a 13 23d LISSUG reference numMD
20. TCHA text Figure 16 Submit external dossier page step 3 Home gt Submit Dossier Intro gt Submit External Dossier Regular registration dossier submission Please pick here using the Browse button the file which contains your dossier your file should have been created using IUCLID 5 and have the extension i5z Enter the text shown Can t read the text below Try another PERS lt For the submission of a file larger than 20 MB please request a large file access code before submission Access code for large files If you have an access code for a large dossier please enter it here Large file access code Click on lt Browse gt to open a dialogue box which allows you to select the dossier file you want to upload Figure 17 Your substance file must have already been created in IUCLID 5 and have the extension 15z More information about UCLID and dossier creation can be found in the IUCLID 5 user manual Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 26 REACH IT Industry User Manual Version 2 0 Figure 17 Dossier selection from i5z files step 3 Home gt Submit Dossier Intro gt Submit External Dossier Regular registry 0 her Please pick here 1 p Look in O 1 2 y Q e pegao File name K aot dta eg mst clit at mst clatg gt aaia Hi Haet IT Te Enter the text s 3 2 t t
21. Your dossier cannot be processed Further informaton can be found in the report Preliminary submission number GY12 5 7 03 Dossier type DU report Filename BRI158 21 22 filled _pass i5z The related communication to your goa ela has been re cele dd pE The communication number ig 5UB Z 2114067 2486 40 04 F The communication was REJECT Download communicshon intormaton File under examination GY72757 7 03 DU report Decision made by the Agency WG12755T 24 ri Show Yes M pPShow Yes 3 4 Cease and restart manufacture In REACH IT the cease and restart manufacture functionalities are located on the main menu as indicated in the figure below Chapter 2 8 explains the general concepts of cease and restart manufacture Figure 37 Cease and restart manufacture menu items Home Company Welcome Name Surname YOu have 0 unread messagersi in your message box YOu last connected on 4011 02 07 16 24 13 0 Pre registration Pre SlEF Online dossiers Phase in Information lew registration notification Joint submission submit registration a f notification Classification and Do o Labelling Claim Notified Substance E pace fi Tl 3C Downstream User 2 Wer aster Mie report User account Legal ian change Restart Manufacture Reference Number History Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 38 REACH IT Indust
22. acture details Registration number 01 2114082176 48 0000 EC Number 204 646 6 CAS number 123 72 8 Chemical Name butyraldehyde Cease Manufacture Type Deactivation based on article 50 2 declare that my company has ceased manufacture and or import of this substance As a consequence the registered volume will be updated to zero and the registration marked as inactive If my company has the lead registrant role for this substance this cease manufacture i action will not relieve me of this role Should my company wish to be relieved of the lead registrant role this needs to be done an via the respective functionality in REACH IT lf at a later stage my company restarts manufacture and or import of this substance at the same volume or less this registration can be reactivated via the Restart manufacture functionality in REACH IT Cancel Next Read and agree with the declaration by ticking the checkbox Click the lt Next gt button The system will direct you to the lt Confirmation gt tab Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 39 Figure 40 Cease manufacture confirmation tab Search Details Confirmation Please confirm your intention to cease manufacture Registration number 01 01 2114082176 48 0000 EC Number 204 646 6 CAS number 123 72 8 Chemical Name butyraldehyde Cease Ma
23. ask you will receive a subsequent message confirming your submission and providing you with a submission date and submission number 3 1 5 Large file access code request In Step 3 Uploading a dossier file you may need to submit a large file gt 20MB In that case you first have to request an access code via the link lt Request a large file access code gt Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 29 before you can proceed with the submission Click on lt Request a large file access code gt Figure 16 A new page will open Figure 23 where you must enter a justification for the request Figure 23 Request access code page Home gt Submit Dossier Intro gt Requ st Access Code Regular registration dossier submission Request large file access code for files larger than 20 MBytes For the submission of a file larger than 20 MB a large file access code is required This access code will be valid for only one submission After you have requested an access code the Agency will process your request and reply through your Message box You can provide a justification for your request by filling in the text area below Insert here the justification for requesting the access code Justification Request access code Cancel submission Then click on lt Request access code gt You may ca
24. ated intermediate registration GOSSICrS STED 2 orii a 20 Figure 6 Specific submission parameters for transported isolated intermediate registration dossiers USTED 2 rorarii A a aaa 20 Figure 7 Specific submission parameters for a PPORD notification step 2 sssssssssnnssnnnn 21 Figure 8 Specific submission parameters for an inquiry notification Step 2 ccsssssssseeeees 21 Figure 9 Specific submission parameters for a C amp L notification Step 2 sssssssssss222 22 Figure 10 Specify if the submission is on behalf Of a groOUpP ssssssssnunnnnnnnnnnnnnnunnnnnnnnnnnnnnnn 22 Figure 11 Specific submission parameters for a substance in article notification step 2 23 Figure 12 Specific submission parameters for downstream user report Step 2 scccsssseess 23 Figure 13 Specifying the reasons for submitting a downstream user report I cssccessseeees 24 Figure 14 Specifying the reasons for submitting a downstream user report 11 ccccsssssess 24 Figure 15 Specifying that the downstream user is relying on the exemptions in Article SICA UC OF F arasina RA AAE EAREN 25 Figure 16 Submit external dossier page step 3 sssss2s 2 225 222222u220u20uu202u2022202220u20n 25 Figure 17 Dossier selection from i5z files step 3 sssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 26 Figure 18 Link to locally stored i5z file in lt File name gt data field Step 3 sssssnssssnns 26
25. ation Use fhe sign as wildeard for your search criteria Dossier type Substance Name Dossier name Submission Number Submission Date fe cammyyyy To E lcammyyyy Reference Number Is it an Update Is it a Joint submission status of the Dossier Advanced Search In case you want to display the whole list of dossiers submitted by your organisation click search without entering any search criterion above Search Some search entry fields are predefined via drop down menus for example lt Dossier type gt while others are free entry fields for example lt Substance Name gt or lt Dossier name gt The lt Submission Number gt is a unique identifier and is given at the beginning of a new dossier submission via REACH IT The lt Submission Date gt allows you to use a date range to search for a dossier The lt Reference number gt can be used to search for dossiers that successfully reached the end of the submission process or to retrieve updates Two questions are added lt Is it an Update gt and lt ls it a Joint Submission gt to allow searching for dossier updates and dossiers sent within a Joint Submission Finally the lt Status of the Dossier gt can be selected from a drop down menu that contains complete pending and failed Wild cards are allowed in the text fields Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa
