N.4 How to complete the IUCLID 5 Dossier Header
Contents
1. UR test_2 helsinki Finland Submitting legal entity sit EUROPEAN COMMISSION European Chemicals Bureau vw Italy gt Z Dossier creation date time 2008 06 19 10 07 23 EEST Dossier submission remark dossier submitted to ECHA used in category Type of submission SS 0 v U0000 0 For general guidance on dossier creation refer to the IUCLID 5 User manual section C 6 Creating a dossier and section D 8 2 Creating dossiers 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 four parts Figure 2 Version 1 2 Page 5 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 2 Four parts of the fourth step Coke craie mard mi mi abs me e mi 1 Dossier submission name and remarks 2 Submission update information only in case of update Brain foi eqed ai be 3 specific Information related to the dossier assessor revision testing proposal confidentiality data sharing opt out fee walver 4 specific Information for isolated intermediates o 2 8 8 2 8 2 8 isti id i vii rt For the creation of a dossier different from a registration PPORD notification A C amp L notification notification of substanc2. a ECHA http echa europa eu Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Document history December 2009 Minor textual revisions web links verified and updated document in new layout July 2008 Major review of document as a result of release of a new version of REACH IT 1 0 June 2008 Creation of document Reference ECHA 08 B 05 EN Issue date 27 November 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 http echa europa eu reach helpdesk echahelp en asp European Chemicals Agency 2009 Reproduction is authorised provided the source is fully acknowledged in the form Source European Chemicals Agency http echa europa eu and provided written notification is given to the ECHA Communication Unit info echa europa eu Version 1 2 Page 2 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Table of Contents 1 INTRODUC TION ora rire 4 Z JUCLEID S DOSSIER HEA DER secsscccostvesccesessscavetsunssseacexcuctebessdeswscstedssacssceveucsnateuscdesava
3. FIGURE 4 IUCLID SCREEN WITH REASON FOR UPDATING cccccssccsscccscccssccesccesccescceusceusceesseusceesccesseusceusceeceeenss 8 FIGURE 5 REACH IT MESSAGE FOR SUCCESSFUL NONS CLAIM cccccscccsscccscccscceesccesccecceesccesccessseusseesceesseencs 8 FIGURE 6 UPDATING PREVIOUS NONS AFTER THE CLAIMING OF THE REGISTRATION NUMBER eve 9 FIGURE 7 REASON FOR UPDATING FURTHER TO A REQUEST DECISION FROM REGULATORY BODY 9 FIGURE 8 REASON FOR UPDATING SPONTANEOUS UPDATE ccccseccsccceccescencccsccucceuccesccuscencsenccusseussesscuscenscenceuss 10 FIGURE 9 REASON FOR UPDATING SPONTANEOUS UPDATE OTHER JUSTIFICATION c ssccccsececesccceseceeeceeeeceees 11 FIGURE 10 SEVERAL REASONS FOR UPDATING SPONTANEOUS UPDATE cccceccseccssccuccsceuccenccescencseuscescenseenceues 11 FIGURE 11 REGISTRATION DOSSIER SPECIFIC INFORMATION cccccccssccsccssccscccuccesceuccesccusceuccenccussencseuscussescencenss 12 FIGURE 12 TICK BOX REVIEW BY AN ASSESSOR i irrita 13 FIGURE 13 TICK BOX TESTING PROPOSAL S INCLUDED ccccccceeccescccsecceeccencceeceeeceeseseeeseencseseseeseeeceuseseeesens 13 FIGURE 14 CONFIDENTIALLY REQUEST ON THE TONNAGE BAND c ccseccscccsccsccsccesccscesscesccscesccesscscesseescenseaece 14 FIGURE 15 CONFIDENTIALITY FOR IUCLID SECTION 3 5 AND 3 0 irene eee 14 FIGURE 16 INDICATING A DATA SHARING ISSUE IN IUCLID
4. ccecccscccsccescccscessceesseesscessceesseesseeseees 15 FIGURE 17 INDICATING OPT OUT N IUC LID Sn arme desde tac banni eapena a blues eat notes 15 FIGURE 18 REQUEST OF FEE WAIVING TICK BOX IUCLID iii eee ceeceeceeeeceeceececeneenee 16 FIGURE 19 TICK BOXES FOR ISOLATED INTERMEDIATES ccccceccssccscccssccsscesscescessccsscescesscesscescesscessescesscesceeseess 16 Version 1 2 Page 3 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu 1 Introduction This document explains how to complete the IUCLID 5 dossier header information to ensure that a dossier can be accepted by REACH IT during the submission process Dossiers submitted to REACH IT undergo some basic checks before being accepted for further processing These checks are carried out for the following reasons e the dossier is in the correct format i e it is a genuine IUCLID 5 dossier and does not contain a virus e the information in the dossier header is sufficient to allow the dossier to be processed correctly Dossier header The dossier header of a IUCLID 5 dossier consists of information used for administrative purposes and is completed by the applicant when preparing his dossier from the substance data set The information related to the both points can be complex and if incomplete or incorrect can result in dossiers not being accepted for further proc
