Home

REACH-IT Data Submission Manual 8 Business Rules validation

1. only a Classification and Labelling http echa europa eu doc reachit compl tech dossier manual pdf to information in IUCLID 5 Section 2 1 correctly complete the Classification and Labelling information GHS used for submitting Under the transitional provisions for the European Regulation on information on C amp L under the CLP Classification Labelling and Packaging of Substances and Mixtures CLP Regulation Regulation C amp L must currently provided using at least the DSD DSP format However after the first transitional deadline and until 1 June 2015 section 2 1 must contain at least the CLP GHS classification and labelling Therefore ECHA advises completing the C amp L information in both formats whenever possible Please make the necessary modification and submit your new dossier via REACH IT z ep Z a gt v LUI lt n A gt DC O l 2 E Version 1 0 Page 16 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_REG_UC03_ BR160 INITIAL SUBMISSION SUB_INQ_UC03 B R20 INQUIRY SUBMISSION SUBMISSION SUB_GBL_UC02_ BR170 Version 1 0 Release date 17 April 2009 According to the information present in IUCLID Section 1 1 Role in the supply chain and Section 3 4 Form in the supply chain it would appear that the registration dossier is invalid In Section 1 1 only the box for downstrea
2. specify that it is a spontaneous update and provide a suitable Justification In order to identify whether the dossier should be submitted as an update of a previous dossier or not as well as the information that you have to report please refer to pages 6 9 of Data Submission Manual 4 http echa europa eu doc reachit how_ submit valid dossier pdf Please make the necessary modification and re submit your dossier as a new submission or update of a previous one REACH IT Data Submission Manual 8 AN ECHI A Business Rules validation http echa europa eu REACH IT REACH IT Rule message Explanation of the reason of Whatto do to avoid a failure in your next submission Business rule failure Code CLN_UC02 _BR10 You have already registered this You have already received a If you need to update the Classification and Labelling information for this substance To update the C amp L registration number for this substance you should submit a dossier update and you should not create information for this substance you substance a new Classification and Labelling notification have to submit an update of your Therefore you are not allowed to Please note that in this update you should indicate the submission number registration dossier submit a Classification and of the last complete dossier submitted for this substance in the Last Labelling C amp L notification submission number field Moreover in
3. REACH IT Business Code SUB_INQ UC03 B R10 INQUIRY SIBMISSION SIBMISSION SUB_INQ_UC03 B R30 INQUIRY SUB_REG_UC03_ BR170 2 V 2 a gt Vv LUI H lt OQ A SUB_REG_UC03_ BR180 SUBMISSION INITIAL OR UPDATE Version 1 0 Release date 17 April 2009 Your inquiry dossier contains a category and therefore it cannot be processed Please make the necessary modification and submit a new dossier The registration number you specified in section 1 3 of your IUCLID 5 inquiry dossier is not valid Please make sure that you have reported the correct identifier related to your company and the substance for which you sent this Inquiry dossier You indicated in section 1 3 of your IUCLID 5 dossier a notification number NCD number As all notified substances are considered registered you should also indicate in this section the correct registration number In case you do not have a registration number for this substance yet you can claim it in REACH IT You indicated the fee waiver in the IUCLID dossier header but did not indicate it in REACH IT during submission ECHA is unsure how to process and invoice your dossier and it has been aborted Depending on whether you intended to claim the fee waiver please resubmit accordingly AECHA http echa europa eu Your inquiry dossier contains a IUCLID 5 category Your inquiry dossier contains an invalid registration number in IUCLID 5
4. REACH IT Data Submission Manual 8 For the latest news and the most up to date information please consult the ECHA website REACH IT Data Submission Manual 8 Business Rules validation a ECHA http echa europa eu Document history Version 1 0 15 04 2009 first version Reference ECHA 09 B 12 EN Issue date April 2009 Language English If you have questions or comments that relate to this document please send them using the information request form to ECHA helpdesk Quote the reference and issue date as stated above The information request form can be accessed via the ECHA website under the section for the REACH helpdesk at the following address Nttp echa europa eu reach helpdesk echahelp_en asp European Chemicals Agency 2009 Reproduction is authorised provided the source is fully acknowledged in the form Source European Chemicals Agency http echa europa eu and provided written notification is given to the ECHA Communication Unit info echa europa eu Version 1 0 Page 2 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation AECHA hnttp echa europa eu Table of Contents 1 INIFOGUGIHON lineare ica lire ira 4 2 Business rule valiGationi cucinino nit 5 2 1 Wihatare DUSIness ENIeSt iii 5 2 2 Why are there two different types Of business FUIES Mn nni 5 2 3 Where can find further information on dossier S
5. e Industry User Manual Part 4 Online Pre Registration amp e Industry User Manual Part 5 Pre SIEF E e Industry User Manual Part 6 Dossier Submission e Industry User Manual Part 7 Joint Submission 1 e Industry User Manual Part 8 Invoices e Industry User Manual Part 10 Claim of a registration number for a_notified substance e Data Submission Manual 1 How to prepare and submit a PPORD notification lel e Data Submission Manual 2 How to prepare and submit an inquiry dossier e Data Submission Manual 4 How to submit a valid dossier to ECHA and complete the dossier header enl e Data Submission Manual 5 How to Complete a Technical Dossier for Registrations and PPORD Notifications Version 1 0 Page 6 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 LN ECHI A Business Rules validation http echa europa eu 3 Annexes Annex List of automated business rules REACH IT REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission Business rule failure Code SUB_GBL_UC02_F There was no Reference substance You did not provide a Reference Ensure that at least one Reference substance is linked in section 1 1 and in 6 C030 in section 1 1 of your IUCLID 5 substance neither in IUCLID 5 section 1 2 under Constituents in the dossier that you are submitting in n SUB_GBL_UC02_F dossier and all constituent
6. step 1 for example if you were previously registering your substance using the REACH Registration 10 100 tonnes you should submit your update dossier with a different template To proceed please complete the following steps during the dossier creation tick the checkbox Is the submission an update enter the last valid submission number in the Last submission number field related to the last valid submission of your dossier select the checkbox Spontaneous update Add a repeatable block in which you select the Change o tonnage band picklist entry in the justification field Please make the necessary modification and submit your new dossier update via REACH IT REACH IT Data Submission Manual 8 Business Rules validation UPDATE SUBMISSION Version 1 0 REACH IT Business Code SUB _GBL_UC02_ BR30 SUB_REG_UC03_ BR10 SUB_PPD_ UC02_BR10 Release date 17 April 2009 inconsistency has been RR in the type of dossier submitted Please verify that you have not sent an update instead of an initial dossier or vice versa This submission has been aborted Please make the necessary modification and submit a new dossier AECHA http echa europa eu You have submitted an invalid update dossier or you have submitted an invalid initial dossier Page 14 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure
