Joint submission

All companies registering the same substance need to agree on the data to be submitted jointly in their joint submission. This is a collective responsibility which applies equally to all co-registrants.

In practice, companies may agree to submit information jointly with all their co-registrants, or to submit some or all the information separately if:

  • they do not agree with the information submitted jointly;
  • the jointly submitted data is too expensive for them and they have alternative affordable data; or
  • submitting jointly would lead to the disclosure of confidential business information.
 
Lead registrant

Registrant acting with the agreement of the other assenting registrants, who creates the joint submission in REACH-IT, submits first the joint data allowing the rest of the member registrants to submit their registration dossiers, and gives access to the joint submission in REACH-IT with a token. The registration dossier submitted by a lead registrant contains the data to be submitted jointly on behalf of all the member registrants, and their specific data as registrant.

Member registrant relying fully on the jointly submitted data

Registrants who rely fully on the data submitted jointly by the lead registrant. The lead registrant gives them the token to access the joint submission in REACH-IT.

Member registrant submitting data partially or fully separately as an opt-out

Registrants who submit some or all of the data separately if they do not agree with the selection of joint data, if the jointly submitted data is too expensive for them and they have alternative affordable data, or if submitting jointly would lead to the disclosure of confidential business information.

When a member registrant wants to submit separately some data (‘partial opt-out’), the lead registrant gives access to the joint submission with a token, and the member submits their member dossier with their own information for the endpoints they have opted out from.

When a member registrant decides to submit separately all the relevant information required for registration purposes (‘full opt-out’), they can either use a token issued by the lead registrant, or request ECHA to provide them with a token to access the joint submission.

If a potential registrant intends to fully opt-out but cannot register because the lead registrant does not give them access to the joint submission, they can request a token from ECHA to access the joint submission. When using a token provided by ECHA, the registrant must provide all the data needed to satisfy the information requirements of their registration and cannot rely on any of jointly submitted data provided by the lead registrant.

During the technical completeness check of an opt-out dossier, ECHA will ensure that all the information required under Articles 10 and 12 or under Articles 17 or 18 of REACH is included in the dossier, and that a justification to submit data separately is provided in the registration dossier.

Member registrant with an opt-out after a dispute

If, despite their efforts, registrants cannot find an agreement on the sharing and joint submission of data, the potential registrant can file a dispute with ECHA as a last resort.

ECHA assesses the case and may give permission to refer to some or all data and provide a token to access the joint submission. The registrant can then register in the joint submission with the other registrants of the same substance.

During the technical completeness check of an opt-out dossier, ECHA will ensure that all the information required under Articles 10 and 12 or under Articles 17 or 18 of REACH is included in the dossier, and that a justification to submit data separately is provided in the registration dossier.

Are you in line with the joint submission obligation?

Registrants are in breach of the joint submission obligation if:

  • one or more (individual) registrations of the same type (full or intermediate under strictly controlled conditions) exist outside of an existing joint submission for the same substance;
  • multiple (individual) registrations of the same type exist without any joint submission for the same substance;
  • multiple joint submissions of the same type for the same substance exist;
  • there are combinations of the scenarios mentioned above.

Verify your registration status and the status of your co-registrants (on the Co-Registrants Page in REACH-IT) to find if the joint submission obligation is being breached and work proactively to remedy the situation:

  • If your registration is outside of an existing joint submission, start negotiating to get access to the joint submission and to the jointly submitted data.
  • If you have registered your substance and no joint submission has been formed, start negotiating with the other (individual) registrants to form a joint submission and, to submit the data jointly.
  • If you have registered in a joint submission, get ready for registrants seeking access to the joint submission. Once they make their request, you must make every effort to find an agreement with them.