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REACH-IT Industry User Manual

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1. anana naars ennn eenn ennn eene nnanrenannennrnennennenenn 2 6 1 JEE UOS Ur nenten neee ae mates meme ane Rae ARNE 2 6 2 Submission of spontaneous updates nnanenennene nennen eenn ennen nnen enensenenvenenennenennnnrnenenvenenennen 2 6 3 Submission of updates by request nanne nennen nnen ennen enannnnenrnnenenennnnenenvenenennnnennnnrnenenveneneenen 2 7 Cease and restart manufacture nansennennnanrennennnnseneennnnnensennnnnrennennnanrennennnanrennnnnnanennnnnnnnensenn 2 7 1 Cease manufacture for commercial reasons nnsnnnsennennnnn enn ennnnneenennnnnennennnnrennnnnensennnnnnnnennnnnnnvennnnnnnen 2 7 2 Cease manufacture upon receipt of a draft decision nanne nennen nennen nnenenennnnennnrnnenrn ennen EE 3 Step by step dossier SUbMISSION aannamen mene mene menen anmenen nne nene mens nens mens enre nnen nnennnennnnn 3 1 External SUBMISSIOM macys aoro r EAE r Erara 3 1 1 Step 1 starting a dossier submission ansnnnnanenenenennenenenennanen eenen nenenenennnnenenenennenenenennenenenenennnnen 3 1 2 Step 2 Selecting a dossier type EE 3 1 3 Step 3 Uploading a dossier fIl nanne nennen eenen ennenenennnnenennenennnnrnenenvenenennenennnnrnennneeneneenen 3 1 4 Step 4 Confirming Dossier S bmISSION ezssrmeernienensinder eden nedenene dienden inne Ee 3 1 5 Large Te access code FEGWESE mitment a shite meet aundieeiindeskeenne 3 2 Search and viewing dos
2. 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 want 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 Version 1 5 Page 38 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 3 4 2 Restart manufacture Click the lt Restart manufacture gt menu item 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 39 Restart manufacture search tab Search Details Confirmation Registration Search Criteria Registration number Registration date From dd mm yyyy To dd mm yyyy Registration status Inactive Substance related cr
3. 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 domain 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 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 22 Version 1 5 Page 28 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 22 REACH IT search function for dossiers Home Company You have 0 unread message s in your message box Pre registration Pre SlIEF Phase in Information Joint submission Submit EE registration Message box notification Se Claim Notified Substance
4. 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 iSz File name ergen EET Zen ausland est D ossiers I 2 Browse Enter the text shown cf8n5 2 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 Submit dossier Enter the CAPTCHA text shown 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 14 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 15 Version 1 5 Page 24 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 15 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 Ori
5. Dossiers gt Dossier Details Details Submission Report Accounting Annotations Dossier Dossier type Registration Submission Submission Number Bs 20340 2 submission Date Oev0S 2008 Is the submission an update TEs Is it a joint submission No status of the dossier Complete Substance Reference Number Substance Name aloha 2 dichloro 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 27 Request submitted file page Home gt Submitted Dossiers gt Dossier Details gt Request oUbmitted File Details Submission Report Accounting Annotations A justification is needed for requesting the file submitted Fields marked wih an asterisk Col are mandatory Hovering over a 7 sign displays helo information Request submitted file Justification Send request 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 28 to sav
6. 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 than undergoes a virus and XML format check and additionally a Business Rules BR validation These are discussed in the chapters 2 2 2 2 2 3 2 2 4 2 2 5 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 2 10 3 2 2 3 and 2 2 9 Part D End of process If the dossier fails the CC and or validation the dossier can not be accepted and the registrant has to submit a new initial dossier or send an update within the deadline More details are provided in chapter 2 2 11 A The result of a dossier submission but also the main inte
7. Philippe s Company O Show No Reference number assigned HL120301 58 04 09 2008 21 26 Party Philippe s Company O Show No New Pre SIEF member was added 04 09 2008 21 28 Party Philippe s Company O Show Yes Submitted file received HL120501 58 Pre registration bulk 04 09 2008 21 23 User phb EI Show No me file received KP120300 49 Pre registration 04 09 2008 21 22 User phb _ Move to Message box folder Version 1 5 Page 35 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 7 explains the general concepts of cease and restart manufacture Figure 33 Cease and restart manufacture menu items Home Company Welcome TA_FN12653747 Pre registration Pre SIEF You have 123 unread mess Si z T os pi PO On Online dossiers You last connected on 201 Phase in Information View registration notification Joint submission Submit registration notification Classification and Labelling Claim Noted Substance Cease Manufacture kW Restart Manufacture Message box User account Inventories Legal entity change Invoices Search Version 1 5 Page 36 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission
8. Search The search page is displayed Figure 23 which gives you the possibility to search dossiers submitted by your company only Figure 23 Submitted dossier Search page Home gt Submitted Dossiers Search Internal Search Dossiers Submitted by your Organisation Wise fhe sign as wildeard for your search criteria Dossier type Substance Name Dossier name Submission Number Submission Date fe dc mm yyyy To f dc mmiyyyy 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
9. The confirmed failures of overrulable business rules are available in a communication attached to your dossier For mandatory rules the business rule failure is highlighted in red Figure 28 For optional rules the business rule failure is highlighted in orange Figure 28 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 Version 1 5 Page 11 of 41 Release date May 2010 REACH IT Industry User Manual Ra EC I A Part 06 Dossier submission dp http echa europa eu here More details on BR validation can be found in Data Submission Manual 8 Business Rule validation available on the ECHA website 2 2 6 Dossier storage Dossiers which have a correct structure and have passed the business rules check are stored in the REACH IT database 2 2 7 Substance identi
