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Part 4 How to Pass Business Rule Verification ("Enforce Rules")

1. Home gt Search gt Details Search Details Dossier Dossier Dossier type Reqstration Submission Submission Number TC122364 48 Submission Date 11 03 2010 Is the submission an No update ls it a joint submission No Status of the dossier Pending substance Reference Number Substance Name chem_o008 Return to search 5 Choose the Submission Report tab Version 2 3 Page 11 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 7 Dossier Further Details Home gt Submitted Dossiers gt Dossier Details Submission Report Details Accounting Annotations Dossier Dossier type Registration Submission Submission Number TG 46 Submission Date 11 03 2010 Is the submission an No Update Is it a joint submission No Status of the dossier Pending Substance Reference Number Substance Name Request submitted file 6 In the bottom of the Submission report you will find a button to export the EC Inventory Entry in IUCLID format Figure 8 Exporting EC number from REACH IT Passed Tasks No Task Remark Virus check i File format validation Check XML structure Enforce Rules M e a Store Dossier m4 Create Substance Identity Assign MSCAs co Technical Completeness Check 1 Pay Submission
2. REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 40 Submission report with details H Succeeded Failed Rule Name SUB GBL_UCO BR30 Rule Level Mandatory Reason of failure Rule Result Mot Satistied Rule Message An inconsistency has been detected in the type of dossier submitted Please verity that you have not sent an update instead of an initial dossier or vice versa This submission has been aborted Please make the necessary modification and submit a new dossier What happens when a dossier fails a manually checked business rule If the submitted dossier cannot be processed due to one or more manually checked business rules ECHA sends a message to the registrant s notifiers REACH IT mailbox This message entitled lt Dossier business rule failure gt is displayed in Figure 41 Figure 41 REACH IT message on BR failure manual check Dossier business rule failure Feat ann Hide YES G AsrAm mas ato O es ii i ao ia frat ae SEN ae eo The submitted dossier cannot b processed Depending on the type of failure further information can b found either a in the submission report or fb in the communicabon available in the annotation section Of the dossier SUbMISSION NUMBER Cicer coe od Submission timestamp O Ste9g oo Dossier type Inquiry Download submission Go to dossier As stated in the m
3. AWECHA http echa europa eu REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Document history 2 3 Change in wording in App 1 1 LE and TPR part Figure 29 changed 2 2 March 2010 Redesigned document and incorporated essential elements of DSM 8 1 2 December 2009 Minor textual revisions web links verified and updated document in new layout 1 1 July 2008 Major review of document as a result of release of a new version of REACH IT 1 0 June 2008 Creation of document Reference ECHA 08 B 05 EN Issue date 15 April 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 2010 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 2 3 Page 2 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BEC
4. Enter administrative information Version 2 3 Page 18 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Checklist BECHA http echa europa eu 1 On Site Isolated Intermediate Tonnage 4 Do you want to claim a Fee waiver for Band Transported Isolated Intermediate substances in the 1 10 tonnage band Tonnage Band If your registration includes Appendix 5 4 2 either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists 2 Was the submission reviewed by an 5 If the submission includes registration of an assessor This information is not compulsory intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 3 Do you want to claim confidentiality for the Tonnage Band of the submission Appendix 5 4 1 Version 2 3 Page 19 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 2 Single Submission Spontaneous Update Figure 12 Single Submission Spontaneous Update p Dossier creation wizard x Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Mame given by user Spontaneous Update of Substance A Doss
5. 3 Page 39 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 24 IUCLID screen with reason for updating Submission update ls the submission an updates Reason for updating Further to arequest decision from regulatory body EES OSSEI bere we eos S PEL mt bk MU Ber OO OO 4 spontaneous update Appendix 5 3 2 Updating a Substance Notified Under Previous Legislation NONS The substance is a notified substance under Directive 67 548 EEC considered as being registered by the claimant under REACH Before proceeding you should claim the registration number following the information given in ECHA web site related to the NONS http echa europa eu reachit nons en asp If the claim is successful you will receive in your REACH IT mailbox both the registration number and the submission number Figure 25 Figure 25 REACH IT message for successful NONS claim YOU have claimed 1 registration number s in relation to Notification number 4356 78936 EC Number 200 001 8 1 successfully claimed submission and registration numbers In order to update your dossier you should proceed as follows e The registration number received should be reported in section 1 3 of the IUCLID 5 dossier e The notification number NCD number should be reported in section 1 3 of the IUCLID 5 dossier e In
6. O00 A Remarks E spontaneous update Version 2 3 Page 34 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Checklist BECHA http echa europa eu 1 The Joint Submission checkbox must be 8 Do you want to claim confidentiality for the ticked Appendix 5 2 Tonnage Band of the submission Appendix 5 4 1 2 Chemical Safety Report tick this box if the CSR was supplied by the lead on your behalf 9 Have there been any Data Sharing Issues This information is not part of the Business Rule check 3 Guidance on Safe Use tick this box if the Guidance on Safe Use was supplied by the lead on your behalf 10 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 11 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 4 Review by Assessor this information is not part of the Business Rule check 12 Make sure that you are using the assigned EC number Appendix 1 2 1 5 Information on tonnage band When acting aS a member in a joint submission these fields are used to indicate your own registration tonnage bands On Site Isolated Intermediate Tonnage Band Transported Isolated Intermediate Tonnage Band If your registration includes either
7. Submission after 01 12 2010 The dossier must contain GHS Section 2 1 classification For more information on Classification and Labelling please see Data Submission Manual 5 available at http echa europa eu doc reachit compl_ tech dossier manual pdf Appendix 1 7 Section 3 3 Sites This section is a repeatable block section which offers the possibility to list all sites where the Substance is produced and or used This is done by creating for each site a link with the relevant information stored in the Legal entity site inventory The minimum data required is the country where the site is located Please note that in the case of an importer no information is required in this section however if a site is provided the same requirement applies Appendix 1 8 Section 3 4 Form in the supply chain If Downstream user is selected in Section 1 1 Role in the supply chain then the Substance in article box must be marked Appendix 2 Identify Submission Context The submission context is the regulatory context in which you make the submission An example could be the initial submission of a 1 10 tpa dossier as a member of a Joint Submission This context defines which information must be available in the dossier to enable it to be processed The main factors in identifying the submission context is if the submission is a Single Submission or Joint Submission or initial or update In case of a joint
8. UN O nE E S A E E Specific information for isolated intermediates dossier header part 5 ccseseeee OD OUTS a E E E E aneceaeeen Finding information about your submission ccccseeeeeeeeseeeeeeeeeeeseeneseneseenenees Page 7 of 52 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Table of Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 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 Version 2 3 Four Steps of Passing Business Rule Verification cccccssscecccsseeeceseeeceeseeeceaseeessegeeessegseeseaeeeesaas 6 Example for identifying the reference SUDStANCE cccceeccceeeeeeeeeeeeeeeeaeeeeeeeeeeeeseaeeeessaeeesseeeeesaeeeneas 9 BE Prt NO yl Ee E E E A E OE E E EE AA 10 SGarching for Dossier in REACH Tesime iini a aaa aaa E 11 Search Results in REACH auna a a aa aa a a aaa aa a a aa Na iai 11 DOSSO DOI corae E E EE EE R 11 Dossier Further Detalls srssrenrenenrine ri E gees i eects aE aE Ei
9. be indicated in the corresponding field Figure 29 Figure 29 Reason for updating spontaneous update other justification Reason for updating L Funther to a request decision from regulatory body spontaneous update other T Justification other O SA Justification for choosing other is Finally if you need to indicate more than one reason for updating your dossier an additional repeatable block should be created for each reason Figure 30 Please note that a justification has to be provided in all the blocks Version 2 3 Page 43 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 30 Several reasons for updating spontaneous update Reason for updating Further to a request decision from regulatory body Spontaneous update change of tonnage band i P Justification change of tonnage band OO NI Remarks Change in tonnage band from 34 to YYY i change in company rale inthe supply chain Justification change in company role inthe supply s wo Remarks Starting from oo the company is not an importer but a manu s For more information on different types of registration dossiers and the related requirements refer to the Guidance on registration section 9 guidance on update of dossier http guidance echa europa eu Appendix 5 4 Specific inf
