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Data Sharing

B. Data sharing, registration

How to obtain data submitted less than 12 years previously from a previous registrant?

The situation:

The substance has been registered but the relevant studies were submitted less than 12 years before the inquiry. ECHA informs the potential registrant of the names and addresses of the previous registrants but cannot provide a copy of the (robust) study summaries. Rights and obligations - For the purposes of data sharing, the potential registrant will need to contact the previous registrants (and/or the other inquirers) identified by ECHA.

A request for sharing information must be made for any studies involving vertebrate animals. However, a potential registrant has to request data from the previous registrants if that data does not involve testing on vertebrate animals. The previous registrant and the potential registrant have to make every effort to reach an agreement on the sharing of the data requested and its costs. The obligation to make every effort applies to any information requested, whether it concerns vertebrate or non-vertebrate animal studies.

The process:

Once a data sharing request for studies submitted less than 12 years ago has been made, both the previous and potential registrants must make every effort:

  • to reach an agreement on the sharing of the information requested by the potential registrant;
  • to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way.

See Q&A 102 for access to data submitted more than 12 years previously. 

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