10. also contain all the previously s Fields marked with an asterisk are mandatory Submission type Registration of transported isolated intermediate Purchase order Iw 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 Joint submission Related to a joint submission E Opt in for confidentiality claim s claim confidentiality according to Article 10 a xi of the REACH Declaration Regulation for the following study summaries or robust study summaries for which confidentiality was claimed in the registration submitted by the lead registrant 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 Click the checkbox related to the statement agreement for registration dossiers of on site isolated intermediates or of transported isolated intermediates Version 1 5 Page 20 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H
11. files created in IUCLID 5 will be called substance dossiers Table 1 Overview of dossier types supported by REACH IT NE E update Submission Registration Yes Yes Yes Registration of on site isolated intermediate Yes Yes Yes Registration of transported isolated intermediate Yes Yes Yes Process and Product Oriented Research and Development Yes Yes No PPORD notification Classification and Labelling C amp L notification Yes Yes Yes Inquiry notification Yes No No 2 2 Submission parameters 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 Submission parameters Dossier type C oO oO D Ke ES 2 Be OI oO ke O urchase order nquiry statement Oo Z E Registration O M NR Registration of on site isolated intermediate O M NR Registration of transported isolated H M Eg intermediate PPORD notification lo M NR C amp L notification NR NR NR Inquiry notification NR NR M Version 1 5 Page 9 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu M Mandatory submission parameter O optional parameter NR parameter not relev
12. select All Select None Select Details Read Subject Creation Date Expire Date Recipient 05 12 2008 15 49 User ECHALH201008 The submitted dossier cannot be processed Depending on the type of failure further information can be found either a in the submission report or b in the communication available in the annotation section of the dossier Submission number ZN124890 15 Submission timestamp 05 12 2008 15 49 Dossier type Registration regular Hide Yes Dossier business rule failure ZN124890 15 Download submission report Go to dossier Show No Submitted file received ZN124890 15 Registration ren 05 12 2008 15 49 Delete Move to Mes sage box folder v User ECHALH201008 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 before you can proceed with the submission Click on lt Request a large file access code gt Figure 12 A new page will open Figure 19 where you must enter a justification for the request Version 1 5 Page 26 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 19 Request access code page Home gt Submit Dossier Intro gt Request Access Code Regular registration dossier submission Request lar
13. substance is given a reference number depending on the dossier type for example a registration number according to a predefined format see chapter 2 4 2 3 Following up on submissions 2 3 1 Internal message Every main steps of the dossier submission 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 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 Version 1 5 Page 12 of 41 Release date May 2010 REACH IT Industry User Manual LS EC j A Part 06 Dossier submission g j http echa europa eu Successfully reached the end of the dossier processing this message is sent at the end of a successful submission process Each message includes a hyperlink to the dossier information page and or submission report 2 3 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 invoici
14. 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 Figure 24 shows the example of a search for complete update registration dossiers having a submission number containing the number 120 Version 1 5 Page 29 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 24 Search combination for submissions Home gt Submitted Dossiers Search MG ut Search Dossiers Submitted by your Organisation Lise the sign as Wildcard for your search criteria Dossier type Registration substance Mame Dossier name submission Number Submission Date fe cdmm yyyy To Elogmmmnennd 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 25 Figure 25 Search results for submissions Home gt Submitted Dossiers Search Buur Search Dossiers Submitted by your Organisation Use the sign as wildcard for your search criteria Dossier type Registratio
15. 359 19 A submission report indicating the status of this submission will be available in your Message box shortly Please use this submission number if you need to contact the Agency about this submission until you receive the reference number s You will receive the reference number s upon successful processing of this submission by ECHA s systems At any time you can also consult the status of your dossier and the submission report in the menu Registration notification View registration notification and indicating your submission number to retrieve it A Save your submission number as you might need it for further communication If you click on lt Message box gt you will have access to the submission report Click on lt Download submission report gt Figure 18 Figure 18 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 30 days To view all internal messages click here Message box folder 7 User folder Organisation folder Role folder Deleted messages
16. 6 Dossier submission EL H i http echa europa eu 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 3 Step 3 Uploading a dossier file For any dossier type described in Step 2 the dossier upload page opens Figure 12 Fill in the mandatory fields related to the file name and the CAPTCHA text Figure 12 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 Access code for large files For the submission of a file larger than 20 MB please request a large file access code before submission If you have an access code for a large dossier please enter it here Large file access code Submit dossier Click on lt Browse gt to open a dialogue box which allows you to select the dossier file you want to upload Figure 13 Your substance file must have already been created in I