10. by selecting either the Phase in or the Non phase in radio button Some of the information reported in this block and listed below directly influences the fee calculation therefore they are part of the Business Rule check e Confidentiality request on tonnage band is made in the dossier e There is a request of fee waiving Appendix 5 4 1 Confidentiality Confidentiality request the Confidentiality request checkbox in the dossier header can only be used in combination with the Specific request on tonnage band to claim confidentiality on the tonnage band These fields cannot be used for any other type of confidentiality claim When requesting confidentiality on the tonnage band both boxes must be ticked in any other case the boxes must not be ticked Confidentiality request on the tonnage band If the registrant wants to keep the tonnage band for which he registers as confidential information the checkboxes Confidentiality Request and Specific request on tonnage band in the dossier header should be selected as this is the only way to request the confidentiality flag A justification must be provided Figure 32 Version 2 3 Page 45 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 32 Confidentially request on the tonnage band Confidentiality request Specific request an tonnage ban
11. of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists 13 If the Requested Update is for a previously registered substance make sure that the required regulatory identifiers were included in Section 1 3 of your substance dataset Appendix 1 4 6 Last submission number must be indicated For a Technical Completeness Check TCC update i e further information being submitted following a TCC failure this will be the submission number associated with the dossier that failed TCC For other types of regulatory update see Appendix 5 3 7 The Communication Number must be indicated In the case of a TCC failure this will be the communication number provided in the letter which requested further information For further information please see Appendix 5 3 1 or Appendix 5 3 3 1 ee ee ee ee eee eee es ee ee ee ee ee Version 2 3 Page 35 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 5 Further information on the IUCLID 5 Dossier Header The dossier header has a significant impact e On the processing of the dossier e On the calculation of fees and preparation of the invoice During the IUCLID 5 dossier creation procedure the dossier creation wizard requests the user to Enter additional administrative information concerning your dos
12. submission there are further options as the dossier can be a Lead or a Member A submission can be e Initial no Registration number has been assigned to the submitting company for this substance e Spontaneous Update the substance has already been successfully registered but an update is needed Possible reasons for the update can be found in section Appendix 5 3 0 2 Version 2 3 Page 14 of 52 Release April 2010 REACH IT Data Submission Manual fa ECI IA Part 4 How to Pass Business Rule Verification http echa europa eu Enforce Rules l l o e Requested Update a submission has failed Technical Completeness Check or after successful registration further information was requested e g compliance check After identifying your submission you can follow the links to the specific annexes where you ll find examples of how your dossier header should look like together with a checklist of special issues you have to take care of SE Joint Submission Joint Submission Submission Lead Member Initial Appendix 4 1 Appendix 4 4 Appendix 4 7 Spontaneous Update Appendix 4 2 Appendix 4 5 Appendix 4 8 Requested Update Appendix 4 3 Appendix 4 6 Appendix 4 9 Appendix 3 Creating the dossier Appendix 3 1 Choosing the correct IUCLID 5 template Choosing the correct dossier template is an important step in a successful submission as the template indicates the tonnage band of the submission a
13. template with the Registration corresponding tonnage band e g REACH Registration 10 100 tonnes Standard Registration Registration template with the Registration Intermediate s corresponding tonnage band e g REACH Registration 10 100 tonnes Registration of one type of Intermediate template with the Registration of transported intermediate i e On Site OR corresponding type and tonnage isolated intermediate or Transported band e g REACH Registration Registration of on site isolated On Site Isolated Intermediates intermediate above 1 tonne Combination of Intermediates Transported Isolated Intermediate Registration of transported template with the corresponding isolated intermediate tonnage band e g REACH Registration transported isolated intermediates 1 1000 tonnes Standard Registration REACH Registration member of a Registration joint submission general case Standard Registration REACH Registration member of a Registration Intermediate s joint submission general case Registration of one type of REACH Registration member of a Registration of transported intermediate i e On Site OR joint submission intermediates isolated intermediate or Transported Registration of on site isolated intermediate Combination of Intermediates REACH Registration member of a Registration of transported joint submission Intermediates isolated intermediate Appendix 3
14. the Tonnage band pick list appears In case of Joint Submissions the IUCLID 5 template determines the Joint Submission tonnage band lead registrant dossiers or does not indicate a tonnage band at all member dossiers Therefore the submitting company s annual manufactured imported tonnage of the substance can only be indicated in this Tonnage band field If the dossier is a combined submission for non intermediate and intermediate use the intermediate tonnage bands need to be indicated in this part of the dossier header Version 2 3 Page 38 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 23 Type of submission Type of submission v Joint submission Information provided by the lead on behalf of the member s Chemical safety report Guidance on safe use Review by an assessor Tannageband S S SSSCSCSC CSCSCSC tonnage band Toen ceii e N tonnage band Appendix 5 3 Submission update information dossier header part 3 It is important to identify whether the dossier should be submitted as an update of a previous dossier or not Please note the following If a submitted dossier is marked as an update although it should not be then it cannot be processed by REACH IT and the Submission failure submission rule violation message is sent to your REACH IT inbox T
15. the dossier header you should indicate in the Last submission number field Figure 26 the Submission number as indicated in the Registration number successfully claimed message Version 2 3 Page 40 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu e Select the checkbox Spontaneous update and specify the reason for the update by selecting it from the drop down list in the Justification field Figure 26 Figure 26 Updating previous NONS after the claiming of the registration number Submission update Is the submission an Update Last submission number AADO 00 i Reason for updating a Further to a request decision from regulatory body Spontaneous Update change of tonnage band i x Justification change of tonnage band wO N Appendix 5 3 3 Previously Registered Under REACH The substance was previously registered by your company under REACH In this case the submission number of the last complete dossier submitted for this substance or the submission number of your update which failed completeness check should be reported in the Last submission number field and the registration number should be indicated in the section 1 3 of the IUCLID 5 dossier It should also be reported whether the update is an update made on request from regulatory body for example when an update
16. wizard Enter additional administrative information concerning your dossier Dossier template RESCH Registration 1 10 tonnes standard requirements Ee Dossier submission name and remarks Dossier submission remark Type of submission C Joint submission Information about the intermediates tonnage eII band and possibility to oncseiettedinemedines mark ifthe dossier is part tonnage band D a at submission tonnage band Submission update v Is the submission an update piae E ai a aa gt information to be filled out only in case of an update Reason for updating Further to arequest decision from regulatory body _ Spontaneous update Registration dossier specific information Phase in lo Phase in O Non phase in Reviewed by an assessor ere aq Specific information related to the dossier phase in non phase in accessor revision acumen confidentiality data Confidentiality request sharing fee waiver _ Data sharing issues E Fee waiving 1 10 tonnes complete dossier Version 2 3 Page 37 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Specific information for isolated intermediates Production and use under stricly controlled conditions F Registrant confirms that the intermediate is used in accordance with the conditions
17. 2 Creation of a Dossier from a substance dataset Dossier header The dossier header is derived from information entered when creating the dossier It consists of information used for administrative purposes and is completed by the applicant when preparing his dossier from the substance data set This chapter explains how to complete the IUCLID 5 dossier header information The information contained in the dossier header is crucial for Business Rules checking when you submit your dossier Missing or incorrect information can result in the dossier not being accepted for further processing For example it might be unclear whether the dossier is intended as an update of a previous registration due to a tonnage band increase or an update due to a request for further information after a first completeness check under Article 20 of REACH Because it is critical that ECHA clearly understands both the type of dossier and the specific circumstances behind the submission REACH IT will not process the dossier if this information is unclear and or incorrect Depending on the submission context Version 2 3 Page 17 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 Completing the dossier header Having identified your submission context according to Appendix 2 the following subchapters explain how to take the final step duri
