Clock Stop

When EFSA issues an additional data request, the regulatory assessment clock is formally stopped. The nine-month assessment period prescribed by Regulation (EU) 2015/2283 pauses until the applicant submits the requested information. Once the data is received and deemed sufficient, the clock resumes.

Clock stops account for a substantial share of total evaluation time. Based on available data from post-2018 dossiers, roughly half of the total time between application submission and published opinion is spent in clock-stop periods — that is, waiting for the applicant to respond (Neytinck et al., 2025).

The nine-month statutory deadline for EFSA to deliver its scientific opinion has, in practice, never been met in dossiers for which overrun data is available. The median total time from application to published opinion is around 16 months (Neytinck et al., 2025).

An applicant can reduce clock-stop risk by addressing the most common triggers before submission. The Section Guide on this site covers the specific gaps EFSA most frequently flags in each of the ten mandatory assessment sections.