How to make changes to joint submissions

How to make changes to joint submissions

When a joint submission has been created in REACH-IT, it is sometimes necessary to make changes to correct mistakes or to adapt to a new situation.

The lead registrant of the joint submission can make some changes to the joint submission, but changes to certain information of the joint submission have to be made by ECHA. To request the change, you would need to contact ECHA through the contact form.

 

Change of lead registrant

Co-registrants can transfer the lead registrant role in REACH-IT if the previous lead registrant and the new lead registrant agree. The new lead registrant will need to resubmit the lead registration dossier to finalise the transfer of the lead role.

If the lead registrant is no longer responding to your communications, for example, due to bankruptcy, death or some other reason, the co-registrants can nominate a new lead registrant. You can request ECHA to reassign the lead role in REACH-IT. You will need to submit evidence on the nomination of the new lead registrant. Before reassigning the lead role, ECHA will contact the unresponsive lead registrant.

 

Tonnage band of the joint submission

The lead registrant indicates the tonnage band coverage of the joint submission in the lead registrant dossier. This determines the information requirements that need to be fulfilled by the information submitted jointly in the lead registrant dossier. Members of the joint submission cannot register in a higher tonnage band, unless they submit the required additional information as an opt-out.

As a lead registrant, you can increase and decrease the tonnage band of the joint submission yourself when you update the lead registration dossier. To decrease the tonnage band of the joint submission, all members relying in the information provided by the lead must have registrations at the same or lower tonnage band of the new tonnage band. Members may need to update their dossier to lower their tonnage band before the lead registrant can lower the tonnage band of the joint submission.

When lowering the tonnage band of the joint submission, you must not remove any data satisfying the information requirements for the higher tonnage band, as you have the obligation to provide all data you have on the substance and this data was already available.

 

Jointly submitted documents

The guidance on safe use and the chemical safety report can be submitted by the lead registrant on behalf of all the members or, alternatively, separately by each registrant.

If you, as the lead registrant, have indicated that these documents are submitted jointly in the lead registrant dossier, you can change this later by submitting an update of the lead dossier. However, in order to proceed with the change all members of the joint submission have to indicate in their dossiers that they provide these documents on their own.

 

Type of joint submission

There are two types of joint submissions – ‘full’ and ‘intermediate’. A ‘full’ joint submission can contain any combination of full (standard) registrations and intermediate registrations. An ‘intermediate’ joint submission must only contain registrations for a substance used as an intermediate that is (manufactured or) used under strictly controlled conditions. Having one ‘full’ joint submission and one ‘intermediate’ joint submission for the same substance does not breach the joint submission obligation.

As a lead registrant, you indicate the type of joint submission in REACH-IT when you create it and you cannot change it afterwards. However, you can request ECHA to change the type of the joint submission if all registrations fit the new type and no joint submission of that type already exists.

 

Name of the joint submission

As a lead registrant, you choose the name of the joint submission when you create it in REACH-IT and you cannot change it afterwards. In cases that are well justified, (for example if after a substance ID change of the joint submission the name of the joint submission no longer reflects the substance correctly) you can request ECHA to change the name.

 

Deletion of an empty joint submission

The lead registrant can delete a joint submission they have created in REACH-IT as long as none of the co-registrants have submitted a dossier. Following a submission (regardless if it is successful or not), if the joint submission is no longer needed, the lead registrant will need to contact ECHA in order to close the joint submission.

If a lead registrant does not delete an empty joint submission, the joint submission will be automatically closed three months after its creation. Once the joint submission is closed any other potential registrant can create another joint submission for the same substance.