7. You submitted a dossier which included chargeable confidentiality claim s not supported by a justification Chargeable confidentiality claims are ones falling under Articles 10 a xi and Article 119 2 of the REACH Regulation REACH requires that such claims must include a justification as to why publication could be harmful for your or any other concerned party s commercial interests The absence of a justification means that ECHA is unsure whether you genuinely intend to support and receive a fee for the unjustified claims Please resubmit the dossier either a adding the appropriate justifications or b removing any confidentiality claims which you do not wish to support The validity of your claims will be assessed by ECHA at a later date Further information on confidentiality claims is available in the Guidance on Registration at ECHA s website AECHA nttp echa europa eu Your dossier includes confidentiality requests which are subject to a fee but you have not provided a justification for all of them REACH IT Rule message Explanation the What to do to avoid a failure in your next submission rule reason of ine Any time a flag for a confidentiality subject to a fee is indicated CBI IP or no PA in your IUCLID 5 dossier the justification as to why publication on the Internet could be damaging must be provided in the adjacent field Administrative Data P CBI The justification Purpose flag key
8. section 3 3 Page 17 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure If you are a Downstream user you should tick the checkbox Downstream user in IUCLID 5 Section 1 1 Be informed that the only circumstances where a downstream user can register a substance is as a producer of articles meeting the criteria presented in Article 7 1 of the REACH Regulation Therefore if you are a Downstream user you should provide the correct information in IUCLID 5 section 3 4 where under the Form in the supply chain header you should select the Substance in article checkbox Please make the necessary modification and submit your new dossier via REACH IT In Section 13 of your IUCLID 5 inquiry dossier you need to attach your information requirements as a report All information related to the Inquiry submission process can be found in ECHA web page hittp echa europa eu reachit inquiry _en asp Please make the necessary modification and submit your new inquiry via REACH IT If you are a manufacturer and you tick the related box in section 1 1 please make sure that you have defined a production site in section 3 3 Do not forget to check if a valid Site link is attached to this IUCLID 5 section 3 3 Please make the necessary modification and submit your new dossier via REACH IT REACH IT Data Submission Manual 8 Business Rules validation
9. As an inconsistency has been detected in the dossier you have submitted please read carefully the following before submitting a new dossier via REACH IT If your dossier was an initial one please make sure that the dossier header has not the checkbox Is the submission an update ticked the same substance has not been already submitted by your company i e by the same Legal Entity signed up in REACH IT If your dossier was an update please make sure that inthe dossier header you have ticked the checkbox Is the submission an update in the dossier header you have indicated the right_ last submission number i e the submission number of the latest accepted dossier for the same substance and the same company In case that you have been requested to submit an update further to a request of a regulatory body indicate in the dossier header a valid communication decision number In case of a spontaneous update specify a Justification chosen from the picklist If you need to submit an update of a NONS notified substance under directive 67 548 EEC for which you have already claimed the registration number in REACH IT check that in the dossier header you have ticked the checkbox Is the submission an update in the dossier header you have indicated the right last submission number to the one you have received with the claim of the registration number of your previous nofitication
10. IT the information on the lead company Before submission define your joint submission in REACH IT For more information on Joint submissions please refer to http echa europa eu reachit joint submission en asp Please make the necessary modification and submit a new dossier If you want to claim confidentiality on the tonnage band and or in sections 3 5 or 3 6 of your IUCLID 5 dossier please tick the checkbox Confidentiality request in the dossier header and state your request with a justification in the Justification field Specific request on tonnage band Confidentiality request Justification confidentiality is claimed for the information submitted in section 3 6 of this dossier The justification However if you want to claim confidentiality on any other section use the confidentiality flag present in that section Endpoint study record Density 001 Detail level all fields Administrative Data Data source Materials and methods Results and discussion Overall remarks attachments Applicant s summary and conclusion Administrative Data JP CBI The justification v robust study Purpose flag key study Data waiving Please make the necessary modification and submit a new dossier Page 25 of 31 REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code n SUB_REG_UC03 Z _BR130 Version 1 0 Release date 17 April 2009
11. Page 20 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure If you are not a member of a Joint submission you should not use the member dossier templates i e REACH Registration member of a joint submission general case or REACH Registration member of a joint submission intermediates Please make sure to select the correct template in IUCLID 5 while creating a new dossier If you are a member of a Joint submission please make sure that you have completed all the following steps confirm the membership in REACH IT using the information provided by the lead of the Joint submission joint submission name and token indicate in IUCLID 5 in section 1 5 all information related to the Joint submission i e the name of the Joint submission and the Lead of the Joint submission receive from the Lead the information that a registration number was issued for the lead dossier of the Joint submission submit the dossier using one of the following template REACH Registration member of a joint submission general case REACH Registration member of a joint submission intermediates Please make the necessary modification and submit a new dossier If you are a member of a Joint submission you must submit your dossier only once the Lead has successfully registered the substance The Lead should inform you that a registration or noti
12. dossier via REACH IT REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_GBL_UC02_ BR110 Mixtures are not allowed to be submitted INITIAL SUBMISSION SUB_REG_UC02_ FC010 The Legal Entity indicated in IUCLID 5 section 1 1 for the Third Party Representative should be already registered in REACH IT i e same UUID INITIAL SUBMISSION SUB_GBL_UC02_F C090 An error was detected in section 1 8 of your IUCLID 5 dossier contact address of the recipient s is are not complete A legal entity must be provided for each recipient You must provide also the contact address for each recipient including town and country in the corresponding IUCLID 5 fields ALL SUBMISSIONS Version 1 0 Release date 17 April 2009 AECHA http echa europa eu In your dossier a Mixture dataset was detected IUCLID 5 Mixtures datasets are not allowed to be submitted as registration notification dossiers via REACH IT The Legal Entity of the Third party representative you have specified in IUCLID 5 section 1 1 was not signed up in REACH IT as Third Party Representative If you have created a repeatable block in section 1 8 of your IUCLID 5 dossier you must have a link to a valid Legal entity with contact address and country specified If you do not have any recipient s to indicate please do not create any empty repeatable block REACH IT will fail the dossier if a valid Le