17. 7 ECHA http echa europa eu REACH IT Industry User Manual Part 06 Dossier submission j DE Je Eh e gf REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Document history May 2010 Figure 1 updated March 2010 Update to REACH IT 2 0 December 2009 P 7 Text added to introduce submission pipeline flow diagram chapter 2 P 8 Inclusion of a flow diagram for the submission pipeline Figure 1 Flow diagram for dossier submission P 26 Sentence on large access code added in chapter 3 1 5 Minor textual revisions Document in new layout December 2008 First version Reference ECHA 08 B 14 EN Issue date 28 May 2010 Language English If you have questions or comments that relate to this document please send them using the information request form to ECHA helpdesk Quote the reference and issue date as stated above The information request form can be accessed via the ECHA website under the section for the REACH helpdesk at the following address http echa europa eu reach helpdesk echahelp en asp European Chemicals Agency 2009 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 info echa europa eu Version 1 5 Page 2 of 41 Releas
18. EL H i http echa europa eu 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 Le your active registrations Figure 34 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 35 Cease manufacture details tab Search Details Confirmation Cease Manu
19. UCLID 5 and have the extension i5z More information about IUCLID and dossier creation can be found in the UCLID 5 user manual Version 1 5 Page 23 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 13 Dossier selection from i5z files step 3 Home gt Submit Dossier Intro gt Submit External Dossier Regular registry obt Please pick here File name Enter the text s 3 My Recent weng s a Documents g S metra emt ante Satan dn 3 Ei M pl glwa viad gu Access code fo Desktop Eee sagt Zet r oj ten uh Ee fa es ms iiti ef BIN Trets g EL e k Stoluene reg lead 10 100 init i5z e sie Hep vrare vl Th Oren vene tat ets ad thy 3 abp rdja ei GC tii tatty For the submissic If you have an ac Large file acces Submit dos 4 mp emi it ital Sig tii Tam Ets t t t KC Stilts tty e gt ome i At tiha t t as thy T eap Haa H gog A t gt ih teats m8 P ee ea eves My Computer Wil eS File name toluene reg lead 1 0 100 init i52 My Network Files of type a 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 14 Figure 14 Link to locally stored i5z file in lt File name gt data field step 3
20. ance 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 6 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 6 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 are legally required under REACH Regulation Article 22 1 2 6 3 Submission of updates 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 submit
21. ange submission number given to previous legal entity Reference number given to previous legal entity Acquisition of rights to a previous submission Confidentiality claims Declaration Number of study summaries rabust study summaries for which a fee will be levied List of study surmmaries robust study summaries for which confidentiality is claimed Submitting justification s for the above confidentiality claim s Confirm submission Cancel submission 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 Version 1 5 Page 25 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 submission successful page opens Figure 17 after you confirm the submission It shows a confirmation message and provides your submission number An_ internal message is simultaneously sent to your REACH IT Message box Figure 17 Successful dossier submission with submission number step 4 classification and labelling C amp L notification submission Submission number Your submission has received the following submission number LS120
22. ant for that dossier type except in the case of the submission of a registration covering both types of intermediates only 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 No restriction statement this is an acknowledgement that the substance for which the dossier is submitted is not subject to any restrictions in existing legislation s or to any exemptions under REACH 2 2 1 Data Submission process The submission of a dossier and its subsequent processing by REACH IT is a complex procedure that is executed as 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 O E c p ee Les x T Kai Leg ZS Lo S Q O Kl oO e ie ez c IEN la ae a ee Oe Lei GI a CH o DE a CO Virusscan NN File format validation Y Y Y Y Internal structure validation Y Y Ivv Business rule validation Y y Y Y Dossier storage Y Y Y Y Substance identity creation Y Y Y Y Assign MSCA LY LY IN IN Technical Completeness Check Y Y N IN Pay submissionfee Y Y N N Overall completeness check Y Y N N Issue reference number Y Y N Y Ste
23. ation 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 Click the checkbox related to the statement agreement 3 1 2 4 Submitting an Inquiry notification om ei fields you have to fill in are identical as the ones for a full registration dossier igure 9 Figure 9 Specific submission parameters for an inquiry 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 sub Fields marked with an asterisk are mandatory Submission type Inquiry notification Proceed Click on lt Proceed gt to go to the next step Version 1 5 Page 21 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 3 1 2 5 Submitting a C amp L notification Quantity produced or imported Indicate the volume range of the substance notified and the year In the case the substa
24. ation based on article 50 2 i 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 37 Cease manufacture confirmation message Search Details Confirmation Please confirm your intention to cease manufacture 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 de 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 38 Cease manufacture internal message Message box folder User folder Organisation folder Role folder Deleted messages Previous 1 10 of45 Next 10 Select All Select None Select Details Read Subject LI nde Yes Creation Date Expire Date Recipient 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 claim performed by party
