For various reasons, registrations already completed and submitted may need to be updated. Officially, there are two forms and these are spontaneous (ie at the initiative of the registrant) or enforced (request by ECHA). Either way, there is a need to update registration; this may however be the role of the lead registrant only, or it may need action by all registrants.
In the case of changes to data or classification, only the lead registrant need make an update, but if the registration is being updated to include new uses or changes in substance identity, this will be needed by all registrants affected.
Enforced updates are needed when requested by ECHA in response to questions raised after review of the dossier. This may be needed by only the lead registrant if relating to test data (either as a result of new testing requests, or questions over data interpretation), but Joint Registrants will need to be involved if the questions relate to issues specific to each registrant, such as substance identity, analysis etc. Normally, only the Lead Registrant need make this update and it is accepted that the Joint Registrants are party to the updates. Obviously, if there have been requirements for new data, the Joint Registrants may need to pay for new testing or administration costs.
Spontaneous updates by the Lead Registrant are needed when new data are available, when classification has been changed, when DNELs or PNECs are revised, or when any other changes are needed to the dossier that is relevant to all registrants and was part of the joint dossier.
Joint Registrants need to consider spontaneous updates if they have new uses to add to those that were part of the initial registration or if any other changes to their specific part of the dossier (substance identity, guidance on safe use, tonnages etc). In some cases, all registrants may need to make an update if uses on the joint CSR have been changed or voluntary restrictions put in place.
Whether updating the full dossier submitted by the lead registrant, or the reduced dossier prepared by the joint registrant, it is necessary to take the original IUCLD substance file, make the changes needed and prepare a new dossier, with Step 6 in the dossier preparation ticking the box ‘update’ and indicating if spontaneous of enforced.
The new dossier is then submitted with REACH IT as before, waiting for responses from ECHA to show completion in ‘pipeline’. Some updates may attract a fee from ECHA.
It is important that if updates result in the addition of new data, changes in use, changes in classification or any other change that is considered ‘significant’ for hazard communication, the SDS must also be updated without delay.
REACH Dossier checks and updates
REACH Dossier updates
Denehurst offers a service to review exisint registrations, CSRs, SDS, etc and advise if the details of the registrtation cover the actual uses and applications of the substance. Classification checks can also be made if needed.
It is important not to wait for a formal review under CoRAP or to wait for compliance check questions from ECHA, but instead pro-actively check and update dossiers of registrations already submitted.
See CoRAP page