Updating individual registrations to Joint submission
Contents
1. es e238 cefic Updating individual registrations to Joint Submission version 18 February 2011 This paper explains the process that companies have to follow in case they have submitted individually and they now want to update their dossiers in order to become part of a Joint Submission in accordance to article 11 The following steps need to be followed 1 Contact the Lead Registrant consortium The first step needs to be done outside REACH IT It consists of contacting the corresponding Lead Registrant or consortium in order to learn about the conditions to receive the information that has been jointly submitted the name of the Joint Submission Object and the token In some cases it may imply the signature of the SIEF agreement and the subsequent payment of a Letter of Access The price of such Letter of Access needs to be in line with the principles of fair transparent and non discriminatory cost sharing For more information see documents below Cefic recommendation on Letters of Access http cefic org Documents IndustrySupport Cefic_ recommendation letter_of access FINAL pdf Cefic note on transparency in cost sharing http cefic org Documents IndustrySupport Cefic note_transparency on cost sharing IN SIEFs 310510 pdf Cefic note on fair cost sharing http cefic org Documents IndustrySupport Cefic note_fair cost sharing 20in 20SIEFs 070910 pdf In some cases the company may not know who the Lead Reg2. he IUCLID dossier e There will be no fee associated to such an update unless it is an actual change to a higher tonnage band than previously registered or additional claims on confidentiality have been included e It should also be noted that the dossier submitted as an update will undergo the current Business Rules and Technical Completeness Checks In case of failure of the update submission the initial dossier is not deleted The information contained in this paper is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available is to be relied upon at the user s own risk No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted by Cefic nor any company participating in Cefic for damages of any nature whatsoever resulting from the use of or reliance on the information This document does not necessarily represent the views of any company participating in Cetfic The technical rationale behind this is that for REACH IT the current tonnage band of the member in the JSO is going to be updated from non existing as the member registration is still not part of the JSO to the actual tonnage band In case a different reason for updating is selected in the dossier header the dossier will fail the Business rules check 2
3. istrant is In order to find out companies are invited to check the pre SIEF page in REACH IT and their mailboxes as there may be messages from the Lead Registrant An alternative is to consult lists of consortia publicly available or to contact the ECHA helpdesk and ask for help in identifying the relevant Lead Registrant 2 Sign up to the Joint Submission in REACH IT Once the company is in possession of the name of the JSO and the token it needs to sign up to the JSO The ECHA user manual part 7 explains the process in detail http echa europa eu doc reachit industry user _manual reachit joint submission _en pdf 3 Re submit registration dossier as an update Finally the last step is a re submission of the registration dossier as a spontaneous update of the previously submitted dossier When doing a spontaneous update the company is requested to provide the reason that has triggered the update In the particular case of an individual registration being updated to become a member of a Joint Submission companies have to select Change of tonnage Please note that the token has a validity of 30 days The token may have expired and needs to be re generated by the Lead Registrant Please consult the ECHA manual on Joint submission for more information on the token htto echa europa eu doc reachit industry_user_manual reachit joint submission _en odf 1 band in the dossier creation wizard see image below This reason fo
4. r updating has to be selected for technical reasons even if there is no actual change of tonnage band T Dossier creation wizard Enter additional adn inisirative infomation conceming your dossier UOSSIEP TEM plate HEAL H REQIST Pal On Member of 3 joint SUBMISSION general Cate Name tgiven by user Spontaneous Update of Substance A Dossier submission remark This Is an example of hows Jain Submizsion Member Dossier Spontaneour Update s dossier header should look This example represents the Dasic case depending en yaur submission context your daszier header might laa k differe ri Type of submission Infurnnativn provided by the lead un behalf of Lhe member s v Chemical rafety report Guidance on safe use Heview DY af astes tor Tonnage band Between 100to 1000 tonnes year gt ni elte colar edt Incermediaier tonnage dand Transported isolated intermediates tonnage dand e Submission update v isthe submiszion an updater Last submission number 123456 78 Reason for updating Furtherto arequest decision from regulatory body v Spontaneous update y R P change of tonnage band a tix justification change of tonnage band kd The image above also shows that the latest submission number in this case related to the individual submission needs to be provided Please note e The previous registration number will have to be included in section 1 3 of t
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