CEFIC: Joint Submission Process in REACH
Contents
1. 7 Home ossier retro Registration potfiestion submassion Here you can ine submit an shen contain Dosser type Registration Tonge band On site isolated intermediates tonnage i bang Trans pormens On air healated intenmectes S tonnage barg Fee Waiing r Pnaie in Phase Non phasein Purchase order i athnosiedge Mha the substance for wach iwant to submit T a cossa is not subject to any rarincbons in astry lageiatons Or any Gempoons under REACH REACHT 120 Testy ere OO ST After clicking the Proceed button user can now browse his folders and select the file containing the dossier file i5z made in IUCLID 5 And finally he presses Submit dossier button to send the dossier GECHA me Leach io You am comepcted at an behalf ef Ol REFINING BVEA Home gt Suini Djia nig gt Subm Eternal Dossier Regular registration dossier submission Riga pick here uiing the Erowse button the file which contains your dossier your fie should hae Deen oreabed using MELD 3 and have thet extention 192 Fie name Enter that best SHAT ki Browne yw Try angther Access code for large files For fie submission of a Ale langar than 20 WB please egeeet 9 large fie ett coje before submisison you have an acness code for a large dossier please erter E here Lange fie Kets Cade Sebma dossier REACHT 1 2 0 Testing Verson ORTR200S 1 557 Ariane2. the disclosure of information would be likely to lead to substantial commercial detriment or disagreement with the lead registrant on the selection of the information submitted in the Joint Submission A Member of a joint submission may also decide to opt in for one or more confidentialities claimed by the lead in the Joint registration dossier The opt in has to be indicated in REACH IT and the confidentiality claims should be indicated in his member dossier 1 1 Lead and member registrants The company taking the role of the lead registrant has the responsibility to create the joint submission in REACH IT to submit the lead dossier and to manage the joint submission The other companies called member registrants who want to be part of a joint submission first have to confirm their membership to the joint submission in REACH IT before submitting their individual dossiers In a joint submission the lead registrant has to submit and get his dossier accepted first before other SIEF members can submit their part of the dossier see detail below 1 2 The security token To ensure the unambiguous relation among the lead registrant and the member s a security token is created for each joint submission and serves to the confirmation of membership by the members of a joint submission see Lead Registrant process When a potential member wants to confirm his membership he has to enter the name of the joint submission and the security token in
3. BONTEMPS abs cefic be 11 April 2009 REACH IT News Joint Submission Process d The user who submitted the dossier will receive a submission number in the internal message box of REACH IT ys Submission_Report_J File name Stream A Leadisz Z121787 99 pdf e The invoice is then created by the Agency Invoices are still sent to all users of the party The Invoice Manager role which is a contact name role is only used by ECHA for personal communication Select Details Read Subject Creation Date Expire Date Recipient 18 09 2008 Party OlL REFINING vHide Yes invoice has been opened OV 121802 10 SVAA SVBA For Party User Contact person and other technical definitions within REACH IT please refer to the Industry User Manual Ariane BONTEMPS abs cefic be 12 April 2009 REACH IT News Joint Submission Process Users can download the invoice via the menu Registration Notification gt view Registration Notification In this menu the user can see the Submission report and check the process followed by the dossier as well as the accounting details baih E aa ai izcaming Ammatatiens Dosser Dossier type Subritean Submission humoer Suterission Date isthe sutmission an wiae ist ajoit submbsiar TMu of te dossier Substance Pefersnce hamber Toan Name ot Reuetuammsio REACHAT 12 0 Testing Wersion j 080008 15 57 CETHA Reach ME bi Yo are coreected rE an bekal ef