13. indicated both in the Dossier header and in the on line REACH IT submission form i e if in the dossier you have ticked the checkbox fee waiver you should remember to tick also the checkbox fee waiver in REACH IT during the on line submission procedure and vice versa Please make the necessary modification and re submit your dossier as a new submission REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_REG_UC03_ BR190 SUBMISSION INITIAL OR UPDATE BR80 CLN_UC02_BR40 O U L a u LUI lt m A gt DC O l OC ui ep ep oO n Q lt LU l I 74 O U di a Vv H O Version 1 0 Release date 17 April 2009 SUB_REG_UC03_ The tonnage band you have indicated in REACH IT during the submission of your dossier does not match the tonnage band indicated in the dossier template of your IUCLID 5 dossier Consequently we are not able to process your dossier You are the lead of a joint submission for the substance mentioned in your dossier Consequently you are not allowed to submit a member dossier for this substance Please send anew dossier for this substance using the correct dossier template AECHA http echa europa eu The tonnage band entered in REACH IT field Tonnage Band is not the same as the tonnage band of your IUCLID 5 dossier template If you are the lead of a joint submission
14. 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 include e Registrations e Notifications for PPORD Product and Process Orientated Research and Development exemptions e Inquiry dossiers e Classification and Labelling Notifications This document outlines how and why these checks are carried out It also explains the business rules which are used in the REACH IT application to enforce them Annex 3 1 and 3 2 provides a complete list of REACH IT current business rules together with advice on how to ensure that a dossier will pass them Annex 3 3 provides further information to help registrants and notifiers to locate the information relevant to a specific submission within REACH IT Therefore these annexes can be used as a reference to identify the reason why a dossier could not be accepted for processing and what amendments are necessary in order to make a successful submission 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 in
15. section 1 3 IUCLID 5 Section 1 3 of the dossier you have submitted does not contain the REACH Registration number assigned to your previous notified substance under directive 67 548 EEC You have claimed in your dossier header the fee waiver but you have not selected this option on the on line REACH IT submission form Page 18 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure If you are submitting an inquiry dossier the category approach should not be applied Before creating a new dossier please ensure to delete the category from IUCLID 5 section 0 2 Please make the necessary modification and re submit your inquiry dossier as a new submission If you are submitting an inquiry dossier for a substance already registered under REACH you should indicate in IUCLID 5 section 1 3 the registration number Please make the necessary modification and re submit your inquiry dossier as a new submission If you have submitted an update of a previous notified substance under directive 67 548 EEC you should indicate in section 1 3 the following information Notification number assigned under the directive 67 548 EEC Registration number claimed in REACH IT for the indicated notified substance Please make the necessary modification and submit a new update dossier Please make sure that the same information related to the fee waiver is
16. study A vl Data waiving M v robust study For detailed information on the confidentiality requests which are subject to a fee please consult Annex 2 of Data Submission Manual 5 following this link http echa europa eu doc reachit compl tech dossier manual pdf Page 26 of 31 REACH IT Data Submission Manual 8 Business Rules validation a ECHA http echa europa eu 3 3 Annex III Finding information about your submission What happens when a dossier fails an automated business rule lf the submitted dossier fails at the automated business rule step REACH IT immediately sends a message to the registrant notifier in the REACH IT mailbox In this message Dossier business rule failure the following information is displayed see Figure 1 Figure 1 REACH IT message on BR failure auto check Pl Fhide Wes e User 1 22 75 The submitted dossier cannot be processed Depending on the type of failure further information can be found either fai in the submission report or b in the communication available in the annotation section of the dossier submission NUMBEr are SUbMISssIon fimestampi ea aaa Dossier type Inquiry Download submission report Go to dossier If you click the lt Go to dossier gt link you will also notice that in the lt Dossier details gt tab the status of the dossier has changed from lt Pending gt to lt Failed gt as shown here below see Figure 2 Figure 2
17. Status of a dossier in the dossier details tab Home gt Submitted Dossiers gt Dossier Details Company Details Bee i Meter mm Meee ce Pre registration Pre SIEF Dossier Dossier type Registration Submission Online dossiers Phase in Information Submission Number AO a Registration i Submission Late SCAR ASE notification Is the submission an update Joint submission y P Status of the dossier Failed Y PS 5 a C il DO w Substance User account Reference Number substance Name ssp Fequest submitted file The complete list of the failed automated business rules is available by clicking the tab lt Submission Report gt followed by lt Passed Task gt and check under the number lt 4 Enforce Rules gt section see Figure 3 Version 1 0 Page 27 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation a ECHA http echa europa eu Figure 3 Tab for checking complete list of failed automated business rules Home gt Submitted Dossiers gt Dossier Details Details submission Report Accounting Annotations Dossier Company Pre registration alli Dossier type Registration Submission Phase In Information Submission Number BOEEN val Registration i Submission Date SC notification Is the submission an Update Mo Is it a joint submission No Status of the dossier Failed Substance Reference Number Substance Name Sissa Request submitted fi
18. UCLID 5 dossier Please make the necessary modification and submit a new dossier header is not valid UPDATE SUBMISSION SUB _GBL_UC02 You have submitted an update following The decision number s If you need to submit an update following a request decision please _BR60 a request decision but the decision indicated in your IUCLID complete the following steps number s indicated in your dossier is 5 dossier header is are in the dossier header you have ticked the checkbox Is the are incorrect incorrect or empty submission an update in the dossier header you have indicated the correct_ last submission number In case that you have been requested to submit an update further to a request of a regulatory body indicate in the dossier header a valid communication or decision number Incase of a spontaneous update specify a Justification You can find the correct number in the annotations tab of your dossier in REACH IT and or in the letter attached to an internal message sent for your dossier For more information please read chapter 1 2 of Data Submission Manual 4 http echa europa eu doc reachit how submit valid dossier pdaf Please make the necessary modification and submit a new dossier SUB GBL _UC02 Spontaneous updates are not allowed You have submitted a If you need to submit a spontaneous update please do not forget to _BR80 without a correct reference number and spontaneous upda
