Regulatory context
The European Commission defines “Novel Food” as “food that had not been widely consumed by people in the EU before 15 May 1997”. In practical terms, Novel Foods include innovative, newly developed foods and foods produced using new processes or technologies.
Therefore, most ingredients at the forefront of foodtech such as many alternative proteins, precision-fermentation-derived ingredients, edible insects, human milk oligosaccharides and probiotics belonging to non-classical taxonomies fall under the scope of Novel Foods.
Regulation (EU) 2015/2283, which governs them, states that Novel Foods must be first and foremost safe, and that their manufacturers need to prove their safety through a pre-market authorization process.
The Novel Food procedure, alongside other legislative acts, are additionally subject to Regulation (EU) 2019/1381, known as the Transparency Regulation. This law became applicable on March 27th, 2021 and has the goal of making risk assessment of the food chain more transparent, reliable, objective, and independent.
Amongst many other things, it establishes that all studies or tests supporting a request for a scientific output for a Novel Food must be actively notified to the European Food Safety Authority (EFSA) before they are initiated, in order to demonstrate that there is no selection bias in the results of the studies.
Transparency Regulation behind all terminations
A total of 51 new Novel Food applications have been submitted since the applicability of the Transparency Regulation. Around two thirds of them have not yet been reviewed (and are therefore in “Intake” stage), and 19 have been evaluated. Of those, 9 have made it to the next step (“Safety assessment”). However, the remaining 10 applications have been terminated by EFSA – this is a 53% termination rate at the very first step of the process.
Figure 1. Summary of new Novel Food applications submitted after the applicability of the Transparency Regulation. *An additional 8 applications have been submitted since March 27th, 2021. However, these have not been taken into account for this analysis as they were not new applications, but rather modifications or extensions for previously-authorized Novel Foods.
These 10 “Terminated” applications were received between 25 August 2021 and 29 July 2022, and the reason for termination in all cases was non-compliance with the Transparency Regulation as far as the notification of studies is concerned. More precisely:
- 60% of the cases were terminated due to a delay in the notification (i.e. these dossiers contained studies which were notified after, rather than before, they were initiated).
- 30% of the cases were terminated due to lack of notification of one or more studies contained in the dossier.
- The remaining 10% is a case which was terminated for several reasons (delayed notification, non-notification, a study notified but not included in the dossier).
These terminated dossiers comprehend a total of 79 supporting studies, of which 74 started after March 27th, 2021, and were therefore subject to the Transparency Regulation. According to EFSA’s assessment, only 5 of these studies (7%) were properly notified. This means that 93% of the studies have not been properly notified by the applicants; specifically, 71% of them were notified with delay and 22% were not notified at all.
Not only animal and human studies need to be notified
From the Transparency Regulation and EFSA guidelines, it is clear that the tests and studies upon which food safety will be based need to be notified before they are conducted. Therefore, applicants have, in general, notified animal toxicology and human safety studies correctly and timely. However, EFSA’s notification requirements go well beyond these.
In fact, the vast majority (71%) of the tests flagged in these terminations were related to the "Compositional data and Stability" section of the Novel Food dossier. More precisely, 33% were compositional analyses, 20% had to do with stability testing; and 18% were linked to certificates of analysis.
Consequences of non-compliance – and ways to avoid them.
All terminated applications had been subject to the same consequence: a 6-month time penalty. After that period, these dossiers may be resubmitted and the tests previously flagged do not need to be repeated. This may sound somehow relieving, but 6 additional months in an already lengthy process can be really damaging for applicants.
It is therefore crucial that applicants are fully aware of this situation in order to carefully plan in advance, and to properly coordinate all parties involved in their Novel Food processes, from R&D to Regulatory to Manufacturing and Quality.