18. 3 Figure 33 Request of fee waiving tick box IUCLID Fee waiving 1 10 tonnes complete dossier lustification al the information required in Annex WI is submitted as part of this registratratio n AS the tonnage of the dossier includes 8 tonnes of on site isolated intermediates 7 tonnes of non intermediate use We request the fee waiving in accordance with Appendix 5 5 Specific information for isolated intermediates dossier header part 5 When the dossier covers also a volume used as isolated intermediate specific information should be reported in the dossier header The exemption from standard information requirements only applies to isolated intermediates that are manufactured or used under strictly controlled conditions and this will be regarded as Claimed by the registrant only if the appropriate checkbox is selected Figure 34 Version 2 3 Page 46 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu A Please note that the strictly controlled conditions will have to be carefully documented More information can be found in the Guidance on intermediates available from the ECHA website http quidance echa europa eu In addition different information requirements apply to on site and transported intermediates and more information can be found in the Guidance for intermediates
19. Fee 10 Overall Completeness Check Issue Reference Number End of Pipeline Activities Data Dissemination k k Ln fee To Trigger WorkFlow Download submission report l Export submitted EC substance s 7 Import the downloaded i5z file into your IUCLID installation and use it in your update dossiers Appendix 1 3 Section 1 2 Composition A Substance is defined by its composition The composition of a Substance can consist of constituents impurities and additives This section is a repeatable block section The following information has to be included in this section e In Section 1 2 in all cases a There must be at least one composition with at least one constituent Version 2 3 Page 12 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification BECHA http echa europa eu Enforce Rules o Each constituent must have at least one identifier EC number or CAS number or IUPAC name Further requirements for Constituents o For mono constituent substance there can only be one constituent included in Section 1 2 which has the same identity as given in Section 1 1 o For multi constituent substance at least two constituents must be present None of these constituents can be the same as the one used in Section 1 1 In exceptional cases there can also be only one constituent present but under these circumstances this constit
20. HA http echa europa eu Table of Contents 1 How to use this manual see tis cececeetests ac aenccasasusaicaeman tee sa ceannecaasetsennieceacuouesteaeeceeeaesceeeeeoassesaensacases 4 2 NEVER OCIUC HON sen E 4 2 1 BUSINESS Rule VeritiC Atl OMe siescececenetnccscecinecnesescsicesiioenncaiseencenantveanntanvsnnncedanceaeecueaenstesmndantamenccuvenncecteacsanens 4 2 1 1 What are DUSINGSS PUNCS suosta e a 4 2 1 2 Different types of business rules nassnnnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn ennan ennan mennan ennnen nanenane 5 2 1 3 Business rules versus TOC erneiere e EAEAN E aE 5 2 1 4 Where can I find further information on dossier submission s ssssssssssssnunnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnn nennen 5 3 How to Pass Business Rules IUCLID 5 preparations ccccccecceeeeeeeeeeeeeeeeneseneseneeenes 5 Version 2 3 Page 3 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu 1 Howto use this manual Chapters 2 and 3 give a short overview of the steps required to ensure that a dossier passes Business Rules for submissions under the REACH Regulation 1907 2006 This three page summary contains the basic information that you need to know In the appendices you will find detailed information relevant to your specific situations 2 Introduction The aim of this documen
21. IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 1 Complete the IUCLID Substance Dataset The substance dataset contains a number of data fields which are crucial Regardless of the type of submission the information for these fields needs to be present In addition given parts of the IUCLID file only have to be populated in specific cases Below you can find the general information and guidance for the most crucial sections in IUCLID to be filled out for a successful business rule validation Appendix 1 1 Legal Entity in REACH IT and in IUCLID Dossier In the process of creating a dataset creating a dossier and submitting it there are three instances where the legal entity needs to be indicated To avoid any ambiguity you have to ensure that all these legal entities are the same e Section 1 1 The substance dataset is linked to a specific IUCLID legal entity This must be the same as the REACH IT legal entity from which the dossier will be submitted e Dossier Creation When creating the dossier you must ensure that you have selected the IUCLID legal entity which corresponds with the submitting legal entity in REACH IT e REACH IT The account you use will determine the legal entity that ECHA will consider as associated with all the regulatory processes and or communications concerning the submitted dossier If the three above mentioned le
22. Ie ACSI MUGO 5 serian ee eE DOE E EEE EEE 36 Step 6 of the Dossier Creation WIZAI ccccccccscccceeeeceneeccencecseeeessaueeseueeeseuceeseueessaeeesueessaeeeesaaees 37 Specifying the name of the GOSSIEL cccccccseeeeeeeeeeeeecseeeeeeseeeeeeeeeeeesseeeeesseeeeeeseeeeeeseaeeeessegeeessaeeeeeeas 38 Type OP SUMS SO srira ne a ear Baek heme EEA OE SE EE ens EEE E EE T Eed 39 IUCLID screen with reason for updating nnnnsnnnenennnsnnnesenrnnrnrnrsrrrnnrnrersrnrrnrnrrrsrnrrnrnrrnnrnnenrnennn nnen 40 REACH IT message for successful NONS claim ccccecccccseeceeceeeeecaeeeeeeeeeseeesaeeeesseeeesseeeeesaaeeeeeas 40 Updating previous NONS after the claiming of the registration NUMDED cccceeceeeeeeeeeeeeeeeeeaeeeees 41 Reason for updating further to a request decision from regulatory body cccceeseeeeeeeeeeeeeaeeeees 42 Reason for updating spontaneous update cc ccecccceecceceeecceeeeeceeceesecesaeecesseeeeseaeeeseeesaeeeeseeeessnes 43 Reason for updating spontaneous update other justification cecccceseeeeeeeeeeeeeaeeeeeeseeeeesaeeeeees 43 Several reasons for updating spontaneous update ccc ceecccsecceceeeeceeeeeseeeeeeeeesseeeeseeeeeseeeesseeeeas 44 Registration dossier Specific information cccccsesececcsseeceeseeeceeseeeceeuseeessaeesssaaeeeeseuseesseuseessaageees 45 Confidentially request on the tonnage band cccccccseeecee
23. LP Regulation CLH dossier Endpoints information OECD harmonised templates OECD S05 REACH Annex xW Restriction REACH Annex xW SWH REACH Application for authorisation REACH Downstream user report REACH Inquiry REACH Notification of substance in article REACH PPORD REACH Registration 1 10 tonnes physicochemical requirements REACH Registration 1 10 tonnes standard requirements REACH Registration 10 100 tonnes REACH Registration LOO 1000 tonnes REACH Registration above 1000 tonnes REACH Registration member of ajoint submission general case REACH Registration member of ajoint submission intermediates REACH Registration on site isolated intermediates above 1 tonne REACH Registration transported isolated intermediates 1 1000 tonnes REACH Registration transported isolated intermediates above 1000 tonnes REACH Substance Evaluation Mote The dossier template is used to determine which substance endpoints will be selected by default The selection can be modified manually in a subsequent step of the dossier creation gt 0 8 8 0 8 5 2 0 es ee ee Select a dossier template Version 2 3 Page 16 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Context IUCLID 5 Template Dossier type in REACH IT BECHA http echa europa eu Individual submission dossier or Lead dossier Standard Registration Registration
24. Last submission number e145 456 765 a Reason for updating C Further to a request decision from regulatory body Spontaneous update change of tonnage band et I p Justification change of tonnage band a ey SSS SN Remarks Due to increase in production volume the tonnage band has to a Version 2 3 Page 26 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Checklist BECHA http echa europa eu 1 Joint Submission checkbox must be ticked 7 Last submission number must be indicated Appendix 5 2 For a spontaneous update this will be the submission number associated with the most recent registration for that substance For registrations derived from a NONS claim and other special cases see Appendix 5 3 2 Chemical Safety Report tick this box if you are supplying the CSR on behalf of members 8 Justification for Spontaneous Update must be provided Chapter Appendix 5 3 3 2 3 Guidance on Safe Use tick this box if you are supplying the Guidance on Safe Use on behalf of members 9 Do you want to claim confidentiality for the Tonnage Band of the submission Appendix 5 4 1 4 Review by Assessor this information is not part of the Business Rule check 10 Have there been any Data Sharing Issues This information is not part of the Business Rule check 5 Information
25. Updater Last submission number X14 5450 78 a Reason for updating Further to a request decisian fram regulatory body Ret biKx Number Oe a g spontaneous update Version 2 3 Page 22 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Checklist BECHA http echa europa eu 1 On Site Isolated Intermediate Tonnage 6 If the Requested Update is for a previously Band Transported Isolated Intermediate registered substance make sure that the Tonnage Band If your registration includes required regulatory identifiers were included in either of these intermediate registration types Section 1 3 of your substance dataset you must indicate your relevant tonnage Appendix 1 4 band s in the drop down lists 7 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 3 Last submission number must be indicated 8 If the submission includes registration of an For a Technical Completeness Check TCC intermediate the Specific Information for 2 Transported Isolated Intermediate Tonnage Band Isolated Intermediates part must be filled out Appendix 5 5 update i e further information being submitted following a TCC failure this will be the submission number associated with the dossier that failed TCC For other types of regulatory update see Appendix 5 3 9 Make
