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How to Pass Business Rule Verification

1. Appendix 4 6 J oint Submission Lead Requested Update Figure 30 Joint Submission Lead Requested Update Fr x p Dossier creation wizard x Enter additional administrative information concerning your dossier Dossier template REACH Registration 1 10 tonnes standard requirements Mame given by user Registration of Substance A 4 Dossier submission remark This is an example of howa joint submission lead dossier requested update submission s dossier header should look This example is the basic case depending on your submission context your dossier header might look different Type of submission Aso 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 Tonnage band s of the lead registran AcoHHY_ Tonnage band Between 1 to 10 tonnes year M a ES tonnage band REACH Article 17 tonnage band REACH Article 15 Specific submissions mmm The submission is an update Last submission number 46123456 75 a Reason for updating Further to arequest decision from regulatory body PI I BIL Ber ee R A Remarks Spontaneous update Dossier specific informati ad_ ATAHYY aor ooo Phas e in 9 Fhase in Non phase in Reviewed by an assessor Remarks Document ia Confidentiality claim on registration number Confidentiality claim on tonnage band Data sharing issues a Fee waivi
2. Phase in Non phase in Reviewed by an assessor Remarks comes EN a Confidentiality claim on registration rumber a Confidentiality claim on tonnage band Data sharing issues a Fee waiving 1 10 tonnes complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly cortrolled conditions F Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 15 4 F Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set out in Article 18 4 2 B b 8 _ 5 B f B8 lt Back Mext gt Cancel Enter administrative information Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 36 Data Submission Manual Version 3 0 Checklist 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 Isolat
3. Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 46 Data Submission Manual Version 3 0 Appendix 5 Further information on the I UCLID 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 dossier in the 6th step A To create a dossier in IUCLID 5 the user should start from the substance dataset select the template corresponding to the submission e g REACH Registration 10 100 tonnes REACH PPORD and follow the dossier creation wizard Note the guidance in Appendix 1 1 bullet point 2 with respect to the legal entity of the IUCLID 5 user In Step 5 of the dossier creation the user will see the legal entity the dossier is being created for and once the dossier is created the user can view the dossier header where the name of the submitting legal entity is shown This information will then be embedded in the UCLID 5 dossier header Below is an example Figure 34 of how a dossier header appears once the dossier is created Figure 34 Dossier header in IUCLID 5 ad Dossier 005_pa_reg_100 1000_substH_Sh_sp_upd eae Dossier header Dossier template Mame RE amp CH Registration 1
4. 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 The 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 business 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 IUCLI D must be selected Figure 38 and the communication number indicated in the request for further information must be entered in the adjacent Number field in IUCLID see Figure 38 This only applies to su
5. Joint 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 s of the lead registran AsoomYYYY YYY TT Tonnage band Between ltolOtonnesfyear 000 lto 10 tonnes ysyear Between lto10tonnesfyear O O Z OZO OoOo OM tonnage band REA CH Article 17 tonnage band REACH Article 15 Specific submissions The submission is an update Dossier specific information Phas e in e Phase in CO Non phase in Reviewed by an assessor Remarks Confidentiality claim on registration num ber a Confidentiality claim on tonnage band Data sharing issues Fee waiving 1 10 tonnes complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly controlled conditions 3 Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 16 it E Registrant has received confirmation from the users that the intermediate iz Used in accordance with the conditions zet out in Article 16 4 g e a d a l O a 8 Back _ next gt Finish Cancel Enter administrative information Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 34 Data Submission Manual Version 3 0 Che
6. Manufacturer Importer Only representative Downstream user wemicals Agency H Legal entity flags Legal entity e Inthe Information field under the Information tab you can find the UUID of the legal entity associated with this substance Figure 5 The legal entity assigned to the reference substance FF Legal entity European Chemicals Agency l Helsinki y Finland 2 Sealed Copy protected Subset of original Official entry LEO e Dossier Creation When creating the dossier you must ensure that you use a UCLID User Account for the legal entity which corresponds with the submitting legal entity in REACH IT This legal entity is visible at the bottom of IUCLID 5 screen in the status bar How to find the legal entity that is creating the dossier e On the bottom of the IUCLID main screen the selected legal entity is visible Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Figure 6 File Edit Go Window Help y J fa b TASKS woe Legal entity Wee Create and update company organisation related information Ny e e p New Update Substance Create and update substance related information j New Update d Inventiones Template Create and update template related information New Update Dossier View dossier data View Compare Inventory View EC inventory re
7. REACH IT message on BR failure manual check sssssssnsnnnunnnnnnnnnnnnnnnnnnnnnnnnn 60 Annotations tab with Communications sssssssssss22u 222u 222us22uusuuuunnununnnnunnnnnnnnnn 60 Attached communication in the dossier info ssssssssssssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 60 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 1 How to 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 document 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 are e Registrations 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 succ
8. at least one row in Article service life in section 3 5 must be filled in The role Only representative cannot be selected together with Manufacturer or Importer For more information on Guidance for identification please see Guidance for identification and naming of substances under REACH Available at http echa europa eu web guest support guidance on reach and clp implementation 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 These automatically created EC Inventory entries can be downloaded in i5z IUCLID 5 file format from REACH IT To download the EC number please follow the steps below Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 1 Log in to REACH IT and click on Search for Dossier Figure 13 REACH IT Home Screen FECHA EUROPEAN CHEMICALS AGENCY Home Company Welcome ii 45 Pre registration Pre SIEF You have 33 unread message s in your message box Online dossiers You last connected on 2011 07 06 11 21 04 0 Phase in Information Registration notification Joint submission Classification and Labelling Message box Downstream user report User ac
9. FI 00121 HELSINKI FINLAND ECHA EUROPA EU
10. 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 50 Figure 50 REACH IT message on BR failure auto check T wHide Yes Decision made by the Agency UE128759 22 11 03 2011 19 56 Your dossier cannot be processed Further information can be found in the report Preliminary submission number UE128759 22 Dossier type Registration iregular File name Zinc_2 _dossieri5z Download SUBMISSION repor Go to dossier The related communication to your dossier has been reeccived The communication number is SUB C 21140683 4 42 07 F The communication was REJECT Download communication information 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 51 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 58 Data Submission Manual Version 3 0 Figure 51 Status of a dossier in the dossier details tab Home gt submitted Dossiers gt Dossier Details Company Details Festi a a EL Fre registration Pre SIEF Dossier Dossier type Registration Online dossiers Submission Phase in Information Submission
11. Labelling and Packaging EU PPP Plant Proteccian Products Cirective 91 414 EEC FU REACH Registraion Evaluation and Authorisation of Chemicals CAD COPA Cxisting Substances Program under COPA LA PCPA Pest Contool Products Act JP CSEL Chemical Substances Comrol Law OECD APY HP Chemicals Progremme US EPA HPW APY Chemical Challeage Programm LIS FIFRA Federal Insecticide Fungicide and Rodenticide Act US TS2A Toxic Substances Contre Act v Any other Mo reculatory purpose Mote for z RESCH dossier all informaticn should be pert of the dossier ie all flag showld he selected ar the default values s nuld he weed P a t b B f E E l N xt Finish Cancel Select data protection flags 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 during dossier creation for each submission context In case further information is needed go to Appendix 5 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 27 Appendix 4 1 Single Initial Submission Figure 25 Single Initial Submission F p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration
12. Number LONE a Registration Submission Date AT notification Is the submission an update Joint submission Maini in Status of the dossier Failed substance Reference Number substance Name Siena Request submitted file The complete list of the failed automated business rules is available by clicking the tab lt Submission Report gt see Figure 52 and Figure 53 Figure 52 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 Submission Phase in Information Submission Number Sc sa Registration Submission Date eas Online dossiers notification Is the submission an update No Is it a joint submission Mo Sats of the dossier Failed Substance Joint submission Message box User accoun ene Reference Number Substance Name aye y Request submitted file Figure 53 provides an example of how the information on the automated business rules is displayed in the submission report Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 59 Figure 53 Submission report Passed Tasks No Remark Result Virus check Succeeded Fil format validation Succeeded Ch
