REACH-IT Industry User Manual
Contents
1. The different types of pre SIEF participants and their respective role in the pre SIEF are given below e Potential registrant parties who have pre registered information in REACH IT on a given phase in substance These include o Manufacturers and Importers of phase in substances having pre registered that substance o Producers and Importers of articles having pre registered that phase in substance if intended to be released from articles o Only Representatives of non EU Manufacturers having pre registered that phase in substance The potential registrant can see the whole content of a pre SIEF navigate to pre SIEF similar substances read across entries and become SIEF formation facilitator e Registrant Registrant including early and of substances considered as registered who have submitted a complete registration dossier for a phase in substance not part of pre SIEFs Version 1 1 Page 8 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AWECHA http echa europa eu e Third Party Representative TPR the TPR substitutes the pre registrant or registrant company in the pre SIEF If a TPR is configured during pre registration the company will never be allowed to be displayed in a pre SIEF e Data Holder MI below one tonne downstream user and Data holder registered as such in the system 3 2 Becoming member of a pre SIEF The only one way to become member of a pre SIEF2. el tortestseneralname Date 21 05 2008 13 56 Recipient Party tortestGeneralname Subject Pre SIEF member was deactivated Pre SIEF 4 amino 3 methy 6 phenyl 1 2 4 triazin 3 0ne Timestamp 21 05 2006 13 56 44 Text content Member TestComapyol AG 50 to Pre SIEF The system takes you back to the main pre SIEF page after you confirmed the reactivation of a pre SIEF Under the lt Pre SIEF partnership gt pane you can check that your status has switched from I inactive Figure 16 to A active Figure 18 By reactivating all the pre SIEF functionalities become available again Version 1 1 Page 17 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http eacha europa eu Figure 18 Pre SIEF partnership pane with status active organisation Pre SIEF partnership Select Contact organisation Status Info Participant type Reference No Contact person e TestComapy01 AG 4 i Potential Registrant 05 2114082125 55 0000 TestComapyO1 AG Chemical Experts Group A Li Potential Registrant 05 21140602126 45 0000 Tom smith The holder of data dataholder4 A i Data Holder 09 2114062126 55 0000 The holder of data dataholders View member information View contact information Export the full Pre SlEF description in wL format Overview all information Modify own information Deactivate Become Facilitator Return to pre SIEF list 3 8 Managing contact details using th
3. i Potential Registrant 05 2114082125 55 0000 TestComapyl1 AG tortestiseneralname A Li Potential Registrant O5 211405 120 49 0000 tortestGeneralname The holder of data dataholder4 A Li Data Holder 09 2114082126 33 0000 The holder of data dataholder 3 10 Acting as SIEF formation facilitator As a pre SIEF facilitator you are authorised to manage the information given in the lt Information from the SIEF formation facilitator gt pane This data field contains text and is situated on the main pre SIEF page Figure 23 Figure 23 Information pane from the pre SIEF facilitator AECHA _ Reac You are connected as i on behalf of CompanyTest Preferences Logout Home gt View Pre SIEF Memberships View Pre SIEF Contact Company Pre SlEF Read across details Substance details Pre registration Pre SIEF Pre SIEF definition Online dossiers Caution notice Registration The Agency does not take any legal liability or responsibility for information shared over this page notification Joint submission Substance identification Reaction mass of 4 nitroaniline and formaldehyde Message box User account The substance is identified by the following constituent s Inventories EC number CAS number Name 202 510 1 700 01 6 4 nitroanilin 200 001 8 z0 00 0 formaldehyde Invoices Search Information from the SIEF formation facilitator This is general information from the SIEF facilitator and the following acti
4. Participant type gt in the pre SIEF The substance name identifies the corresponding pre SIEF group The button lt Change criteria gt can be used to change the search criteria if the desired pre SIEF is not found In the search results pane the link Figure 3 of the relevant entry in the lt Pre SIEF for suostance gt column can be clicked to enter the desired pre SIEF Figure 3 Search results for a given substance pre SIEF ome gt View Pre SIEF Memberships Pre SlEF memberships The results of your criteria are listed below EC number 25 CAS number Chemical name Change criteria Pre SIEF for substance Participant type 4 amino 3 methyt 6 phenyt 1 2 4 tiazin 5 one Potential Registrant S formy 2 2 5 5 tetramethyithiazolidine 4 carboxylic acid Potential Registrant 3 4 Consulting a pre SIEF The selected pre SIEF page opens and displays information across three tabs Figure 4 e lt Pre SIEF gt main information e lt Read across details gt e lt Substance details gt Version 1 1 Page 10 of 23 Release date December 2009 REACH IT Industry User Manual A ECI i A Part 05 PreSIEF i http echa europa eu Figure 4 Selection of the pre SIEF tab Home gt View Pre SlIEF Memberships gt wiew Pre slEF Pre SlEF Read accross details Substance details 3 4 1 Pre SIEF main information tab The following details are available under the lt Pre SIEF gt tab Figure 5 e Substance identification e Infor