26. a 12 Exporting EC number from REACHED ssicsacictcssvachesianecsavasaiedaantossedwetssensanesledincevocticvnsieduiediennet ale 12 Regulatory programme identifiers in Section 1 3 0 0 cccccecceecceeeeeeeeeeeecaeeeeeeseeeeeeeeeeeeeeaeaeeeseaeeeesaaeeeees 13 Dossier Template Selection in IUCLID 0 0 0 ccccccesceceeeeeceeeeeceeeeceaceeseecessaeeesseseessaeeeseneeeseneessees 16 SNCS Mial SUIS SION sine i a dasa a ea a e ei dads a N Eain 18 Single Submission Spontaneous UpCate cece ccecccceececeeeeceeececeeeeeeeeceeseeeesseeeesseeeseeeesseeeeeseeeenas 20 Single Submission Requested Update cccccccccssecccesseeceeeeceneeeceeeeseaceeseeeesseseessseseeeeeseseeesseneeees 22 Joint Submission Lead Initial SUDMISSION 0 eee cece ec eceececeececuececeeaeceeaeceeaeceeneaecueaeaeeaeeeeaeeneaeans 24 Joint Submission Lead Spontaneous Update cc ccccccccccceeececeeeeeceeeeeeeceeauecesseeeeseeeeseneeeseeeessees 26 Joint Submission Lead Requested Update cc cccccccccccsssceceeeeeseeeeceeeeeseacesseeeessaeeessaeeeseeeeeseeessaas 28 Joint Submission Member Initial SUDMISSION 00 ieee ee cece eeceeeeeeeeeeneceeceeeeeeeeeeeeeneeneeeeeeeneeneeeesenness 30 Joint Submission Member Spontaneous Update cc ceccccsecccceececeeeeeseeceeseeceeseeeeseeeeeseueeesaeeeesnes 32 Joint Submission Member Requested Update cc ccccccseccceeececeeeeeeeeeeeceeceeseeesseeeesaeeeesaeesaueessees 34 DOSSIer
27. age band Between 1 to 10 tonnes year a M omsteaedinnmadins I tonnage band Trapani ermeteg OO tonnage band Submission update ls the submission an update Version 2 3 Page 24 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules 1 Joint submission checkbox must be ticked Appendix 5 2 2 Chemical Safety Report tick this box if you are supplying the CSR on behalf of members 3 Guidance on Safe Use tick this box if you are supplying the Guidance on Safe Use on behalf of members 4 Review by Assessor this information is not part of the Business Rule check 5 Information on tonnage band When acting as the lead in a joint submission these fields are used to indicate your own registration tonnage bands On Site Isolated Intermediate Tonnage Band Transported Isolated Intermediate Tonnage Band If your registration includes either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists Note The overall tonnage band of the Joint Submission is determined by the IUCLID 5 template that was used Version 2 3 Release April 2010 Checklist Checklist BECHA http echa europa eu 6 Do you want to claim confidentiality for the Tonnage Band of the submission Appendix 5 4 1 7 Have there been any Da
28. al completeness check TCC and invoicing If the dossier submission fails at the business rule level the dossier cannot be accepted for processing and a new submission is required before any regulatory processes can be initiated 2 1 2 Different types of business rules The majority of business rules are checked automatically by REACH IT These are called Mandatory Business Rules However once the Mandatory Business Rules have successfully passed certain further Business Rules are carefully checked by ECHA staff These are called Overrulable Business Rules In case your dossier failed Mandatory Business Rules you can see the results directly in your Submission Report Overrulable Business Rule failures are sent to you by an official communication available as a PDF in the Annotations tab in your Submission Report For further details on how to access this information see Appendix 6 2 1 3 Business rules versus TCC The business rules check includes format validation and more specifically includes a technical validation of information that is required for processing This process is not part of the Technical Completeness Check as described in the REACH regulation 2 1 4 Where can find further information on dossier submission Further information on how to submit a notification or registration to ECHA is available on ECHA s website hittp echa europa eu reachit en asp The information helps you to understand the to
29. are the dossier header can be found in Appendix 3 2 For general guidance on dossier creation refer to the IUCLID 5 User manual e section C 6 Creating a dossier and section D 8 2 Creating dossiers Version 2 3 Page 6 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Table of Appendices Appendix 1 Appendix 1 1 Appendix 1 2 Appendix 1 2 1 Appendix 1 3 Appendix 1 4 Appendix 1 5 Appendix 1 6 Appendix 1 7 Appendix 1 8 Appendix 2 Appendix 3 Appendix 3 1 Appendix 3 2 Appendix 4 Appendix 4 1 Appendix 4 2 Appendix 4 3 Appendix 4 4 Appendix 4 5 Appendix 4 6 Appendix 4 7 Appendix 4 8 Appendix 4 9 Appendix 5 Appendix 5 1 Appendix 5 2 Appendix 5 3 Appendix 5 3 1 Appendix 5 3 2 Appendix 5 3 3 Appendix 5 4 Appendix 5 4 1 Appendix 5 4 2 Appendix 5 5 Appendix 5 6 Appendix 6 Version 2 3 Release April 2010 Complete the IUCLID Substance Dataset cccccccseceeeceeeeeeeeseseeeeesneeneeeeeeees Legal Entity in REACH IT and in IUCLID DoSSiefP ccccccceeeseeeeeeeeneeeseeneeseeseeeseaeneenenens DECOM Veli TASTING ALON sssusa a i a a Downloading the EC number from REACHGIT ccccseeeeeseeeeeeseeeeeeneeseasneeeeeneeeseeseeseanenenenseseaeneenes Section 1 2 COMPOSITION cccecceeeceee ee ee cess cece neeeceneeseaeeseaaeesaseeesaaeeseaaesseeesea
30. available from the ECHA website http quidance echa europa eu Figure 34 Tick boxes for isolated intermediates Specific information for isolated intermediates Production and use under stricly controlled conditions Justification The substace is used as Strictly controlled conditions can be demonstrated a Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 165 45 E Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set out in Article 16 4 When a dossier is made for a substance used both as isolated intermediates under strictly controlled conditions and as non intermediates the fees will be calculated as the sum of individual fees for intermediate and non intermediate as if separate dossiers had been submitted Appendix 5 6 Opt outs Opt out from a joint submission if the registrant is part of a joint submission and wants to opt out according to Article 11 3 of the REACH Regulation by submitting separately information which should normally be submitted jointly he should select the sections of the dossier for which the opt out is requested at the 7th step of the dossier creation wizard A justification should be provided in the last column for every section selected Figure 35 Please note that this step only available in case of a joint submission The eventual opt in for confidentiality claim ca
31. be ticked 7 Justification for Spontaneous Update must Appendix 5 2 be provided Chapter Appendix 5 3 3 2 BECHA http echa europa eu 2 Chemical Safety Report tick this box if the 8 Do you want to claim confidentiality for the CSR was supplied by the lead on your behalf Tonnage Band of the submission Appendix 5 4 1 3 Guidance on Safe Use tick this box if the Guidance on Safe Use was supplied by the lead on your behalf 9 Have there been any Data Sharing Issues This information is not part of the Business Rule check 10 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 5 Information on tonnage band 11 If the submission includes registration of When acting as a member in a joint an intermediate the Specific Information for 4 Review by Assessor this information is not part of the Business Rule check Isolated Intermediates part must be filled out submission these fields are used to indicate i Appendix 5 5 your own registration tonnage bands On Site Isolated Intermediate Tonnage Band Transported Isolated Intermediate Tonnage Band If your registration includes either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists 6 Last submission number must be indicated For a spontaneous update this will be the submission number associated with the most rec
32. bmission checkbox must be ticked 6 Do you want to claim confidentiality for the Appendix 5 2 Tonnage Band of the submission Appendix 5 4 1 BECHA http echa europa eu 2 Chemical Safety Report tick this box if the CSR was supplied by the lead on your behalf 7 Have there been any Data Sharing Issues This information is not part of the Business Rule check 3 Guidance on Safe Use tick this box if the Guidance on Safe Use was supplied by the lead on your behalf 8 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 Isolated Intermediates part must be filled out Appendix 5 5 5 Information on tonnage band When acting as a member in a joint submission these fields are used to indicate your own registration tonnage bands On Site Isolated Intermediate Tonnage Band Transported Isolated Intermediate Tonnage Band If your registration includes either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists Ooo T l O l B 4 Review by Assessor this information is 9 If the submission includes registration of an not part of the Business Rule check intermediate the Specific Information for Version 2 3 Page 31 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa eu
33. d Justification 4 specific request on tonnage band is asked because The confidentiality flag in section 3 2 of IUCLID 5 cannot be used to request confidentiality for your tonnage band because that section relates to the actual A tonnage manufactured imported which is always treated as confidential information A registrant can request that certain information that is submitted to the Agency according to Art 10 of the REACH regulation is not published on the internet because publication could be harmful for his or any other concerned party s commercial interests All other confidentiality requests must be made in the relevant section of the substance dataset A justification has to be provided for every confidentiality request Further information can be found in the latest version of the Data A Submission Manual 5 on how to complete a technical dossier for registration and PPORD notification on the ECHA website http echa europa eu doc reachit compl_tech dossier manual pdf Appendix 5 4 2 Fee waiving Request of fee waiving Only in case a registration is made for a tonnage below 10 tonnes an exemption of the fee can be requested if all information required by Annex VII of REACH is provided in accordance with Art 3 1 and 4 1 of the Fee Regulation EC 340 2008 In this case the checkbox Fee waiving 1 10 tonnes complete dossier must be selected and a justification must be provided in the appropriate text box Figure 3