13. The Reference Substance has to be identified with at least one of the following identifiers EC Number CAS Number IUPAC Name Please note that in order to be able to facilitate dissemination of information contained in the IUCLID dossier a IUPAC name ALWAYS has to be present in section 1 1 Figure 12 Example for identifying the reference substance Reference substance i S methyl benzocl 2 sithiadiazole carbothioate methyl benzotl 2 sithiadiazole carbothioate f methyl benzotl 2 sithiadiazole EC number EC name 470 050 0 s S methyl benzoil sithiadiazole carbothioate i CAS number CAS name S methyl benzotl 2 sithiadiazole carbothioate IUPAC name S methyl benzoacl 2 sithiadiazole carbothioate 4 Absence of the EC Number assigned to the substance will lead to Business Rules failures in the following cases The submission is an update 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 The following information has to be taken into account when choosing the correct Role in the supply chain If Manufacturer is selected a production site in section 3 3 Sites must be provided And it has to be linked to a Manufacture use in section 3 5 The role Downstream user cannot be selected if the submission only covers intermediates If Downstream user is selected
14. alternative name request CLP notification CLP Regulation CLH dossier Endpoints information OECD harmonised templates OECD SIDS REACH Annex xw Restriction REACH Annex aw SWHC REACH Application for authorisation REACH Downstream User report REACH Inquiry REACH Notification of substance in article REACH PRORD REACH Registration 1 10 tonnes physicochemical requirements REACH Registration 1 10 tonnes standard requirements REACH Registration 10 100 tonnes REACH Registration 100 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 abowe 1 tonne REACH Registration transported isolated intermediates 1 1000 tonnes REACH Registration transported isolated intermediate 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 8 5 8 8 5 2 B em C J sn _ cancel Select a dossier template Individual submission dossier or Lead dossier IUCLID 5 Template Dossier type in REACH IT Standard Registration Registration template with Registration the corresponding tonnage band e g REACH Registration 10 100 tonnes Standard Registration Registration template with R
15. dossier Dossier template REACH Registration member of ajoint submission general case Mame fqiven ay User Registration af Substance A Dossier submissior remark This is an example of howajoint submission member dossier requested update sUbrmissiurn dussier header should look This example isthe basit case de peridiniy on your subnission 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 bandis of the member registrant Tonnage band Between 1 to 10 tonnes fycar i tonnage band REACH Article 171 tonnage band REACH Article Lin Specific submissions The submission iz an update Last submission number ABLZ53456 78 4 Remon for updal iny Further to a requests decision from regulatory body PR a Hum Ber 08 200 E Remarks Spontaneous update Dossier specific information Pliase in r 0 hon phase in a Phase in Reviewed by an assessor Remarks Docum er a Confidentiality claim on registration number Fi Confidentiality claim on tannage band Daa shariqg issues r Tee waiving 1 10 connmes complete dossier Compulsory information for isolated intermedmtes under ROACH Article 17 and 18 Production and use under strictly controlled coaditions a Registrant confirms that he intermediate is used in accordance wit
16. in example in Figure 45 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 support dossier submission tools Figure 45 Registration dossier specific information Dossier specific information Phas in Phase in D Non phase in Reviewed by an assessor Remarks Confidentiality claim on registration number lustific ation ie t Declaration We MAME claim SHORT SUMMARY OF INFORMATION confidential in accordan ce with RELEWANT REFERENCE TO THE LEGISLATION We MARIE hereby declare that to the best af our knowdedge as of today DATE 1 and in accordance with the due measures of protection that we have implement Confidentiality claim on tonnage band Justification ie p Declaration Wwe NAME claim SHORT SUMMARY OF INFORMA TION confidential in accordar ce with RELEVANT REFERENCE TO THE LEGISLATION We MAME hereby declare that to the best of our knowdedge as of today CATE 1 andin accordance with the due measures of protection that we have implement Data sharing issues Justification Fee waiving 1 10 tonnes complete dossier Ustific ation Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 H
17. lead registrants can only update this information from Q not providing to providing This is implemented in order to avoid scenarios where member registrations would become incomplete after an update of the lead dossier When the Joint Submission tick box is marked the Tonnage band pick list appears for member dossiers it is available by default 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 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 49 Figure 37 Type of submission Type of submission ONT SubMmMIssian Information provided by the lead on behalf of the member s Chemical safety report Guidance on sate use Reviews by an assessor Tonnage band s of the lead registrat AoYY_V_ H Tonnagehend OOOO A tonnage band REACH Article 173 tonnage band REACH Article Le
18. notification ae Communications Joint submission Classification and lt Outcome Creation date Process type SUB C 2114088032 56 01 F REJECT 09 03 2011 Submission Pipeline Message box Downst ream user report Opinions User account Id Outcome Creation date Process type Legal entity change l No records Invoices Search 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 57 containing all details on the failure e the actions you should take to submit a valid dossier Figure 57 Attached communication in the dossier info Home gt Submitted Dossiers gt View Dossier Decision Communication Info Compan pan Communication Outcome REJECT Pre SIEF Type Communication on overrulable business rule Online dossiers Communication number SUB C 2114088032 56 01 F External deadline Pre registration Phase in Information Registration notification Content Content Please see the attachment Attachments Joint submission Classification and Labelling Name Attached file Message box REG_BRREJ_GG128383 49 pdf Downstream user Sato EDO as Pe report User account Legal entity change Invoices Search Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu EUROPEAN CHEMICALS AGENCY ANNANKATU 18 P O BOX 400
19. the tonnage band of the submission and 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 Figure 23 Dossier Template Selection in I UCLI D Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 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 f ail substance Complete Biocides Active ingredients Biocides Biocidal products Biocides Substances of concern CLP
20. this box if you are providing Guidance on Safe Use independently from the lead i e within your own dossier 9 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 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 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 41 Appendix 4 8 Joint Submission Member Spontaneous Update Figure 32 Joint Submission Member Spontaneous Update Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 42 Data Submission Manual Version 3 0 p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration member of ajoint submission general case Mame given by
21. 00 1000 tonnes Wersian 2010 01 25 Mame igien by user O05_pa_reg_100 1000_substH_Sh_sp_upd Dossier subject Mame SUbSsStH NONS f S methyl benzoil sithiadiazole carbothioate f S methyl benzocl 2 sithiadiazoale 7 gt Public name submitting legal entity oi PirComp_F_large Espoo Finland 4 gt ad Dossier creation datestime 2010 02 09 15 02 05 EET a COS Used in category In the following pages a detailed guide on how to fill in properly the information requested during the 6 step of the dossier creation wizard is given The screen at this step is divided in five parts Figure 35 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 47 Figure 35 Step 6 of the Dossier Creation Wizard 2 p Dossier creation wizard Eg Enter additional administrative information concerning your dossier Dossier template REACH Registration 1 10 tonnes standard requirements Name given by User Registration of Substance A Dossier submission remark y Dossier submission name and remarks Type of submission Joint submission Information about the intermediates tonnage band and possibility to mark if the dossier is part tonnage band REACH Article 17 tonnage band REACH Article 19 Specific submissions Tonnage band s of
22. 1 10 tonnes standard requirements Mame given by User Registration of Substance A ia Dossier submission remark This is an example of how a single initial submission s dossier header should look This example is the basic case depending on your submission context your dossier header might look different Type of submission Joint submission Tonnage band s of the registrant Op site izolated intermediates tonnage band REACH Article 17 Transported isolated intermediates tonnage band REACH Article 18 Specific submissions The submission is an update Dossier specific information gt Phas e in 8 Phase in O Non phase in Reviewed by an assessor Remarks Confidentiality claim on registration number C Confidentiality claim on tonnage band _ Data sharing issues Fee waiving 1 10 tonnes complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly controlled conditions a Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 16 44 a Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set aut in Article 15 44 B 8 5 S 5 a 8 lt Back fia Enter administrative information Annankatu 18 P O Box 400 FIl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68