5. as shown in Figure 13 To view the details of a given pre SIEF member select the member by using the radio button fd in the left column and click on the button lt View member information gt Figure 6 The same radio button can be used for viewing the contact information from a pre SIEF member By selecting the member via the same radio button E in the left column and clicking on the lt View contact information gt button Figure 6 pre SIEF member details are displayed Version 1 1 Page 12 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu Figure 6 Selection of pre SIEF member s or contact information Pre SIEF partnership Select Contact organisation Status Info Participant type Reference No Contact person fi Potential Registrant Potential Fegistrant The holder of data The holder of data dataholderd A i Data Holder 09 271 14082126 53 0000 dataholder View member information View contact information Testlomapyol AG F 05 2114062125 55 0000 John Smith tortestGeneralname Aa B 05 2114082128 49 0000 tprtestGeneralname 3 4 2 Read across details The lt Read across details gt tab Figure 7 provides information via two tables as shown in Figure 8 and Figure 9 Figure 7 Selection of the view pre SIEF read across details tab ome gt View Pre SlEF Memberships gt View Pre SlEF Read Across Details Pre SlEF Read accross deta
6. no management role beyond facilitating discussions and they have no legal basis to force other pre SIEF participants to co operate with them SFFs cannot demand information or fees for their services unless mutually agreed The SFF role is not formally recognised under REACH therefore pre registrants have no obligation to use a SFF to form a SIEF A SFF can review their position at any time and decide not to continue in this role see the Guidance on Data Sharing available from the ECHA website http guidance echa europa eu Data in REACH IT may only be used for the purposes of meeting legal obligations under the REACH Regulation The data may not be used for any other purposes 2 3 SIEF Formation A SIEF is formed when companies have agreed that their substance is the same Companies in the SIEF are free to choose how they communicate and organise themselves ECHA will not participate in discussions between potential registrants and will not confirm or disallow the creation of a particular SIEF ECHA recommends that companies contact their relevant trade associations for further advice on how best to proceed from pre SIEFs to SIEFs Version 1 1 Page 6 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AWECHA http echa europa eu ECHA advises all companies to decide what role they wish to take in the SIEF The chemical manufacturers association CEFIC and distributors association F
7. A http echa europa eu 3 4 3 Substance details This tab displays the substance identification details Figure 10 This is especially important for multi constituent substances reaction mass Figure 11 Figure 10 Selection of the substance details tab ome gt View Pre slEF Memberships gt View Substance Details Pre SlEF Read accross details Substance details Figure 11 Substance details for a reaction mass Home gt View Pre SlIEF Memberships gt View Substance Details FPre SIEF Read accross details Substance details Reaction mass of oxyphenonium bromide and 1 Pyrimidin 2 yl ethanone and 4 6 methyl 2 phenyl 5 prop acid The substance is identified by the following constituent s EC number CAS number Name 200 010 7 50 10 2 oxvoOhenonium bromide Sood e 27 1 1 Pyrimidin 2 y ethanone 4 f6 methy 2 pheny S prop 2 eny pyrimicin 4 ylamino benzoic acid 3 5 Updating your own pre SIEF information From the main pre SIEF page click on the button lt Modify own information gt at the bottom of the page Figure 12 Version 1 1 Page 14 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu Figure 12 Pre SIEF tab with modify own information button ome gt View Pre SIEF Memberships gt View Pre SIEF Pre SlEF Read accross details Substance details Pre SlIEF definition Caution notice The Agency does not take any legal liability or responsibil
8. Caution notice The Agency does not take any legal liability or responsibility for information shared over this page Joint submission Message box Substance identification User account 5 methyluracil Soar The substance is identified by the following constituent s Invoices EC number CAS number Name Search 200 616 1 65 71 4 5 methyluracil Information from the SIEF formation facilitator This is a pr SIEF and contact persons from each company will receive further information by email Pre SIEF partnership Select Contact organisation Status Info Participant type Reference No Contact person CompanyTest A i Potential Registrant 05 2114489247 36 0000 Jonn Doe oraa A Potential Reaistrant 05 2114489114 47 0000 John M eller Version 1 1 Page 22 of 23 Release date December 2009 14 European Chemicals Agency PO Box 400 Annankatu 18 Fl 00121 Helsinki Finland http echa europa eu