5. XL 0123456 78 Download submission report In order to update your dossier you should proceed as follows Figure 6 e The registration number received should be reported in section 1 3 of the IUCLID 5 dossier e The notification number NCD number should be reported in section 1 3 of the IUCLID 5 dossier e In the dossier header you should indicate in the Last submission number field 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 Version 1 2 Page 8 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 6 Updating previous NONS after the claiming of the registration number Type of submission Submission update jw ls the submission an update Last submizzion number AADO04xxx 00 Reason for updating Furtherto a requestfdecizion from regulatory body Spontaneous update change of tonnage band Justification Change of tonnage band Remarks the change of tonnage 4 2 2 3 Previously registered 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 should be reported in the Last
6. intermediates avaible from the ECHA website http quidance echa europa eu Figure 19 Tick boxes for isolated intermediates Specific information for isolated intermediates On site above 1 tonne Transported 1 1000 tannes Production and use under stricly controlled conditions Justification The substance is used as Strictly controlled conditions can be demonstrated because B 6T 6 0 6 G u lt Back Next Cancel Enter administrative information When a dossier is made for a substance used both as isolated intermediates under strictly controlled conditions and as non intermediates the fees will be calculated as the sum of individual fees for intermediate and non intermediate as if separate dossiers had been submitted 3 How to submit a valid dossier via REACH IT 3 1 Fee determination Fee determination relates only to dossiers submitted for PPORD notifications and registrations The fee determination and the preparation of the invoice are based on Version 1 2 Page 16 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu e the information reported in the dossier header see Section 2 for more information e the information provided in REACH IT during the submission process related to o the tonnage band of the registration o the indication of intermediate use if the tonnage for such a use is
7. submission number field and the registration number should be indicated in the section 1 3 of the IUCLID 5 dossier lt 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 2 2 3 1 Update on request In case of an update made on request of a regulatory body the checkbox Further to a request decision from regulatory body must be selected and the communication number in the request letter must be entered in the adjacent Decision number field Figure 7 Figure 7 Reason for updating further to a request decision from regulatory body Reason for updating Further to a request decision from regulatory body SS a deo a Decision number xxx X xXXxXXxXXXXM XX XXTX Remarks 2 2 3 2 Spontaneous update In case of spontaneous update the checkbox spontaneous update should be selected Figure 8 and the reason for the update should be chosen from the drop down list in the justification field Figure 8 The drop down list is reporting the following update reasons Version 1 2 Page 9 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu e change in company identity e change in company role
8. and a justification given see Figure 15 Version 1 2 Page 18 of 19 Release date November 2009 European Chemicals Agency PO Box 400 Annankatu 18 F 00121 Helsinki Finland http echa europa eu
9. d a justification should be provided in the appropriate text box Figure 18 Version 1 2 Page 15 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 18 Request of fee waiving tick box IUCLID Fee waiving 1 10 tonnes complete dossier Justification allthe information required in Annex VII is submitted as part of this regi stration As the tonnage of this dossier includes Stonnes of on site isolated intermediates 7 tonnes of non intermediate use we request the fee walving in accordance with 2 4 Specific information for isolated intermediates dossier header part 4 When the dossier covers also a volume used as isolated intermediate specific information should be reported 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 19 A Please note that the strictly controlled conditions will have to be carefully documented More information can be found in the Guidance on intermediates available from the ECHA website http quidance echa europa eu In addition different information requirements apply to on site and transported intermediates and more information can be found in the Guidance for
10. e in article inquiry a reduced set of information is needed to prepare a proper dossier header For registrations to compile the IUCLID 5 dossier before the submission to ECHA you should complete the information related to the four parts described above However unless the dossier is an update no information on submission update should be reported see chapter 2 2 2 1 Dossier submission name and remarks dossier header part 1 The first part allows you to specify the name of the dossier Figure 3 as well as any additional information you wants to point out Version 1 2 Page 6 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 3 Specifying the name of the dossier Dossier creation wizard Enter additional administrative information concerning your dossier Dossier template REACH Registration 10 100 tonnes Name given by user Registration of substance i Dossier submission remark The dossier covers both the use of A used as intermediates under strictly controlled conditions and use das non intermediate 2 2 Submission update information dossier header part 2 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 the dossier is submitted as an update although it is not then it cannot be processed by REACH IT and