23. 1 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 57 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 1 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 7 step of the dossier creation wizard Note that the 7 step of the dossier creation wizard will appear only if the registrant who is part of a joint submission has entered data into one or more of section 2 to 8 of his dataset If no information from these sections is selected then step 7 is skipped A justification should be provided in the last column for every section selected Figure 49 Please note that this step only available in case of a joint submission Figure 49 Indicating opt out in I UCLI D Data selected for opt out Select for opt out Document Origin Section justification for opt out Test substance Eu 2 1 GHS justification a Test substance f Eu 2 DSD DPD Appendix 6 Finding information about your submission What happens when a dossier fails an automated business rule
24. 2220220022 2 35 Figure 30 Joint Submission Lead Requested Update ssssss2222225222222222252222u2022202220220 200 37 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Figure 47 Figure 48 Figure 49 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Figure 56 Figure 57 Joint Submission Member Initial SUDMISSION sssssssununnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 39 Joint Submission Member Spontaneous Update cccsscseceeeeeeeesseneeeseeeeeeeeeeeeaas 41 Joint Submission Member Requested Update ssscesssscceeeseeeessnnneeeseeeeeeeeeeeaas 44 Dossier NeacGer In VUCEID 5 seesecacescsccasiumesacsusescdeausareuselasusincetemesarseewsennentunwersismencs 46 Step 6 of the Dossier Creation Wizard s sss2 22 225u2252220220u2202200u20uu20u220unnnnnnnnn 47 Specifying the name Of the dOSS fr sssss2222 252 2 2 2 22522222222220u20uu20u220un20unnnnnnnnn 48 Type of SUDMISSION cisiiiicsencseesneictesssenncswwaeheeisasesnmmasierieiendssicsnasaemeieieadssnetentinetadeecnes 49 I UCLI D screen with reason for updating ccceeeeeeeeeeeeeeeseneeeeeeeeeeeeeeeessanaaeseneneees 50 REACH IT message for
25. 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 39 Appendix 4 7 Joint Submission Member Initial Submission Figure 31 Joint Submission Member Initial Submission r Iio Dossier creation wizard x Enter additional administrative inform atian concerning your dossier Dossier template REACH Registration member of ajoint submission general case Mame given by user Registration af Substance A Dossier submission remark This is an example of how a joint submission member dossier initial submission s dossier header should look This exam ple is the basic case depending on your submission context your dossier header might look different Type of submission Information prowided by the lead on behalf of the member s Chemical safety report Guidance on safe Use Review by an assessor Tonnage band s of the member registrant Tonnage band Between 1 to 10 tonnes year a Sila 4 ES tonnage band REACH Article 17 ee tonnage band REACH Article 154 Specific submissions The submission is an update Dossier specific information Phas e in 9 Phase in CO Non phase in Reviewed by an assessor Re marks Confidentiality claim on registration number F Confidentiality claim on tonnage band Data sharing issues a Fee waiving 1 10 tonnes complete dossier Compulsory information for isolated int
26. 618210 echa europa eu 28 Data Submission Manual Version 3 0 Checklist 1 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 2 Was the submission reviewed by an assessor This information is not compulsory 3 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 Checklist 4 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 5 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 29 Appendix 4 2 Single Submission Spontaneous Update Figure 26 Single Submission Spontaneous Update z w 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 Dossier submission remark This is an example of howa single spontaneous update s dossier
27. 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 Appendix 4 5 Joint Submission Lead Spontaneous Update Figure 29 Joint Submission Lead Spontaneous Update E Dossier creation wizard R Enter additional administrative information concerning your dossier Dossier template REACH Registration 1 10 tonnes standard requirements Mame given by user Registration of Substance A 7 Dossier submission remark Thijs is an example of howa joint submission lead dossier spontaneous update sdbmission s dossier header should look This example is 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 Tonnage band s of the lead registrant Tonnage band B2tween 1 to 10 tonnes year 4 M tonnage band REACH Article 17 tonnage band REACH Article 15 Specific submissions The submission is an Update ast submission number AbBL2Z5456 78 a Reason for updating Further to arequest decision from eguilatory body Spontaneous update change of tonnage band ge t 3 bl x Justification change of tonnage band 4 oo S Remarks Due to increase in production volume the tonnage has tobe ch Dossier specific information Phase in
28. CECHA EUROPEAN CHEMICALS AGENCY MANUAL 2 Data Submission Manual Version 3 0 Version 3 2 5 2 2 3 2 1 m z i l l l O N N D O Changes 07 2012 Update to reflect changes due to IUCLID 5 4 update multiple screenshots Updated visual identity Minor textual revision 04 2011 Update to reflect changes due to IUCLID update multiple screenshots Minor textual revision 06 2010 Further clarification about the legal entities and minor revision 04 2010 Change in wording in App 1 1 LE and TPR part Figure 29 changed 03 2010 Redesigned document and incorporated essential elements of DSM 8 12 2009 Minor textual revisions web links verified and updated document in new layout 07 2008 Major review of document as a result of release of a new version of REACH IT 06 2008 Creation of document Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 3 Part 04 How to Pass Business Rule Verification Enforce Rules Reference ECHA 12 G 33 EN Publ date July 2012 Language EN European Chemicals Agency 2012 Cover page European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form Source European Chemicals Agency http echa europa eu and provided written notificat
29. FOOLOO4 O0 Appendix 1 5 Section 1 5 Joint submission The information of the Joint Submission is completely derived from REACH IT the joint Submission name must be provided in REACH IT while uploading the dossier 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 However should you be submitting an individual dossier this section has to be empty Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 20 Data Submission Manual Version 3 0 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 e Since 01 12 2010 the dossier must contain the classification and labelling information according to the GHS Section 2 1 classification For more information on Classification and Labelling please see Data Submission Manual 5 available at http echa europa eu support dossier submission tools Appendix 1 7 Section 2 3 PBT Assess
30. REACH I f sssssssnnnnsnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 16 Figure 15 Search Results in REACHED bissana 17 FIGUTE TG Do sSSIEr DEAS eaae E EEES 17 Figure 17 Dossier Further D tallS scssssisiiissssnnns naa aaa 17 Figure 18 Exporting EC number from REACH IT sssssssss22222222u2202202u202220u200220u220u220unnnnnnnnn 18 Figure 19 Regulatory programme identifiers in Section 1 3 sssssssss22n222222220222022202202 0 19 Figure 20 PBT Assessment not required ssssssss2s2252 252225u2222202220u220u200u20uun0unnnunnnnnnnnnnnnnnn 20 Figure 21 Linking Manufacturing use tO a S te sssss22 2222u222u20u220u220u20u20uun0nnnnnn 21 Figure 22 Article Servic lfe cccns a a a A 21 Figure 23 Dossier Template Selection in UCLI D sssssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 22 Figure 24 Filtering information during the dossier creation procesSS sssssssnnnnnnnnnnnnnnnnnnnn 26 Figure 25 Single Initial SUBMISSION ssssrssisssiinesnnnnna aa aa ai 27 Figure 26 Single Submission Spontaneous Update ssssss22222222222222222222u222220222022202202 2 nn 29 Figure 27 Single Submission Requested Update sssssss22222222u225u22222222202222202u202220 220 20n 31 Figure 28 Joint Submission Lead Initial SUDMISSION ssssssssnnunnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 33 Figure 29 Joint Submission Lead Spontaneous Update ssssss222 25222522252222225222
31. Sy O A Remarks Jue ta increase in production volume the tonnage band has tos 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 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 let
32. T message for successful NONS claim You have claimed 1 registration number s in relation to Notification number 4456 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 UCLID 5 dossier e Inthe dossier header you should indicate in the Last submission number field Figure 40 the Submission number as indicated in the Registration number successfully claimed message 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 40 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 51 Figure 40 Updating previous NONS after the claiming of the registration number Specific submissions e The SUBMISSION is an Update Last s4bmizsion number lt 12 456 76 i Reason for updating AA A DDM aaAa AaAAaAaAaAJaAANAN U OUN jN _A oo rc C Furtherto a r2quest decisior fram regLlator body Spontaneous update chaage of tonnage band Justificaion hange of onnage bend at
33. abelling block in section 2 1 Appendix 1 4 Section 1 3 Identifiers Certain regulatory identifiers must be included in Section 1 3 as outlined below e 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 Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 19 in Section 1 1 of the dossier In case you are updating an already registered substance please use the registration number you obtained when you submitted your dossier e Notification Number NCD If your registration number was granted by ECHA for a substance previously notified under Directive 67 548 EEC you must 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 identity must be the same in the dossier and in the notification e REACH Pre registration number When provided ie when submitting a registration for a pre registered phase in substance the indicated pre registration number has to belong to the submitting company e REACH PPORD Notification Number For PPORD notificat