9. ECC have agreed on a proposal that includes the harmonised classification of pre registrants according to their desired level of SIEF involvement and an early identification of SFFs The proposal is available on the CEFIC website at htto cefic org T emplates shwStory asp NID 719 amp HID 714 2 4 Lead Registrants All SIEFs must select a Lead Registrant This is a mandatory role laid down by the REACH Regulation Note that the role is not automatically given to the company that facilitated the formation of the SIEF REACH does not specify rules as to how the Lead Registrant should be s elected The Lead Registrant must act with the agreement of the other assenting registrants and submit the joint submission dossier which contains information on the intrinsic properties of the substance The other Registrants then have to submit their company specific own registration dossier Lead Registrants are encouraged to submit their registrations well before the first registration deadline in 2010 The Lead Registrants are advised to inform ECHA of their nomination using the following web form https comments echa europa eu Comments LeadRegistrantNomination aspx Informing ECHA allows you to benefit from the ECHA special service e Lead Registrant Forum http lr echa europa eu provide a platform for exchange of information and free space Exclusively for Lead Registrants e Monthly webinars http Wwww echa europa eu news webinars en asp tar
10. RECHA http echa europa eu REACH IT Industry User Manual Part 05 PreSIEF REACH IT Industry User Manual Part 05 PreSIEF AWECHA http eacha europa eu Document history 1 1 December 2009 P 5 Inclusion of chapter 2 on Key principles of SIEF Removal of images related to internal REACH IT messaging Minor textual revisions Document in new layout September 2008 First version Reference ECHA 08 B 07 EN Issue date 15 December 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 1 Page 2 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AWECHA http echa europa eu Table of Contents 1 2 2 1 2 2 2 3 2 4 2 5 2 6 3 3 1 3 2 3 3 3 4 3 4 1 3 4 2 3 4 3 3 9 3 6 3 7 3 8 3 9 3 10 3 11 PFITROGUC HOM
11. e XML file You can export the complete pre SIEF contact details of each memeberr to a local XML structured file If you wish so you click on the lt XML gt link from the main pre SIEF page Figure 19 Figure 19 Exporting all pre SIEF information to XML file Pre SIEF partnership Select Contact organisation Status Info Participant type Reference No Contact person r TestComapyi AG a fi Potential Registrant 05 21 14082125 55 0000 TestComapy01 AG c Chemical Experts Group iA 1 Potential Registrant 05 2114082126 49 0000 Tom Smith C The holder of data dataholders a M Data Holder 09 21 14082126 53 0000 The holder of data dataholdera View mambar information View contact information Export the full Pre SIEF description in XML format b ee ee el Overview all information Become Facilitator _ Return to pre SiEF list After clicking on the lt XML gt link your browser opens up a dialogue box and gives you the options to open the file option lt Open with gt or save the file to disk lt Save to Disc gt option The last option stores the file on your local hard drive so you can further process it You can select the desired option and click on the lt OK gt button Version 1 1 Page 18 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu Figure 20 Save dialogue box Opening preSief_1711925 757 709 xml You have chosen to open
12. eeesessaaass 13 Figure 10 Selection of the substance details tab cccccecccccccccesccseeseeeceeeeeeeeeeeeseceeeeessaeeeeseeeeeeessuaaseeeeeeessaaaaeses 14 Figure 11 Substance details for a reaction MASS cccccseeeccccceeeeseeeecaaeeeeeeceeeeeeeeesaeueecesessaaeceeesseaeeeessaaeeeeeessagess 14 Figure 12 Pre SIEF tab with modify own information DUttON ccccceeccceceseeeeeeeeeeaeeeeeeeeseeeeeeessseeseeeeeseaeeeeeeeaas 15 Figure 13 Pre SIEF information in the editor DAGE cccccccccssseeeceeceeeeeceeeceeeeceeseuaeseeeeesseueeceeesseaeeeessaaeeeesessaaess 15 Figure 14 Pre SIEF page with deactivation DUttON cccccccccseeeceeeceeeeeeeeeeeeeseeeeeeaeeeeeeeesseaeeesesseeeeessaaeeesessaaees 16 Figure 15 Confirmation message for deactivation a Pre SIEF 2 0 ceeccccccceeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeesseaeeeeeeeeeeeeeaas 16 Figure 16 Pre SIEF partnership pane with status inactive organisation ccccccssseeeceeeeeeeseeeeeeeeeeeeeesseeeeeeeeeas 17 Figure 17 Confirmation message for reactivation a Pre SIEF cccccecccccccceeseeeeeceeeeeeeeeeseeeeeeeeesseeeeeesseeeeeeeeeaas 17 Figure 18 Pre SIEF partnership pane with status active organisation cccseceeeececeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeaes 18 Version 1 1 Page 3 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figu