11. essing 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 dossiers and the specific circumstances behind the submission REACH IT will not process the dossier if this information is unclear and or incorrect The present document is divided in two different parts e the first one describes the initial processing steps of dossiers submitted to ECHA in order to determine whether further processing can take place e the second one gives detailed explanations on how to prepare an appropriate dossier header 2 IUCLID 5 Dossier Header As already mentioned the dossier header has a significant impact e onthe processing of the dossier see chapter 2 e onthe calculation of fees and preparation of the invoice see chapter 3 During the IUCLID 5 dossier creation procedure the dossier creation wizard requests the user to Enter additional administrative information concerning your dossier in the 6 step To create a dossier in IUCLID 5 you should start from the IUCLID 5 substance dataset select the template corresponding to your submission for e g REACH Registration 10 100 tonnes REACH PPORD follow the dossier creation wizard guide export the dossier and save
12. f registrant involving change in legal personality e List of confidentiality claims o Confidentiality claim on the degree of purity and or identity of impurities or additives o Confidentiality claim on the tonnage band o Confidentiality claim on study summaries or robust study summaries o Confidentiality claim on the information in the safety data sheet Version 1 2 Page 17 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu o Confidentiality claim on the substance trade name o Confidentiality claim on the IUPAC name for non phase in dangerous substance o Confidentiality claim on the IUPAC name for dangerous substances used as intermediates in scientific research and development or PPORD 4 Confidentiality request 4 1 Introduction A registrant can request that information 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 partys commercial interests Article 119 2 specifies which information requires publication by ECHA If the information falls under Article 119 2 of the REACH regulation and Annex IV of the Fee Regulation then the Agency will request a fee payment for these confidentiality requests Fee Regulation COMMISSION REGULATION EC No 340 2008 of 16 April 2008 on the fees and charges payable to
13. 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 the 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 exemption DU obligations If for example your company needs to inform ECHA of a change in the annual quantity manufactured or imported you should select from the drop down list the change of tonnage band Figure 8 Figure 8 Reason for updating spontaneous update Reason for updating Further to a request decision from regulatory body Spontaneous update j ih change of tonnage band a X justification change of tonnage band i Remarks tonnage band from the one indicated inthe 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 adjacent field Figure 9 Version 1 2 Page 10 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 9 Reas
14. it in on your local drive For dossier creation containing a substance which is part of a category the 7 wizard step is related to the dossier header This information will then be contained in what is called the IUCLID 5 dossier header The dossier header is the part of the dossier that reports information fundamental to pass the Version 1 2 Page 4 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu administrative technical verification and on which a part of the fee calculation is based Here below an example Figure 1 of how a dossier header appears once the dossier is created Figure 1 Dossier header in IUCLID 5 G IUCLID 5 Fo File Edit Go Window Help Plugins GO OS HR Z Q S INA E E AN fet Navigation mamil M Dossier test for ECHA sumission i Query results Components Dossier header n n SPARTA p Dossier header Dossier template Name REACH Registration 10 100 tonnes a Version 2007 03 19 w test reference substance 50 21 EUROPEAN COMMISSION Europe Name given by user test for ECHA sumission x SA MadeSystems Helsinki Finland BR R_10 100 Substance testchemi 2008 06 19 test for ECHA sum Dossier subject qA test_1 Dortmund Germany rele A A Name testchemical test reference substance 50 21 5 test_2 helsinki Finland gt de fe