34. and Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 Figure 36 Specifying the name of the dossier p Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes 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 for a lead dossier 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 Please note that this tick box is not available in dossier templates for member registrants Please note Tick the Chemical Safety Report box Guidance on Safe Use box as a lead registrant only if you submit them on behalf of your members while as a member registrant only if they are supplied by the lead on your behalf and as such you have not added them to your own dataset Do not tick these boxes if you are providing this information independently from the lead i e within your own dataset While member registrants can with a simple spontaneous update change their status of relying on CSR and or Guidance on Safe Use submitted by the lead registrant
35. bmissions 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 x 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 as the one that failed Business Rule validation Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 50 Data Submission Manual Version 3 0 Figure 38 IUCLID screen with reason for updating specitic submissions The TUBMIssion is an update Last s4bmizsion number xX lt 124 456 76 i Reason for updating AANA A A A A A A Furtherto a request decisior fram regtlatory bad I I I Oe PU ber 2 R E E A Remarks F SHAtaneods 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 web guest support dossier submission tools reach it nons If the claim is successful you will receive in your REACH IT mailbox both the registration number and the submission number Figure 39 Figure 39 REACH I
36. cklist 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 IUCLI D 5 template that was used Checklist 6 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 7 Have there been any Data 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 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9
37. count Legal entity change Invoices Pre SIEF Pre registration View submitted C amp L Manage a saved query 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 14 Searching for Dossier in REACH IT FECHA EUROPEAN CHEMICALS AGENCY Home gt Search ompany Search Pre registration Pre SIEF Onine dossiers Search Domain search Domalr Select query CIF nd hy suhmissin MA Phase in Information i Query specifie flelds Submission context Submission number Registration notification Joint submission Submission date from ciate ddim yyy To dd mmiywyy Classification anc Labell m 7 nee is it an Update Message box ee eet Last submission number Downstream user ae ee 5 Is ita Joint Submission report o _ eee acon Dossier evalualiun slalus Leyal entity change Process step D Process slep slalus Comnent available E Dossier attribute Dossier UIID Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 3 In the results field click on the UUID of the dossier Figure 15 Search Results in REACH IT Submission number Submission date Submission update Status Process step Process step status D
38. d 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 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 technical completeness Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 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 Overr
39. diate 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 recent registration for that substance For registrations derived from a NONS claim and other special cases see Appendix 5 3 Checklist 7 Justification for Spontaneous Update must be provided Chapter Appendix 5 3 3 2 8 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 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 11 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 12 Make sure that you are using the assigned EC number 0 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 4 4 Data Submission Manual Version 3 0 Appendix 4 9 Joint Submission Member Requested Update Figure 33 Joint Submission Member Requested Update p Dossier creation wizard Enter additioral administrative infornation concerning your
40. e dataset can be flagged to be used specifically for the purpose of certain regulatory programmes Furthermore flags indicating request for confidentiality claim can also be introduced for these information If any of the fields within the substance dataset are flagged let it be for confidentiality claim or for marking it for separate regulatory programmes if that category is not specifically indicated to be included in the dossier Figure 24 the information will not be exported into the newly created dossier For most cases ECHA would recommend you to select all the checkboxes making sure that all required elements of the substance dataset are used Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 26 Data Submission Manual Version 3 0 Figure 24 Filtering information during the dossier creation process p Dossier creation wizard Select all Confidentiality and Regulatory purpose flags or clear checkboxes for properties for which the information shall not be included into the dossier Dossier template REACH Registration 1 LO tonnes standard requirements Confidentiality Deselect all CBI confidential business information IP intellectual property no PA not public available Not confidential Use restricted to selected regulatory programmes Deselect all EU BPD Biocidal Products Directive 96 6 EC FU CLP Classification
41. e if used in accordance with The condhklons set outin Artice l gH Fi Registrant has received covtirmation trom the users that the imiermedizte iz Weed in accordaace withthe randitions set oat in amp eticle 1A i4 CE S m Sr M Mr R lt Back i Fit Cancel Enter administrative infcrmetian Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 32 Data Submission Manual Version 3 0 Checklist 1 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 2 Transported Isolated Intermediate Tonnage Band 3 Last submission number must be Checklist 6 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 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 8 If the submission includes 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 4 The Communication Number must be indicated In the case of a TCC failure this will be the communication
42. eck XML structure Succeeded Enforce Rules Failed Pre check Falled Rule Name BRO19 Rule Level Mandatory Failed Rule Result Not Satisfied Rule Message One or more constitucnts defined in section 1 2 were not linked to a reference substance Rule Jame RROAN Rule Level Mandatory Rule Result Not Satistied Panes Rule Message This Business Rule has not been executed because of an initial failure of another Business Rule please check Submission Report Please proceed with the correction of the initial Business Rule failure and re submit your dossier At least one fundamental ousiness rule failed The following errors might be detected only due to fundamental failure s Format Failed Rule Name BROSO Rule Level Mandatory Failed Rule Result Not Satisfied Rule Message No constituent reference substances have heen specified in the first compesition bork of section 1 For each failed automated business rule the lt Submission report gt gives the reason of failure as indicated in Figure 54 Figure 54 Submission report with details Rule Name BRO19 t Rule Level Mandatory Failed Rule Result Not Satisfied Rule Message One or more constituents defined in section 1 2 were not linked to a reference substance 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 reg
43. ed 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 O 7 Last submission number must be indicated 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 8 Justification for Spontaneous Update must be provided Chapter Appendix 5 3 3 2 9 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 10 Have there been any Data Sharing Issues 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 12 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 37
44. egistration Intermediate s the corresponding tonnage band e g REACH Registration 10 100 tonnes Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 24 Data Submission Manual Version 3 0 Registration of one type of intermediate i e On Site OR Transported Combination of Intermediates i e On Site Transported Intermediate template with the corresponding type and tonnage band e g REACH Registration On Site Isolated Intermediates above 1 tonne Transported Isolated Intermediate template with the corresponding tonnage Registration of transported isolated intermediate or Registration of on site isolated intermediate Registration of transported isolated intermediate Isolated Intermediates band e g REACH Registration transported isolated intermediates 1 1000 tonnes IUCLID 5 Template Dossier type in REACH IT REACH Registration member of a joint Submission general case Member dossier Context Standard Registration Registration Registration Registration of transported isolated intermediate or Registration of on site isolated intermediate Standard Registration Intermediate s REACH Registration member of a joint Submission general case Registration of one type of intermediate i e On Site OR Transported REACH Registration member of a joint Submission intermediates Combination of Inter
45. eneral information field contains the UUID of the submitting legal entity Figure 11 Information about the submitting legal entity in REACH IT General information Party Name UUID D U N S number VAT number Remarks If the three above mentioned legal entities are not the same the submission will be rejected A Please note that only official legal entity file used in IUCLID will be accepted for the purpose of dossier submission within the REACH IT system Official legal entity files LEOX are generated by REACH IT or on the IUCLID website A legal entity created strictly within IUCLID 5 is not considered to be an Official legal entity A After the submission of the dossier the REACH IT system will compare the three above mentioned legal entities during the business rules verification step The comparison is carried out on the UUIDs associated with the legal entities not on their respective names 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 If 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 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 15