13. geted to help the Lead Registrant clarifications of technical issues and webinars are available online e Special Helodesk support which focus on Lead Registrants National help desk will support others There is no individual service but response will be provided to collective concerns A time limited phone service outbound only close to the deadline will be provided 2 5 Consortia Consortia are a more formal type of co operation between registrants set up in order to provide practical help with SIEF data sharing obligations and the preparation of registrations There is however no requirement to form consortia under the REACH Regulation It is possible that several consortia could be formed among the members of one SIEF or that one consortium could cover registrants from different SIEFs for example in the case of related substances 2 6 Further information Detailed information on pre SIEFs can be found on the ECHA website http echa europa eu sief_en asp in the Guidance on Data Sharing and in this manual Guidance on Data Sharing e Sections 4 3 and 5 1 Data sharing obligations e Chapter 4 and section 4 5 Formation of a SIEF e Section 4 5 2 Role of SFF and role of Lead Registrant e Section 8 3 Lead Registrant appointment and tasks e Chapter 10 and section 10 1 Forms of cooperation to share data Version 1 1 Page 7 of 23 Release date December 2009 REACH IT Industry User Manual LS EC A Part 05 PreSIEF ht
14. ils Substance details lt Read Across To gt shows all substances that are included in the pre SIEF Figure 8 and are indicated by members as substances to read across to Figure 8 Read across to table Read Across To Substance name References Contact organisation 3 formiyl 2 2 5 5 tetramethylthiazolidine 4 carboxylic acid 2 Chemical Experts Group The holder of data 4 tert bubyltoluene 2 Chemical Experts Group TestCormapyO1 AG 6 phenyl 1 3 5 triazine 2 4 dividiamine 2 Chemical Experts Group TestComapy01 AG The lt Read Across From gt table shows all pre SIEFs related to the current substance and shows other members that want to read across from this pre SIEF Figure 9 This table shows one substance name but depending on the substance the list can be more extensive Figure 9 Read across from table Read Across From Substance name References Contact organisation J formyl 2 2 9 O tetramethyithiazolidine 4 carboxyvlic acid 1 Chemical Experts Group Both tables show in the lt References gt the number of pre SIEF members that selected the read across and the lt Contact organisation gt shows the contact person Via the buttons lt View member information gt and lt View contact information gt details about the contact can be obtained This tab is not available for Data Holders Version 1 1 Page 13 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AWECH
15. ing pre registration the organisation general contact information will be used in the pre SIEF Version 1 1 Page 11 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu Figure 5 Pre SIEF information tab with detailed information Se eae ee Pre SiEF definition Caution notice Substance identification l AMine 3 methyl 6 phenyl 1 2 4 triazin 5 one e substance is identified by the following constituent s EC number CAS number Hame 295349 3 d1394 05 2 i Amini meth phenyt 1 2 4 biazin one Information from the SIEF formation facilitator Substances to read accross S Tomy 22 5 5 tatrameinyiiearoiine 4 Carhooyviic acid 4 tert Dutiolene e penn 13 nanne 2 4 diidianeane Read from substances diom 2 3 5 Letrameiriin ATONE s Carthy iaj Pre SIEF partnership Select Contact organisation Status Inte Participant type Reference No Contact person C iprtesiGenerainamne M Potential Registrant 05 21 14087128 49 0000 tpriestGenerainame Co Testlomapyii AG F O Potential Registrant 05 2114082125 55 0000 John Smth C The h pem i ala WN iasrorlseabel A O Data Moker 09 27 14082126 53 0000 The holder of data dataholderd Viw mar imatan View contactinfonnason Export the full Pre SIEF description in XML format When hovering over the information button i you will be provided with information filled in by the member in the Information text field
16. ity for information shared over this page Substance identification formaldehyde The substance is identified by the following constituent s EC number CAS number Name U0 O001 6 S0 O0 0 formaldehyde Pre SIEF partnership Select Contact organisation Status Info Participant type Reference No Contact person P Co 4 Li Potential Registrant O5 21174082125 55 0000 col HAGG ECHA SAT 4 il Potential Registrant 05 2114082127 51 0000 HAGG ECHA SAT View member information View contact information Export the Tull Pre SlEF description in ML format Overview all information Modify own information Deactivate Become Facilitator Returm to pre SlEF list By clicking on the lt Modify own information gt button the editor page opens Figure 13 The header displays the last modification details like lt Organisation name gt lt Last change gt and the lt Information text gt field This field offers you the possibility to manage your information inside the pre SIEF and can be modified as needed By clicking on the button lt Save gt Figure 13 the new information you entered is saved and becomes available for others in the pre SIEF Figure 13 Pre SIEF information in the editor page ome gt View Pre SiIEF Memberships gt View Pre SiIEF Member Info Pre SiEF j Read accross details Substance details Information from member Organisation name Author Last change aso reviewed wiih fox and classinicaton into