4. REACH IT If the information is correct REACH IT will display the joint submission information and will ask additional confirmation from the new joint submission member Each security token has a limited validity of 30 days from its creation If it expires only the lead registrant can create a new security token using REACH IT for the joint submission upon request of a potential member The lead registrant has to communicate with the potential new member s about the new security token outside REACH IT Ariane BONTEMPS abs cefic be 2 April 2009 cefic REACH IT News Joint Submission Process 2 STEP BY STEP explanation 2 1 STEP 1 Joint Submission object in REACH IT Lead Registrant process Following the ECHA key principles on SIEF all SIEFs must select a Lead Registrant REACH does not specify rules as to how the Lead Registrant should be selected The Lead Registrant must act with the agreement of the other assenting registrants The Lead Registrants preparing for the first registration deadline are advised to inform ECHA of their nomination These nominations should be sent by e mail to lead registrant echa europa eu a First step the LR has to create a Joint Submission object via the Menu Joint Submission gt create Joint Submission Important note This step has to be done prior to dossier submission q gt al BECHA Reach l i a You are cormected ss on bedal of OF REFINING BVEA Home gt Create Joint Subm
5. CAL REFINING BVEA Homs gt Gunmited Dossiers gt Dossier Accounting eS me Accea e Agency account information IAM Fii tiunt number Payment Piease ttk on Dre link below to Open your irate imie J Lit REACH IT 1 2 0 Tesiing Wermion ORT 2008 14 57 And all users of the party all users of the same LE which submitted the dossier will receive a message when one of them has made the download of the invoice for the first time M pShow No invoice Gownloaded for the first ime 10 J en 19 09 2008 Party OlL REFINING vHide for the fi r r ves invoice downloaded for the first ime 0303 BVBA You have downloaded for the first tine the revoke corresponding to the following reference Reference number 10000117 Download tine 19 09 2008 09 09 tananana Paes OCENA Ariane BONTEMPS abs cefic be 13 April 2009 PAicefi ic REACH IT News Joint Submission Process f After payment of the invoice and the success of the dossier TCC technical completeness check the registration number will be sent to the registrant through the internal REACH IT mailbox with the same date as the submission date Important note As a member of a JS the user MUST wait for the completion of the registration by the Lead Registrant prior to be able to submit his own dossier the optimal time is 21 days up to 2 months before the next registration deadline If submitted before the completion of the registration by the Lead Registrant his
6. bership gt Security Toxen Teken Name WELAMNE ARIANE TOKEN Bak home It s important to notice that the list of Joint Submission members is filled up in REACH IT It is filled up by the JS members when they confirm their membership to the JS Important note The Lead Registrant is the only one who can access to the list of all names of the JS members The Lead Registrant can see all official LEs even the ones previously hidden behind a TPR The JS members can NOT see the list of members The members can see the Lead Registrant by using the SEARCH module Ariane BONTEMPS abs cefic be 8 April 2009 EAcefic REACH IT News Joint Submission Process STEP 2 Registration of a dossier The submission of a dossier to register a substance has to be made via the same REACH IT process and module for any registrant a Lead Registrant a member of a joint submission a single registrant Note As explained above the token is only mandatory for the JS member to confirm his membership to the JS However for the specific task of submitting a dossier itself neither the LR nor the JS members will need the token Important The Lead Registrant has to submit the JS part and his own part of the dossier FIRST Once the LR dossier registration is complete Invoice is paid TCC is successful and then the LR has received the registration number other members of the JS can submit their specific dossier for the same s
7. cefic REACH IT News Joint Submission Process JOINT SUBMISSION PROCESS in REACH IT To be able to submit a dossier as Lead Registrant or member of a joint submission JS the lead registrant has first to create a JS object in REACH IT Afterwards the member has to confirm his membership within this JS object prior to make dossier submission For an extensive explanation of each step here after described please refer to the ECHA Industry User Manuals 1 Link to the Regulation Manufacturers importers or only representatives are individually obliged to submit a registration for each substance they are responsible for In cases where a substance is manufactured or imported by more than one company potential registrants are required to submit certain information together This is called the joint submission JS of data Joint submission may apply to a substance to be registered REACH article 11 as well as on site or transported isolated intermediates REACH article 19 Registrants are required to jointly submit information on the hazardous properties of the substance its classification and labeling and testing proposal s if any It is also possible to jointly submit the chemical safety report and guidance on safe use REACH Article 11 if an agreement among the members is reached The information that needs to be submitted jointly is provided only by the Lead registrant on behalf of the others Each member of the jo
