A fundamental aspect of REACH is the requirement to share information about the substances being manufactured, imported, placed on the market and used in the EU. By doing this, registrants of the same substance can reduce costs and avoid unnecessary testing on vertebrate animals. When information is available, studies involving vertebrate animal testing must be shared between registrants in order to prevent the duplication of tests. New studies involving vertebrate animals can only be conducted as a last resort.
Sharing data also precedes joint registration when a substance is manufactured or imported by more than one company.
There are two mechanisms for data sharing:
- Substance Information Exchange Fora (SIEFs), used for phase-in substances that have been pre-registered
- Inquiry, used for non-phase-in substances and for phase-in substances that have not been pre-registered
Registrants must make every effort to ensure that the cost of sharing the information required for joint registration is determined in a fair, transparent and non-discriminatory way. All parties must fulfil their data sharing obligations in a timely manner.
Data sharing disputes
ECHA can assist in the resolution of data sharing disputes between existing and potential registrants. A claim must only be initiated as a last resort after all possible avenues have been explored between the parties.
Any potential registrant who lodges a data sharing dispute with ECHA must always obtain a decision from ECHA before submitting the registration dossier.
If there is a dispute, ECHA's decision will be based on an assessment of the parties' respective efforts to reach an agreement on the sharing of the data and its costs in a fair, transparent and non-discriminatory way.
A potential registrant initiating a data sharing dispute procedure with ECHA must demonstrate the efforts made by all the parties to reach an agreement and must provide appropriate documentary evidence.