Disputes in practice
Disputes can relate to sharing of data or to access to the joint submission, or, most frequently, to both. In all cases, ECHA has ensured that the same principles and procedures apply.
Filing a dispute is only the last resort, when your negotiations have failed. ECHA assesses whether the parties have made every effort to reach a fair, transparent and non-discriminatory agreement. The decision will depend on the efforts made by the parties. Consequently, before filing a dispute, you need to make sure that you have made every effort to reach an agreement.
The dispute procedure follows certain steps and timelines. It can be managed without legal support and is free of charge.
The outcome of the dispute can never satisfy any party in a way a voluntary agreement would. You are encouraged to continue efforts to find an agreement that will be satisfactory for both parties despite the initiated dispute procedure (or even after receiving ECHA’s decision).
ECHA assesses your dispute based on documentary evidence of the efforts made during the negotiations. This means that you need to record and collect all communication between yourself and the other party, for example, in a ZIP or a PDF file.
You don't need to submit any additional information (e.g. internal messages, documents or calculations, which were not exchanged during the negotiations), explanatory notes or legal considerations.
There are two forms available for submitting your dispute depending on whether you have pre-registered or inquired about your substance.
The forms are available below.
If ECHA finds your claim to be admissible, it requests the other party to submit their documentary evidence regarding the negotiations within 10 working days.
ECHA starts assessing the dispute after the documentary evidence is submitted by the other party (or after the expiry of the 10-working day deadline).
Based on the documented communication between you and the other party, ECHA establishes whether or not every effort to reach an agreement has been made.
Several outcomes are possible:
- Most of the disputes concern both the access to data and access to the joint submission: if ECHA concludes that you have made every effort but the other party has failed to do so, it will issue a decision granting you permission to refer to the data. You will also receive a copy of the robust study summaries from the existing registration. In addition, ECHA will give you acces to the joint submission with a token. This token is a passcode, which allows you to register as an opt-out withint the existing joint submission.
- For disputes related to access to a joint submission: if ECHA concludes that you have made every effort but the other party has failed to do so, it will give you access to the joint submission with a token. This token is a passcode, which allows you to register as an opt-out within the existing joint submission.
- For disputes related to data: if ECHA concludes that you have made every effort but the other party has failed to do so, it will issue a decision granting you permission to refer to the data. You will also receive a copy of the robust study summaries from the existing registration. It is also possible to have a dispute concerning data that has not been submitted yet. In this case, ECHA will grant you permission to proceed with your registration without the disputed data, and you will be given a proportionate time to develop and submit the data that is not covered by the permission to refer (e.g. studies not involving vertebrate animals).
- If ECHA concludes that you did not make every effort to reach an agreement, it will not grant you permission to refer to the requested data or access to the joint submission. You will then need to continue negotiations with the other party.
Once you have reached an agreement with the other party or received a decision by ECHA granting you a permission to refer to data and/or access to the joint submission, you can submit your registration dossier.
File a dispute
The dispute procedure is slightly different depending on whether your substance is subject to pre-registration or inquiry.
Fill out the form to submit a dispute to ECHA:
Disputes in practice
- Guidance on data sharing [PDF]
- SIEF, data sharing and joint submission [PDF]
- Data sharing in brief[PDF]
- Joining an existing SIEF [PDF] [EN]
- Typical cost elements in data-sharing negotiations [PDF]
- Checklist to hire a consultant [PDF] [EN]
- Fair, transparent and non-discriminatory cost sharing in SIEFs[PDF] [EN]
- Commission Implementing Regulation on joint submission of data and data sharing(EurLex)
Help with terminology