Disputes in practice
Filing a dispute is only the last resort, when your negotiations on access to data and/or access to the joint submission have failed. Before filing the 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 having received 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:
- 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 submit your own registration within the joint submission in REACH-IT.
- 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. If the data has not been submitted yet, you will receive permission to proceed with registration without the disputed data. There is an important difference between whether you have pre-registered or whether you have inquired for data:
- If you have pre-registered, ECHA can only grant you permission to refer to tests involving vertebrate animals.
- If you have inquired, ECHA can grant permission to refer to all requested data. In addition, you will need to submit a proof of payment before the decision becomes final. In practice, this means that you will first receive a draft decision and a request for proof of payment from ECHA.
- It is also possible that the dispute covers both the access to data and access to the joint submission.
- 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.
You must always get a decision from ECHA before you can submit your registration dossier.
Did you pre-register or inquire?
The dispute procedure is slightly different depending on whether you have pre-registered or inquired about your substance.
File a dispute
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