25. e Wo records Hack Export as PDF Click on lt Back gt to go back to the Annotations tab Figure 30 And click on the lt Export as PDF gt button to download the annotation in PDF format Figure 31 3 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 32 for example the dossier violates a business rule is technically incomplete Technical Completeness Check or the file format is invalid see chapter 2 2 4 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 Version 1 5 Page 34 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission SEL H i http echa europa eu Figure 32 Internal message with dossier submission failure details 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
26. e Result Not Satistied In your submission form Rule Level Optional Rule Result Not Satisfied Version 1 5 Release date May 2010 Accounting Rule Name SUB_GBL_UCO2 BRIO Rule Name SUB_GBL_UCO2 BR20 Annotations Submission Report ZN124890 15 Registration ZN 1 24896 15 Failed Between 100 to 1000 tannes year vas Na SUB PPD Wet TC20_ nitial_ dossier vanadium with _customers_no 152 IUCS 1dOB0d64 5h0e 4 hel h327 1973927180370 SUB PFP UCD TC20_ nitial dossier vanadium with _customers_no 152 ECHA SAT No No Wa mA No Remark Result Succeeded Succeeded Succeeded 5 Failed Rule Message The dossier type specified during the creation of the submitted dossier is not equal to the dossier type mentioned Rule Message The cormbany Information In vour dossier is not the same as the company recorded in REACH IT Please note that this is an Optional Business Rule and that your dossier will continue to be processed Page 32 of 41 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 29 Figure 29 Accounting page Home gt submitted Dossiers gt Dossier Accounting Detai
27. e date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Table of Contents 1 Uu de e Dei de sitenaam E a EE vans 6 2 General concept of dossier submission aaan anna menenene mene mene neme nensnensnansnnrsenrnennn 2 1 Supported dossier VCS nanne aanne adenine benadeelt usenet 2 2 Submission parameters ennen eege 2 2 1 Data Submission procesSS EE 2 2 2 VITUS SCA aient entente spans einen Seren eben nennen tan heakenka Sasiaxneseeemeneuntaensaieeacseat 2 2 3 Eet eege ee 2 2 4 internal structure te d e BE 2 2 5 BUSINESS rules validation E 2 2 6 DOS SION STO E 2 2 7 Substance identity ChE AOI E 2 2 8 PS SUN MS CA E 2 2 9 Technical Completeness Check TCC eneen ennenenennnnenenenensenanenennnnenenenensnnenenenenrennnenenennenen 2 2 10 Pay Submission TE 2 2 11 Overall completeness CEC EE 2 2 12 Issue references E e E 2 3 POMOWING UPON SUDMIS SIO INS osere aa EE E OAE E Ta 2 3 1 mema NS SS A E E 2 3 2 Dossier information page and submission report nanne n nnn enen nennen nnen ennrnenenennenvennnenennrnenenenn 2 4 Submission number and reference number nnnnnnnnnnnnennennenenensennnneennnnnnnnennnnnnnnnennennnnenennenn 2 4 1 SUITS S 1 MUTCD E 2 4 2 Reference Une 2 5 External versus internal submissions cccccesseeeeeeeeeeeeeeeeeeeeesneeeeeseesseesneeseaeseesseeneeseonseessnaeseessoees 2 6 Initial submission versus Update submissions
28. e this report as a PDF document Version 1 5 Page 31 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 28 Dossier submission report page ZEIEN Submission Report Submission report Dossier type Submission number Reference date Reference number Submission date Current state Submitted information Tonnage band On site isolated intermediates tannage band Transported isolated intermediates tonnage band Is phase In Purchase order Fee waiver Dossier file name Dossier content Dossier information Dossier UID Dossier creator Dossier subject Name given by the dossier creator Submitting legal entity Legal entity change Legal Entity Change submission number given to previous legal entity Reference number given to previous legal entity Declaration of acquisition of rights to a previous submission Type of submission Submission of an update Is the submission an update Fee calculation information Joint submission Company Size Invoice contact name Invoice Tax numbet Declaration Number of study summaries robust study summaries List of study summaries robust study summaries Justificatian s for the above confidentiality claim s Passed Tasks No Task 1 Virus check bo File format validatan Check XML structure D ow Enforce Rules Rule Level Mandatory Rul
29. e 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 t is a unique number generated for each submission and which has a specific format e tis 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 A The submission number will be used in all further communications from REACH IT to Version 1 5 Page 13 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu the user concerning the corresponding dossier 2 4 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 c
30. ecision 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 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 UM 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 Version 1 5 Page 16 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 3 Step by step dossier submission 3 1 External submission Advanced search allows the user to search via a combination of domain 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 EN The upload of dossiers with file size above 20 MB Megabytes has first to be approved by ECHA 3 1 1 Step 1 starting a dossier submission To start the dossier submission go to the lt Registration notification gt menu and click on lt Submit registration notification gt Figure 2 Figure 2 Starting a dossier submissio
31. entated 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 n 100 File name l SE 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 the text shown B27 4f Ed Cant read the text below Try another fee 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 16 Figure 16 Confirm dossier submission page step 3 Home gt Submit Dossier Intra gt Confirm Dossier submission Confirm Dossier Submission Dossier type Registration regular erf een heeten d mere ACHT files Dossier file name for versions 1 pe 3S d A T initial dossier vanadium with customers mo ID Organisation Name OF FD ae ECHA SAT Company size Medium Invoice Contact Name Helene HOFFSTADT Tonnage band Between 100 to 1000 tonnesvear On site Isolated Intermediates Tonnage band Transported Isolated Intermediates Tonnage band Fee Waiver Phase in Legal entity change Legal entity ch