46. eraiecasoeus 22 Appendix 3 1 Choosing the correct IUCLID 5 template sssessrrsrrerrrrnrrsrrrrerrerrrrrrrsrrsrrrrerrerrere 22 Appendix 3 2 Creation of a Dossier from a Substance dataset s ssrsererrerrsrrrrrrrsrrsrrrrerrerrere 24 Appendix 3 3 Filtering the information to be included in the GOSSIEL ccc cececeee eee eee eens 25 Appendix 4 Completing the dossier header sssssssns2u2022222225u2022202220u220u202u202u2uunnnnnnnnnnnnnn 26 Appendix 4 1 Single Initial SUDMISSION lt csivetustesbisconaianueataiatend seedaseswsaadeeheethacentawsedalvedaxsestaecs 27 Appendix 4 2 Single Submission Spontaneous Update sesssssrssrsrrerrsrrrrerrrrrsrrrrerrerrrrerrerere 29 Appendix 4 3 Single Submission Requested Update ssesssrsrserrrrorenrrrrrrrrrrsrrrrrrrerrerrrrererrere 31 Appendix 4 4 Joint Submission Lead Initial SUDMISSION sssssssssssrsrrsrrsrrsrerrerrsrrsrrrrsrrsrrrrerrerree 33 Appendix 4 5 Joint Submission Lead Spontaneous Update sssssrsersrssrrsrerrerrrrrrrsrrsrrrrerrerree 35 Appendix 4 6 Joint Submission Lead Requested Update ssssssrsrrsrrssrrsrrrrrrerrsrrrrrrerrerrrrrrerrere 37 Appendix 4 7 Joint Submission Member Initial SUbMISSION ssesssserssrssrerrnrrsrrrrrrrnrrsrrrrerrrrrsrrne 39 Appendix 4 8 Joint Submission Member Spontaneous Update sssssssrrsrssrrrrsrrsrrrrerrerrrrrsrrerrne 41 Appendix 4 9 Joint Submission Member Requested Update sssersrssrr
47. erification Enforce Rules Release date July 2012 31 Appendix 4 3 Single Submission Requested Update Figure 27 Single Submission Requested Update F A p Dossier creation wizard E3 Erter additional acministretive infcrm ation concerning your dossie Dossiertenplate ROACH Registrat on 2 LO tonnes standard regu rement Mane given by user Registration af Substance A Dossier subir ission remark hisis an example of how a single requested spdate s dossier header should look His example 1S the basic cass depending ON YOU submission Context YCUr Coss er header night look different Type of submission Jont submissian Tonnage band s of the registrant tonnace band REACH Article 17 tonnace band REACH Article 15 Specific submissions The submissicn is an update Las submission number AbL434956 78 Reason for updating Further to a eqvestsdec sion from regulators body zi T l x Num ber EE Sooo ood beta T C Spontaneous update Dossier specific information Phase in Fhase in Nan phase in Reviewed by an assessor E a Confidentiality claim o1 registration nember Fi Curitidterihialily claim wi Lonrnage barid Data sharing issues L Fee wiwing 1 10 tonnas complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly cont olled conditions Registrant cortirms that the invert ediat
48. ermediates under REACH Article 17 and 18 LI Production and use under strictly controlled conditions O Registrant confirm s that the intermediate is used in accordance with the conditions set aut in Article 16 i4 Oo Registrant has received confirmation from the users that the intermediate is used in accordance with the conditions set out in Article 16 45 8808008 Eni Enter administrative information Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 40 Data Submission Manual Version 3 0 Checklist Checklist J oint Submission checkbox must be ticked Appendix 5 2 6 Do you want to claim confidentiality on the registration number or for the 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 and as such you have not added a CSR to your own dataset 7 Have there been any Data Sharing Issues This information is not part of the Business Rule check Do not tick this box if you are providing a CSR independently from the lead i e within your own dossier 3 Guidance on Safe Use tick this box 8 Do you want to claim a Fee if the Guidance on Safe Use was supplied waiver for substances in the 1 10 by the lead on your behalf and as such tonnage band Appendix 5 4 2 you have not added Guidance on Safe Use to your own dataset Do not tick
49. ess rule validation Appendix 1 1 Legal Entity in REACH IT and in I UCLI D 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 How to find the legal entity linked to the substance dataset Click on Substance in the IUCLID main screen Figure 2 IUCLID main screen Substance e Choose the substance in question from the query list Figure 3 Query list Substances Test substance Test substance European e Click on the blue arrow on the right end side of the Legal entity field Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 11 Figure 4 Section 1 1 Substance identification amp Substance Test substance i Test substance f European Chemicals Agency j He gt mm Substance identification Chemical name Test substance A Fa elzinki r Finland P CBI Confidential business related information EU RESCH g Third party flags miraray o I Fole in the supply chain Role
50. essfully 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 A 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 administrative 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 is 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 handle
51. europa eu 56 Data Submission Manual Version 3 0 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 47 Figure 47 Request of fee waiving tick box I UCLI D Fee waiving 1 10 tonnes complete dossier JUStIFICatiOn al the information required in Annex Wilis submitted as part of this registratratio n As the tonnage of the dossier includes tonnes of on site isolated intermediates l 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 48 Please note that both checkboxes must be selected Registrant confir
52. h the comditinns set aut in Article 1A i4 Registrant has received confirm tion from the veers that the irtermediate is Weed in accordance with the conditions set aut in Article 10 i4 E T E F P To B a B 0 B 0 8 8 Enter administ ative irformation Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 45 Checklist Checklist 1 The Joint Submission checkbox must be ticked Appendix 5 2 8 Do you want to claim confidentiality on the registration number or for the 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 and as such you have not added a CSR to your own dataset 9 Have there been any Data Sharing Issues This information is not part of the Do not tick this box if you are providing a CSR Business Rule check independently from the lead i e within your own dossier 3 Guidance on Safe Use tick this box if the Guidance on Safe Use was supplied by the lead on your behalf and as such you have not added Guidance on Safe Use to your own dataset 10 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 Do not tick this box if you are providing Guidance on Safe Use independently from the lead i e within your o
53. h the conditions set out in Article 18 4 F Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set out in Article 18 4 B e 8 u E E E lt Back next gt Enter administrative information Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 43 Checklist 1 Joint Submission checkbox must be ticked Appendix 5 2 2 Chemical Safety Report tick this box if the CSR was supplied by the lead on your behalf and as such you have not added a CSR to your own dataset Do not tick this box if you are providing a CSR independently from the lead i e within your own dossier 3 Guidance on Safe Use tick this box if the Guidance on Safe Use was supplied by the lead on your behalf and as such you have not added Guidance on Safe Use to your own dataset Do not tick this box if you are providing Guidance on Safe Use independently from the lead i e within your own dossier 4 Review by Assessor this information is not part of the Business Rule check 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 Interme
54. 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 Tonnage band s of the registrant On site jzolated intermediates tonnage band REACH Article 17 Transported isolated intermediates tonnage band REACH Article 18 Specific submissions The submission is an update Last submission number ABLZ5456 75 Reas on for updating a Further to arequest decision from regulatory body Spontaneous update change of tonnage band Justification change of tonnage band 4 M Remarks Due to increase in production volume the tonnage band hasto Dossier specific information Phas e in a Phase in m Mon phase in Rewiewed by an assessor Rem arks Document Confidentiality claim on registration number Confidentiality claim on tonnage band _ Data sharing issues Fee waiving 1 10 tonnes complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly controlled conditions Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 16 4 i Registrant has recetved confirm ation from the users that the intermediate is used in accordance with the conditions set out in Article 16 4 B B B B p HB Back Next gt Cancel Enter administrative information Annan
55. ification Enforce Rules Release date July 2012 13 Figure 8 Query list Legal entities ie Navigation Query results e Inthe Information field under the Information tab you can find the UUID of the selected legal entity Figure 9 Information about the legal entity creating the dossier aE IUCLID 520 Seles File Edit Go Window Help Go laeae ewealal ab a4 a F Legal entity European Chemicals Agency Helsinki Finland i Query results General information Iden SER ntact info ion Sit PS E Information Information E Legal entity q UUID UCS 25 a ee Se ee a Sealed Copy protected Subset of original Official entry LEO 8 European Chemicals Agency f Helsinki f 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 How to find the submitting legal entity in REACH IT e Point to Company and click on View Annankatu 18 P O Box 400 FIl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 14 Data Submission Manual Version 3 0 Figure 10 REACH IT main screen FECHA EUROPEAN CHEMICALS AGENCY Pre registration Pre SIEF Online dossiers You last connected on 2011 07 06 11 21 04 0 Phasen Information e The second row in the G