34. e dossier submission AUMEN Cites od Submission timestamp a7 22S Co ee Dossier type Inquiry Download submission report 50 to dossier If you click the lt Go to dossier gt link you will also notice that in the lt Dossier details gt tab the status of the dossier has changed from lt Pending gt to lt Failed gt as shown here below see Figure 37 Figure 37 Status of a dossier in the dossier details tab Home gt Submitted Dossiers gt Dossier Details Company Details E a E a ELE Fre registration Pre SIEF Dossier Dossier type Registration Online dossiers Submission Phase in Information Submission Number AONE iy Registration Submission Date ALAC notification Is the submission an update Joint submission Substance Reference Number Substance Name Sere Request submitted file The complete list of the failed automated business rules is available by clicking the tab lt Submission Report gt see Figure 38 and Figure 39 Version 2 3 Page 48 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 38 Tab for checking complete list of failed automated business rules Home gt submitted Dossiers gt Dossier Details Company Details Submission Report accounting Annotations Pre registration Pre SIEF Dossier Dossier type Registration Online dossiers Submi
35. e following information has to be taken into account when choosing the correct Role in the supply chain e lf Manufacturer is selected a production site in section 3 3 Sites must be provided e The role Downstream user cannot be selected if the submission only covers intermediates e lf Downstream user is selected Substance in article must be ticked in section 3 4 Form in the supply chain e The role Only representative cannot be selected together with Manufacturer or Importer Appendix 1 2 1 Downloading the EC number from REACH IT In case you were unable to provide an EC number in your initial submission REACH IT will have automatically assigned one This number must be used in any subsequent updates This automatically created EC Inventory entry can be downloaded in i5z IUCLID file format from REACH IT To download the EC number please follow the steps below 1 Log in to REACH IT and click on Search for Dossier Figure 3 REACH IT Home Screen ECHA Home Company Welcome Pre registration Pre SIEF You last connected on 2010 03 22 14 36 52 0 Online dossiers Phase in Information Registration notification Joint submission Classification and Labelling Message box User account Inventones Legal entity change Invoices Pre SIEF Pre registration Version 2 3 Page 10 of 52 Release April 2010 REACH IT Data Sub
36. eeeeeeeeeeeeeesaeeeesaeeeeeesseeeeeesaeeeeeaeeeeeesaeeeeenas 46 Request of fee waiving tick box IUCLID cc ceccecceeeeeeeeeeeeeeaeeeesseeeeeeseaeeessaeeeesaeeeeeesaeeeesaaneeees 46 Tick boxes for isolated INterMeCiates ccccccccceeccccececeeeceeeeeceseeeeeseeeeseeeeeseeeesseeeesseeeesseeeeseeeesseeeeees 47 Indicating opt out in IUCLID 00 cccc cece eee eeeeeeeeeeeeeseeeeeeaeeseeesaeeeeseaeeeesseeseesseaseeeseeseeesaeeeesaaeees 47 REACH IT message on BR failure auto CHECK ce ccccceeeeceeeeeeeeeeaeeeeeeeeeeeeeseeeeeeseeeeesaeeeeeaeeeseesaees 48 Status of a dossier in the dossier details tab cccccecccccsseceeeeeeeeeeeeeeeeseeeeeeseaeeeeeseeeeeseaeeeesseeseeesaaes 48 Tab for checking complete list of failed automated business TUIeS cee ececeeeceeeeeeeeeeeeeeeeseeeeeees 49 SUDMISSIONM VODOMT erasoren E a a a a E E OEE E Eo OEE 49 Submission report with details cece ccecccceeeceeeeeecseeeesaeeeeeeeeeeseeeeseeeeeseeeeeseeeesseeeesseeesseeeeseneeeseeeenes 50 REACH IT message on BR failure manual check ccecceceeeceeceeeeeeeeeeeeseeeeeesuaeeeeeaeeeesaeeeeeesaaes 50 Annotations tab with Communications ccccccccceecccceceeeeececaeececeeeeeseeeeseeeeeseueesseeeesseueessaeeesaneeesaeees 50 Attached communication in the dossier info cccecccccseeeeeeeeeeeeeceeeeeeaeeeeeeseeeeeeseeeeeessaeeeeseeeseeesaeeeeeens 51 Page 8 of 52 Release April 2010 REACH
37. ent registration for that substance For registrations derived from a NONS claim and other special cases see Appendix 5 3 12 Make sure that you are using the assigned EC number Appendix 1 2 1 O d ee i Version 2 3 Page 33 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 9 Joint Submission Member Requested Update Figure 19 Joint Submission Member Requested Update p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration member of ajoint submission general case Name given by user Requested Update of Substance A Dossier submission remark Thijs is an example of howa Joint Submission Member Dossier Requested Update s dossier header should look This example represents the basic case depending on your submission context your dassier header might look different Type of submission Information provided by the lead on behalf of the member s Chemical safety report Guidance on sate Use Review by an assessor Tonnage band Between 100 to 1000 tonnes year a do o o o tonnage band N I tonnage band Submission update ls the submission an update Last submission number paxlz 3456 78 a Reason for updating Further to arequest decision from regulatory body PI FA RE OE PO Number
38. essage further information is available in the lt Annotation gt tab under lt Communications gt in the dossier The easiest way to access that information is clicking the lt Go to dossier gt link and then click the lt Annotations gt tab see Figure 42 Figure 42 Annotations tab with Communications Home gt Submitted Dossiers gt Dossier Annotations Company Details Submission Report Accounting Annotations Pre registration Decisions Pre SIEF Online dixssiers Id Outcome Creation date Process type Phase in Information No neonnnds Fiegisination 7 ayy PS AGG at iar Communitations haint submission Sutcome Creation date Process type REJECT Submission Pipeline Clicking the link of the lt Communication number gt the one in the inner red box in the above screenshot you will be able to open the attachment a PDF document see Figure 43 containing e all details on the failure Version 2 3 Page 50 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu e the actions you should take to submit a valid dossier Figure 43 Attached communication in the dossier info Home gt Submitted Dossiers gt View Dossier Decision Communication info Communit ation Outcome REJECT aa Type Communication Of CVETTUIMe business Mule Online dossiers Communication number Eemal deadline Phat bntenmaie
39. gal entities are not the same the submission will be rejected Appendix 1 2 Section 1 1 Identification Section 1 1 in IUCLID is used for basic identification of both the substance and the submitting company lf a Third party representative is included in the dossier the company in question has to be already registered in REACH IT as a Third Party Representative The Reference Substance has to be identified with at least one of the following identifiers e EC Number e CAS Number e IUPAC Name Figure 2 Example for identifying the reference substance Reference substance ia methyl benzoil 2 sithiadiazole carbothioate f methyl benzotl 2 sithiadiazole carbothioate f S methyl benzotl 2 sithiadiazole EC number EC name 420 050 0 s S methyl benzotl 2 sithiadiazole carbothioate 4 CAS number CAS name S methyl benzotl 2 sithiadiazoale carbothioate IUPAC name S methyl benzagl 2 sithiadiazole carbothioate 4 Version 2 3 Page 9 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Absence of the EC Number assigned to the substance will lead to Business Rules failures in the following cases e The submission is an update e The submission contains a valid Inquiry number in Section 1 3 the EC number given in the inquiry result has to be in line with the one used in Section 1 1 Th
40. he following situations are the only situations where the submission should be considered as an update Appendix 5 3 1 Requested Update for an Incomplete Initial Submission A registration dossier has been sent before for the same substance but although it passed the initial rule verification steps in REACH IT the registration was considered as incomplete by ECHA during completeness check The submission of an updated dossier in this case is meant to fulfil the request for further information made by the Agency within a set deadline Under these circumstances the last submission number i e the one attributed to the dossier which resulted in the request for further information must be reported in the Last submission number field the checkbox Further to a request decision from regulatory body in IUCLID must be selected Figure 24 and the communication number indicated in the request for further information must be entered in the adjacent Number field in IUCLID see Figure 24 This only applies to submissions which were considered incomplete by the Agency during the completeness check and which resulted in a letter titled Request for further information on your registration under Regulation EC No 1907 2006 If you receive a communication of Business Rule validation failure then you should submit the same type of dossier initial or spontaneous update with the one that failed Business Rule validation Version 2
41. ier submission remark This is an example of howa single spontaneous update s dossier header should look This example represents the basic case depending on your submission context your dossier header might look ditferent Type of submission Joint submission on state iermedes FO tonnage band Transported somam I tonnage band Submission update Is the submission an Updater Last submission number xxX145456 78 a Reason for updating a Further to a request decision from regulatory body Spontanequs Update change of tonnage band 4 Justification change of tonnage band a bs OOOO O N Remarks Due to increase in production volume the tonnage band has to Version 2 3 Page 20 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Checklist BECHA http echa europa eu 1 On Site Isolated Intermediate Tonnage 5 Do you want to claim confidentiality for the Band Transported Isolated Intermediate Tonnage Band of the submission Appendix Tonnage Band If your registration includes 5 4 1 either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists 2 Last submission number must be indicated 6 Do you want to claim a Fee waiver for For a spontaneous update this will be the substances in the 1 10 tonnage band submission number associated wi
42. ilure this will be the submission number associated with the dossier that failed TCC For other types of regulatory update see Appendix 5 3 es es ee ee ee eee Version 2 3 Page 29 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 7 Joint Submission Member Initial Submission Figure 17 Joint Submission Member Initial Submission p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration member of ajoint submission general case Mame given by user Registration of Substance A Dossier submission remark This is an example of howa Joint Submission Member Dossier Initial submission s dossier header should look This example represents the basic case depending on Your submissian context your dossier header might look different Type of submission Information provided by the lead on behalf of the member s Chemical safety report Guidance on safe use Review by an assessor Tonnage band Between 100 to 1000 tonnes year a M o o tonnage band CO tonnage band Submission update isthe submission an update Version 2 3 Page 30 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Joint Su