32. ernal usage 17 Late Pre registration reserved to pre registrations according to REACH Regulation Article 28 6 lt BASE NUMBER gt is a 10 digit number generated randomly 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 INDEX NUMBER gt is a 4 digit number that can be used to indicate the index of a Member in a Joint Submission Version 1 5 Page 14 of 41 Release date May 2010 REACH IT Industry User Manual Ra ECI i N Part 06 Dossier submission http echa europa eu 2 5 External versus internal submissions REACH IT supports the submission of dossier files that have been prepared in IUCLID 5 outside of the REACH IT system This type of submission is called an external submission Future releases of REACH IT are expected to allow the creation and submission of some dossier types directly within the REACH IT application This type of submission is called an internal submission and for example the creation of an online inquiry dossier can be done in REACH IT 2 6 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 subst
33. essage 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 Preterenres 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 Userfolder Organisation folder Role folder Deleted messages Select All select Mone Select Details Read Subject Creation Date Expire Date Recipient 06 1 2 2008 User 16 16 ECHALH20 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 ukAtI1xS 95 E ride Yes Large file one time access code 05 1 2 2008 User 13 49 ECHALH201008 Submitted file received 7N124890 15 05 12 2008 User Registration treg 15 49 ECHALH201008 Delete Moveto Message box folder E kb Show Yes Dossier business rule failure M1248690 15 a bk 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 12 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
34. facture details 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 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 igi 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 e 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 Version 1 5 Page 37 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 36 Cease manufacture confirmation tab 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 Deactiv
35. ge 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 OU 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 cancel 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 20 Figure 20 Submission request sent page Home gt Submit Dossier Intro gt submission Request sent Transported isolated intermediate T I 1 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 21 Version 1 5 Page 27 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 21 Internal REACH IT message regarding Large file one time access code Home gt Messages This internal m
36. ges Previous 1 10 of46 Next10 select All Select None Select Details Read Subject Creation Date Expire Date Recipient VHide 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 O Show Yes Manufacture ceased for registration 01 2114082176 48 0000 22 03 2010 15 22 Party LEA Version 1 5 Page 40 of 41 Release date May 2010 European Chemicals Agency PO Box 400 Annankatu 18 Fl 00121 Helsinki Finland http echa europa eu
37. hereof and you may have to resubmit the dossier The list of supported attachment file types are txt doc jpeg tiff mol pdf jog and rtf in addition the following file types are also accepted in Inquiry notifications asp htm and html 2 2 5 Business rules validation 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 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 successful submission of the Lead dossier e When the dossier is an update dossier it contains all appropriate references to the previous submission number and when necessary to the previous 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
38. i http echa europa eu Opt in for confidentiality claim s Click the checkbox wherever applicable In case you as a Member of a Joint Submission would like to confirm that you want to keep confidential robust study summaries from IUCLID sections 4 to 7 submitted by the Lead of the Joint Submission you have to click the check box related to the declaration for confidentiality and fill in the following fields that are displayed Figure 5 This is only applicable in the case of a Member of a Joint Submission for example not for the Lead When all relevant data entry fields are completed Figure 6 and Figure 7 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 8 Figure 8 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 minie marlon with on octorich mre mandotnr Hieids Marked with an astensk rel are manaaton 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 Declar
39. ion dossiers step Zi 18 Figure 5 Opt in for confidentiality claim s step 3 anna nennennenenseneennsenr ennen ennen renners ennnenesnnnenvennns 19 Figure 6 Specific submission parameters for on site isolated intermediate registration dossiers step 2 20 Figure 7 Specific submission parameters for transported isolated intermediate registration dossiers step 2 20 Figure 8 Specific submission parameters for a PPORD notification step 2 un unannnenn ennn eene nen ene ennn 21 Figure 9 Specific submission parameters for an inquiry notification step Zi 21 Figure 10 Specific submission parameters for a C amp L notification step 2 nun ennennnenr eneen eens enr ennn 22 Figure 11 Specify if the submission is on behalf Of a group 22 Figure 12 Submit external dossier page step 3 naan eerennnenn vennen ve nnenrennnennvennnenvennnenr ensen vennnenrennns 23 Figure 13 Dossier selection from i5z files step 3 onsen nennen ee nnenrennnennvennnenvennnenrennnenvennnenrennns 24 Figure 14 Link to locally stored i5z file in lt File name gt data field step 32 24 Figure 15 Dossier upload progress bar step 3 EE 25 Figure 16 Confirm dossier submission page step 32 25 Figure 17 Successful dossier submission with submission number step A 26 Figure 18 View in message box Date 26 Figure 19 Request access code page ununrsunnerne ners n ennen vennen ve nenevenene ennen en
40. iteria 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 40 Restart manufacture details tab Search Details Confirmation Restart Manufacture details 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 declare that my company will restart manufacture and or import of this substance As a consequence the registered volume will be updated to the j 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 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 Version 1 5 Page 39 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submis