19. UDMISSION rire 6 3 PATIOS acre cereus acne canederli E E E AEA 7 3 1 Annex List of automated business rules cccceeeeeeeeeeeeenseeeseeeesseeeeeoeneeeeeeenseeeeeoeesseeeeeoenseeessonoass 7 3 2 Annex II List of manually checked business rules 11 2rrrrrrrrniiiiiri iii 22 3 3 Annex III Finding information about your SUDMISSION cccccceeesseeeseeeesseeseeeenseeeseeeenseeseoeenseessees 27 Table of Figures Figure 1 REACH IT message on BR failure auto ChECK ennn 27 Figure 2 Status of a dossier in the dossier details tab 27 Figure 3 Tab for checking complete list of failed automated business FUIES ceeeeeeee ee eeeeeeeeeeeeeeeeesaaeeeeeeeaes 28 Figure 4 SUBMISSION TCD O iraniana 28 Figure 5 Submission report with details 29 Figure 6 REACH IT message on BR failure manual Check ccccseeeeceeeeeeeeeeeeeeeeeeeeeeaaeeceeeeeeeeeesaaanseeeeeseesaaas 29 Figure 7 Annotations tab with CommunicatioNS i 29 Figure 8 Attached communication in the dossier info e 30 Version 1 0 Page 3 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation AECHA http echa europa eu 1 Introduction The aim of this document is to help ensure that companies can successfully submit a dossier through REACH IT and in
20. age 21 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure In case of a Joint submission the system verifies the following the substance identity indicated in the submitted dossier the substance identity and the name of the Joint submission defined by the lead in REACH IT for that joint submission Therefore before submitting a new dossier via REACH IT please check the Joint submission information entered in REACH IT and make sure that there is a one to one correspondence between the here above listed identifiers Please make the necessary modification and submit a new dossier REACH IT Data Submission Manual 8 Business Rules validation AECHA http echa europa eu 3 2 Annex II List of manually checked business rules REACH IT REACH IT Rule message Explanation of the Whattodoto avoid a failure in your next submission Business rule reason of failure Code SUB_REG_UC03 _BR50 INITIAL AND UPDATE REGISTRATION DOSSIER SUB_REG_UC04 _BR40 JOINT SUBMISSION SUB_REG_UC03 _BR50 INITIAL AND UPDATE REGISTRATION DOSSIER Version 1 0 Release date 17 April 2009 The EC number of the dossier is not in line with those indicated in the result of your previous inquiry on this substance You are a member of a voint Submission You cannot send an update for a higher tonnage band than the tonnage band covered by the Lead dossier un
21. art A provides detailed information on how REACH IT displays the status of a specific submission with respect to this type of rule e Manually checked rules These are checked by ECHA staff Annex part B provides a comprehensive list of the manually checked business rules together with advice on the action needed to correct a dossier that cannot be accepted for processing Annex II part B provides detailed information on how REACH IT displays the status of a specific submission with respect to this type of rule Version 1 0 Page 5 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation AECHA nttp echa europa eu 2 3 Where can find further information on dossier submission Further information on how to submit a notification or registration to ECHA is available on ECHA s website htip echa europa eu reachit en asp The information helps you to understand the topics covered and provides access to relevant documents tools and web pages The lenl icon indicates that the linked material is currently available only in English In particular we would recommend you to consult Data Submission Manual 4 How to submit a valid dossier to ECHA and complete the dossier header bW Furthermore e Industry User Manual Part 1 Getting started with REACH IT E e Industry User Manual Part 2 Sign up and account management e Industry User Manual Part 3 Login and Message Box
22. ate 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_GBL_UC02_F o reference substance in section and or the reference ERE indicated in section 1 2 of your IUCLID 5 dossier must be updated Either EC number or CAS number or IUPAC name or Description must be provided in the corresponding IUCLID 5 fields for each reference substance It is not enough to provide the required information only in the reference substance name INITIAL SUBMISSION SUB_GBL_UC02_ BR10 The dossier type specified during the creation of the submitted dossier is not equal to the dossier type mentioned in REACH IT INITIAL SUBMISSION Version 1 0 Release date 17 April 2009 AECHA http echa europa eu At least one of the Reference substances that you have indicated in your dossier does not contain a valid identifier EC number CAS number IUPAC name or Description The system cannot accept a reference substance without any of these identifiers The dossier type indicated in REACH IT during the submission step does not match with the one indicated in the IUCLID 5 dossier template submitted For example you might have indicated in your Dossier template Registration of on site isolated intermediate while in REACH IT during the dossier submission step you have indicated REACH Registration 10 100 tonnes In this case and whenever a mismatch is detected the submissio
23. ber in the You have reported in section 1 3 an invalid reference number Either the number does not exist or it is not assigned to the same substance company or dossier type If your dossier has been rejected following the second Technical Completeness Check step you must resubmit it as an initial one You did not submit your updated dossier within the given deadline granted after the first TCC Technical Completeness Check failure Please make sure that in section 1 3 of are IUCLID 5 dossier you indicate the correct reference number s i e inquiry number pre registration number registration Ae Po notification number authorisation number classification amp labelling number notification number NCD related to the same substance company and dossier type Please make the necessary modification and submit your dossier as a new submission Be aware of the fact that you cannot submit an update of your dossier in case you have failed the second time the Technical Completeness Check in that case you should have received a decision stating that your dossier was rejected Therefore depending on your particular case you are asked to submit either a new initial dossier for your substance In this case do not mention any communication decision number in the dossier header and or in the dossier Or anew update for your substance in case you need to send an update due to for example a change of
24. block your dossier Therefore the dossier field cannot be processed by ECHA In case of Spontaneous update you should indicate in the field Justification one of the pre defined picklist entries using the field remarks to add more information In case of Further to a request decision from a regulatory body update you should indicate in the field Number the communication decision number related to the update Finally before submitting a new update dossier make sure to have also completed the following steps tick the checkbox Is the submission an update enter the last valid submission number in the Last submission number field note that the submission number of any dossiers previously not accepted at the business rules stage should not be used it must be the submission number of the last dossier which was accepted for processing e g an initial submission which failed the technical completeness check select the checkbox Spontaneous update if you want to spontaneously update your dossier Then add a repeatable block in which you should enter the justification of your update select the box Further to a request decision from regulatory body Then add a repeatable block in which you will indicate the related communication number Please make the necessary modification and submit again your new dossier update via REACH IT For more information on how to correctly enter data in t
25. er has been created with the correct template please submit it via REACH IT REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_REG_UC03_ BR100 JOINT SUBMISSION BR20 z O D co n oc D oO O a OC LUI a LUI I O ep a gt Vv H O 5 Version 1 0 Release date 17 April 2009 SUB_REG_UC03_ You do not belong to a joint submission for the substance mentioned in your dossier Consequently you are not allowed to submit a member dossier for this substance Please send a new dossier for this substance using the correct dossier template The system has detected that you are part of a Joint Submission for this substance as a member Hence you are not allowed to submit your dossier before the lead has successfully registered the substance or sent a C amp L notification i e before he has a registration number or a notification number AECHA http echa europa eu You have submitted a dossier as a member of a Joint submission i e REACH Registration member of a joint submission general case REACH Registration member of a joint submission intermediates but you have not confirmed the membership to the Joint submission for that substance in REACH IT You have submitted your dossier as a member of a Joint submission before the registration notification dossier of the lead was completely processed