26. dates by request By request updates are updates made to provide information explicitly requested by ECHA Such information request may happen for example after the evaluation of a testing proposal or after a dossier compliance evaluation In this case the communication or decision number has to be quoted so to associate the update submission with the communication or decision issued by ECHA Any dossier update either submitted spontaneously or by request will undergo the business rules validation steps again This will cover all aspects of the dossier and not only the ones for which an update has been submitted That is why an update shall always contain all the information available for that substance Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 17 2 8 Cease and restart manufacture REACH IT provides functionality to inform ECHA of cease and restart manufacture The consequences of cease manufacture depend on the context in which cease manufacture is claimed by the registrant These consequences are described in chapters 2 8 1 and 2 8 2 2 8 1 Cease manufacture for commercial reasons Pursuant to REACH Regulation Article 50 2 if a registrant has ceased the manufacture e g for commercial reasons he shall inform ECHA of this fact with the following consequences e The registered volume is u
27. der Role folder Deleted messages Select All select None Select Details Read Subject Creation Date Expire Date Recipient Dail 2 2008 User 16 16 ECHALH2ZO 1006 Your request for a one time access code for submission of a file larger than 20 MB has been granted One time access code uKk4fl1xS 95 E Hide Yes Large file one time access code 0142005 User 15 49 ECHALH201005 Submitted file received ZM124890 15 0612 2008 User Registration req 15 49 ECHALH201008 Delete Move to Message box folder E P Show Yes Dossier business rule failure 4N124690 15 E P Show Yes The large file access code can be used one time and needs to be inserted copy paste in the relevant field when submitting a large submission file Figure 16 If you want to submit another submission dossier which file is larger than 20 mb you need to request a new one large file access code 3 2 Search and viewing dossier details 3 2 1 Searching submissions REACH IT provides two complementary mechanisms to search dossiers or submissions They are described below simple and advanced search and in more detail in part 9 Advanced search of the REACH IT Industry User Manual Simple search dossiers submitted by a company can be retrieved according to a series of simple search criteria such the submission number the type of dossier the status of the submission Advanced search allows the user to search via a combination of doma
28. e Rules available on the ECHA website 2 3 5 Store dossier Dossiers which have a correct structure and have passed the business rules check are stored in the REACH IT database 2 3 6 Create substance identity A substance identity is assigned to the substance included in the dossier The rules that govern the creation of a substance identity rely on the content of the substance documented in the dossier i5z file and are directly related to the IUCLID 5 sections 1 1 Identification and 1 2 Composition 2 3 7 Assign MSCA At this stage the concerned Member State Competent Authority MSCA are identified by the system from the relevant parts of the dossier and based on the information sent with the Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 13 dossier Depending on the dossier type this can be determined based on the country where the manufacturing site notifier or user is located Consequently the MSCA will be informed via REACH IT that a dossier was submitted and in future stages about the status of the submitted dossier 2 3 8 Technical Completeness Check TCC The Technical Completeness Check TCC of the dossier is performed and may succeed or fail At this stage all required information is verified 2 3 9 Pay submission fee Depending on the submitted dossier Table 3 and if r
29. e details for each structure element Table 4 Structure reference number lt TYPE gt IS a 2 digit number giving the type of number Registration C amp L notification Substance in article PPORD Pre registration reserved to pre registrations according REACH 28 2 Inquiry Data Holder notification Downstream User notification Application for Authorisation Substance Evaluation Annex XV C amp L Harmonization Annex XV Authorisation Annex XV Restriction Internal usage Late Pre registration reserved to pre registrations according to REACH Regulation Article 28 6 lt BASE is a 10 digit number generated randomly NUMBER gt lt CHECKSUM gt is a 2 digit checksum computed using only lt TYPE gt and lt BASE NUMBER gt which allows for error detection lt I NDEX is a 4 digit number that can be used to Indicate the index of a NUMBER gt Member in a Joint Submission 2 6 External versus internal submissions REACH IT supports the submission of dossier files that have been prepared in IUCLID 5 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 16 REACH IT Industry User Manual Version 2 0 outside of the REACH IT system This type of submission is called an external submission REACH IT also allows the creation and submission of some dossier types directly within the REACH IT application for example creation of an online inquir
30. earch results f r SUDMISSIONS sisissciscewsinecanscensuawnesinsintuenesinsnusnetaidansuedbisneutueeridenss 32 DOSSI details Page srann E E EE 33 Re guest submitted THE pag siiiiiciiesseseecedssueicdnacraswiedsteecencannecudwedwentaanesenesewdeeveradaes 33 Dossier submission report page sssssss ss 2222u222u202220uu20u220u20ununnnnnnnnnnnnnnnnnn 34 AC CODNTNO DAGE ea a E E S E E 35 Annotati n PAGES sisirain a a E 35 Annotation page with detailed information ssssss222222222u252222u222220222022202202 n 36 Internal message with dossier submission failure details sssnssnnnnnnnnnnnnnnnnnnn 37 Cease and restart manufacture menu ITEMS ssss sss s ss2uussunusnununnnnn 37 Cease manufacture search tabi isisnisiassranninan iaai 38 Cease manufacture GEtANS tap ciate ccindniiinacatescecanseiweeniinweietinedadinn senteiennacaidintwinamawcnteenie 38 Cease manufacture confirmation tab ssssssssss s ussuuuunununnununnununnnnnnnnnn 39 Cease manufacture confirmation MESSAGE ssssss2s222u222225u222220uu20uu20u20unnnnnnnnnn 39 Cease manufacture internal Message sssss2s222522222252u252225u20uu20uu20unuuunnnnnnnnnnnnnn 39 Restart manufacture S arch tab cnisidesiiscewnecnsedevias cdinwncciawesinesawewasnasecdwans lt tmewecassmsinias 40 Restart manufacture details tab iccisisiiicnetsiauienvesiwewnswtsceninuicwavenetaausevewewawesederewentinenes 40 Restart manufacture confirmation tab
31. ee Dede ede deed dee beeen nen EE EE EES 21 3 1 5 Large file access code request s ssssrssrsrrsrrrrrerrnrrrrrrrrrrerrerrrrorrerrrrerrrrrsrrrrerrerrrrerrrrrrrenas 28 3 2 Search and viewing dossier details ssssssssssrsrrsrrerrrrerrnrrsrrrrrrrsrrerrrrerrrrrrrrrrrnrerrerrrrerrerenn 30 3 2 1 Searching SUBMISSIONS x cccccnccchcansqanestoatebeaneseivecesanansbeasndaussaaendes cies a a a adaa Tia E aE 30 32 2 DOSSICrs IMOM ON Pages siirryn nun EEO E EA 33 3 2 2 1 Details W I 33 2e SUOMEN REPO aeaa EE 33 CO Wane A OCOUNUNG AD een E E E E E E E ee ee E ea ee ee 34 A E E T 35 323 Dossier SUDMISSION Tail UVES eerren nEn a EA EE EEE REEN ETAR 36 3 4 Cease and restart manufacture sssssesrsresrsresrerrsrerrererrerinrererrerirnererrerernererrerernererrerrererran 37 594 1 Cease Na a aara a E A ve oiauaas aactenesbes eae sae damenneesea ee 38 SA RE TArt MANUI WINS eane ear E EEEN EE A maa EEEE TEE N E been caunaeeut 39 Table of Figures Figure 1 Flow diagram for dossier SUDMISSION ssssssss2u22222222222202220u2202202u200u20uu20nunnnnnnnnnnn 8 Figure 2 Starting a dossier submission step 1 ssssssnsussnnnuunnuunununnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 18 Figure 3 Selecting a dossier type Step 2 sviniiiissieciesnernserwiiwartewnewmerssesnendneiwewecnerertewsiewee ens 18 Figure 4 Specific submission parameters for registration dossiers step 2 scccsssssssennnnees 19 Figure 5 Specific submission parameters for on site isol
