Novel Foods: EFSA to the rescue of applicants struggling with the Transparency Regulation

Right before the summer, we published an article​ where we analysed how and why more than half of all new Novel Food (NF) applications submitted since 2021 had been terminated by EFSA due to lack of compliance with the Transparency Regulation (TR). In fact, just over the last three months, an additional four new NF applications have been also terminated based on virtually identical grounds.

Surely aware of this situation and its impact on food innovation in Europe, EFSA recently updated its Practical Arrangements guide​ with numerous clarifications regarding the NF process, with a special emphasis on TR-related matters.

By far the main point of confusion, directly or indirectly leading to all terminations, emerged from the lack of clarity on which studies should be notified to EFSA prior to its performance to comply with the provisions of the TR. In this new guidance document, EFSA clarifies that some tests, such as stability studies, are indeed regarded as necessary to fully demonstrate product safety and that they must therefore be notified. Termination due to non-notification of stability studies, or delayed notification of those, has so far been behind almost 60% of all terminations.

On the other hand, EFSA now states that analyses to assess the identity/composition of a product, including the determination of its impurities and whole genome sequencing, as well as analyses to determine its physico-chemical properties, are exempted from the obligation of notification. Until now, lack of or delayed notification of studies of these types have been behind over 60% of all terminations.

Another point of controversy has been whether method validation tests should be notified, with EFSA terminating 20% of all new novel food applications based on its opinion that they should be. Now, method validation is excluded from the definition of “study” to determine product safety, and therefore also exempted from notification.

Although some questions and uncertainties remain, and each application is assessed on a case-by-case basis, this much-needed new guidelines from EFSA will surely help food innovators access the European market.