26. europa eu info echa europa eu
27. fication number has been assigned to the lead Joint submission dossier he submitted on behalf of the members Only at this point the member can submit his dossier using one of the two following templates REACH Registration member of a joint submission general case REACH Registration member of a joint submission intermediates REACH C amp L notification member of a joint submission Please make the necessary modification and submit a new dossier REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_GBL_UC01_ BR180 O ep di a gt Vv E O z O D co gt D onl lt E zZ oc D oO O A Version 1 0 Release date 17 April 2009 The substance identity in your dossier does not correspond to the information available in the joint submission you have mentioned in REACH IT Or There are more than one joint submission that correspond to the substance identity in your dossier and you did not specify which one is the appropriate a ECHA http echa europa eu The dossier you have submitted cannot be processed by ECHA because there is no link between the substance identity defined in REACH IT for this Joint submission and the substance identity in the dossier submitted there are more than one Joint submission defined in REACH IT that correspond to the same substance identity you have specified in your dossier P
28. formation on categories is provided in Section D6 and D8 2 5 of the IUCLID 5 end user manual Note that ECHA will develop and apply new business rules when required Please check the web page regularly for updates Version 1 0 Page 4 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation a ECHA nttp echa europa eu 2 Business rule validation 2 1 Whatare 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 three reasons e Format In order to be processed correctly REACH IT must establish whether the dossier in the correct IUCLID 5 format For example a PPORD notification must not be in the format of a registration dossier e Administrative Before accepting a dossier for processing ECHA must establish that it can be properly handled This requires that certain often quite complex 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 impossib
29. gal entity link is not properly indicated when a repeatable block is created Page 9 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure Please create a new dossier that does not contain any IUCLID 5 Mixtures dataset and submit it via REACH IT Make sure that the Third Party Representative Legal entity is signed up in REACH IT as a Third Party Representative before proceeding with a submission of a new dossier For more information see chapter 2 2 of REACH IT Industry User Manual Part 2 http echa europa eu doc reachit industry user manual reachit signup ac cmngt_en pdf Please submit a new dossier via REACH IT If you have created a repeatable block in section 1 8 of your IUCLID 5 dossier keep in mind that you have to link to it a valid Legal entity with at least the contact address and country specified If you do not have any recipient s to indicate please do not create any empty repeatable block REACH IT will not process the dossier further if a valid Legal entity link is not properly indicated when a repeatable block is created An empty repeatable block contains information neither in the normal view nor in the compressed one see screenshots here below Recipients Recipients Please make the necessary modification and submit a new dossier REACH IT Data Submission Manual 8 Business Rules validation REACH IT Co Code Busines
30. he dossier header in case of update please refer to Data Submission Manual 4 http echa europa eu doc reachit how_ submit valid dossier pdf UPDATE SUBMISSION Version 1 0 Page 12 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation REACH IT Business Code SUB_REG_UC04_ BR80 U 2 a gt ep LUI H lt n A gt Version 1 0 Release date 17 April 2009 You have submitted an update for a change in tonnage band However the previous tonnage band recorded in the database for this substance is identical to the one indicated in your update Consequently your dossier will not be processed You should check the correctness of your dossier prior to resubmit AECHA http echa europa eu You have updated you dossier indicating a change in the tonnage band However REACH IT has detected that the tonnage band of the submitted dossier is the same as the one indicated in the previously accepted dossier Therefore this update submission cannot be processed by ECHA Page 13 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure If you need to submit an update of a previously registered substance because your tonnage band has changed you should make sure to create an update dossier using the correct IUCLID 5 dossier template in the IUCLID 5 dossier creation wizard
31. issued for it should proceed by updating the previous registration dossier You will be able to submit a valid updated dossier only after you have received the registration number from ECHA for it i e when the submitted dossier has reached the end of the pipeline DC O 7 q FE o U 2 a gt Vv LUI rn lt Q a gt INITIAL OR UPDATE SUBMISSION Version 1 0 Page 15 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 LN ECH A Business Rules validation http echa europa eu REACH IT REACH IT Rule message Explanation of the reason of Whatto do to avoid a failure in your next submission Business rule failure Code CLN_UC02_BR30 You have provided the C amp L You did not specify in your dossier To submit a valid dossier to ECHA you are asked to complete at least the information in an incorrect format a valid Classification and Labelling Classification and Labelling according to the DSD DPD the Dangerous Please respect the deadlines in section 2 2 of your IUCLID 5 Substance Directive 67 548 ECC Dangerous i Directive concerning the submission of C amp L dossier 1999 45 EC IUCLID 5 Section 2 2 Therefore a classification and labelling information according to DSD and Please note that this failure repeatable block in this section should be created and filled in GHS format appears also if you have specified Please follow the information you find in Data Submission Manual 5
32. it is possible to claim confidentiality by selecting a confidentiality flag In that case the claim has to be made directly in the appropriate section We are not able to process your dossier as we cannot calculate the appropriate fee For more information please refer to manuals 4 and 5 available on ECHA website http echa europa eu reachit registratio n it_en asp We invite you to make the necessary modifications and resubmit the dossier as an initial one AECHA http echa europa eu You have submitted an individual dossier i e not part of a joint submission but you have created a repeatable block in section 1 5 of your IUCLID 5 dossier Only use section 1 5 to give information on Joint submission You have ticked the checkbox Confidentiality request in your IUCLID 5 dossier header and in the Justification field you have indicated that you want some sections of the dossier to be kept confidential However you have not flagged those sections as confidential REACH IT Rule message Explanation the What to do to avoid a failure in your next submission rule reason of AA If you are not the lead or a member of a joint submission you should not create any record in section 1 5 of your IUCLID 5 dossier If you are the lead or a member of a joint submission in section 1 5 of your lead member dossier you should insert the following information the joint submission name defined by the lead in REACH
