EFSA Publishes 'Stop-the-Clock' Timelines for Regulated Product Applications
By Heidi Parsons
The European Food Safety Authority (EFSA) today released new guidance that sets out indicative timelines the Authority will use when requesting information it needs to complete its evaluation when it performs risk assessments of regulated products such as food contact materials, GMOs or feed additives.
The guidance document provides deadlines for a range of requests for each regulated product area covered by EFSA. "When this happens, the clock on the regulatory timetable for the risk assessment is stopped until the new data is supplied," an EFSA statement explained. "This will ensure applications are assessed on a case-by-case basis in the most time-efficient way."
The EFSA summarized its Scientific Report as follows:
The Scientific Evaluation of Regulated Products Directorate (REPRO) supports EFSA’s work in the evaluation of substances, products and claims intended to be used in the food chain in order to protect public, plant and animal health as well as the environment. Its units focus on the following specific areas: feed additives, food additives, food contact materials, food flavourings, enzymes, genetically modified organisms, nutrition, food allergies, novel foods and pesticides.
The regulatory processes that form the basis for EFSA’s evaluation activities of regulated products are defined in a number of sector-specific regulations with different requirements. The streamlining of certain steps under the legal acts governing the risk assessment of regulated products within EFSA aims at streamlining the interaction between EFSA and applicants.
A mapping exercise regarding the timelines used by different Panels to request additional or supplementary information during the risk assessment process was performed within EFSA in 2012. As an outcome of this exercise a proposal for the streamlining of these timelines was prepared. The proposal in form of this report was reviewed and consulted with the EFSA Scientific Panels (ANS, CEF, FEEDAP, GMO, NDA), as well as the Scientific Committee during first half of 2013. The Scientific Committee took note and supported this report during the final consultation in December 2013.
The complete text of the EFSA's Scientific Report may be downloaded here.