17. mation from the SIEF formation facilitator e Read across and read from information you can view the information of the similar substances linked to the pre SIEF by clicking on the lt Substance to read across gt or lt Read from substances gt links The related pre SIEF does not offer a return button to the origin pre SIEF To go back you will have to click on the original pre SIEF name in the current pre SIEF The read across and read from information is available for all active members except data holders The same read across and read from information is also available under the lt Read across details gt tab and further discussed in chapter 3 4 2 e lt Pre SIEF partnership gt table displays all pre SIEF members and various details required for the pre SIEF such as the organisation name status A active I Inactive and F Facilitator participant type reference number and contact person based on the contacts defined in the Pre registration process Part 2 Sign up and account management and Part 4 Late pre registration gives you more details about the creation and use of contact details available from the ECHA website ifa TPR has been defined during pre registration the TPR organisation name will be used in the pre SIEF If no TPR has been defined during pre registration the contact person defined during pre registration will be used in the pre SIEF If no contact person has been defined dur
18. mrena E E A E EE A A E E E E A T 5 Key PINCIDIOS serna e EE a EEEE EAEE E 6 Pre SIET a A seco ven oaaeancusuineeneuseseee eau 6 SIEF F rmation Facilitator seisa E nieaeadanieseacuaneenes 6 SIEF FOM AUOT aE E E EAE EE E i E A E EEEE 6 Lead RegS TaN S aE A E EAA EA RAE 7 CONSONA sraa a ete oct EE a E pa i 7 Further TEMOP Ma LON seisena Na 7 Step by step instructions in REACH IT cccccssssseeesceeseeeecenseeeecoenseeesoaseeeseoeseeeseoeseeeseoensees 8 PSE ACTOS ei a a E Ea E 8 Becoming Member OF a pre SIEF ssrin aaa AaS 9 peleciNng a pre SIE Foc E E eee none ee eee ee Neen 9 COnSUNNO 2 Pre SIEF iui EEE SEEE E O 10 PreSIEF main information aD siseringi aaien rodini 11 Read across d tail S sissa a a 13 SUbSlange delallS sisri E a E E E AA i 14 Updating your own pre SIEF information cccccccseesseeeseesseeeseceesseeesseeseeeeeoenseeeeseossseeeseoesneeessooness 14 Deactivating your pre SIEF membership ssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnmnnn 16 Reactivating your pre SIEF membership ss sssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnmnnn nnmnnn 17 Managing contact details using the XML fil ccesesseeeeeseeeeeeseeeeeesseeeeenseeseenseeeeeesseeseeaseseenseessoaeas 18 Becoming SIEF Formation Facilitator secicscsscscstecesiesnctenscastueeansieniwcsnsasamecnnstasnecus das sianccnasesnsbbsecsawedsencds 19 Acting AS SIEF formation facilitator vas
19. on about roles is given in Part 1 Getting Started with REACH IT The deactivation of a pre SIEF does not generate any cost After deactivating a pre SIEF a confirmation message will appear To confirm the deactivation click lt Yes gt Figure 15 If you wish not to deactivate the pre SIEF click on lt No gt Figure 15 Confirmation message for deactivation a pre SIEF ome gt View Pre SIEF Memberships gt Confirm Pre SIEF Action Pre SlEF Read accross details Substance details Do you really want to deactivate your membership for this pre SIEF _Yes _No The system takes you back to the main pre SIEF page after you confirmed the deactivation of a pre SIEF Under the lt Pre SIEF partnership gt pane you can check that your status has switched from A active Figure 14 to I inactive Figure 16 Version 1 1 Page 16 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu Figure 16 Pre SIEF partnership pane with status inactive organisation Pre SIEF partnership Contact organisation Status Participant type Reference No Contact person Testlomapyo1 AG 1 Potential Registrant 05 2114082125 55 0000 Testcomapyii AG Chemical Experts Group A Potential Registrant 05 2114082128 49 0000 Tom Smith The holder of data dataholder4 A Data Holder O9 2714062126 55 0000 The holder of data dataholder4 Activate Return to pre SlEF list Inacti
20. ons will be taken shortly Contacting all pre SIEF members Setting up meeting Drafting contracts Agree on contracts Organise SIEF To add text or change it you can click on the lt Modify gt button at the bottom of the main pre SIEF page An editor page will open and the header displays the last modification details like lt Substance name gt lt Organisation name gt lt Last change gt and the lt Message text gt that offers you the possibility to manage and share your information inside the pre SIEF You can modify the information text as needed and to save the text click on the lt Save gt button To keep the previous text and not save the changes click on the lt Cancel gt button A All changes that happen in the pre SIEF are recorded under the heading Pre SIEF definition Figure 5 Figure 12 Figure 13 Figure 14 Figure 23 Figure 28 Only the last change Is displayed Version 1 1 Page 20 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF http echa europa eu Figure 24 Editor for the facilitator s message Contact GECHA __ Reac a You are connected as on behalf of CompanyTest Preferences Logout Home gt View Pre SIEF Memberships gt View Pre SIEF Facilitator Info Company Pre SIEF WETEA EEE ciety EE A ce be Pre registration Pre SIEF Edit Facilitator Message Substance name Reaction mass of 4 nitroaniline and formaldehyde Online dos