33. le Joint submission Message box User account Figure 4 provides an example of how the information on the automated business rules is displayed in the submission report Figure 4 Submission report Passed Tasks No Task Result Eo Vines Check Succeeded 2 File format validation Succeeded 3 Check ML structure Succeeded 4 Enforce Rules Failed Fule Ente i pi Le ip a 70 Rule Level Mandatory Rule Result Not Satisfied Fule Message Your dossier does not contain the information related to a production site in CLO 5 section 3 3 whereas in section 1 1 the checkbox manufacturer was ticked Please make the necessary modification and submit a new dossier Rule Name SUB_REG_UC03_ER190 Rule Level Mandatory Rule Result Not Satisfied Rule Message The tonnage band you have indicated in REACH IT during the submission of your dossier does not match the tonnage band indicated in the dossier template of your IUCLID 5 dossier Consequentiy we are not able to process your dossier For each failed automated business rule the lt Submission report gt gives the reason of failure as indicated in Figure 5 Version 1 0 Page 28 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation AECHA http echa europa eu Figure 5 Submission report with details name of the failing Mandatory Business rule succeeded Failed Rule Name SUB GBL_UCO BRS0 Rule Level Mandatory Reason
34. le to establish a link with the previous dossier Under other circumstances it might be unclear how the dossier should be invoiced e Technical After dossier submission REACH IT extracts a large amount of technical information directly from the dossier and this is used by the software to initiate numerous regulatory processes The business rules ensure that this information can be properly handled within the software For example incomplete or contradictory substance identifiers would result in errors in the database if these were not corrected prior to accepting the dossier 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 check 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 2 Why are there two different types of business rules At this time it has not been possible to fully automate the checking of all the business rules in REACH IT Therefore there are currently two types of business rules e Automated business rules These are checked by REACH IT Annex I part A provides a comprehensive list of the automated business rules together with advice on the action needed to correct a dossier that cannot be accepted for processing Annex Il p
35. less you opt out for the additional information requirements Otherwise the Lead should update the common dossier in advance One or several identifiers indicated in section 1 3 of your IUCLID 5 dossier are not valid For information the validity of the following identifiers is checked at this stage if relevant REACH inquiry number REACH pre registration number Please make sure that you have reported only identifiers related to your company and the substance for which you sent this dossier You have submitted an inquiry for which you number Then you have submitted a dossier reporting either no EC number or a different one You have submitted a dossier update for change to a_ higher tonnage band as a member of a Joint Submission However your updated tonnage band is not covered by the Lead dossier In section 1 3 of your IUCLID 5 dossier you have indicated a REACH inquiry number and or a REACH pre registration number this se which are not valid If in your dossier you have indicated in section 1 3 that you submitted an inquiry you should ensure to use the same EC number in the received a certain EC Reference substance you link to section 1 1 Please make the necessary modification and submit your dossier as a new submission If you need to submit an update for a change to a higher tonnage a band not covered by the Lead dossier you should either opt out for the additional information re
36. m user was ticked The only circumstances where a downstream user can register is as a producer of articles meeting the criteria presented in the Article 7 1 of the REACH Regulation However Section 3 4 did not indicate Substance in article under Form in the supply chain Please re submit a registration dossier either indicating that you are a manufacturer importer or only representative in Section 1 1 and or updating Section 3 4 Form in the supply chain as appropriate Your inquiry dossier does not contain your information requirements in IUCLID 5 section 13 Please make the necessary modification and submit a new dossier Your dossier does not contain the information related to a production site in IUCLID 5 section 3 3 whereas in section 1 1 the checkbox manufacturer was ticked Please make the necessary modification and submit a new dossier AECHA http echa europa eu A downstream user can register a substance only if he she is a producer of articles meeting the criteria presented in Article 7 1 of the REACH Regulation In your dossier you have not indicated in IUCLID 5 Section 3 4 Substance in article under Form in the supply chain In your inquiry dossier you did not attach your information requirements as a report in IUCLID 5 Section 13 If you are a manufacturer and you tick the related box in section 1 1 please make sure that you have defined a production site in
37. n fails Page 8 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure Each Reference substance that you link to your dossier either in IUCLID 5 section 1 1 or 1 2 needs to be defined by at least a a identifier among the following EC number CAS number and name IUPAC name Description Note that in case the only available information is related to CAS both the CAS number and name should be given Be careful to indicate at least one identifier in every Reference substance that you indicate in the dossier In case you have an unknown impurity you should write unknown impurity in the IUPAC name field of the corresponding Impurity Reference substance In order to avoid any inconsistency related to the identification of a chemical a Reference substance cannot be defined by completing only the field name Finally in the subsequent Technical Completeness Check step the presence of the molecular and structural information in each Reference substance molecular formula molecular weight range and structural formula or justification for not providing the information will be checked Please make the necessary modification and submit a new dossier You should take care to specify in the REACH IT submission page the same Dossier type specified in the IUCLID 5 dossier template during the IUCLID 5 dossier creation step Please submit a new
38. number of the last dossier which was accepted for processing e g an initial submission which failed the technical completeness check select the checkbox Spontaneous update if you want to spontaneously update your dossier Then add a repeatable block in which you should enter the justification of your update select the box Further to a request decision from regulatory body if you have received a formal communication from ECHA or another regulatory body Then add a repeatable block in which you will indicate the related communication number For more information on how to correctly enter data in the dossier header in case of an update please refer to Data Submission Manual 4 http echa europa eu doc reachit how_ submit valid dossier pdaf Please make the necessary modification and submit a new dossier SUB_GBL_UC02_ No spontaneous update is allowed You have submitted a If you have submitted a registration dossier you cannot spontaneously BR140 after a submission which was spontaneous update for a dossier update it before a reference number e g registration number is assigned rejected due to a 1st TCC failure that previously failed the first to it i e until it has been completely processed Only after having received Technical Completeness Check the reference number can you submit a spontaneous update dossier TCC Be aware that under these circumstances you should resubmit a dossier update f