8. dossier will be rejected The registration number issued by the system is the same for all JS members except the 4 last digits This first part of the registration number all digits but the last 4 as a reference can be used in order to communicate between LR and members to proof the completion of the LR registration Ariane BONTEMPS abs cefic be 14 April 2009 PAicefi ic REACH IT News Joint Submission Process ANNEX Reference number Extract of GUIDANCE on REGISTRATION ECHA http reach jrc it public 2 getdoc php file registration en Once the registration is complete the REACH IT system at the Agency automatically assigns a registration number to the registrant for the substance concerned and a registration date that will be the same as the submission date The Agency without delay communicates the registration number and date to the concerned registrant From that moment on the registrant shall use the registration number for the subsequent correspondence regarding registration procedures Articles 20 3 Moreover the registration number will have to be incorporated in the SDSs for any supply after reception of that registration number For a given substance distinct dossier types may apply For example a substance initially notified as a PPORD may require the submission of a registration dossier at the end of the exemption period if the PPORD leads to a commercial use of the substance Also a substance for wh
9. e to have two identical JS names in REACH IT When the dossier is submitted in REACH IT the UUID Universal Unique Identifier of the Legal Entity and the substance ID are both checked against the information contained in REACH IT Ariane BONTEMPS abs cefic be 5 April 2009 REACH IT News Joint Submission Process c On behalf of Joint Submission where needed and after agreement of JS members the LR will indicate whether a Guidance on Safe use CSR and a review by assessor will be provided Homa gt Creste Joint Submission gt information senne es IN Julh Joint submission information Name ELA Description Provided by the lead F Guidance on safe use Ti i agara Chemical Safety Report a T Rewew by an assessor eal capous Cancel Heisa REACHIT 1 2 0 Tairg Verson OR OM2008 15 57 And add a new contact name or choose one among contact names already created during the sign up to become responsible for Joint Submission follow up for the LR Comtact RECHA Reach S Yeu am eoreacied ir on behat ef Cal REFI bioma gt Create Joint Submission gt Cont tts Subiiance Joni Sobminakce Contact Vaiaso t yu ompa re av 3i q mi Foii Ou can ij Select First Hame Last Mame Phone Fax Erabil Contact Types iai s i Joint Submission k ECHA Mas ose reach podrefining bie General a a Prout Nets REACHAT 1 2 0 Testing wersion DRO92008 15 57 A
10. ich initially a notification of the classification and labeling was submitted may later lead to the submission of a registration dossier In those cases the substance will hold an identification number of each kind a PPORD number and a registration number in the first above example and a C amp L number and a registration number in the second above example All those numbers are called Reference numbers have the following structure lt TYPE gt lt BASE NUMBER gt lt CHECKSUM gt lt INDEX NUMBER3 gt where lt TYPE gt is a 2 digit number giving the type of number 01 Registration 02 C amp L notification 03 Substance in article 04 PPORD 05 Pre registration 06 Inquiries 07 On site isolated intermediates 08 Transported on site isolated intermediates 09 Data Holder notifications 10 Downstream User notifications 11 Applications for Authorisation 12 Substance Evaluations 13 Annex XV C amp L Harmonization 14 Annex XV Authorisation 15 Annex XV Restriction 16 Internal usage 17 Late Pre registration reserved to pre registrations According to REACH Regulation Article 28 6 lt BASE NUMBER is a 10 digit number lt CHECKSUMs is a 2 digit number lt INDEX NUMBER3 is a 4 digit number giving the index of a member in a joint submission Type numbers 07 and 08 have been used for registration of intermediates but they are not used anymore Instead the type number 01 is now used for all registration t