21. ow they can submit and view data within REACH IT As REACH IT evolves additional and updated parts of this IUM will be released and made available via the ECHA website Prior to using this Part 5 Pre SIEF it is strongly recommended that the user reads Part 1 Getting started with REACH IT where the following topics are discussed in more detail e structure of this IUM e conventions used in terms of icons text buttons links e background information on REACH IT and its link to the IUCLID 5 website and application How to get additional support is also described in Part 1 Each subsequent parts of this IUM will therefore cover the step by step instructions to perform the tasks required for submission of data under REACH Version 1 1 Page 5 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AWECHA http echa europa eu 2 Key principles The goal of a Substance Information Exchange Forum SIEF is to help potential registrants of the same substance to share information about the substance and to avoid duplication of testing The main activity for companies that pre registered substances in 2008 is to form SIEFs and make them operational as early as possible This is critical for data sharing and the subsequent preparation of joint registration dossiers 2 1 Pre SIEF The concept of the pre SIEF was not foreseen in the REACH Regulation but was introduced with support from indus
22. preSief 1211925752709 xml which is a XML Document from Ake 88 218 118 68 7701 What should Firefox do with this File Open with XML Editor default y Do this automatically For Files like this From now on 3 9 Becoming SIEF Formation Facilitator From the main pre SIEF page Figure 12 or Figure 14 click on the button lt Become facilitator gt at the bottom of the page After clicking on the button lt Become facilitator gt a confirmation message will be shown By clicking on the lt Yes gt button you become facilitator and by clicking on the lt No gt button you decline Figure 21 Confirmation message for pre SIEF facilitator Home gt View Pre SlEF Memberships gt confirm Pre slEF Action Pre SlEF Read accross details Substance details Lio wou realy want to be the facilitator of this pre SlEF The system takes you back to the main pre SIEF page after you confirmed to become facilitator of a pre SIEF Under the lt Pre SIEF partnership gt pane you can check that your status has switched from A active Figure 18 or Figure 19 to F facilitator Figure 22 Version 1 1 Page 19 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu Figure 22 Pre SIEF Pre SIEF partnership partnership pane with status facilitator Select Contact organisation Status Info Participant type Reference No Contact person Testlomapyol AG F
23. re 25 Figure 26 Figure 27 Figure 28 Version 1 1 AWECHA http echa europa eu Exporting all pre SIEF information to XML file ce ccccceeecceceeeseeeeeseeeeeeeeeseaeeeeeeeesseeseeeeseaaeeeessaeaeeees TO INV SO IIS DO ae E A E E E daceinsat toads E R Confirmation message for pre SIEF facilitator cc ccceccccccccecceeseeseeeeeeeeeeeeeeeeeceeeeeeseeeaeeeeeeesssaaaaeeeeees Pre SIEF partnership pane with status facilitator cccccccccccccsseeeeeeceeeseeeeeeaeeeeceeessaeeeeesseaeeeeeesaaeees Information pane from the pre SIEF facilitator cccccccseeeccecceesseceeseaeeeeceeeeaeeeeeeesseaeeeeessaeeeeeeesaaeeees Editor for the facilitators message ccccccssscecceeseecceaseeccceuscecceuseeecsuseeecsaseecseaseeessaeecsneeesseneeesseaes Slp PE S IEF TaCilatOr DUON sorosiane aa e T aeaa Confirmation message to stop as pre SIEF facilitatOr cccccsseeeeeeeeeeeeeeeeeseeeeeeeeesaaeeseeeeeeseeseaeaeeees Pre SIEF partnership pane with status back to active MEMDET cccccccseeeeceeeeaeeeeeeeesaeeeeesaaeeeees Disabled modify button for former facilitator ce cccccccsseeeceeecaeeeeceeecaeeeeeeeesaeeseeeeesseaeeeeeesaaseeeesaaeeeeees Page 4 of 23 Release date December 2009 REACH IT Industry User Manual LN EC I A Part 05 PreSIEF http echa europa eu 1 Introduction The Industry User Manual IUM is the reference manual that describes to industry users h
24. rnmnatar Information text Save Cantel This editor is restricted to plain text only Allactive members in the pre SIEF can read the information entered in this field Version 1 1 Page 15 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http echa europa eu 3 6 Deactivating your pre SIEF membership lf you want to deactivate your pre SIEF you click on the button lt Deactivate gt at the bottom of the main pre SIEF page Figure 14 Figure 14 Pre SIEF page with deactivation button Home gt View Pre SIEF Memberships gt View Pre SiEF Pre SIEF Read accross details substance details Pre SliEF definition Caution notice Substance identification formaldehyde The substance is identified by the following constituent s EC number CAS number Name 00 001 8 50 00 0 formaldenyde Pre SIEF partnership Select Contact organisation Status Info Participant type Reference No Contact person cot A i Potentiali Registrant 05 2114062125 55 0000 coi H GG ECHA SAT A 0S 2114062127 51 0000 H4GG ECHA SAT View memberinformation View contactinformation Export the full Pre SiEF description in XML format Genie all information Modify own information i Deactivate Become Facilitator Returnto pre SIEF list A user can deactivate his pre SIEF membership at any time however the user role normal should be assigned to his profile More informati