56. ion is given to the ECHA Communication Unit publications echa europa eu This document will be available in the following 22 languages Bulgarian Czech Danish Dutch English Estonian Finnish French German Greek Hungarian Italian Latvian Lithuanian Maltese Polish Portuguese Romanian Slovakian Slovenian Spanish and Swedish If you have questions or comments in relation to this document please send them quote the reference and issue date using the information request form The information request form can be accessed via the Contact ECHA page at http echa europa eu about contact_en asp European Chemicals Agency Mailing address P O Box 400 Fl 00121 Helsinki Finland Visiting address Annankatu 18 Helsinki Finland Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 Table of Contents 1 H w to USE CNIS manual snrocranaian aa ata bi rare Slat a ws ere dn a ee 7 2 iM MEFOGUCEION siiciciinseawancucsencemetinansicindcuta A deans eawimadeenncumnseiuindeneis 7 2 1 BUSINESS RUIG Verca EO eserine anea Ee aunex Sede EN Ea EEE cap EE 7 21 14 What are DUSINGSS MUGS Gvcndvcenuescssvseessscanvssesspiegoeneubequcase E AT 7 2 1 2 Different types of business ruleS ssssssssrsrrsrssrrrrsrrsrrrrrrrnrrrrrrrrrrerrerrrrerrerrrrrrrsrrsrrrrerrerrt 8 Jue BUSINESS VUES vers s TCC vaso ea argent EAE AE ect ereentase
57. ions 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 e REACH Inquiry Number When provided i e when submitting a registration following an inquiry 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 e REACH downstream user report number When updating a Downstream user report this number has to be included in the update dossier The number has to be in the correct format has to belong to the submitting legal entity and has to refer to the correct substance i e same EC number e REACH substance in article notification number When updating a Substance in article notification this number has to be provided in the update dossier The number has to be in the correct format has to belong to the submitting legal entity and has to refer to the correct substance i e same EC number Please note that the downloadable TCC plug in for UCLID checks the format of the regulatory identifier but as it is not connected the to REACH IT database it CAN NOT check the validity of these numbers Figure 19 Regulatory programme identifiers in Section 1 3 Regulatory programme identifiers Regulatory programme Remarks notification number WCD4 08 04 1004 notified substance REACH registration number O1 7 7 001004 00 0000 submission of notified substance F
58. istrant s notifier s REACH IT mailbox This message entitled lt Dossier business rule failure gt is displayed in Figure 55 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 60 Data Submission Manual Version 3 0 Figure 55 REACH IT message on BR failure manual check FHide Yes Dossier business rule failure GG126363 49 09 03 2011 13 47 User Your dossier cannot be processed Further information is available in the communication in the annotation section of your dossier Preliminary submission number GG128363 49 Dossier type Registration regular File name Zinc_dossicr iiz Down oad submission report Go to dossier The related communication to your dossier has been received The communication number is SUB C 2114088032 56 01 F The communication was REJECT Down oad communication information As stated in the message 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 56 Figure 56 Annotations tab with Communications Home gt Submitted Dossiers gt Dossier Annotations Company Pace MS ieee e Annotations Pre registration Pre SIEF Online dossiers Id Outcome Creation date Process type Decisions Phase in Information No records Registration
59. katu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 30 Data Submission Manual Version 3 0 Checklist 1 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 2 Last submission number must be indicated 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 3 Justification for the spontaneous update must be provided Appendix se e 4 Was the submission reviewed by an assessor This information is not compulsory Checklist 5 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 6 Do you want to claim a Fee waiver for substances in the 1 10 tonnage band Appendix 5 4 2 7 If the submission includes registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 8 Make sure that you are using the assigned EC number 0 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule V
60. lated information View Import Reference substance Create and update reference substance related information New Update eles igel lelreigisteidog Manage users roles preferences etc ws User preferences Set password User management Role management Bulk export Export multiple documents Run I UCLI D main screen Active legal entity we D Legal entity site Create and update legal entity sites New Update Mixture Create and update mixture related information New Update Category Create and update category related information New Update Literature reference View and exchange literature reference inventory related information View Exchange Import Import datafrom other IUCLID 5 systems Import Bulk import Test 2 P e Click on Legal entity on the IUCLID main screen Figure 7 Legal entity Create and Update company organisation related information Mew Update Substance Create and Update substance related information Mew Update Template Create and Update template related information Mew Update Dossier Wiew dossier data G Wiews Compare e Choose the same legal entity from the query list what you have seen at the bottom of the main screen previously I UCLI D main screen Legal entity Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Ver
61. mediates REACH Registration member of a joint Submission Intermediates Registration of transported isolated intermediate Appendix 3 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 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 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 25 is unclear and or incorrect Appendix 3 3 Filtering the information to be included in the dossier Most information entered into a IUCLID substanc
62. ment If a Chemical Safety Report CSR is required the outcome of the PBT assessment must be provided CSR is required in the following cases e Individual dossier containing standard registration for above 10 t year e Member submissions for standard registrations for above 10 t year e Lead submissions for standard registrations for above 10 t year e Lead submissions regardless of the registered tonnage band in case they declare that they are providing the CSR on behalf of their members In case registrant selects PBT assessment does not apply from the drop down list a justification must be provided to explain this situation Figure 20 Figure 20 PBT Assessment not required FET assessment overall result Justification oie li A F BIB fFAa Veale BE Normal Default font Tustification why PBT assessment does not apply Appendix 1 8 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 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 21 town city and the country where the site is located Please no
63. ms that the intermediate and Registrant has received confirmation in case of Registration of Transported Isolated Intermediates Art 18 registration 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 echa europa eu web guest support guidance on reach and clp implementation In addition different information requirements apply to on site and transported intermediates and more information can be found in the Guidance for intermediates available from the ECHA website http echa europa eu web guest support guidance on reach and clp implementation Figure 48 Tick boxes for isolated intermediates Specific information for isolated intermediates Production and use under stricly controlled conditions Justification The substace is used as strict controlled conditions can be demonstrated a Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 15 45 a 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 Annankatu 18 P O Box 400 Fl 0012
64. n again on the final version of your dossier This IUCLID 5 plug in will check completeness of your dossier but it also checks your dossier against most business rules before exporting it and submitting it to ECHA through REACH IT To do that right click on your substance dataset or dossier and select lt Run TCC gt You can download the latest version of the TCC plug in from the IUCLID 5 website http iuclid echa europa eu Please note that as some of the business rules depend on information that is stored within the REACH IT database the plug in cannot simulate all the business rules checked at ECHA Furthermore it is the submitter s responsibility to check the submission report after submitting the dossier to REACH IT for potential business rule failures Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 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 it is 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 Choose the Correct UCLID Templa
65. ng 1 10 tonnes complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly controlled conditions Registrant confirms that the intermediate is used in accordance with the conditions set out in Article 18 4 Registrant has received confirmation from the users that the intermediate is Used in accordance with the conditions set out in Article 16 4 LE Se s r E lt Back Cus Cancel Enter administrative information Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 Checklist Checklist 8 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 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 9 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 3 Guidance on Safe Use tick this box 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 Revie