32. elevant a submission fee is calculated and an invoice is generated for the submission 2 3 10 Overall completeness check When both the TCC is successful and the invoice is paid the submission is considered successful and can proceed This step is called the overall completeness check 2 3 11 Issue reference number At the end of a successful initial submission the substance is given a reference number depending on the dossier type for example a registration number according to a predefined format see chapter 2 5 2 4 Following up on submissions 2 4 1 Internal message Every main steps of dossier processing will generate an internal message sent to the applicant s internal REACH IT message box These messages are related to Submitted file received this message is sent as soon as the dossier file has been received and a preliminary submission number has been given to the submission Submission failure submission rule violation this message is sent when a business rule violation is detected Reference number assigned this message is sent at the end of the successful submission process once a reference number is given to the submitted substance this step is not performed for updates instead the previously assigned reference number is retrieved Submission reached the end of the dossier processing this message is sent at the end of the submission process Each message includes a hyperlink to the dossier informa
33. elevant information on our use s and the further supply chain due user report to Exposure scenario title s is are inconsistent with our actual use s O Our conditions of use are outside the conditions described in the exposure scenario O Our use is advised against by the supplier C Other reason s Include exemptions for DU CSR O Proceed Declaration Include exemptions for DU CSR tick this box in case you are not preparing a chemical safety report CSR relying on the exception under Article 37 4 c or f of the REACH Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 25 Regulation Selecting the tick box will open two more tick boxes for the relevant Articles Figure 15 Figure 15 Specifying that the downstream user is relying on the exemptions in Article 37 4 c or f Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandatory Submission type Downstream user report b The submitting party declares the information above i
34. ered in the exposure scenarios received from our supplier although we communicated relevant information on our use s and the further supply chain due to Include exemptions for DU CSR Fi Proceed Declaration Tick the checkbox related to the statement agreement Reason s for submitting downstream user report one of the following two options has to be selected e The particular use s is are not covered in the exposure scenarios received from our Supplier because we prefer not to provide the information on our uses and our further Supply chain due to a Confidential business information reasons b Burdens of Supply chain communication mechanisms c Other reasons please specify those reasons in the adjacent free text field Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 24 REACH IT Industry User Manual Version 2 0 e Figure 13 Figure 13 Specifying the reasons for submitting a downstream user report 1 Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandatory Submissi
35. ers importers that are part of the group and that the manufacturer svimporteri s acknowledge that they remain solely and full responsible to Tulrill all their obligations associated with the notification You may be required to present such documentation to enforcement authorities Registration 7 notification Joint subrnissian ie D l Please find below the list of group of Manufacturer s vimporterts that YOU have already created in REACH IT and who can notify to ECHA the C Classification and Under the CLP regulation Labe ling If YOL want to view andor Up date the information related to a group me mber of the group mem ber details a click on the group s Hame YOU Can also create a new group of Manufacturertsyimporterisi 7 if needed Downstream user repor Select Group name Last update User account y Group of wil 01 1406201 2 Legal entity change O Group of Ml 2 14062012 nvoices Click here TO deselect Ine currentie selected group Cancel Next Search On this screen you can e select a group of MI and assign it to your submission e continue without selecting a group of MI by clicking lt next gt e create a new group For more details on the functionalities offered in this screen please consult IUM part 15 on How to create and manage your group of manufacturers or importers for C amp L notification Submission When completed click on lt next gt to go to the next step 3 1 2 6 Submitting a notif
36. etion of business rule validation If you click on lt Message box gt you will have access to the submission report Click on lt Download submission report gt Figure 22 Figure 22 View in message box page Home gt Messages This internal message box is dedicated to the reception of messages sent by REACH IT ECHA to the user You will not receive messages from REACH IT concerning your actions on this site in your private or professional email account However if you want to receive alerts when a message is received in this internal message system you can define this as an option in your User Preferences The list below displays the internal messages that were sent to you the last 50 days To view all internal messages click here Message box folder F User folder Organisation folder Role folder Deleted messages Previous 1 100f14 WNext4 select All Select None Select Details Read Subject Creation Date Expire Date Recipient File under examination Z 127642 95 01 03 2011 O FHide Yes Registration reg 12 24 else 1 Your dossier is under examination by our IT systems Preliminary submission number ZY127642 95 Dossier type Registration regular File name Member2_toluene_feewaiver_1 i6z Download submission report Go to dossier Your dossier is under examination by our IT systems to ensure that it is a valid dossier and it can be processed correctly Following the successful completion of this t
37. h Details Confirmation Please confirm your intention to restart manufacture Registration number 01 21140821 76 48 0000 EC Number 204 646 6 CAS number 123 72 8 Chemical Name butyraldehyde Original tonnage band Between 1 to 10 tonnes year Cease Manufacture Type Deactivation based on article 50 2 sig confirm that want to claim restart manufacture for registration number 01 21140821 76 48 0000 Cancel Restart manufacture On the lt Confirmation gt tab confirm your intention to restart manufacture for the selected registration by ticking the checkbox Click the lt Restart manufacture gt button The system will confirm that you have successfully restarted manufacture Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 41 Figure 46 Restart manufacture confirmation message Search Details Confirmation Please confirm your intention to restart manufacture Registration number 01 2114082176 48 0000 EC Number 204 646 6 CAS number 123 72 8 Chemical Name butyraldehyde Original tonnage band Cease Manufacture Type Deactivation based on article 50 2 R confirm that want to claim restart manufacture for registration number 01 21140821 76 48 0000 You will also receive an internal message confirming the restart manufacture in your internal message box Figure 47 Restart