25. scscs sce cceseicveviwestvinGosssteiseweeecnsiweeviersnesecstesuweuecsieveccsuasienecdethacetsaueds 20 Stopping SIEF Formation Facilitator role ccccccecessssssseeeeeeeeeeeeessseeeeseeeeeesseeeeeeeeeeoesssseeeeeseeoonenes 21 Table of Figures Figure 1 Selection of view pre SIEF from REACH IT Menu cccccccccccecceaeeeeeeeeeeeeesaeeseeeeeeeessueeeeuseeeeeessaaaaeees 9 Figure 2 Pre SIEF search page sssrinin a Ra EE ae a Aaea 10 Figure 3 Search results for a given substance pre SIEF ccecccccccssseeceeeceeeeeeeeeeaeeeeeeeesaeeseeeeessaeeeeessaaeeeesenaess 10 Figure 4 Selection of the pre SIEF tab cc ccccsscescecessscesseeeeeecenscccassenseeeeseccesseneeeeeecssesseeeeeescseccseeseeeeesssceesens 11 Figure 5 Pre SIEF information tab with detailed information cccccccceccceccseeeeeeeceeeseeeeeeeseeeeeeeseeaeeeeesessaeeeeeeeaas 12 Figure 6 Selection of pre SIEF member s or Contact information ccccccceeeeeeeeeeeeeeeeeeeesaeeeeeeeeseeeeeeeseseaeeeeeeeeas 13 Figure 7 Selection of the view pre SIEF read across details tab ccccccccccsseeseeeeeeeeeeaaeeeeeeeeeeeeeaeaaseeeeeeseeeaaas 13 Figure 8 Read across tO table cccccccccsssseeecccaeseececccaeeseeecceaeaeeeeeseauseceeessauseceessaaseeeessuaaeceeesseageeeeessaaseeesessaages 13 Figure 9 Read across from table ccccccssssccccccsessececcceeeecccceeeeeeeessauaeeeeeseeuaeeeesesaueceessuaaeeeeessuaeeeeessaag
26. siers Organisation name CompanyTest Registration Last change 2006 13 96 notification This is general information from the SIEF facilitator and the following actions will be taken shortly Contacting all pre SIEF members Message box Setting up meeting Drafting contracts Agree on contracts Inventories Organise SIEF Message text Pay fees Joint submission User account Invoices Search Save Cancel 3 11 Stopping SIEF Formation Facilitator role To stop acting as a SIEF facilitator you can click on the lt Stop Facilitator gt button from the main pre SIEF page This button is situated at the bottom of the page and all buttons are given in Figure 25 Figure 25 Stop pre SIEF facilitator button Qyerview all information Modify own information Deactivate Stop Facilitator Return to pre SIEF list After clicking on the lt Stop Facilitator gt button a confirmation message will appear as given in Figure 26 If you click on the button lt Yes gt you are no longer pre SIEF facilitator and if you click on the button lt No gt the process will be terminated and you will stay pre SIEF facilitator Figure 26 Confirmation message to stop as pre SIEF facilitator ome gt View Pre SIEF Memberships gt Confirm Pre slEF Action Pre SlEF Read accross details Substance details Dio vou really want to stop being the facilitator of this pre SlEF After you selected lt Yes gt to stop being the facilitator the
27. system takes you back to the main pre SIEF page Under the lt Pre SIEF partnership gt pane you can check that your status has switched back to A for active member instead of F for facilitator Version 1 1 Page 21 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http eacha europa eu Figure 27 Pre SIEF Pre SIEF partnership partnership pane with status back to active member Select Contact organisation Status Info Participant type Reference No Contact person e TestComapy01 AG 4 i Potential Registrant 05 2114082125 55 0000 TestComapy01 AG tortestGeneralname 4 i Potential Registrant 05 2114082128 49 0000 tortestGeneralname 7 Data Holder 09 2114082126 53 0000 The holder of data dataholderd A In case a facilitator deactivates his membership in the pre SIEF his facilitator role will be automatically stopped At this stage you do no longer have the possibility to update the information facilitators section AS you can see from Figure 28 the lt Modify gt button is disabled not visible anymore Figure 23 shows the page where the lt Modify gt button is not disabled Figure 28 Disabled modify button for former facilitator ECHA Home gt View Pre SIEF Memberships gt View Pre SIEF Company Pre SIEF Read across details Substance details Pre registration Pre SIEF Pre SIEF definition Online dossiers Registration notification