41. lation EC No 1907 2006 Opt in for confidentiality claim s Click the checkbox wherever applicable In case you are a Member of a Joint Submission and would like to confirm that you want to keep confidential robust study summaries from IUCLID sections 4 to 7 submitted by the Lead of the Joint Submission you have to click the check box related to the declaration for confidentiality and fill in the following fields that are displayed Figure 5 A This is only applicable in the case of a Member of a Joint Submission Figure 5 Opt in for confidentiality claim s step 3 Opt in for confidentiality claim s Iw claim confidentiality according to Article 10 a xi of the REACH Declaration Regulation for the following study summaries or robust study summaries for which confidentiality was claimed in the registration submitted by the lead registrant The number of study summaries robust study summaries for which a fee will be levied is The list of study summaries robust study summaries for which confidentiality is claimed please give a number to each study and indicate the associated endpoint LUID in the lead dossier if known the IUCLID 5 section the endpoint name and the reference of the study In addition to Other than justifications submitted by the lead registrant submit the following justification s for the above confidentiality claim s please use the same number as in
42. ls Submission Report Accounting Annotations Agency account information BAN Fll2 3456 7890 1254 56 account number SU0001 O0000000 Payment Please click on the link below to open your Invoice Inwalce 10000025 3 2 2 4 Annotations tab The Dossier Annotations tab shows annotations related to decisions communications opinions and comments provided by ECHA Each annotation is identified by an annotation number Id Figure 30 Figure 30 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 SWB C 21 14065655 45 0 1 F REJECT 05 12 2006 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 31 Version 1 5 Page 33 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 31 Annotation page with detailed information Home gt submitted Dossiers gt View Dossier Decision Lommunication Info Communication Outcome REJECT Type Communication on mandatory business rule DIE SUB C 2114083833 43 01 F number External deadline Content Content Attachments Name Attached fil
43. mission 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 s Fields marked with an asterisk are mandatory Submission type Purchase order Iv The submitting party declares the information above is correct and the company size to be calculated according to Annex to Commission Declaration Recommendation 2003 36 1 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 Joint submission Related to a joint submission E Opt in for confidentiality claim s E claim confidentiality according to Article 10 a xi of the REACH Declaration Regulation for the following study summaries or robust study summaries for which confidentiality was claimed in the registration submitted by the lead registrant Proceed Figure 7 Specific submission parameters for transported isolated intermediate registration dossiers 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
44. n step 1 BECHA Home Company Welcome pirjo ahtiainen Pre registration Pre SIEF You have 1 unread message s in your message box You last connected on 2010 03 17 10 30 58 0 Online dossiers Phase in Information View registration notification Joint submission Classification and Labelling Claim Noted Substance Message box User account Cease Manufacture Inventones Restart Legal entity change Manufacture Invoices 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 IUCLID 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 Version 1 5 Page 17 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 in the drop down menu shown below To process as for the initial submission The new dossier submitted as an update must also contain all the p
45. n k Substance Name Dossier name Submission Number 120 submission Date From idam Im yyy TO loo mAn Reference Number Is it an Update Yes Is it a Joint Submission 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 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 res 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 26 Figure 24 and Figure 25 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 Version 1 5 Page 30 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 26 and Figure 27 Figure 26 Dossier details page Home gt Submitted
46. nanstnann ennn se nnnn venne renners 27 Figure 20 Submission request sent page 27 Figure 21 Internal REACH IT message regarding Large file One time accesscode eneen 28 Figure 22 REACH IT search function for dossiers unne oanennnennenenseneennsenrennnerrenensenrennnenseansenesnnsens ennn 29 Figure 23 Submitted dossier Search page 29 Figure 24 Search combination for submissions un anunns enn ennnersennnsensennsenrennnerrennnsenrennnensdeneeneennsens ennn 30 Figure 25 Search results for submissions annen nennen eennsenrennnerr ennen eennsensennnenrennnsnrsnnnenseneneenesennenv ennn 30 Figure 26 Dossier details page uunnnnnneneensennenenenenensennenennneneennenvenenr venen venensvenenenenensennensennendenenn eenen 31 Figure 27 Request submitted file page ann enn ennn eene nens enn ennnenr ennen eennnens ennen enensensennnensennneenesnnnenv ennn 31 Figure 28 Dossier submission report page un annnonenenenenenene eenen ennnenvenenrvenenrvenenesenenennnnennenvennenvenenn eenen 32 Foure 29E ACCOUNINO DAOC E 33 Foure 30 AMMON PAJE ects trina et upc ct ceric hn able tla bl ieee 33 Figure 31 Annotation page with detailed information cccccccseeccceseeeeeceeeeeeeaeeeeeeseeeeeesaeeeeeeseaeeeesaaeeeesaeeeesaaees 34 Figure 32 Internal message with dossier submission failure details aanne nennen ennenenseneennnens ennn 35 Figure 33 Cease and restart manufacture MENU items an
47. nce 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 Figure 10 Specific submission parameters for a C amp L 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 sul 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 10 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 11 Figure 11 Specify if the submission is on behalf of a group ER BECHA __Reach You are con