43. inistrative checks called business rules The business rules are a set of pre requisites that must be fulfilled before ECHA can establish that the dossier can be handled properly and that the required regulatory processes can be successfully carried out The business rules are checked using the REACH IT software and exist for two reasons e Format In order to be processed correctly REACH IT must establish whether the dossier in the correct IUCLID 5 format For example a PPORD notification must not be in the format of a registration dossier e Administrative Before accepting a dossier for processing ECHA must establish that it can be properly handled This requires that certain administrative information has to be checked to ensure that it is consistent with the submission type For example if the dossier is an update following a regulatory request but the reference number Version 2 3 Page 4 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu provided for the previous submission is incorrect it would be impossible to establish a link with the previous dossier Under other circumstances it might be unclear how the dossier should be invoiced A dossier can be accepted for processing by ECHA only if all of the relevant business rules are satisfied After that the submission can proceed to the next steps e g technic
44. mission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu 2 From the query list select Find by submission and enter the submission number of the dossier you wish to update into the appropriate field Figure 4 Searching for Dossier in REACH IT ECHA teal SS CAG You are connected as Home gt Search Company Search Pre registration Pre SIEF Search Domain Search Domain Dossier Online dossiers Select query Phase in Information se Query specific fields Registration Submission context notification es Submission number TC 48l Joint submission Choici iat Submission date from dd mm yyyy To dd mm yyyy Labellin 9 Is it an Update he Message box 3 TR g Is it a Joint Submission v User account T Dossier evaluation status vi Inventories i Process step sg Legal entity change 9 y 9 Process step status v Invoices Dossier attribute Search Dossier UUID 3 In the results field click on the UUID of the dossier Figure 5 Search Results in REACH IT Submission number Submission date Submission update Status Process step Process step status Dossier UUID Dossier type R Pay TO AB 11 03 2010 No Pending Submission Started Fee Registration 4 Click again on the Dossier s UUID in the new page Figure 6 Dossier Details
45. n be indicated during the submission of the joint member submission dossier For more information on Joint submission refer to industry user manual Part 7 Joint submission A available on the ECHA website http echa europa eu doc reachit industry user _manual reachit_joint_submiss ion_en pdf Figure 35 Indicating opt out in IUCLID Data selected for opt out Justification for opt out select for opt out Document Origin section Test substance f Eu 2 1 GHS justification a Test substance f Eu 2 2 05D DPD Version 2 3 Page 47 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 6 Finding information about your submission What happens when a dossier fails an automated business rule If the submitted dossier fails at the automated business rule step REACH IT immediately sends a message to the registrant in the REACH IT mailbox In this message Dossier business rule failure the following information is displayed see Figure 36 Figure 36 REACH IT message on BR failure auto check m el oe ahead Dossier business rule failure I ee AA FHide Yes Lees O iea ee 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 th
46. nd determines amongst many other things which substance endpoints will be selected by default to export into your dossier Before exporting the data you have to make sure that the template selected corresponds with the intended submission e g correct dossier type Inquiry PPORD Registration etc correct tonnage band Note that in the case of a lead dossier in a Joint Submission additional information about tonnage band has to be provided more information about that can be found in Appendix 5 2 Please note there is no specific template available for lead of Joint Submission as for those cases the generic registration both general and intermediate and classification amp labelling templates should be used The information about the joint submission has to be indicated in those cases in the dossier header Appendix 5 2 Version 2 3 Page 15 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 10 Dossier Template Selection in IUCLID p Dossier creation wizard Select a dossier template which meets your specific requirements regulatory programme type of dossier tonnage band member of ajoint submission etc a substance Dossier templates available for a substance Complete Biocides Active ingredients Biocides Biocidal products Biocides Substances of concern LP notification
47. neesesessonaeses DO CUION F551 C ICONS E E T E A A N O Section 1 5 Joint submission s sssssssssssnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nennen Section 2 1 GHS and Section 2 2 DSD DPD snassssnasssnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn SECON a SMES icia E ese uenstienn uacan cen rnneceneubecesaudmueden Section 3 4 Form in the supply chain ccccccceseeeeeeeeeeeeeeeeeseeeceseeeeeseeseneeseaneeseasesseaeeees Identify Submission CONTEXE cece cece eee ee eeeeeee eee eeeeeneeaaeseaeeeaaeesaesseessanssaneseanesens Creating the GOSSIGN ixsais cenicesicceddceccccssedcceeditieccereceacecteceesteactcesszcecvsdeaedieicesestecieisezcdxes Choosing the correct IUCLID 5 template eee ceseeeseeeseeeeeeeeeeeeeesseeseesneesseeeesseeneeeseasnees Creation of a Dossier from a Substance dataset cccssssceseseeeeseseeeseseeeeseeseessneneeseeenees Completing the dossier NC AGEN saciiiccceesadecesibennsvensrsceccessecariecsscacasenuentecveusemssexeneceuate Single Initial Submission cisiesascssicnacstecnncstavesacatcesnccuntavessactcansaapeseencenntubiaindcuinnsabiuasawebaevenenaanwns Single Submission Spontaneous Update ccceccecceeeeeeeeeeeeeeeeceneeeeeeeeeeseeseeneeseeeessaneeess Single Submission Requested Update cceccccsscceseseeeeeeeeseseeeceseeeeeseeseeneeseasessaneeseneeees Joint Submission Lead Initial Submission 2 0 0 0 ccc ceeceesesesee
48. ng dossier creation for each submission context In case further information is needed go to Appendix 5 Appendix 4 1 Single Initial Submission Figure 11 Single Initial Submission p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 1 10 tonnes standard requirements Mame given by user Registration of Substance A i Dossier submission remark This is an example of howa single initial submission s dossier header should look s This example is the basic case depending on your submission context your dossier header might look different Type of submission Joint submission on eisinedimermedits FI tonnage band Taspone toed maemeite 8 tonnage band Submission update ls the submission an update Registration dossier specific information Phase in e Phase in O Non phase in Reviewed by an assessor Remarks Confidentiality request Data sharing issues ry Fee waiving 1 10 tonnes complete dossie Specific information for isolated intermediates Production and use under stricly controlled conditions i Registrant confirm s that the intermediate is used in accordance with the conditions set out in Article 16 g4 a Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set aut in Article 18 45 a e a 0 8 6 8 E Ci n cancel
49. om the drop down list in the justification field Figure 28 The drop down list is reporting the following update reasons Change in company identity NB This update reason cannot be used in the context of REACH IT submissions Change in company role in the supply chain Change in composition of the substance Change of tonnage band New identified uses New uses advised against New knowledge of the risks for human health and or environment Change in classification and labelling New or update of CSR or guidance on safe use New testing proposal Change in the access granted to information Prolongation of exemption period for PPORD New uses outside the supplier s conditions DU obligations Change in exemptions DU obligations Other Version 2 3 Page 42 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 28 Reason for updating spontaneous update Reason for updating C Further to a request decision fram regulatory body Spontaneous update change of tonnage band 2 3 x Justification change of tonnage band he a Remarks Due to increase in production volume the tonnage band has to s A If the reason of the spontaneous update is not listed in the drop down list for example in case of manufacture cease the entry other should be selected and the information should
50. on tonnage band 11 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 When acting as the lead in a joint submission these fields are used to indicate your own registration tonnage bands On Site Isolated Intermediate Tonnage Band Transported Isolated Intermediate Tonnage Band If your registration includes either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists Note The overall tonnage band of the Joint Submission is determined by the IUCLID 5 template that was used 6 Make sure that you are using the assigned EC number Appendix 1 2 1 12 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 Ooo o ee i O j f Version 2 3 Page 27 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 6 Joint Submission Lead Requested Update Figure 16 Joint Submission Lead Requested Update p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Mame given by usen Registration of Substance A Dossier submission remark This is an example of how a joint Submission Lead Dossier Requested Update
51. or Regiairaibon f Content notice ation Content Joint submisspon Attachments Ma 55a q dr b Dr Liter a t uni rons Search Version 2 3 Page 51 of 52 Release April 2010 European Chemicals Agency PO Box 400 Annankatu 18 F 00121 Helsinki Finland http echa europa eu