39. of failure Rule Result Not satisfied Rule Message An inconsistency has been detected in the type of dossier submitted Please verify that you have not sent an update instead of an initial dossier or vice versa This submission has been aborted Please make the necessary modification and submit a new dossier What happens when a dossier fails a manually checked business rule If the submitted dossier cannot be processed due to one or more manually check business rules ECHA sends a message to the registrant notifiers REACH IT mailbox This message entitled lt Dossier business rule failure gt is displayed in Figure 6 Figure 6 REACH IT message on BR failure manual check CC Hide Yes e ca User 0 The submitted dossier cannot be processed Depending on the ype of failure further information can be found either a in the submission report or 6 in the communication available in the annotation section of the dossier SUBMISSION number Oy aroan ond Submission imestamp ITT 0 24 Dossier type Inquiry 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 7 Figure 7 Annotations tab with Communications Home gt Submitted Dossiers gt Dossier Annotations Company Details Submission Report Accoun
40. ollowing a first Technical Completeness Check communication of failure sent to you via REACH IT In this case you must resubmit your dossier and during step 7 of the IUCLID 5 dossier creation wizard tick the box Further to a request decision from a regulatory body Do not forget to indicate in the field Number the communication number given to you by ECHA Please make the necessary modification and submit again your new dossier via REACH IT For more information on how to correctly enter data in the dossier header in case of an update please refer to Data Submission Manual 4 http echa europa eu doc reachit how_ submit valid _dossier pdf Version 1 0 Page 11 of 31 Release date 17 April 2009 UPDATE SUBMISSION UPDATE SUBMISSION REACH IT Data Submission Manual 8 AN ECHI A Business Rules validation http echa europa eu REACH IT REACH IT Rule message Explanation of the reason of Whatto do to avoid a failure in your next submission Business rule failure Code SUB_GBL_UC02_ The submitted dossier is an update You have submitted a dossier If you want to submit an update either Spontaneous or Further to a BR55 without update reason Request by update but you have not specified request decision from a regulatory body type you should not forget to authority Spontaneous specified the reason why you are updating specify the reason for the update in the corresponding repeatable
41. quirements or ask the Lead to submit an update of the common dossier in advance Please make the necessary modification and submit a new dossier Please make sure that all the identifiers that you report in section 1 3 of your IUCLID 5 dossier are related to your company and or to the substance for which you send your dossier Please make sure to always indicate all identifiers you have Here below you find a list of examples of identifiers that can be indicated in ction inquiry number pre registration number notification number assigned under the directive 67 548 EEC registration number in case of update of a notified substance for which you have claimed a registration number or in case of update of a previous registered substance Please make the necessary modification and submit a new dossier Page 22 of 31 REACH IT Data Submission Manual 8 AN EC I IA Business Rules validation http echa europa eu REACH IT REACH IT Rule message Explanation of the What to do to avoid a failure in your next submission Business rule reason of failure Code SUB_GBL_UCO02 You have submitted an update but the The submission number If you want to update a dossier please make sure that you indicate in _BR50 last submission number indicated in indicated in the Last the Last submission number field the submission number of your your dossier is incorrect submission number field latest dossier accepted by ECHA in your I
42. s INITIAL SUBMISSION SUB_REG_UC03_ BR120 z O D co a lt E zZ SUB_REG_UC03_ BR200 INITIAL SUBMISSION Version 1 0 Release date 17 April 2009 SUB_GBL_UC02_F An error was detected in section 3 3 of your IUCLID 5 dossier you must update your site s and provide also the contact address for the site s including town and country in the corresponding IUCLID 5 fields It is not enough to provide the required information in the name of the site s The system has identified that you have submitted a dossier where it is indicated in section 1 1 that you are a Manufacturer Importer AND an Only Representative Please submit a separate registration for each of your role in the supply chain i e one as a Manufacturer Importer and one per non EU manufacturer you are representing The IUCLID 5 dossier template REACH registration 1 10 tonnes physicochemical requirements can be used only for phase in substances see REACH Article 12 1 b AECHA http echa europa eu In section 3 3 of your IUCLID 5 Dossier you have added a link to a Site in which you have not indicated the complete contact address Keep in mind that empty repeatable blocks created in section 3 3 are triggering the same error in REACH IT You have ticked in IUCLID 5 section 1 1 that you are both Manufacture Importer Only Representative ECHA cannot accept this dossier for further processing because you cannot ha
43. s of the section 1 1 nor in 1 2 REACH IT SOLI first composition of section 1 2 A Reference substance should A Reference substance cannot be defined by completing only the field D were not linked to a Reference always be present in IUCLID 5 name To be valid a Reference substance should have at least one of the lt substance section 1 1 and in section 1 2 If following identifiers a not the dossier cannot be linked to EC number or a substance and it cannot be CAS number and name or processed by ECHA IUPAC name or This Business Rule also fails in Description case_an empty repeatable block for composition and or constituent Note that in case the only available information is related to CAS both the is created in a dossier CAS number and name should be given Ensure you indicate at least one valid identifier in every Reference substances that you use in the dossier In case you have an unknown impurity you should write unknown impurity in the IUPAC name field of the corresponding Impurity Reference substance Finally in the subsequent Technical Completeness Check step the presence of the molecular and structural information in each Reference substance molecular formula molecular weight range and structural formula or justification for not providing the information will be checked Please make the necessary modification and submit a new dossier Version 1 0 Page 7 of 31 Release d
44. section 1 3 of the IUCLID 5 dossier If you need to update the please add the registration number you have received for this substance Classification and Labelling For detailed information please refer to chapter 1 2 of Data Submission information you should instead Manual 4 submit an update of the already http echa europa eu doc reachit how submit valid dossier pdf registered substance Please make the necessary modification and submit your new dossier update via REACH IT CLN_UC02_BR20 No Classification and Labelling You have submitted a You have submitted a Classification and Labelling notification dossier for a notification submission is allowed Classification and Labelling substance that has the status pending in a previous registration while a registration dossier for the notification for a substance for submission This means that you have already submitted a registration same substance is still pending in which you have submitted a dossier for this substance and this dossier has not yet reached the end of the submission process registration dossier Moreover this the registration process Be aware of the fact that you are not allowed to registration has not yet reached the submit a new Classification and Labelling notification dossier for the same end of the registration process and substance no registration number has been If you need to update the classification and labelling information you yet