66. number 9 Make sure that you are using the assigned EC number 0 provided in the letter which requested further information For further information please see Appendix 5 3 1 or Appendix 5 3 3 1 5 Was the submission reviewed by an assessor This information is not compulsory registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 failed TCC For other types of regulatory update see Appendix 5 3 10 Do you want to claim confidentiality on the registration number or for the Tonnage Band of the submission Appendix 5 4 1 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 33 Appendix 4 4 Joint Submission Lead Initial Submission Figure 28 Joint Submission Lead Initial Submission F glia p Dossier creation wizard x Enter additional administrative information concerning your dossier Dossier template REACH Registration 1 10 tonnes standard requirements Mame given by User Registration of Substance A Dossier submission remark This is an example of how a joint submission lead dossier initial submission s dossier header should look This example i the basic case depending an your submission context your dossier header might look different Type of submission
67. onnage band Confidentiality claim on tonnage band Justification usp at Declaration We NAMC claim S IORT SUMMARY OF INFORMA TIOM confidential in accordan ce with RELEVANT REFEREMCE TO THE LEGISLATION We NAME hereby declare that to the best of our Knowledge as af today DATE Band in accordance with the due measures of protection that we have im plement The confidentiality flag in section 3 2 of UCLID 5 cannot be used to request confidentiality for your tonnage band because that section relates to the A actual 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 Submission Manual Part 16 Confidentiality Claims How to make confidentiality claims and how to write Art 119 2 confidentiality claim justification on the ECHA website http echa europa eu support dossier submission tools Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa
68. or each reason Figure 44 Please note that a justification has to be provided in all the blocks Figure 44 Several reasons for updating spontaneous update Reason for updating Further to a request decision from regulatory body Spontaneous update change of tonnage band gst blk Justification change of tonnage band A OO NI Remarks Change in tonnage band from 34 to 777 i change in company rale inthe supply chain Justification change in company role inthe supply s A A Remarks Starting from soo the company is not an importer but a manu s For more information on different types of registration dossiers and the o related requirements refer to the Guidance on registration section 9 guidance on update of dossier http guidance echa europa eu Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 54 Data Submission Manual Version 3 0 Appendix 5 4 Specific information 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 claim on tonnage band fee waiving is ticked the associated free text field below the box should be filled
69. or updating L Further to a request decision fram regulatory body Spontaneous update change of tonnage band 2 ih x Justification change of tonnage band a O Remarks Due to increase in production volume the tonnage band has to Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 53 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 be indicated in the corresponding field Figure 43 A Please note that for technical reasons if you are updating an individually Submitted dossier to be part of a joint submission as a lead or member you have to indicate Change of tonnage band as one of the reason s for updating your dossier In case your actual tonnage band stays the same as for your previous submission this will not trigger an invoice Figure 43 Reason for updating spontaneous update other justification Reason for updating Further to arequest decisian from regulatory body Spontaneous update other z i 2 Justification other O S 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 f
70. ossier UUID Dossier type R Pay TO 45 11 03 2010 No Pending Submission Started Fee Registration 4 Click again on the Dossier s UUID in the new page Figure 16 Dossier Details Home gt Search gt Details Search Details Dossier Dossier Dossier type Submission Submission Number TC122384 48 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 chem 008 Return to search 5 Choose the Submission Report tab Figure 17 Dossier Further Details Home gt Submitted Dossiers gt Dossier Details Submission Report Details Accounting Annotations Dossier Dossier type Registration Submission Submission Number Ms A8 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 5 format Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 18 Data Submission Manual Version 3 0 Figure 18 Exporting EC number from REACH IT Passed Tasks No Task Remark Technical Completeness Check Pay Submission Fee 10 Overall Completeness Check ss
71. our submission ccessseeeeseeeeeeeeeeeeesssnneeeseneeeeeeeeeaas 57 Table of Figures Figure 1 Four Steps of Passing Business Rule Verification ssssssnsunsnnnnunnnnnnnnnnnnnnnnnnnnn 9 Figure 2 I UCLI D main Screen Substance sssss2s2222252222u202u20u220u220u20uu20uunuunnnnnnnnnnnnnnnnn 10 Figure 3 Query ISt SUDSTANCOS sii cecsiaicedecesnciawsnanvetedewniasaendsweswdedcininactsidawesdewewesneseuewondien 10 Figure 4 Section 1 1 Substance identification cccccccesceneeessccceeeeeeeessenneeeeseeeeeeeeeeessaaaness 11 Figure 5 The legal entity assigned to the reference SUDStANCE ccceeseeeeeeeeeeeeseenneeeeeeeeees 11 Figure 6 IUCLI D main screen Active legal entity ccccccccceeeeeeesenneeeeseeeeeeeeeeessaanesoooeeees 12 Figure 7 IUCLI D main Screen Legal entity vivisisccvensisscenwniicseesiesnseneneansrerndenewexsdasecswerenewenwes 12 Figure 8 Query list Legal Gules sssirisniirsis a a a 13 Figure 9 Information about the legal entity creating the dossier sssssssnnnunnnnnnnnnnnnnnnnnn 13 Figure 10 REACH IT main SCreCD ivstiirsiesinseavestaneniaddeecawanarserratindawssewestedndeunatertwesweeseneeaeanenes 14 Figure 11 Information about the submitting legal entity in REACH IT ssssssssnsnsnnnnnnnnnnnnnn 14 Figure 12 Example for identifying the reference substanCe sssssssus22u222220222022202200 2 0 15 Figure 13 REACH IT HOMe Screen saisan R Ai 16 Figure 14 Searching for Dossier in
72. ow to Pass Business Rule Verification Enforce Rules Release date July 2012 55 The phase in status has to be marked 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 the registration number 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 claim on the registration number or on the tonnage band If the registrant wants to keep the registration number or the tonnage band for which he registers as confidential information the relevant checkbox either Confidentiality claim on registration number or Confidentiality claim on tonnage band in the dossier header should be selected For tonnage band this is the only way to request the confidentiality while the registration number can be flagged as confidential information in Section 1 3 also in case of an update dossier A justification must be provided Figure 46 in both cases These fields cannot be used for any other type of confidentiality claims When requesting confidentiality on the tonnage band or on the registration number the relevant check box must be ticked in any other case the check box must not be ticked Figure 46 Confidentially request on the t
73. san 8 2 1 4 Where can find further information on dossier SUDMISSION ccc cece cece eee eee e nena 8 3 How to Pass Business Rules I UCLI D 5 preparatiOns cccccsseccsseneeesscceceeeeeeeeeneeeeseeeeeeeeeenas 8 Appendix 1 Complete the I UCLI D Substance Dataset ccccccceeeeeessnneeesseeeeeeeeeeessnaenssnneeees 10 Appendix 1 1 Legal Entity in REACH IT and tn IUCLID DOSSIEL cccccce cess eee eeeeee eee eeeeeeeeeeneees 10 Appendix 1 2 Section dl AGHUMCAWN ON iiansanicrxsxce ncemenandaccreteseomeanadeas oeduesesdeaniencascdweatncssendast 14 Appendix 1 2 Downloading the EC number from REACH CIT ccc cece cece cece eee eeeeeeeeeeeeeeeeeeeenes 15 Appendix 1 3 sac Uon EZ COMPOS IU OM rsr as n estates csneecese N E 18 Appendix 1 4 SEGUOM e A e E Ae E P E E E E E E E A E E TT 18 Appendix 1 5 Section L3 Jont SUDIMISSION issaraen a i a A TE EN 19 Appendix 1 6 Section 2 1 GHS and Section 2 2 DSD DPD ccc eee eee eeeeeeenes 20 Appendix 1 7 Secon 2 3 PBT Assessment ocisasecsstane sr ccandoneenaentnodeneiveseaecdateiendaunsanenianbsstaneaabheoe 20 Appendix 1 8 SOCIO Bi eS acts are du ntaarandenaenqcces EEE EEE 20 Appendix 1 9 Section 3 5 Life Cycle GESCIIPtlON ccc ccc ccc cccceee cece eee e ence cece teen ee eeeeeeeeeeneeeenenanas 21 Appendix 2 ldentify SUBMISSION Context sasis A Aai 21 Appendix 3 Creating the dOSSIE sesiscminissetcicasccnaiwudtoiwensassmneciedeldanesanatanwieaaweddenssausw
74. srerrerrsrrsrrrrsrrsrrrrerrerrene 44 Appendix 5 Further information on the I UCLI D 5 Dossier Header ssssssunnnnnnnnnnnnnnnnnnnnnnn 46 Appendix 5 1 Dossier submission name and remarks dossier header part 1 cece eee eee ees 47 Appendix 5 2 Type of Submission dossier header Part 2 ccccccccccce eee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeenes 48 Appendix 5 3 Submission update information dossier header part 3 c cece eee eeeeeeeeeeeeeeeeeeeeas 49 Appendix 5 3 1 Requested Update for an Incomplete Initial SUDMISSION cccceeeeeeee ee eeeeee eens 49 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Part 04 How to Pass Business Rule Verification Enforce Rules Release date July 2012 Appendix 5 3 2 Updating a Substance Notified Under Previous Legislation NONS 00000ee 50 Appendix 5 3 3 Previously Registered Under REACH cccccccccce cece cece eee eeeeeeeeeeeeeeeeeeeneeeneees 51 Appendix 5 4 Specific information related to the dossier dossier header part 4 cccceeeeeeeees 54 Appendix 5 4 1 oe ies a ee ee ee ee ere 55 Appendix 5 4 2 PES WAV NG cess canes bc cee caseeetansaeetusccauss eee case A E A 56 Appendix 5 5 Specific information for isolated intermediates dossier header part 5 000e 56 Appendix 5 6 OPEO oer een ee ee eee ee ee E ee ee E ee eee 57 Appendix 6 Finding information about y