48. nected as P t1 on behalf of Chemicals and co Ds eh Home gt Submit Dossier Intro gt Select group of Manufacturer s Importer s Company Group of Manufacturer s Importer s Pre registration KC s If the notifier of this C amp L notification is a group of Manufacturer s Importer s you shall select it from the list below and click on next Pre SIEF If you do not notify this C amp L as a group of Manufacturer s Importer s click on next Online dossie SES Please find below the list of group of Manufacturer s Importer s that you have already created in REACH IT and who can notify to ECHA the C amp L under the CLP Phase in Information regulation Peele If you want to view and or update the information related to a group member of the group member details click on the group s name notification You can also create a new group of Manufacturer s Importer s 2 if needed Joint submission Classification and Select Group name Last update Labelling Group of MI 01 02 03 2010 Message box Group of MI 02 02 03 2010 User account Group of MI 03 02 03 2010 Inventories Group of MI 04 02 03 2010 Legal entity change invoices Click here to deselect the currently selected group Search Cancel Next gt gt On this screen you can e select a group of MI and assign it to your submission Version 1 5 Page 22 of 41 Release date May 2010 REACH IT Industry User Manual Part 0
49. nen ennnsensennnerrennnerrennnsensennnensennneeneennenr ennn 36 Figure 34 Cease manufacture search ab 37 Figure 35 Cease manufacture details ab 37 Figure 36 Cease manufacture confirmation Iab ennen ennnsenrennnenssensenesennenrennns 38 Figure 37 Cease manufacture confirmation MESSAGE n nuunennennnseneennnenrennnerrennnsenrennnensennneenennnser ennn 38 Figure 38 Cease manufacture internal message u nnunnsensennnenrenensensennsenrennnerrennnsenrennnensennennennnnenr ennn 38 Figure 39 Restart manufacture search ab 39 Figure 40 Restart manufacture details toab 39 Version 1 5 Page 4 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 41 Restart manufacture confirmation Lab 40 Figure 42 Restart manufacture confirmation message uuunnennenenseneennnenr eneen ennnsenvennnensennnenneennens ennn 40 Figure 43 Restart manufacture internal MESSAGE nuu unnennnenn ennen renners ennnerrennnsenvennnensennneneennnensennns 40 Version 1 5 Page 5 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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
50. ng 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 28 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 The dossier information page contains the following sections tabs Figure 20 to Figure 23 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 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 comments which are issued by Authorities opinion being an official position of for example a MSCA 2 4 Submission number and reference number 2 4 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 th
51. ompany 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 e APPORD 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 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 the details for each structure element Table 4 Structure reference number lt TYPE gt is a 2 digit number giving the type of number 01 Registration 02 C amp L notification 03 Substance in article 04 PPORD 05 Pre registration reserved to pre registrations according REACH 828 2 06 Inquiry 07 On site isolated intermediates 08 Transported isolated intermediates 09 Data Holder notification 10 Downstream User notification 11 Application for Authorisation 12 Substance Evaluation 13 Annex XV C amp L Harmonization 14 Annex XV Authorisation 15 Annex XV Restriction 16 Int
52. p occurs Y yes N no given during the inquiry process not during submission 2 2 2 Virus scan The submitted dossier file is scanned for known viruses Only virus free dossier files will proceed to the next step 2 2 3 File format validation The file format validation is verification that the submitted dossier file is of the appropriate format i5z file format and is compliant with the XML schema used by IUCLID 5 2 2 4 Internal structure validation 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 Version 1 5 Page 10 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 submission contained unsupported attachment file type s Please note Your submission is still being processed During further processing the file type may cause non acceptance of the submission In that case ECHA will inform you t
53. 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 and 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 Version 1 5 Page 6 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 echa europa eu help help docs en asp
54. reviously submit Fields marked with an asterisk are mandatory Submission type Registration Registration of on site isolated intermediate Registration of transported isolated intermediate Product and Process Orientated Research and Development PPORD notification Classification and Labelling C amp L notification Inguiry 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 3 1 2 1 Submitting a Registration dossier Figure 4 Specific submission parameters for 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 process as for the initial submission The new dossier submitted as an update must also contain all the previously submij Fields marked with an asterisk are mandatory Submission type Registration si 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 regis
55. rmediates results either a failure or a success will be sent as an internal message to the company s REACH IT Message inbox Version 1 5 Page 7 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu Figure 1 Flow diagram for dossier submission Initial or Update Dossier submission Acknowledgement of receipt Virus x ML format check Business Rules validation e ED Vos Yes if applicable Invoicing Dossier can not be accepted Completeness Check CC H Technical TCC and Financial F Ci TOC FCC Payment Invoice Passed TCC Passed We Paid before Invoice due date reminder No No ie ee Yes or no payment needed Non Communicator nd TC GD er S Update dossier Mo within deadline Faig before extended due date Yes or no payment needed 5 Decision message Decision message Dossier rejected dossier accepted zy REACHAT message Version 1 5 Page 8 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 2 1 Supported dossier types Table 1 provides an overview of the supported dossier types which can be submitted via REACH IT Information about Joint Submissions is provided in the Industry User Manual Part 7 Joint Submission available from the ECHA website By convention i5z
