EFSA Publishes 'Stop-The-Clock' Timelines for Regulated Product Applications

3 Feb 2014 --- During the risk assessment of regulated products such as food contact materials, GMOs or feed additives EFSA may ask for additional information in order to complete its evaluation. The Authority has developed new guidance that sets out indicative timelines that it will use when requesting such data.

The document outlines 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. This will ensure applications are assessed on a case-by-case basis in the most time-efficient way.

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.