15. lation EC No 1907 2006 If you receive a communication of Business Rule validation failure then you should remember to submit an initial dossier More information on Business Rule validation can be found in Data Submission Manual 8 Business Rules validation that is available from the ECHA website http echa europa eu Version 1 2 Page 7 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 4 IUCLID screen with reason for updating Submission update la the submission an update Last submission number xxxxxxxx Xx Reason for updating Further to a request decision from regulatory body ire He OG e na Decision number xxx X XXxXxXXXxXxoKxoxxfx Remarks 2 2 2 NONS The substance is a notified substance under Directive 67 548 EEC considered as being registered under REACH Before proceeding you should claim the registration number following the information given in ECHA web site related to the NONS http echa europa eu reachit nons en asp If the claim is successful you will receive in your REACH IT mailbox both the registration number and the submission number Figure 5 Figure 5 REACH IT message for successful NONS claim ou have claimed 1 registration number s in relation to Notification number 456 78956 EC Number 200 001 8 1 successfully claimed submission and registration numbers
16. not covered by the tonnage band given above o the statement that a full annex VII is submitted related to fee waiver reasons for registration of less than 10 tonnes of substance e the information contained in the substance dataset such as the confidentiality requests Please note that a fee is requested only for those confidentiality requests which are falling under Art 119 2 of REACH and Annex IV of the fee regulation EC 340 2008 The justification for a confidentiality claim will be checked only before xX information is published In case a confidentiality request would then be rejected by ECHA the fee would not be reimbursed The following list indicates what kind of items can be associated to a given chargeable service type and more information can be found in Part 8 Invoices of the REACH IT Industry User Manual e Registration initial submission o Registration fee for substance intermediate o Change in identity of registrant involving change in legal personality o List of confidentiality claims see here after e Registration update o Change in identity of registrant involving change in legal personality o Update of registration tonnage o List of confidentiality claims see here after o Intermediate tonnage gt 10 tons e PPORD notification o PPORD notification o Change in identity of registrant involving change in legal personality e PPORD exemption extension o PPORD exemption extension o Change in identity o
17. ntiality flag in section 3 2 of IUCLID 5 cannot be used to request A confidentiality for your tonnage band because that section relates to the actual tonnage always confidential information Confidentiality requests which cannot be made in the detailed sections of the IUCLID dossier A registrant can request that 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 1 Further information on confidentiality requests can be found in chapter 4 Some of these confidentiality requests cannot be made in the detailed sections of the IUCLID dossier and so the dossier header must be used as follows Parts of IUCLID 5 dossier sections 3 5 and 3 6 fall under the Art 119 2 d of the REACH Regulation and thus are subject to a confidentiality request and payment of fee The current version of IUCLID 5 does not offer the possibility to claim confidentiality directly in these sections Art 119 2 d refers to information contained in the safety data sheet that is not already published by ECHA according to Art 119 1 The following information falls into this category e 3 5 Identified uses and exposure scenarios Main use category and Specification for industrial and professional use e 3 6 Uses advised against Consequently if confidentiality is claimed on information reported in
18. of the substance has been reviewed by Dr 2 3 2 2 Testing proposal Testing proposal included by ticking the checkbox Testing proposal included the registrant declares that at least one testing proposal is present in the endpoint section of the dossier submitted It should be stated in the endpoint concerned text box which endpoint s is are concerned in the dossier Figure 13 Figure 13 Tick box testing proposal s included Testing proposalfs included Endpoint concerned 5632 Bioaccumulation terrestrial 5 4 1 Adsorpition desorption 2 3 2 3 Confidentiality Confidentiality request the confidentiality request in the dossier header shall be used only to indicate the following cases Confidentiality request on the tonnage band If the registrant wants to keep the tonnage band for which he registers a confidential information the checkbox Specific request on tonnage band in the dossier header should be selected as this is the only way to request the confidentiality flag A justification should be provided Figure 14 Version 1 2 Page 13 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu Figure 14 Confidentially request on the tonnage band Confidentiality request Specific request on tonnage band Justification a specific request on tonnage band is asked because The confide