52. ormation related to the dossier dossier header part 4 This part of the dossier header allows giving information about the phase in status of the substance along with more general information on the IUCLID 5 dossier submitted As a general rule when one of the boxes of the block registration dossier specific information review by an assessor confidentiality request fee waiving is ticked the associated free text field below the box should be filled in example in Figure 31 For more information on how to complete this section of the dossier header please consult the latest version of the Data Submission Manual 5 How to Complete a Technical Dossier for Registrations and PPORD Notifications available from the ECHA website http echa europa eu doc reachit compl tech dossier _ manual pdf Version 2 3 Page 44 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 31 Registration dossier specific information Registration dossier specific information Phase in Fhase in C Non phase in Reviewed by an assessor Remarks e Confidentiality request specific request on tonnage band Justification Confidentiality on the tonnage band is requested because Data sharing issues Justification Fee waiving 1 10 tonnes complete dossier Justification The phase in status has to be marked
53. ox if you are supplying the Guidance on Safe Use on behalf of members 10 Have there been any Data Sharing Issues This information is not part of the Business Rule check 4 Review by Assessor this information is not part of the Business Rule check 11 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 5 Information on tonnage band 12 If the submission includes registration of When acting as the lead in a joint submission an intermediate the Specific Information for these fields are used to indicate your own Isolated Intermediates part must be filled out registration tonnage bands Appendix 5 5 On Site Isolated Intermediate Tonnage Band Transported Isolated Intermediate Tonnage Band If your registration includes either of these intermediate registration types you must indicate your relevant tonnage band s in the drop down lists Note The overall tonnage band of the Joint Submission is determined by the IUCLID 5 template that was used 6 Make sure that you are using the assigned EC number Appendix 1 2 1 13 If the Requested Update is for a previously registered substance make sure that the required regulatory identifiers were included in Section 1 3 of your substance dataset Appendix 1 4 7 Last submission number must be indicated For a Technical Completeness Check TCC update i e further information being submitted following a TCC fa
54. pics covered and provides access to relevant documents tools and web pages 3 Howto Pass Business Rules IUCLID 5 preparations This document is meant to be used as a Business Rule Navigator which will guide you through the basic steps of creating the substance dataset and the IUCLID dossier header At the same time it provides you with a basic understanding of Business Rule verification In essence there are four main steps to ensuring that a dossier can pass the business rule verification These are outlined in Figure 1 below Version 2 3 Page 5 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Figure 1 Four Steps of Passing Business Rule Verification Identify Submission Context 2 The term submission context is the most basic information which is used by REACH IT when determining how your submission must be processed This includes factors like whether itis an initial or update submission and whether it is a single or joint submission Appendix 2 of this document provides help on finding the accurate context Creation of a Dossier 4 The final step performed in IUCLID is to create your dossier When performing this step some final crucial information must be entered e g fee waiver additional information about tonnage band or reference to previous submissions A basic guidance on how to prep
55. ropa eu Appendix 4 8 Joint Submission Member Spontaneous Update Figure 18 Joint Submission Member Spontaneous Update p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration member of ajaint submission general case Mame given by User Spontaneous Update of Substance A as Dossier submission remark This is an example of howa Joint Submission Member Dossier Spontaneous Update s dossier header should look This example represents the basic case depending on your submission context your dossier header might look different Type of submission Information provided by the lead on behalf of the member s Chemical safety report Guidance on safe use Review by an assessor Tonnage band Between 100 to 1000 tonnes year a menoma O tonnage band Tangara meme I tonnage band Submission update Is the submission an Updater Last submission number xx123456 70 A Reason for updating Further to arequest decision fram regulatory body spontaneous update change of tonnage band gt bh x justification change of tonnage band a S Remarks Due to increase in production volume the tonnage band has tol a Version 2 3 Page 32 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist 2 Checklist x 1 Joint Submission checkbox must
56. s dossier header should look This example represents the basic case depending on YoUr submission context your dossier header might look different Type of submission Joint submission Information provided by the lead on behalf of the member s Chemical safety report v Guidance on safe use Review by an assessor Tonnage band Between 1 to 10 tonnes year a M ona o tonnage band Tansporedisoited memede OOOO OA tonnage band Submission update Is the submission an updater Last submission number Hele s456 78 a Reason for updating Further to a request decision fram regulatory body PR A L A Mum ber e 20 R fe a F spontaneous update Version 2 3 Page 28 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules Checklist Checklist BECHA http echa europa eu Joint Submission checkbox must be ticked 8 The Communication Number must be Appendix 5 2 indicated In the case of a TCC failure this will be the communication number provided in the letter which requested further information For further information please see Appendix 5 3 1 or Appendix 5 3 3 1 2 Chemical Safety Report tick this box if you are supplying the CSR on behalf of members 9 Do you want to claim confidentiality for the Tonnage Band of the submission Appendix 5 4 1 3 Guidance on Safe Use tick this b
57. seeseeeeeeeaesesauseuseesaeeeesausausens Joint Submission Lead Spontaneous Update cee eceeceesseeeeeeeeeceeeeeeseeseneeseaneeseeeessans Joint Submission Lead Requested Update c cccccecccseeeeeeseeeeseeesneeeceseeseseeseneesseneesens Joint Submission Member Initial SUBMISSION cccceseeeseseeecesceeeeeeeeeususeuseussesausausees Joint Submission Member Spontaneous Update cccccecceeseeeeseeeeeeeeeeeeeseeneeseeeeneaes Joint Submission Member Requested Update ccccccessseeeeeeeeeceneeeceseeseeeeseeeeeseneessans Further information on the IUCLID 5 Dossier Header cccsseceeseeeeseeeeeenenes Dossier submission name and remarks dossier header part 1 sccccsseseessseeeeeeens Type of Submission dossier header part 2 cccccscecsceseeeeeeeeceseeesaneeeeseeeseneeseenesseneessaes Submission update information dossier header part 3 cscccssseeeseeeeceeeeeeeeeeseeeeees Requested Update for an Incomplete Initial Submission cccesceeeeeeeeeeeeneeeeeeeeeeeeneseneeeeeeeenees Updating a Substance Notified Under Previous Legislation NONS ccccsssseeeesseeeeeeeeeeneeenees Previously Registered Under REACH ssiwtuccnctadesetanauneesatsucdusatonucenotetuuniaendinsinieatureetneteinuiauetinwiotaucns Specific information related to the dossier dossier header part 4 ccccsssseeseeeeees CONTIENE sirasini a E E 0 AN
58. set out in Article 18 4 a as oom Specific information for o Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set out in Article 15 4 isolated intermediates a i B f_ 8 G f 8 Back Next gt Cancel Enter administrative information Appendix 5 1 Dossier submission name and remarks dossier header part 1 The first part allows you to specify the name of the dossier Figure 22 as well as any additional information you want to point out Figure 22 Specifying the name of the dossier p Dossier creation wizard x Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Mame fgiven by user Registration of substance A 4 Dossier submission remark The dossier covers both the use of 4 used as intermediates under strictly controlled conditions and use d as non intermediate Appendix 5 2 Type of Submission dossier header part 2 The second part of the dossier header is where information about involvement in joint submission and possible inclusion of intermediates in the registration can be indicated If the dossier is a part of a joint submission the registrant should mark the Joint submission tick box In case the box is marked further information is required about what is provided by the lead registrant When the Joint Submission tick box is marked
59. should be submitted following an ECHA completeness check communication or an ECHA compliance check communication or whether it is a spontaneous update If the dossier is an update it should be identified by all of the following information e Ticking the box is the submission an update e Including the last submission number the number to be given depends on the circumstances described in the succeeding paragraphs e Completing the reason for updating field If the above mentioned information is not provided ECHA will not be able to process the dossier Appendix 5 3 3 1 Update on request In case of an update made on request of a regulatory body the checkbox Further to a request decision from regulatory body must be selected and the communication number in the request letter must be entered in the adjacent Number field Figure 27 Version 2 3 Page 41 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification BECHA http echa europa eu Enforce Rules Figure 27 Reason for updating further to a request decision from regulatory body Reason for updating Further to a request decision from regulatory body amp 3 MUM Ber tO AAAA A Appendix 5 3 3 2 Spontaneous update In case of spontaneous update the checkbox spontaneous update should be selected Figure 28 and the reason for the update should be chosen fr
