Presentación conjunta de datos

All companies registering the same substance need to agree on the data for their joint REACH registration. 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.

Note: special conditions apply for substances that are registered for uses as an intermediate . See Guidance on Data Sharing, Chapter 6.2 ‘Intermediates under strictly controlled conditions’.

Joint submission for the same substance.

 

 

Member registrant

In most cases, registrants agree on the content of the registration dossier and the joint data is then submitted by the lead registrant on behalf of all co-registrants. The lead registrant gives the members access to the joint submission with a token in REACH-IT.

 

Member registrant with a partially or fully separate submission of data (opt-out)

Registrants can 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. This is called an ‘opt-out’.

In this case, the lead registrant can give access to the joint submission with a token in REACH-IT, but the member submits their own information for the endpoints they have opted out from. See Chapter 6.4 of the Guidance on Data Sharing for more information.

A member registrant can also decide to submit separately all the relevant information (‘full opt-out’). In this case they can either use a token issued by the lead registrant, or request ECHA to provide a token 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 the information provided by the lead registrant. During the technical completeness check of a full 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.

Note: A justification to submit data separately must be provided in the registration dossier and it will be checked during the technical completeness check of the submission. Furthermore, Article 41(5)(a) of REACH requires ECHA to prioritise for compliance check dossiers that contain information submitted separately as per Article 11(3).

 

Member registrant with an opt-out after a dispute

If 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 a token to access the joint submission. The registrant can then register in the joint submission with the other registrants of the same substance, relying on some or all of the jointly submitted data.

If a potential registrant intends to 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. The potential registrant can then register in the joint submission relying entirely on their own data ('full opt-out').

During the technical completeness check of a full 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.

Note: A justification to submit data separately must be provided in the registration dossier and it will be checked during the technical completeness check of the submission. Furthermore, Article 41(5)(a) of REACH requires ECHA to prioritise for compliance check dossiers that contain information submitted separately as per Article 11(3).

 

Are you in line with the joint submission obligation?

Registrants breach 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 for the same substance exist without any joint submission;
  • Multiple joint submissions for the same substance exist;
  • There are combinations of the scenarios mentioned above.

If you do not respect the joint submission obligation, ECHA will contact all registrants of the substance (outside and within the existing joint submission) and, remind them of their collective obligation to agree on the joint submission of data. 

 

Be proactive and resolve your joint submission related issues on a voluntary basis with your co-registrants before ECHA contacts you.

Verify your registration status and the status of your co-registrants (on the Co-Registrants Page in REACH-IT).

  • If you are a registrant outside an existing joint submission, start negotiating to get access to the existing joint submission – and potentially to the joint data.
  • If you have registered your substance and no joint submission has been formed, start negotiating with the other (individual) registrants on forming a joint submission and, potentially, on sharing data.
  • If you have registered in a joint submission, get ready for registrants seeking access to the joint submission. Once they make their request, you have to make every effort to find an agreement with them.

Advice can be found under Working together.

 

What to do if you disagree

If you do not get access to the existing joint submission despite your efforts in the negotiations, as a last resort, you may file a dispute with ECHA. After assessing your case, ECHA may grant access to some or all of the data as well as the token to the joint submission.

Information on disputes can be found under Disputes in practice.

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