19. on dossiers and the related 1 requirements refer to the Guidance on registration section 9 guidance on update of dossier http quidance echa europa eu 2 3 Specific information related to the dossier dossier header part 3 2 3 1 Specific information This part of the dossier header allows giving general information on the IUCLID 5 dossier submitted As a general rule when one of the boxes of the block registration dossier specific Version 1 2 Page 11 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu information review by an assessor testing proposals confidentiality request fee waiving is ticked the associated free text field below the box should be filled in example in Figure 11 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 Figure 11 Registration dossier specific information Registration dossier specific information Review by an assessor Remarks men O EO SO F Testing proposalis included Endpoint concerned FI Confidentiality request C Specific request on tonnage band Justification Data sharing issues Justification Cl Opt out from joint
20. on for updating spontaneous update other justification Reason for updating id Further to a request decisian from regulatory body Spontaneous Update new identified uses Justification newidentified uses new identified uses sewerage TT Remarks new uses have been identified Finally if you need to indicate more than one reason for updating your dossier you should add more than one repeatable block Figure 10 please always providing a justification for doing so Figure 10 Several reasons for updating spontaneous update Reason for updating Further to arequest decision from regulatory body 4 v Spontaneous update y x change of tonnage band gt Justification change of tonnage band II 5 Remarks change indicating the change n change in company role in the supply chain d x Justification change in company role in the supply gt IMI Remarks text indicating the change Where 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 preceding paragraphs e completing the reason for updating field If not provided ECHA will not be able to process the dossier For more information on different types of registrati
21. s no agreement on data sharing related for the relevant study available Inthe SIEF A communication to ECHA was made to and the following ECHA decison was taken 2 3 2 5 Opt outs Opt out from a joint submission if the registrant is part of a joint submission and wants to opt out according to Article 11 3 of the REACH Regulation by submitting separately information which should normally be submitted jointly he should select the checkbox Opt out from joint submission A justification should be provided indicating also in which section of the dossier the opt out is requested Figure 17 The eventual opt in for confidentiality claim can be indicated during the submission of the joint member submission dossier For more information on Joint submission refer to industry user manual Part 7 Joint submission avaiable on the ECHA website htip echa europa eu Figure 17 Indicating opt out in IUCLID Opt out from joint submission Justification ont out forthe following endpoints 5 2 1 biodegradation in water 5 3 1 bigaccumulation 2 3 2 6 Fee waiving Request of fee waiving 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 should be selected an
22. sections 3 5 and or 3 6 of IUCLID 5 the checkbox Confidentiality request should be selected and a justification for those requests should be provided in the Justification field Figure 15 Figure 15 Confidentiality for IUCLID section 3 5 and 3 6 Confidentiality request ual Specific request on tonnage band ustification confidentiality is claimed for the information submitted in section 3 6 of this dossier The justification All other confidentiality requests shall be made in the foreseen places in the technical dossier Further information can be found in the latest version of the Data Submission Manual 5 on how to complete a technical dossier for Version 1 2 Page 14 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu registration and PPORD notification on the ECHA website http echa europa eu 2 3 2 4 Data sharing Data sharing issues if during the data sharing process any issue arises in obtaining information data after a regular inquiry to ECHA or during data sharing within a SIEF related to REACH article 30 from the data owner the registrant can indicate the problem in this section A justification should also be made available and if available the ECHA decision number on this particular situation Figure 16 Figure 16 Indicating a data sharing issue in IUCLID Data sharing issues Justification a