28. tp echa europa eu This manual e Figure 5 View Pre SIEF Information tab shows how the contact information of participants in a pre SIEF can be exported as an XML file by clicking on the lt XML gt link All changes that happen in the pre SIEF are recorded under the heading Pre SIEF definition Figure 5 Figure 12 Figure 13 Figure 14 Figure 23 Figure 28 Only the last change Is displayed e Figure 24 Stop pre SIEF Formation Facilitator role demonstrates how an SFF can step down from his her role by clicking on the lt Stop Facilitator gt button Specific provisions can be found in the REACH Regulation e Articles 25 1 2 and 29 3 Data sharing obligations e Article 29 SIEF formation e Article 11 Joint Submission 3 Step by step instructions in REACH IT This part describes basic concepts of the pre SIEF such as members and roles and the specific tasks performed within a pre SIEF for example consulting and navigating through a pre SIEF updating information managing read across substances from pre registration etc A pre SIEF is the result of the pre registration of substances in REACH IT It is the first step to form up a SIEF by grouping potential registrants and early registrants based on the information on substance identity that they have submitted The potential registrants of subsequent pre registrations of the same substance will be associated to the same pre SIEF 3 1 Pre SIEF actors
29. try in order to bring pre registrants together to facilitate SIEF formation REACH IT automatically placed companies who pre registered substances with either the same name or chemical identifiers in the same pre SIEF Companies in each pre SIEF must decide based on detailed consideration of the substance identity whether the substance in question can be regarded as the same e Pre registrants of the same substance will form one SIEF e Pre registrants who discover they have different substances should seek to form or join other SIEFs The pre SIEF page in REACH IT has a Similar Substance tab which can help companies identify and join the most appropriate pre SIEF The contact information of all other pre SIEF members is available in REACH IT This information can be downloaded from REACH IT into an XML file see chapter 3 8 However in the case companies used the Similar Substance tab they cannot see the corresponding pre SIEF members who are the only ones who can see new members 2 2 SIEF Formation Facilitator The SIEF Formation Facilitator SFF role was created to initiate and conduct discussions after pre registration and to facilitate the exchange of information and data which is required in order to form a SIEF Any pre registrant could volunteer via REACH IT to be the SFF when they are willing to take the initiative to contact the other participants within their pre SIEF with a view to forming the SIEF SFFs have
30. ve members can see all information on the main tab of the pre SIEF including the information from the SIEF formation facilitator and the substance details tab Inactive members have no access to the pre SIEF information provided by the members the member contact details and the read across details A A company assigned to a pre SIEF cannot be deleted and still has datasharing obligations The deactivate feature informs the other members that a company is no longer interested in registering this substance All features except the button lt Activate gt get disabled Figure 16 3 7 Reactivating your pre SIEF membership You can reactivate your pre SIEF membership by clicking on the lt Activate gt button as shown in Figure 16 A user can reactivate his pre SIEF membership at any time however the user role normal should be assigned to his profile More information about roles is given in Part 1 Getting Started with REACH IT The reactivation of a pre SIEF does not generate any cost After reactivating your pre SIEF a confirmation message will appear To confirm the reactivation click on the button lt Yes gt Figure 17 If you wish not to reactivate the pre SIEF click on the button lt No gt Figure 17 Confirmation message for reactivation a pre SIEF Message box folder select All select None Select Details Read Subject Creation Date Expire Date Recipient i Hide Yes Pre SIEF member was deactivated 2 pogua cay
31. was by pre registering a substance The pre SIEF members can be organisations or single registered users If an organisation is a pre SIEF member each registered user of this organisation can view all the data in the pre SIEF Each pre SIEF member is only allowed to use manage his own properties A signed up REACH IT party organisation or data holder can only participate once as member in the pre SIEF 3 3 Selecting a pre SIEF From the pre SIEF menu select View pre SIEF memberships as indicated in Figure 1 Figure 1 Selection of view pre SIEF from REACH IT menu Contact ie BECHA each i You are connected as co M on behalf of col Preferens Horne Company You have 10 unread message s in your message box Pre registration Message Box User account management Search A search page will open that shows several entry fields Figure 2 To find the desired pre SIEF you can enter one of the required substance criteria followed by a click on the button lt Search gt Version 1 1 Page 9 of 23 Release date December 2009 REACH IT Industry User Manual Part 05 PreSIEF AECHA http eacha europa eu Figure 2 Pre SIEF search page me gt View Pre SEF Memiershigps EL number CAS num iner Chemical name The system returns results Figure 3 based on the entered search criteria Figure 2 The results are ordered according to the parameters lt Pre SIEF for substance gt and the lt
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