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Follow up to dossier evaluation decisions

Who is responsible for submitting the requested information if there is a change of lead registrant after the decision has been received?

Any registrant receiving the adopted decision remains legally responsible for providing the information requested in the decision (see Q&A ID 1583), and will be the addressee of any enforcement actions related to evaluation decisions according to their national legislation, where appropriate.

Until 2019, the recipient of a decision was generally the lead registrant. If the recipient of the decision does not submit the requested information because they changed their role, their national enforcement authority will direct any enforcement actions towards them, where appropriate. This is independent from whether a newly appointed lead registrant would have submitted the information.

As of 2019, ECHA issues decisions to all members of a joint submission for which a non-compliance was found. All addressees of the decision are thus responsible for the submission of the requested information. Consequently, a change of lead after the adopted decision has been issued will not change the legal responsibility of the other recipients. In addition, if at the follow-up stage ECHA identifies that the registrants have failed to comply with the information requirements, it will notify the enforcement authorities of all the countries where the incompliant registrants are located.

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