38. he submission of a file larger than 20 MB please request a large file access code before submission Access code for large files lf you have an access code for a large dossier please enter it here Large file access code TA TET Enter the CAPTCHA text shown amp The upload of dossiers with file size above 20 MB has first to be approved by ECHA Click on lt request a large file access code gt Figure 18 More details are given in chapter 3 1 5 on how to obtain a large file access code from ECHA Then click on lt Submit dossier gt After submitting the dossier a progress upload bar opens showing the status of the upload process Figure 19 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 2 Figure 19 Dossier upload progress bar step 3 Home gt Submit Dossier Intro gt Submit External Dossier Here you can submit a PPORD notification dossier Product and Process Orientated Research and Development PPORD notification submission Please pick here using the Browse button the file which contains your dossier your file should have been created using IUCLID 5 and have the extension iSz _ 100 File name eee Please wait The file is being uploaded Do not close the browser or navigate to a different page Otherwise the submission will be cancelled Enter
39. ication of substance in article Once you have selected Substance in article notification as the Submission type you have to Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 23 tick the checkbox related to the declaration Figure 11 Figure 11 Specific submission parameters for a substance in article notification step 2 Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandatory Submission type Substance in article notification v The submitting party declares the information above is correct and the company size to be calculated Declaration according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 Proceed Click on lt Proceed gt to go to the nex
40. in and query types The domain is first defined to help the user decide what area of information in REACH IT is to be searched Then the query is a more specific and detailed area of the domain A An industry user is always allowed to search among his own dossiers submitted to ECHA and cannot view search any other submissions To use the simple search functionality select the lt View registration notification gt from the lt Registration notification gt menu Figure 26 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 31 Figure 26 REACH IT search function for dossiers Home Company Welcome Name Surname Pre registration YOU have 1 unread messages in your message box YOU last connected on 2011 02 07 16 24 13 0 Fre SIEF Online dossiers Phase in Information Joint submission submit registration eee notification Classification and Sia cane Labelling Claim Notified Meeeere bar substance Cease Manufacture Downstream user report Restart Manufacture User account Reference Mumber History Legal entity change Search The search page is displayed Figure 27 which gives you the possibility to search dossiers submitted by your company only Figure 27 Submitted dossier Search page Home Submitted Dossiers Search Internal Search Dossiers Submitted by your Organis
41. ious decision number and if available to the reference number e The update of the dossier is submitted within the deadline A business rule may either succeed or fail Only in the cases where a mandatory or optional business rule fails you can view it in the submission report The confirmed failures of overrulable business rules are available in a communication attached to the Annotations tab in your dossier information page in REACH IT For mandatory rules the business rule failure is highlighted in red Figure 32 For optional rules the business rule failure is highlighted in orange Figure 32 Business rules were put in place to ensure the consistency of submissions A The consequence of business rule failure depends upon the level of the rule e When a business rule is optional failure is turned into a weak warning in the submission report but the overall submission is not impacted and your dossier is still processed e When a business rule is mandatory failure results in the failure of the submission e When a business rule can be overruled failure can still be accepted or rejected by ECHA after manual verification of the dossier When all business rules have either succeeded or been manually overruled the submission proceeds to the next steps Otherwise the submission fails and ends here More details on BR validation can be found in Data Submission Manual 4 How to Pass Business Rule Verification Enforc
42. lated intermediate k Purchase order The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 Please be aware that in accordance with Article 119 of the REACH Regulation certain information from the registration dossier Declaration submitted here will be published on the ECHA website without further notice You are advised to use the IUCLID 5 Dissemination plugin available from http iuclid echa europa eu to preview which information will be published Joint submission Related to a joint submission O Proceed Figure 6 Specific submission parameters for transported isolated intermediate registration dossiers step 2 Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandato
43. m performed by party A A lead registrant may continue acting as a lead on behalf of his joint submission even though he decides to cease manufacture under REACH Regulation Article 50 2 However in the event that he wants to give up this role he may do so by using the Assign new lead functionality explained in IUM Part 7 Joint Submission A The system will not allow cease manufacture for a lead registrant who has received a draft decision Before being able to cease manufacture in this situation the lead registrant must relieve himself of this lead role using the Assign new lead functionality explained in IUM Part 7 Joint submission 3 4 2 Restart manufacture Click the lt Restart manufacture gt menu item Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 40 REACH IT Industry User Manual Version 2 0 REACH IT will direct the user to a search screen where you can search for all the inactive registrations your company currently has by using the search criteria provided Enter desired search criteria and click the lt Search gt button The system will display all the registration for which you can claim restart manufacture i e your inactive registrations Figure 43 Restart manufacture search tab Search Details Confirmation Registration Search Criteria Registration number Registration date From dd mm yyyy To dd mm yyyy Registration s