23. submission Justification FI Fee waiving 1 10 tonnes complete dossier Justification Some of the information reported in this block and listed below directly influences the fee calculation The information affecting the fee are marked with a and for further information see chapter 4 Other information provides a quick overview on the data information present in the particular dossier The specific information reported in this part of the dossier header is whether the e the dossier has been reviewed by an assessor e testing proposals are included e confidentiality request is made in the dossier e there is an issue regarding data sharing Version 1 2 Page 12 of 19 Release date November 2009 Data Submission Manual No 04 How to complete the IUCLID 5 dossier header ECHA http echa europa eu e thereisanoptoutfroma joint submission e there is a request of fee waiving 2 3 2 Reported specific information In details the registration specific information that might should be reported is 2 3 2 1 Reviewer Reviewed by an assessor by ticking the checkbox Review by an assessor the registrant declares that the dossier has been reviewed by an assessor having an appropriate experience in accordance to Art 10 a vill document can also be attached if necessary Figure 12 Figure 12 Tick box review by an assessor Review by an assessor Remarks the infomation an the manufacture and uses
24. the Submission failure submission rule violation message is sent to your REACH IT inbox More information on Business Rule validation can be found in Data Submission Manual 8 Business Rules validation that is available from the ECHA website http echa europa eu The following situations are the only situations where the submission should be considered as an update 2 2 1 Same dossier A registration dossier has been sent before for the same substance but although it passed the initial rule verification steps in REACH IT the registration was considered as incomplete by ECHA during completeness check The submission of an updated dossier in this case is meant to fulfil the request for further information made by the Agency within a set deadline Under these circumstances the last submission number i e the one attributed to the dossier which resulted in the request for further information must be reported in the Last submission number field the checkbox Further to a request decision from regulatory body in IUCLID must be selected Figure 4 and the communication number indicated in the request for further information must be entered in the adjacent Decision number field in IUCLID see Figure 4 This only applies to submissions which were considered incomplete by the Agency during the completeness check and which resulted in a letter entitled Request for further information on your registration under Regu
25. the European Chemicals Agency pursuant to Regulation EC No 1907 2006 of the European Parliament and of the Council on the Registration Evaluation Authorisation and Restriction of Chemicals REACH A Note that the fee has to be paid for the request but it is not a guarantee that the information is not published The Agency will decide based on the provided justification if the reasoning is sufficient to not publishing the information 4 2 Claims subjected to fees Confidentiality requests which are subject to a fee and that appear in the dossier header are 4 2 1 Tonnage band Relevant tonnage band corresponds to Art 119 2 b of REACH Requests in IUCLID 5 e Dossier header Request for the tonnage band checkboxes Confidentiality request and Specific request on tonnage band are selected and a justification is provided see Figure 14 4 2 2 Safety data sheet Information in the safety data sheet corresponds to Art 119 2 d of REACH Requests in IUCLID 5 Dossier header Request for sections e 3 5 Identified uses and exposure scenarios Main use category and Specification for industrial and professional use e 3 6 Uses advised against Requests have to be made in the dossier header as there is no possibility in sections 3 5 and 3 6 to flag the information directly The box Confidentiality request should be ticked and in the justification field the item for which confidentiality is requested should be mentioned
26. vesteesuwcsecdesssetesseseaens 4 2 1 DOSSIER SUBMISSION NAME AND REMARKS DOSSIER HEADER PART 1 6 22 SUBMISSION UPDATE INFORMATION DOSSIER HEADER PART 2 rece f zi Mi lana 7 de 8 2 TIVI zanna 9 A SO DEC D ee de a east eniveaewiasere mosis 9 2 292 PRI aaa 9 2 3 SPECIFIC INFORMATION RELATED TO THE DOSSIER DOSSIER HEADER PART 3 11 COSE TOI RR TA 11 2 3 2 Reported specific information i 13 2 321 RE mee A I ne ee nner en nee ee ee meee E 13 Did TESE PEO DOS a rl raiders 13 2 32 CODE DA di E D ea re eee CL a eo 13 2 3 2 4 D ARE EI AO REID MEI 15 2 329 OP lidia EEZEELZEZ 15 ZAIZ0 ERI ARR ITA 15 24 SPECIFIC INFORMATION FOR ISOLATED INTERMEDIATES DOSSIER HEADER PART 4 16 3 HOW TO SUBMIT A VALID DOSSIER VIA REA CHIT cccccccccccccssssssccccccccssscssccccccccesssees 16 3 1 PEDEN A TTO glia 16 4 CONFIDENTIALITY REQUEST gir ivi 18 4 1 INTIRODUEHON lin 18 4 2 CLAIMS SUBJECTED TO BEES pus 18 da Ilia 18 0 IO ili rit 18 Table of Figures FIGURE 1 DOSSIER HEADER IN IUCLID 5 0 o oo cece ceccecceccecsnccsscceccecceccaccreccccveccescnecseceaccaccscsecssccascsecseceaccaserecsecees 5 FIGURE 2 FOUR PARTS OF THE FOURTH STEP cssccsssccscccsssccscccssceussccscceusceusscescceucseusscesscuscseusscesccesseesseescsuceeunss 6 FIGURE 3 SPECIFYING THE NAME OF THE DOSSIER seccseccsccsccssccsccecccusccnccsccscesccuscesseesscescesscescesceuseusseuseescees 7
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