56. sier detailS anna annanennenrnnennnnennnnanensnnenensenenrennnnanennnnenenenenenenn 3 2 1 Dearehmg SubMISSIONS essentie hade eae ete ocean deed enlenteskenn Version 1 5 Page 3 of 41 Release date May 2010 REACH IT Industry User Manual EL H i Part 06 Dossier submission http echa europa eu 3 2 2 Dossiers information pagesen NEA EN EEE EEE 31 3 3 Dossier submission failur S naan en nnnanennenennnnennnenennenensennnnennnnanenennenensennnnennnnenenenenennnnennenennen 34 3 4 Cease and restart manufacture wisscinccssscccessseccesuacercemaviccossaniecanindsecenenstcnesactteneimcssnermeutsarieousiesesnteeodesnts 36 3 4 1 Cease E UN ET d nende neden neder eenderde beant mie rempeeenuvocer 37 3 4 2 Restart manufacture EE 39 Table of Tables Table 1 Overview of dossier types supported by REACH IT annen nenenenenenenenenennneneensenvensnrvenene vene 9 Table 2 Submission parameters to be specified aaneen eneen ennen eensenvenenrvenene venen vennen vensensnnenvenenr venen 9 Table 3 Submission steps versus submitted dossier type un ananns ens enen eene nensenrennnenr ennen eennnens ennen 10 Table 4 Structure een le 14 Table of Figures Figure 1 Flow diagram for dossier submission un uannensensennsenr ennn errenensensennnensennnenrenensersnnnensenenensenensen 8 Figure 2 Starting a dossier submission step Tt 17 Figure 3 Selecting a dossier type step Zi 18 Figure 4 Specific submission parameters for registrat
57. sion EL H i http echa europa eu Figure 41 Restart manufacture confirmation tab Search 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 2 confirm that want to claim restart manufacture for registration number 01 21140821 76 48 0000 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 Figure 42 Restart manufacture confirmation message Search 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 Cease Manufacture Type Deactivation based on article 50 2 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 43 Restart manufacture internal message Message box folder F User folder Organisation folder Role folder Deleted messa
58. ted That is why an update shall always contain all the information available for that substance Version 1 5 Page 15 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission http echa europa eu 2 7 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 7 1 and 2 7 2 2 7 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 updated 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 2 Cease manufacture upon receipt of a draft decision Pursuant to REACH Regulation Article 50 3 if a registrant decides to cease manufacture upon the receipt of a draft d
59. the previous list to establish a link between the study for which you claim the confidentiality and the justification Proceed Fill in all fields related to the number and list s of studies for which confidentiality is claimed as well as the justifications for each claim if it differs from the justification provided in the Lead dossier Figure 6 When all relevant data entry fields are completed Figure 4 to Figure 5 click on lt Proceed gt to go to the next step Opting in for confidentiality claims will generate a fee In case that you do not wish to opt in for those confidentiality claims you should not tick the box This will not have any consequences in relation to the publication of the information claimed confidential by the Lead as it will not be made publicly available and will not generate a fee The functionality for opting in exists due to elements of the Fee Regulation EC 340 2008 Version 1 5 Page 19 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu 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 6 and Figure 7 Figure 6 Specific submission parameters for on site isolated intermediate registration dossiers step 2 Registration notification submission Here you can begin the sub
60. tration notification is appropriate for registration notification under Regulation EC No 1907 2006 Joint submission Related to a joint submission m Opt in for confidentiality claim s claim confidentiality according to Article 10 a xi of the REACH Declaration Regulation for the following study summaries or robust study summaries for which confidentiality was claimed in the registration submitted by the lead registrant 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 Click 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 Commission Recommendation 2003 361 EC concerning the definition of micro small medium and large sized enterprises The submitting party also Version 1 5 Page 18 of 41 Release date May 2010 REACH IT Industry User Manual Part 06 Dossier submission EL H i http echa europa eu declares that following careful verification the substance subject of the present registration notification is appropriate for registration notification under Regu
61. ty creation 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 very directly related to the IUCLID5 sections 1 1 Identification and 1 2 Composition 2 2 8 Assign MSCA At that 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 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 2 9 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 2 10 Pay submission fee Depending on the submitted dossier Table 3 and if relevant a submission fee is calculated and an invoice is generated for the submission 2 2 11 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 2 12 Issue reference number At the end of a successful initial submission the
62. your User Preferences Message box folder User folder Organisation folder Role folder Deleted messages Previous 10 91 100 of 182 Next 10 select All Select None Select Details Read Subject Creation Date Expire Date Recipient fl Hide Yes submission failure submission rule violation SY 120502 19 04 09 2008 22 13 User phb submission rules have been violated submission number SY120302 19 submission timestamp 04 09 2008 22 12 Dossier type Registration regular Download submission report Go to dossier 1 Rule Name SUB_LREG_UCO3_BR110 Level Overrulable Result Failed Message One or several identifiers indicated in section 1 3 of your IUCLID 5 dossier are not valid For information the validity of the following identifiers is checked at this stage if relevant REACH inquiry number REACH preregistration number Please make sure that you have reported only identifiers related to your company and the substance for which you sent this dossier O Show No Decision made by the Agency 5Y 120302 19 04 09 2008 22 13 User phb O Show Yes Submitted file received SY120302 19 Registration reg 04 09 2008 22 12 User phb O Show Yes successfully reached the end of the pipeline KP120300 49 04 09 2008 21 26 User phb O Show Yes successfully reached the end of the pipeline HL120301 58 04 09 2008 21 28 User phb O Show No Reference number assigned KP120300 49 04 09 2008 21 25 Party

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