44. n the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an Update must also contain all the previously submitted required information Fields marked wih an asterisk 0 are mandatary Submission type PREPEREPEPEO OR PPeR eee Pere eee rere errr eee err rr eeee eee eeee eee eeee rere ere eee rrr eee err rere eer ree eee reer reer eee eee eee rer ee etree rere rire ee errr re eeee eee reer eer eee reer eer ee errr tee eerie eee etree eee rere eee rere errr eee eer ee errr eter e ee eee eee eee ed Proceed Fegistration Registration of on site isolated intermediate Fegistration of transported isolated intermediate Substance in article notification Product and Process Orientated Research and Development PPORD notification Classification and Labelling C amp L notification Downstream user report Inquiry notification The dossier types are discussed in chapter 2 1 Depending on the dossier type you need to submit different additional required submission parameters mandatory and not mandatory will be requested Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 19 3 1 2 1 Submitting a Registration dossier Figure 4 Specific submission parameters for registration dossiers step 2 Home gt Submit Dossier Intro Registra
45. n the submission process of your dossiers for the processes in the drop down menu shown below l process as for the initial submission The new dossier submitted as an update must also contain all the previously suk T Fields marked with an asterisk are mandatory Submission type Inquiry notification Proceed Click on lt Proceed gt to go to the next step 3 1 2 5 Submitting a C amp L notification Quantity produced or imported ndicate the volume range of the substance notified and the year In the case the substance you notify is subject to registration in accordance with the REACH Regulation please indicate in this field the volume range produced or imported In the case the substance you notify is a hazardous substance placed on the market either on its own or in a mixture please indicate in this field the volume range of the substance marketed This information is not mandatory and will if provided not be published on ECHA website but used for internal statistic only Please be aware that if you decide to provide this information both fields quantity and year need to be filled Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu REACH IT Industry User Manual Version 2 0 Figure 9 Specific submission parameters for a C amp L notification step 2 Registration notification submission Here you can begin the submission process of your
46. ncel your request by clicking on lt Cancel Submission gt The large file access code will be sent to your REACH IT Message box This code can only be used for one submission A confirmation message will appear which confirms that the request was sent successfully Figure 24 Figure 24 Submission request sent page Home gt Submit Dossier Intro gt Submission Request Sent Transported isolated intermediate T I registration dossier submission You will receive the Agency s reply in your Message box After ECHA has granted the request the access code is sent to the user s internal message box Figure 25 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu REACH IT Industry User Manual Version 2 0 Figure 25 Internal REACH IT message regarding Large file one time access code Home gt Messages This internal message box is dedicated to the reception of messages sent by REACH IT ECHA to the user ou will not receive messages fram REACH IT concerning your actions on this site in your private or professional email account However if you want to receive alerts when a message is received in this internal message system yOu can define this as an option in your User PrETErECCES The list below displays the internal messages that were sent to you the last 30 days To view all internal messages click here Message box folder 7 Userfolder Organisation fol
47. nd its link to the IUCLID 5 website and application How to get additional support is also described in Part 1 Each subsequent parts of this IUM will therefore cover the step by step instructions to perform the tasks required for submission of data under REACH 2 General concept of dossier submission The dossier submission is one of the Industry core functionality in REACH IT Applicants have to submit dossiers to ECHA to fulfil the legal obligations set out by the REACH regulation REACH IT supports the submission of dossier files that have been prepared outside of the REACH IT system in the IUCLID 5 format For certain dossier types REACH IT may allow the creation and submission of dossiers inside the REACH IT application for example online inquiry You are advised to consult the documentation related to dossier submission registration available on the ECHA website http www echa europa eu web guest support dossier submission tools For information purposes a high level overview of the dossier submission process is provided in Figure 1 The registration process can be presented by dividing it in four parts A D each Shown in the figure Each part is discussed below Part A Verifications The process starts with the submission of a dossier by the registrant The submitted dossier then undergoes a virus and XML format check and additionally a Business Rules BR validation These are discussed in the chapters 2 3 1 2 3 2 2 3
48. nufacture Type Deactivation based on article 50 2 iz confirm that want to claim cease manufacture for registration number 01 21140821 76 48 0000 Cancel Cease manufacture On the lt Confirmation gt tab confirm your intention to cease manufacture for the selected registration by ticking the checkbox Click the lt Cease manufacture gt button The system will confirm that you have successfully ceased manufacture Figure 41 Cease manufacture confirmation message Search Details Confirmation Please confirm your intention to cease manufacture Registration number 01 21140821 76 48 0000 EC Number 204 646 6 CAS number 123 72 8 Chemical Name butyraldehyde Cease Manufacture Type Deactivation based on article 50 2 A confirm that want to claim cease manufacture for registration number 01 21140821 76 48 0000 Cancel Cease manufacture You will also receive an internal message confirming the cease manufacture in your internal message box Figure 42 Cease manufacture internal message Message box folder 7 User folder Organisation folder Role folder Deleted messages Previous 1 10 of45 Next 10 Select All Select None Select Details Read Subject Creation Date Expire Date Recipient Fi MWhHide Yes Manufacture ceased for registration 01 21140821 76 48 0000 22 03 2010 15 22 Party LEA Manufacture has been ceased for registration 01 21140821 76 48 0000 after a cease manufacture clai
49. ocessing the file type may cause non acceptance of the dossier In that case the Agency will inform you thereof and you may have to resubmit the dossier amp The list of supported attachment file types are txt doc jpeg tiff mol pdf jpg and rtf in addition the following file types are also accepted in Inquiry notifications asp htm and html 2 3 4 Enforce rules Consequently REACH IT verifies that the submission is correct according to predefined business rules This is a prerequisite to further proceed with a dossier submission Examples of business rules are e The same dossier for example same dossier UUID has not been submitted already e The dossier type is correct for example the dossier type indicated as a submission parameter is consistent with the dossier type found inside the submitted dossier file Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 12 REACH IT Industry User Manual Version 2 0 e The format of the C amp L section is valid e The dossier contains a correct reference to a pre registration number or an inquiry number e When the dossier is from a Member of a Joint Submission it is to be submitted only after the Lead dossier successfully passed the business rule verification e When the dossier is an update dossier it contains all appropriate references to the previous submission number and when necessary to the prev
