ECHA guidelines

ECHA sets deadlines to provide data after dossier and substance decisions are issued

Following a dossier or substance evaluation from the European Chemicals Agency (ECHA), standard deadlines to provide data (normally, new study data) will be provided in a draft decision letter.

These deadlines are endpoint specific and consider factors such as the time needed to conduct a study, contracting/scheduling time and lab space availability, as well as the time to update and submit the IUCLID dossier and chemical safety report, if needed.

Applicants can only challenge these deadlines at the draft decision letter stage; once the final decision letter is issued, ECHA cannot change the deadline for registrants to provide the data. ECHA, however, will include the option of extensions to help mitigate “long queues in laboratories for the most often requested endpoints.”

There is more to consider though when deciding if the provided deadlines can be met.

As well as factoring in the availability of lab space and expertise in the studies required, applicants should consider the date when their study could start, which may depend on availability of suitable analytical methodology and other necessary resources. Feasibility testing/analytical method development may be needed in advance so studies can start promptly after a final decision letter is issued to support compliance with the final deadlines set by ECHA. This may also help support the choice of study type that should be conducted.