60. sier in the 6th step A To create a dossier in IUCLID 5 you should start from the IUCLID 5 substance dataset select the template corresponding to your submission for e g REACH Registration 10 100 tonnes REACH PPORD follow the dossier creation wizard guide This information will then be embedded in the IUCLID 5 dossier header Here below an example Figure 20 of how a dossier header appears once the dossier is created Figure 20 Dossier header in IUCLID 5 nq Do _ p_upd P Dossier header Dossier template Mame REACH Registration 100 1000 tonnes 4 wersion 2010 01 25 Mame given by user O05_pa_reg_100 1000_substH_Sh_sp_upd lt a Dossier subject Mame SUBbStH NONS f S methyl benzoacl 2 sithiadiazoale carbothioate methyl benzoil 2 3ythiadiazole submitting legal entity oi PirComp_F_large Espoo Finland Dossier creation date time 2010 02 09 15 02 05 EET Dossier submission remark x used in category In the following pages a detailed guide on how to fill in properly the information requested during the 6th step of the dossier creation wizard is given The screen at this step is divided in five parts Figure 21 Version 2 3 Page 36 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules AECHA http echa europa eu Figure 21 Step 6 of the Dossier Creation Wizard Dossier creation
61. ssion Phase in Information Submission Number AORN ji Registration submission Cate PE notification Is the submission an update Ma Is it a joint submission Mo status of the dossier Failed Substance Reference Number Substance Name re Request submitted file Joint submission Message box User account Figure 39 provides an example of how the information on the automated business rules is displayed in the submission report Figure 39 Submission report Passed Tasks No Task Result 1 Mirus check Succeeded 2 File format validation Succeeded 3 Check ML structure Succeeded 4 Enforce Rules Failed Rule Name SUB GBL UCO BR170 Rule Level Mandatory Rule Result Not satisfied Rule Message Your dossier does not contain the information related to a production site in WCLID 6 section 3 3 whereas in section 1 1 the checkbox manufacturer was ticked Please make the necessary modification and submit a new dossier Rule Name SUB REG UCO3 BR190 Rule Level Mandatory Rule Result Not Satisfied Rule Message The tonnage band you have indicated in REACH IT during the submission of your dossier does not match the tonnage band indicated in the dossier template of your IWCLID 5 dossier Consequently we are not able to process your dossier For each failed automated business rule the lt Submission report gt gives the reason of failure as indicated in Figure 40 Version 2 3 Page 49 of 52 Release April 2010
62. sure that you are using the assigned EC number Appendix 1 2 1 4 The Communication Number must be indicated In the case of a TCC failure this will be the communication number provided in the letter which requested further information For further information please see Appendix 5 3 1 or Appendix 5 3 3 1 10 Do you want to claim confidentiality for the Tonnage Band of the submission Appendix 5 4 1 5 Was the submission reviewed by an assessor This information is not compulsory od l O O Version 2 3 Page 23 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 4 Joint Submission Lead Initial Submission Figure 14 Joint Submission Lead Initial Submission p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Mame given by user Registration of Substance A Dossier submission remark This is an example of how ajoint Submission Lead Dossier Initial submission s dossier header should look This example represents the basic case depending on your submission context your dossier header might look different Type of submission v Joint submission Information provided by the lead on behalf of the member s Chemical safety report Guidance on safe use Review by an assessor Tonn
63. t is to help ensure that companies can successfully submit a dossier under the REACH Regulation 1907 2006 through REACH IT and in particular to explain the initial checks that are made by REACH IT to determine whether the dossier can be accepted for further processing Dossier types currently undergoing these checks and described in this manual include e Registrations e Notifications for PPORD Product and Process Orientated Research and Development exemptions e Inquiry dossiers This document outlines how and why these checks are carried out It also aims to give guidance on how to prepare the substance dataset and the dossier header in order to be able to successfully pass the business rule verification One substance one registration REACH operates on the principle of one substance one registration If you have more than one substance to register then you need to make a series of single registrations If you have a number of substances with similar structure and or properties a category approach can be used but it is still necessary to submit a separate registration dossier for each substance being registered More information on categories is provided in Section D6 and D8 2 5 of the IUCLID 5 end user manual Note that ECHA will develop and apply new business rules when required Please check the web page regularly for updates 2 1 Business Rule Verification 2 1 1 What are business rules All dossiers submitted to ECHA undergo adm
64. ta Sharing Issues This information is not part of the Business Rule check 8 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 9 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 Oo O O l i Page 25 of 52 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules AECHA http echa europa eu Appendix 4 5 Joint Submission Lead Spontaneous Update Figure 15 Joint Submission Lead Spontaneous Update p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Mame given by user Registration of Substance A al Dossier submission remark This is an example of how a joint Submission Lead Dossier Spontaneous Update s dossier header should look This example represents the basic case depending on Your submission context your dossier header might look different Type of submission v Joint submission Information provided by the lead on behalf of the member s Chemical safety report Guidance an safe use Review by an assessor Tonnage band Between 1 to 10 tonnes year a M crate hechnermetaes O tonnage band Transported temedies IB tonnage band Submission update Is the submission an updater
65. th the most Appendix 5 4 2 recent registration for that substance For registrations derived from a NONS claim and other special cases see Appendix 5 3 3 Justification for the spontaneous update 7 If the submission includes registration of an must be provided Chapter Appendix 5 3 3 2 intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 4 Was the submission reviewed by an 8 Make sure that you are using the assigned assessor This information is not compulsory EC number Appendix 1 2 1 Version 2 3 Page 21 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 4 3 Single Submission Requested Update Figure 13 Single Submission Requested Update p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Mame given by user Requested Update of Substance A a Dossier submission remark This is an example of howa single requested update s dossier header should look This example represents the basic case depending an your submission context your dassier header might look different Type of submission Joint submission ooo E tonnage band Tansoted sted ermedes I tonnage band Submission update Is the submission an
66. tion number HCD 08 04 1004 notified substance REACH registration number O1 7 7001004 00 0000 submission of notified substance FFOOLOO4 00 Version 2 3 Page 13 of 52 Release April 2010 REACH IT Data Submission Manual Part 4 How to Pass Business Rule Verification Enforce Rules BECHA http echa europa eu Appendix 1 5 Section 1 5 Joint submission The information of the Joint Submission is completely derived from REACH IT and any information in Section 1 5 is not taken into account Section 1 5 can be used for your own administrative purposes but it is important to note that the consistency of any information in this section of IUCLID will not be verified against the information derived from REACH IT Appendix 1 6 Section 2 1 GHS and Section 2 2 DSD DPD In a registration dossier the classification and labelling information must be provided in Section 2 In case of a Joint Submission this information will be provided by the lead and is not expected to be in the member dossier unless in the case Section 2 is part of the information for which an opt out applies The format of the classification depends on the date of submission as follows e Submission before 01 12 2010 the dossier must contain either only the DSD Section 2 2 or both GHS Section 2 1 and DSD Section 2 2 It is strongly recommended that you include both sections to prevent updating the dossier to include the CLP information e
67. uent has to be the same as in Section 1 1 Appendix 1 4 Section 1 3 Identifiers Certain regulatory identifiers must be included in Section 1 3 REACH Registration Number Registration numbers are obtained by successfully registering a substance or by claiming a notified substance The provided number has to belong to the submitting company and has to point to the reference substance used in Section 1 1 of the dossier Notification Number NCD If your registration number was granted by ECHA for a substance previously notified under Directive 67 548 EEC you must in provide the Notification NCD Number in addition to the registration number The dossier s submitting company has to match with the company who claimed the notification in REACH IT Also the substance must be the same in the dossier and in the notification REACH Pre registration number When provided the indicated pre registration number has to belong to the submitting company REACH PPORD Notification Number The provided number has to belong to the submitting company and has to point to the reference substance used in Section 1 1 of the dossier REACH Inquiry Number When provided the number has to belong to the submitting company and the EC number which was provided by ECHA after this inquiry must match the one used in Section 1 1 Figure 9 Regulatory programme identifiers in Section 1 3 Regulatory programme identifiers Regulatory programme Remarks notifica

Part 4 How to Pass Business Rule Verification ("Enforce Rules")

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Part 4 How to Pass Business Rule Verification (&quot;Enforce Rules&quot;)

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Part 4 How to Pass Business Rule Verification ("Enforce Rules")