11. int submission shall submit separately and individually the following administrative information the legal entity identity the substance identity Information on the manufacture and on the use s of the substance including tonnage as well as some exposure information for substances registered in quantities of 1 to 10 tonnes In terms of chronology the lead registrant will have to submit first his registration dossier Only when the joint submission dossier reaches the end of the process the other registrants are allowed to submit their dossier Therefore when the lead registrant will receive the registration number of the joint submission registration he is asked to inform all members REACH IT cannot be used for this that his registration has been completed 1 Part 6 Dossier submission http echa europa eu doc reachit industry user_manual reachit_ dossier submission en pdf Part 7 Joint Submission http echa europa eu doc reachit industry _user_manual reachit_joint submission en pdf Source REACH IT Industry User Manual ECHA http echa europa eu doc reachit industry user _manual reachit joint submission en pdf Ariane BONTEMPS abs cefic be 1 April 2009 PArcefi ic REACH IT News Joint Submission Process A manufacturer or importer may decide to opt out from some or all parts of the Joint registration dossier opt out of joint submission Possible reasons for opting out could be disproportional costs
12. ission gt Search Substance SHOCH ING the substance idenaty C Pre registration number Reference number p gt i number Registraton numer In the context of joint submission the Lead Registrant can select the substance of the joint submission by providing a Reference number type and a Reference number in the corresponding field 3 See http echa europa eu doc reachit sief_key_principles pd See ANNEX for information Ariane BONTEMPS abs cefic be 3 April 2009 cefic REACH IT News Joint Submission Process Pre registration number one of the company s pre registered substances Inquiry number one of the company s inquired substances Registration number one of the company s already registered substances including the Notified substances If none of the above Reference numbers is applicable the user can identify the substance via the same method as the one used for the pre registration Reach pe en baf ef OL REFNN E Hoots gt Create Joint Subm siin gt Substance Sakalas Te l ie substance iderithicaion ettard tor yourjoint submission ecry another sonitiient Repes undi al constiuerts ecconun 10 hve THE RRS DE Arte PETAn ES ENG PUB TCO REET mom m manng Mim SOT Df Galart EG umber GAG Humber Hime There are na rari uani dading for yar eubsiarene E pia REAH IT 12 0 Testing eran 0 1453 First the LR clicks on add another constit
13. ite Citric Acid 77 92 9 f ChemCompany A TEST 09 Brusse fares section tree i Joint submission REACH Registration 1 10 tonnes standar v Sat gt Vv Carolite Jan 09 R IIx 0 Related Information B 1Ge jo AI Identificatio E 1 2 Composition D 1 3 Identifiers General information O 1 4 Analytical information Joint submission name Carolite Jan 09 1 5 Joint submission O 1 6 Sponsors Penares gt 0 1 7 Suppliers Regulatory programme EU REACH A M 1 8 Recipients He ification and Lead dtture Use and exposure 4 4 Physical and chemical AEREO E Chelny CompanyiArubrusscls belgian SEA 5 Environmental fate and pathways 6 Ecotoxicological Information Members 7 Toxicological information 48 TPR Chem Company A Brussels Belgium 8 Analytical methods H e 11 Guidance on safe use 12 Literature search 13 Assessment Reports fig Add il Delete gt Goto link target Ariane BONTEMPS abs cefic be 10 April 2009 REACH IT News Joint Submission Process Technical note REACH IT will check the LE identity together with the substance identity against what it has been put in the Joint Submission list see above for details to assess whether the registrant member or Lead registrant is known as a member of a JS b The user has to provide all necessary details to initiate the submission of a registration notification dossier BECHA n i aye I
14. riane BONTEMPS abs cefic be 6 April 2009 REACH IT News Joint Submission Process d And finally the Lead Registrant validates the Joint Submission object The Lead Registrant will get the TOKEN a string of characters The token has a limited validity of 30 days BECHA Home gt Create Joint Submisseon gt Success a E The message for a confirmation of creation of a new Joint Submission goes to all the users of the Lead Registrant LE so called the party in the message system of REACH IT RECHA Ngack i oy are connected BE on bakal cf Of REP IMRNG OVDA Home gt Messsges Treis internal message box is dedicated to the reception of messages sent iy REACH IT ECHA to fhe user You wii hat receive JES TOR WEALH CONCEMTUNG YoUr ACDOS ON MES SAE IN YO PPVEDE OF peores AOA EMAN AC COLE HEET YOUN WaT nis when a message ia PEC RIC in tis internal message siter you tan define his a3 an aptior ii your Mier der Role toker Deleted messages Preious 10 cf 2 E Het 10 Select All Select None Select Detail Read fubject Creation Date Expire Date Recipient E ashe Tae 2008 Party 0L REFINING Fo Han vea ini cache oreabesi iia EVER lard cube sune brasted Miri subeyssion nama MELAMINE ARIANE 1 bead rejiet OIL REFINING GVEA Timsurrigehiney Subant identity melamine Contact person THe Name test ECHA Organ ON Department The token and the JS name have to be provided to the member