75. submission is a Single Submission or Joint Submission or initial or update In case of a joint 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 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 e Spontaneous Update the substance has already been successfully registered but an update is needed Possible reasons for the update can be found in Appendix 5 3 3 2 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 Single J oint Submission Submission Submission Lead Member Appendix 4 1 Appendix 4 4 Appendix 4 7 Spontaneous Appendix 4 2 Appendix 4 5 Appendix 4 8 Update Requested Update Appendix 4 3 Appendix 4 6 Appendix 4 9 Appendix 3 Creating the dossier Appendix 3 1 Choosing the correct UCLID 5 template Choosing the correct dossier template is an important step in a successful submission as the template indicates
76. successful NONS claim sssssnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 50 Updating previous NONS after the claiming of the registration number 51 Reason for updating further to a request decision from regulatory body 52 Reason for updating spontaneous update cccccccccceeeseeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeees 52 Reason for updating spontaneous update other justification sccccccseeeeeeeees 53 Several reasons for updating spontaneous update cccscessseeeesssseeeeeeeeeessannnees 53 Registration dossier Specific information ccceeeeceeeeeeeeesenneeeeeeeeeeeseeeesssanneneeoeeees 54 Confidentially request on the tonnage band cccessseeceeeeeeeesseneeeeeeeeeeeeeeeesseaanens 55 Request of fee waiving tick box LUCLID sssssnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 56 Tick boxes for isolated intermediates ccccceeeeeeeesceeeeeseeeeeeeeesseeeneeeeesaenneeeeeeaans 56 indicating Ont OUE IN TUCLID sssrini ERa 57 REACH IT message on BR failure auto CheCK ssssnssunsnunnnunnnnnnnnnnnnnnnnnnnnnnnnn 57 Status of a dossier in the dossier details tab sssusssnunnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 58 Tab for checking complete list of failed automated business rulesS ccccccseseeees 58 SUDMISSION FEDOME sisi ssscecincscevedsemenscdadawiewswiceessiiaassiiecunnel akai aa 59 Submission report with GOEANS sssssss2222222222u222220222022202u202220u220u20unnnnnnnnnnnnnnn 59
77. te 3 The template used in IUCLID determines crucial aspects of the processing of your submission Tonnage band and participation in a joint submission are just a few of many parameters to take into account while choosing the correct template You can find help in Appendix 3 1 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 prepare the dossier header can be found in Appendix 32 For general guidance on dossier creation refer to the IUCLID 5 User manual e http iuclid echa europa eu index php fuseaction home documentation section C 6 Creating a dossier and section D 8 2 Creating dossiers Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu Data Submission Manual Version 3 0 Appendix 1 Complete the I UCLI D 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 in for a successful busin
78. te that in the case of an importer no information is required in this section however if a site is provided the same requirement applies If Manufacturer is selected in Section 1 1 Role in the supply chain then at least one site has to be linked to a Manufacture use from Section 3 5 To do this click on the small green cross at the Manufacture own use s section of a site and link a manufacturing use after clicking on the small golden chain Figure 21 Figure 21 Linking Manufacturing use to a site Manufacture own use s Appendix 1 9 Section 3 5 Life Cycle description If Downstream user is selected in Section 1 1 Role in the supply chain then at least one use has to be present in Article service life in Section 3 5 Life Cycle description of IUCLI D Figure 22 Figure 22 Article service life Article service life Flags ao LELEL i h m CA LI Late a 7 a E mF Ta ALELO E LLELE Fiz a eee e e Te 1 Service life name EEE jac 1 Wehicles Further descriptic 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
79. ter must be entered in the adjacent Number field Figure 41 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel 358 9 686180 Fax 358 9 68618210 echa europa eu 52 Data Submission Manual Version 3 0 Figure 41 Reason for updating further to a request decision from regulatory body Reason for updating Further to a request decision from regulatory body BUT ber ee A R A Remarks Appendix 5 3 3 2 Spontaneous update In case of spontaneous update the checkbox spontaneous update should be selected Figure 42 and the reason for the update should be chosen from the drop down list in the justification field Figure 42 The drop down list is reporting the following update reasons e Change in company identity NB This update reason cannot be used in the context of REACH IT submissions e Change in company role in the supply chain e Change in composition of the substance e Change of tonnage band e New identified uses e New uses advised against e New knowledge of the risks for human health and or environment e Change in classification and labelling e New or update of CSR or guidance on safe use e New testing proposal e Change in the access granted to information e Prolongation of exemption period for PPORD e New uses outside the supplier s conditions DU obligations e Change in exemptions DU obligations e Other Figure 42 Reason for updating spontaneous update Reason f
80. the registrant The submission is an update ee Submission update information to be Reason for updating filled in only in case Further to a request decision from regulatory body of an update E Spontaneous update Dossier specific information Phase in LO Phase in C Non phase in Specific information Reviewed by an assessor related to the dossier phase in non phase in assessor revision confidentality on registration number or tonnage band data waler Remarks E Confidentiality claim on registration number C Confidentiality claim on tonnage band Data sharing issues Fee waiving 1 10 tonnes complete dossier Compuls ory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly controlled conditions Specific information with the conditions set out in Article 18 4 p _ for isolated intermediates wi Registrant confirms that the intermediate is used in accordance E Registrant has received confirmation from the users that the intermediate is used in accordance with the conditions set out in Article 16 4 a seek eres eeeh Creer 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 36 as well as any additional information you want to point out Annankatu 18 P O Box 400 Fl 00121 Helsinki Finl
81. ue Reference Number fat Dinaliri e A nnrir I OT ipene Stites M aie ta ke cred Ez on aa Aatimm JISemimnation Ac Data Dis 1 mgge Download submission repart Export submitted EC substances 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 tn this section e In Section 1 2 in all cases e There must be at least one composition with at least one constituent O Each constituent must have at least one identifier EC number or CAS number or IUPAC name e 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 constituent has to be the same as in Section 1 1 If there are 2 or more compositions AND 2 or more classification and labelling block in section 2 1 present ALL the compositions must be linked to at least one classification and l
82. ulable 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 I find further information on dossier submission Further information on how to submit a notification or registration to ECHA is available on ECHA s website http echa europa eu web guest support dossier submission tools reach it The information helps you to understand the topics covered and provides access to relevant documents tools and web pages 3 How to Pass Business Rules UCLID 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 ensure that a dossier can pass the business rule verification These are outlined in Figure 1 below A It is strongly recommended to use the Technical Completeness Check TCC tool on the substance dataset and the
83. user Registration of Substance Dossier submission remark This is an example of howa joint submission member dossier spontaneous update submission s dossier header should look This example is 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 s of the member registrant Tonnage band Between 10 to 100 tonnes year l tonnage band REACH Article 17 tonnage band REACH Article 18 Specific submissions v The submission is an update Last submission number 46123456 76 A Reason for updating Further to a requestidecision from regulatory body w Spontaneous update change of tonnage band za te Justification change of tonnage band wal el NI Remarks Due to increase in production volume the tonnage band has to bs Dossier specific information Phas e in Phase in Non phase in Reviewed by an assessor Remarks a S E Confidentiality claim on registration number C Confidentiality claim on tonnage band Data sharing issues i Fee waiving 1 10 tonnes complete dossier Compulsory information for isolated intermediates under REACH Article 17 and 18 Production and use under strictly controlled conditions ia Registrant confirms that the intermediate iz used in accordance wit
84. w 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 When acting as the lead in a joint registration of an intermediate the submission these fields are used to Specific Information for Isolated indicate your own registration tonnage Intermediates part must be filled out 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 IUCLI D 5 template that was used 6 Make sure that you are using the assigned EC number 0 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 failure this will be the submission number associated with the dossier that failed TCC For other types of regulatory update see Appendix 5 3 Annankatu 18 P O Box 400 Fl 00121 Helsinki Finland Tel
85. wn dossier 4 Review by Assessor this information is not part 11 If the submission includes of the Business Rule check registration of an intermediate the Specific Information for Isolated Intermediates part must be filled out Appendix 5 5 5 Information on tonnage band 12 Make sure that you are using When acting as a member in a joint submission the assigned EC number 0 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 6 Last submission number must be indicated For a 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 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

How to Pass Business Rule Verification

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