50. omments which are issued by Authorities opinion being an official position of for example a MSCA 2 5 Submission number and reference number 2 5 1 Submission number A submission number is a unique number assigned automatically after successful business rule validation and generated per each submission by REACH IT as mentioned in Article 20 REACH Regulation A preliminary submission number is assigned to the dossier at the time of uploading it to REACH IT Consequently the submission date is only set after the completion of business rule validation The upload date which is set directly after successful upload of the dossier via the Submission page is visible until the submission date has been set The submission number has the following characteristics e It is a unique number generated for each submission and which has a specific format e Itis issued for every submission whatever the type of submission or its status e t does not provide any information regarding the dossier type or company information or any other characteristic of the submission The structure of a submission number is as follows the submission number is issued at every submission using the following unique format 2 uppercase letters 6 digits a hyphen and two digits for example RX120340 22 the last two digits being used as checksum which allows for error detection 4 The submission number will be used in all further communications from REACH IT to
51. ommission Recommendation 2003 361 EC concerning the definition of micro small medium and large sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 Related to a joint submission Tick this box if your registration is related to a joint Submission You will then be prompted to enter the name of the joint submission 3 1 2 2 Submitting a Registration dossier of an on site transported isolated intermediate Some of the fields you have to fill in are identical as the ones for a full registration dossier Figure 5 and Figure 6 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 20 REACH IT Industry User Manual Version 2 0 Figure 5 Specific submission parameters for on site isolated intermediate registration dossiers step 2 Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandatory Submission type Registration of on site iso
52. on type Downstream user report b The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 The particular use s is are not covered in the exposure scenarios received from our supplier because we prefer not to provide the information on our uses and our further supply chain due to ae CBI reasons Reason s for submitting Downstream C Burdens of supply chain communication mechanisms user report O other reason s O The particular use s are not covered in the exposure scenarios received from our supplier although we communicated relevant information on our usefs and the further supply chain due to Include exemptions for DU CSR F Proceed Declaration e The particular use s are not covered in the exposure scenarios received from our supplier although we communicated relevant information on our use s and the further Supply chain due to a Exposure scenario title s is are inconsistent with our actual use s b Our conditions of use are outside the conditions described in the exposure scenario c Our use is advised against b
53. ossier submission report page Submission Report VETZ8 759 22 Submission report Hessier bis Hey Annethoe SUBS Sharh Mumbi ares Apie Patera mene pambe miasion an miis igolated intwamediates tonnage band Tranncorted isclated intonnacising tonnag band la please in PUrnSae Onder Fad wahar Lesegier file name Sua hance inlirmabeen Thode canhant Dossier Ronco rare Ramat Dossier information jer WLI ier Peer Dossier subject r ein by fh alg Su bmiting begal entity UID Type Of Gubires Bion Taisa of an update W SUETISSOSn an updaty he Gal CuLeDOn inbormanion Passed Tasks tho 3 2 2 3 Accounting tab If applicable this tab shows the accounting information pertaining to the submission This includes the Agency account information and the invoices linked to your dossier Click on the invoice number link to see the invoice details Figure 33 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 06 Dossier submission Release date July 2012 393 Figure 33 Accounting page Home gt submitted Dossiers gt Dossier Accounting Details Submission Report Accounting Annotations Agency account information BAM Pil 3456 7990 1254 56 account number S00001 00000000 Payment Please click on the link below to open your Invoice Invoice 10000055 3 2 2 4 Annotations tab The Dossier Annotations tab sho
54. pdated to zero the registration s status is marked inactive but it remains a valid registration e The registrant will not be requested to provide further information regarding the registered substance e The registrant may continue acting as the lead registrant for a joint submission if he so chooses e The registrant may restart manufacture of the substance by simply notifying the Agency of this no additional fee will be charged e The Agency shall inform the relevant MSCA 2 8 2 Cease manufacture upon receipt of a draft decision Pursuant to REACH Regulation Article 50 3 tf a registrant decides to cease manufacture upon the receipt of a draft decision he shall inform ECHA of this fact with the following consequences e The registration will no longer be valid and its status will be marked as revoked e The registrant will not be requested to provide further information regarding the registered substance e If the registrant is the lead registrant of a joint submission he will have to give up this lead registrant role using the Assign New Lead functionality as explained in the IUM Part 7 Joint Submission before ceasing manufacture e The registrant may only restart manufacture of the substance by submitting a new registration e The Agency shall inform the relevant MSCA 3 Step by step dossier submission 3 1 External submission 3 1 1 Step 1 starting a dossier submission To start the dossier submission go to
55. ry Submission type Registration of transported isolated intermediate v Purchase order The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 Declaration Joint submission Related to a joint submission O Proceed Purchase Order Where needed fill in with the appropriate reference to be used by ECHA during the generation of the invoice related to your submission Declaration Tick the checkbox related to the statement agreement for registration dossiers of on site isolated intermediates or of transported isolated intermediates Related to a joint submission Tick this box if your registration is related to a joint submission You will then be prompted to enter the name of the joint submission When all relevant data entry fields are completed Figure 5 and Figure 6 click on lt Proceed gt to go to the next step 3 1 2 3 Submitting a PPORD notification Some of the fields you have to fill in are identical as the ones for a full registration dossier Figure 7 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel
56. ry User Manual Version 2 0 3 4 1 Cease manufacture Click the lt Cease manufacture gt menu item REACH IT will direct the user to a search screen where you can search for all the active registrations your company currently has by using the search criteria provided Enter desired search criteria and click the lt Search gt button The system will display all the registration for which you can claim cease manufacture i e your active registrations Figure 38 Cease manufacture search tab Search Details Confirmation Registration Search Criteria Registration number Registration date From dd mm yyyy To dd mm yyyy Tonnage band v Substance related criteria EC Number CAS number Chemical Name Search Search results Select Registration Number Registration Date Registration Status Tonnage Band EC Number CAS Number Chemical Name 01 2114082176 48 0000 05 02 2010 Active Between 1 to 10 tonnes year 204 646 6 123 72 8 butyraldehyde 01 2114082195 48 0000 08 02 2010 Active Between 1 to 10 tonnes year 203 453 4 107 02 8 acrylaldehyde 01 2114082192 54 0000 08 02 2010 Active Between 10 to 100 tonnes year 255 938 5 42779 82 8 clopirac Cease manufacture Select the registration for which you wish to claim cease manufacture for and click the lt Cease manufacture gt button The system will direct you to the lt Details gt tab Figure 39 Cease manufacture details tab Search Details Confirmation Cease Manuf