15. s of the Joint Submission that fulfilled the agreement condition to receive the token Important The token and the JS name are the only ways for a member to confirm his membership within a specific joint submission The LR has to provide a valid token the LR can always re create a token for this purpose if the previous token has expired as many as it s needed Ariane BONTEMPS abs cefic be 7 April 2009 cefic REACH IT News Joint Submission Process Member of a JS process If the information was not yet available a member of a JS has to contact the LR and ask for the JS name and the token Using the token and the JS name the member has to confirm his membership in the Joint Submission The member will receive a confirmation of his successful submission of membership in his own REACH IT message box This confirmation is also sent to the Lead Registrant Important note Only a final registrant LE can be a member of a JS in REACH IT If a member is hidden behind a TPR The TPR will receive the token and the JS name from the lead Registrant The TPR has to bring back both data to its client The member must confirm himself his membership to the JS The member will be disclosed for the Lead Registrant ONLY The member must submit the substance dossier himself see below for details on dossier submission Contact GECHA k N Me You are coraacied at an beka of Ol L REFINNG ev Homi gt Confirm Mem
16. ubstance within the same joint submission and referring where appropriate to the LR dossier a After login the user opens the menu Registration Notification You are cormecitd mi Home Yeu have 15 unesid messagej s in your Message Do REACHAIT 1 20 Testing veron 0E0008 15 57 Ariane BONTEMPS abs cefic be 9 April 2009 REACH IT News Joint Submission Process He chooses the right dossier type see next screen shot Important note Within the Registration Notification in REACH IT there is no possibility to choose I would like to submit a joint submission dossier as member or as LR This specific dossier type is NOT in the drop down list Dossier types drop down list Contact EN benisson of your dorsier report The updated version should contain Maton amd the updated one please refer to relevant guidance gotuments Rirggarch and Qaremigperrearel PERD rabea eng Veron BONDING 1557 For any joint submission dossier as a LR AND as a member the chapter 1 5 in the IUCLID 5 dossier has to be correctly filled in If not filled in the dossier will NOT be considered as a joint submission dossier and be either rejected Member Submission or considered to be a single registration CGo lHbelZ aAalsl OAH M A Boele a tt a A substance Carol
17. uent to identify the constituent s of the substance for which he is creating a JS However in that case the user must provide an explanation as to why he did indicate neither a pre registered inquired substance nor an already registered one ECHA Hoot gt Create Joint Submission gt Search EC Substance Expianaiion on Specify the constituents which are present in the substance al you want to pre register EC number ffl EC mame H CAS numer 7 Ariane BONTEMPS abs cefic be 4 April 2009 EAcefic REACH IT News Joint Submission Process Finally the LR specifies all constituents if any and clicks Continue when finished Contaci i e aa Ee REFINING n Homs gt Create Joint Submission gt erty Constituent Substance Et Humber CAS Humber Hame Fea Lea 10678 1 meiamine Wodiy Catwg REACH IT 1 2 0 Testing Version ji 0602008 15 57 b The LR has to indicate the name of the Joint Submission agreed among JS members so called below the JS name This name will be used by all JS registrant LR and members The joint submission name must have between 8 and 30 characters It is important to use well defined names for the JS and not only rely on the substance identity This JS name and the token please see below for details must be used by all members to confirm their membership Technical note The JS name is unique for the system it s impossibl
18. ypes Important note The Registration Number will be the same for all members and LR of the JS except the index part Ariane BONTEMPS abs cefic be 15 April 2009
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