45. substance is a non phase in substance you are not allowed to create a dossier with the template REACH registration 1 10 tonnes physicochemical requirements Please make sure that your substance is not a phase in substance see REACH Article 3 20 If your substance is non phase in please create a new dossier using the template REACH Registration 1 10 tonnes standard requirements including the required information for this tonnage band and submit it via REACH IT REACH IT Data Submission Manual 8 AN ECHI A Business Rules validation http echa europa eu REACH IT REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission Business rule failure Code SUB_GBL_UC02_ The dossier has already been You have submitted for the second If your intention is to submit an update of a previously submitted dossier BR100 submitted earlier Please create a time the same dossier please create a new dossier and make sure to correctly indicate the new dossier and submit it following information in the Dossier header during the IUCLID 5 dossier creation step 7 of the dossier creation wizard tick the checkbox Is the submission an update enter the last valid submission number in the Last submission number field note that the submission number of any dossiers previously not accepted at the business rules stage should not be used it must be the submission
46. te but indicate the following information without an update reason you have not reported areason for updating in the IUCLID 5 dossier header an update reason in a correct reference number e g a REACH registration number your dossier header in section 1 3 and or a correct If the update is for a previously notified substance under directive reference number in 67 548 EC indicate in section 1 3 the correct NCD notification section 1 3 of your number and the registration number previously claimed in REACH IT dossier Please make the necessary modifications and submit a new dossier UPDATE SUBMISSION UPDATE SUBMISSION Version 1 0 Page 23 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation UPDATE SUBMISSION UPDATE SUBMISSION UPDATE SUBMISSION Version 1 0 _BR90 dossier correct SUB GBL _UC02 The system has detected that two _BR120 completeness check failures already this submission dossier shall be resubmitted as an initial one occurred SUB_GBL_UCO2 The system has detected that your _BR130 submission of an update after a first Completeness Check failure within the given deadline Release date 17 April 2009 IUCLID 5 section 1 3 AECHA http echa europa eu REACH IT REACH IT Rule message Explanation the What to do to avoid a failure in your next submission Business rule reason of ES Code SUB _GBL_UC02 The given reference num
47. ting Armotations z e I egisi rail I Fi Decisione Pre SIEF Online dassiers ld Outcome Creation date Process type Phasein Information NO reggs H f EAE i Pere at Gir i Communications loirt submis sigi Message box Outcome Creation date Process type User account ph aa REJECT Submission Pipeline AOC es search Version 1 0 Page 29 of 31 Release date 17 April 2009 REACH IT Data Submission Manual 8 Business Rules validation a ECHA http echa europa eu 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 8 containing e all details on the failure e the actions you should take to submit a valid dossier Figure 8 Attached communication in the dossier info Fee n i tw 6 SS Skee eer eee ee eee et Lee re Home gt Submitted Dossiers gt View Dossier Decision Communication Info Communication Outcome Pre SIEF Type Online dossiers Communication number External deadline Company Preregistraimn Phatt mionnan Regisziratbon f Content notification Content Joint Submis Attachments hassa qe boa Attached file FTT Uzer aotaund prio cin lata Search Version 1 0 Page 30 of 31 Release date 17 April 2009 European Chemicals Agency Annankatu 18 P O Box 400 FI 00121 Helsinki Finland Tel 358 9 6861 80 Fax 4358 9 6861 8210 http echa
48. tonnage band You have submitted an update dossier after the first TCC Technical Completeness Check failure In the communication letter related to this TCC failure a deadline was indicated Unfortunately you did not submit the update before that date Therefore depending on your particular case you are invited to submit either a new initial dossier for your substance In this case do not mention any communication decision number in the dossier header and or in the dossier Or anew update for your substance in case you need to send an update due to for example a change of tonnage band Page 24 of 31 REACH IT Data Submission Manual 8 Business Rules validation ALL INDIVIDUAL SUBMISSIONS ALL SUBMISSIONS Version 1 0 REACH IT Business Code va _GBL_BR16 SUB_REG_INITIA L_BR140 Release date 17 April 2009 Your submission was not part of a joint submission In that case the section 1 5 of your IUCLID 5 dossier must be empty The checkbox Confidentiality request was ticked in your dossier header Tthe confidentiality request in the dossier header shall only be used in the following cases confidentiality request on the tonnage band and or confidentiality requests which cannot be made in the other sections of the IUCLID dossier e g confidentiality claim on sections 3 5 or 3 6 We have noticed that you would like to claim confidentiality on specific sections of IUCLID for which
49. ve both roles in the same dossier You have submitted a registration for a non phase in substance and you have defined the template REACH registration 1 10 tonnes physicochemical requirements As this template can only be used to register phase in substances ECHA cannot accept the dossier for further processing Page 10 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure If you need to specify a Site in section 3 3 of your IUCLID Dossier please make sure that you have added a link to a Site in which you have indicated the complete contact address Please also note that you should not create any empty repeatable block if you have no intention to indicate a Site REACH IT will be unable to accept the dossier if a valid site is not properly indicated when a repeatable block is created Please make the necessary modification and submit a new dossier You should create a dossier in which your role in the supply chain is either Manufacturer Importer or Only Representative If you need to submit a dossier for the same substance with the two roles you must create two different dossiers one as Manufacturer or Importer in which your you will tick the checkbox Manufacturer Importer one as Only Representative in which you will tick the box Only Representative Please make the necessary modification and submit a new dossier s If your
50. you cannot submit a dossier based on the template that should be used by the members e g REACH Registration member of a joint submission general case REACH Registration member of a joint submission intermediates or or BEACH C amp L notification member of a joint submission Page 19 of 31 REACH IT Rule message Explanation of the reason of What to do to avoid a failure in your next submission rule failure Please make sure that the tonnage band entered in REACH IT during the submission of your dossier matches the tonnage band of the template of your IUCLID 5 dossier Please make the necessary modification and submit a new dossier If you are a Lead of a Joint submission you should not submit a dossier using the following IUCLID 5 templates REACH Registration member of a joint submission general case REACH Registration member of a joint submission intermediates REACH C amp L notification member of a joint submission as they should be used only by a Joint submission member During the dossier creation in IUCLID 5 please use the dossier template for the tonnage band related to your submission for example REACH registration above 1000 tonnes in case your tonnage band is gt 1000 tonnes Do not forget to indicate in IUCLID 5 section 1 5 the necessary joint submission information i e the Joint submission name and the Lead of the Joint submission Once your dossi

REACH-IT Data Submission Manual 8 Business Rules validation

Contents

Download Pdf Manuals

Related Search

Related Contents