57. s correct and the company size to be calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 O The particular use s is are not covered in the exposure scenarios received from our supplier because we prefer not to provide the information on our uses and our further supply chain due to The particular use s are not covered in the exposure scenarios received from our supplier Reason s for submitting Downstream although we communicated relevant information on our use s and the further supply chain due user report to Exposure scenario title s is are inconsistent with our actual use s O Our conditions of use are outside the conditions described in the exposure scenario O Our use is advised against by the supplier C Other reason s Declaration Include exemptions for DU CSR Regarding the DU CSR werelyon M Article 37 4 c exemptions according to C Article 37 4 f Proceed Click on lt Proceed gt to go to the next step 3 1 3 Step 3 Uploading a dossier file For any dossier type described in Step 2 the dossier upload page opens Figure 16 Fill in the mandatory fields related to the file name and the CAP
58. sage box Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 28 REACH IT Industry User Manual Version 2 0 Figure 21 Successful dossier upload with preliminary submission number step 4 er intro gt Dossier Submission Successful Registration Preliminary submission number Your dossier has received the following preliminary submission number ZY127642 95 A report indicating the status of this dossier will be available in your Message box shortly Please use this preliminary submission number if you need to contact the Agency about this dossier until you receive a submission or reference number Your dossier is under examination by our systems to ensure thal as a valld dossier It can be comecth processed Following the successful completion of this task you will receive a subsequent message confirming the submission and providing you with a submission date and submission number YoU will recernve the reference number upon successful processing of this dossier by ECHAS systems At any time you can also consult the status of your dossier and the report in the menu Registationnoticaton View registration notitication and indicating your preliminary submission number to retrieve it A Save your preliminary submission number as you might need it for further communication The final submission number as well as the submission date is only set after the compl
59. t step 3 1 2 7 Submitting a downstream user report The following information has to be entered in case of submission of a downstream user report Figure 12 Figure 12 Specific submission parameters for downstream user report step 2 Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandatory Submission type Downstream user report The submitting party declares the information above is correct and the company size to be Declaration calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 The particular use s is are not covered in the exposure scenarios received from our supplier because we prefer not to provide the information on our uses and our further supply chain due Reason s for submitting Downstream tO user report The particular use s are not cov
60. tatus Inactive Substance related criteria EC Number CAS number Chemical Name Search Search results Select Registration Number Registration Date Registration Status Tonnage Band EC Number CAS Number Chemical Name 01 2114082176 48 0000 2 5 2010 Inactive 204 646 6 123 72 8 butyraldehyde Restart manufacture Select the registration for which you wish to restart manufacture for and click the lt Restart manufacture gt button The system will direct you to the lt Details gt tab Figure 44 Restart manufacture details tab Search Details Confirmation Restart Manufacture details Registration number 01 2114082176 48 0000 EC Number 204 646 6 CAS number 123 72 8 Chemical Name butyraldehyde Original tonnage band Between 1 to 10 tonnes year Cease Manufacture Type Deactivation based on article 50 2 declare that my company will restart manufacture and or import of this substance As a consequence the registered volume will be updated to the original tonnage band registered and the registration will be marked as active Should the production and or import volume not correspond to the original tonnage band registered an update to the registration needs to be submitted hd Cancel Next Read and agree with the declaration by ticking the checkbox Click the lt Next gt button The system will direct you to the lt Confirmation gt tab Figure 45 Restart manufacture confirmation tab Searc
61. the lt Registration notification gt menu and click on lt Submit registration notification gt Figure 2 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 18 REACH IT Industry User Manual Version 2 0 Figure 2 Starting a dossier submission step 1 Home Company Welcome First Name Last Name Pre registration Pre SIEF You have 0 Unread messagers In Your message box Online dossiers Phase in Information View registration 7 notification Joint submission Classification and Labelling Claim Motified Substance Cease Manufacture Downstream user report Fiestart NWanutacture User account f Feference Murmber Legal entity change History Search As there is no possibility to save the submission process and continue it at a later stage you should have all required information available as well as the export file of the dossier prepared in UCLID 5 for your substance before you initiate the first step of a submission The lt Submit Dossier intro gt page opens after the menu selection Figure 3 3 1 2 Step 2 Selecting a dossier type Select the appropriate dossier type from the lt Dossier type gt drop down menu Figure 3 Figure 3 Selecting a dossier type step 2 Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes i
62. the text shown B27 4f z7 can tread the text below Try another For the submission of a file larger than 20 MB please request a large file access code before submission Access code for large files If YOU have an access code for a large dossier please enter it here Large file access code When the dossier file has been uploaded the lt Confirm Dossier Submission gt page opens Figure 20 Figure 20 Confirm dossier submission page step 3 Home gt Submit Dossier Intro gt Confirm Dossier Submission Confirm Dossier Submission Dossier type Registration Dossier file name Member toluene feewaiver_1 j 5z Organisation Name daute Company size Large Invoice Contact Name Name Surname Joint submission Related to a joint submission Yes Joint submission name Toluene Joint Submission Contirm submission Cancel submissian Carefully verify your data and on approval click on lt Confirm submission gt to finalise the dossier submission If you decide not to proceed with the submission click on lt Cancel Submission gt and the uploaded information will not be stored in the REACH IT system as you have terminated the submission process 3 1 4 Step 4 Confirming Dossier submission The dossier upload successful page opens Figure 21 after you confirm the submission It shows a confirmation message and provides your preliminary submission number An internal message Is simultaneously sent to your REACH IT Mes
63. tion notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information FIelgs Marked WiN an asterisk are mandatory Submission type Registration Purchase order The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for Declaration Joint submission Related to a joint submission Fi Proceed Purchase Order Where needed fill in with the appropriate reference to be used by ECHA during the generation of the invoice related to your submission Declaration Tick the checkbox related to the statement agreement entirely reported here below for registration submissions registration dossier or registration dossier of on site isolated intermediate or registration dossier of transported isolated intermediates The submitting party declares the information above is correct and the company size to be calculated according to Annex to C
64. tion page and or submission report 2 4 2 Dossier information page and submission report The time necessary for the processing of a submission may vary days to weeks depending on the TCC and or invoicing steps However the registrant can follow at any time the progression of his her submission either in the dossier information page or in the submission report Figure 32 The dossier information page and or the submission report are directly available by activation of a hyperlink in an internal message or by searching for a given submission Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 14 REACH IT Industry User Manual Version 2 0 The dossier information page contains the following sections tabs Figure 24 to Figure 27 e lt Details gt a summary of key dossier information e lt Submission report gt the complete submission report It shows the situation of a submission at the moment it is consulted It can be saved as a PDF document e lt Accounting gt if applicable the accounting information pertaining to the submission It includes a link to the invoice in the predefined language e lt Annotations gt the dossier annotations related to that submission are a full part of the information and comprise decisions and communications see chapter 3 2 2 4 issued by ECHA to the company on the submitted dossier Annotations cover also opinions and c
65. uld be rejected and a new initial dossier would need to be submitted The result of a dossier submission but also the main intermediates results either a failure or a success will be sent as an internal message to the company s REACH IT Message inbox Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 8 REACH IT Industry User Manual Version 2 0 Figure 1 Flow diagram for dossier submission Initial or Update Dossier submission A Acknowledgement ia of receipt Virus AML format check Dossi ossier can Business Rules validation a not be accepted lt C gt ie Yes if applicable Completeness Check CC i B Technical TCC and Financial Foc Invoicing TOC FEC Fayment Invoice Passed TCC Passed Ye No Invoice reminder Mo Oe Yes or no payment 1 Communicaton ae ez bee Failed 1 TCC 3 Paid before Update dossier Mo extended due within deadline date D Yes or no payment needed Decision message Decision message Dossier rejected dossier accepted REAC HJT message 2 1 Supported dossier types Table 1 provides an overview of the supported dossier types which can be submitted via REACH IT Information about J oint Submissions is provided in the Industry User Manual Part 7 Joint Submission available from the ECHA website e By convention i5z files created in IUCLID 5 will be called substance dossiers
66. ws annotations related to decisions communications opinions and comments provided by ECHA Each annotation is identified by an annotation number Id Figure 34 Figure 34 Annotation page Home gt Submitted Dossiers gt Dossier Annotations Details Submission Report Accounting Annotations Decisions Id Outcome Creation date Process type No records Communications Id Outcome Creation date Process type SUB C 21140636535 45 01 F REJECT O5 1 2 2008 Submission Pipeline Opinions id Outcome Creation date Process type No records Comments Select Creation date Process type No records Click on the annotation number link to see details on the chosen annotation Figure 35 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 36 REACH IT Industry User Manual Version 2 0 Figure 35 Annotation page with detailed information Home gt Submitted Dossiers gt View Dossier Decision Communication Info Communication Outcome RPEJECT Tye Communication on mandatory business rule Communication a Sa Soe SUB G 21140838933 43 0 number SUB C 114083 835 4 5 0 1 F External deadline Content Content Attachments Name Attached file No records Back Export as PDF Click on lt Back gt to go back to the Annotations tab Figure 34 And click on the lt Export as PDF gt button to download the annotation in PDF format Figure 35 3
67. y dossier or an online C amp L notification This type of submission is called an internal submission Future releases of REACH IT are expected to allow the online creation and submission of additional dossier types directly within REACH IT 2 7 Initial submission versus Update submissions REACH IT makes a distinction between the initial submissions and update submissions The initial submission is the first submission of a dossier type for example a registration for a substance The update submissions are all subsequent submissions of the same dossier type for that same substance Therefore an update submission always takes place after the initial Submission is completed The reasons for the submission of an update dossier are classified as either spontaneous or by request 2 7 1 Initial submission At the end of the very first successful submission for a substance the applicant receives e A submission number for that submission for example RX120340 22 e A reference number for the substance and that particular submission type for instance 01 2114367598 30 0000 for a registration 2 7 2 Submission of spontaneous updates Spontaneous updates can be made in situations such as e Change of tonnage band e Change in classification e Change in composition e etc Spontaneous registration updates mentioned in REACH Regulation Article 22 1 are legally required 2 7 3 Submission of up
68. y the supplier d Other reasons please specify those reasons in the adjacent free text field Figure 14 Figure 14 Specifying the reasons for submitting a downstream user report II Home gt Submit Dossier Intro Registration notification submission Here you can begin the submission process of your dossiers for the processes in the drop down menu shown below To submit an update you should use the same process as for the initial submission The new dossier submitted as an update must also contain all the previously submitted required information Fields marked with an asterisk are mandatory Submission type Downstream user report i The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Recommendation 2003 361 EC concerning the definition of micro small and medium sized enterprises The submitting party also declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regulation EC No 1907 2006 O The particular use s is are not covered in the exposure scenarios received from our supplier because we prefer not to provide the information on our uses and our further supply chain due to The particular use s are not covered in the exposure scenarios received from our supplier Reason s for submitting Downstream although we communicated r

ECHA - REACH-IT Industry User Manual: Part 06 Dossier Submission

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