In the European Union, any food that was not consumed to a significant degree before May 1997 is defined as a novel food. This definition is broad and complex, including many types of substances/ingredients/foods. For example, novel foods include new sources of food components such as oil rich in omega-3 fatty acids obtained from krill, or novel ingredients used to fortify certain foods with nutrients, such as phytosterols (plant sterols) or foods produced using new methods such as nanotechnology (1). Novel food can also be food which is or has been traditionally eaten outside of the EU, in this case, a specific procedure for the authorization is available.
In the regulatory context of Regulation (EU) 2015/2283, all novel foods need to be authorized by the European commission following an EFSA opinion regarding their safety. A guidance has been developed by the EFSA to provide inputs for applicants, and a first revision was published in March, 2021, originally published in September 2016 (2).
Applicants can also submit a request to the European Commission about whether products or substances are subject to the Novel Food Regulation. The answers are listed in the Novel Food Catalogue.
Human data from clinical studies are not mandatory for a novel food application for authorization, but if available, can be included in the application to assess the safety of the product. It should be noted that if the novel food has a specific pharmacodynamics effect, the clinical data needs to be obtained at the proposed consumption matching the one in the application.
The types of data that can be used are “physical examination, blood chemistry, hematology, urine analysis, blood pressure and organ function tests and/or monitoring of adverse reactions”. All these aspects correspond to the safety monitoring performed during clinical trials. Currently safety monitoring performed into clinical trials can include:
Biological parameters: Red blood cells, hemoglobin, platelets, hematocrit, leukocytes (neutrophils, eosinophils, basophils, lymphocytes, monocytes) and the mean blood volume, AST/ALT, Creatinine, Urea, etc. Representing current parameters for immunity, liver and kidney safety;
Vital signs and anthropometric data (systolic and diastolic blood pressure, heart rate);
Clinical examination performed by the investigator;
Monitoring of adverse events;
Regarding the monitoring of adverse events, a specific coding can be used as MedDRA coding. The collection of Adverse events (AE) allows the comparison between groups of:
Total number of AEs;
Number of AEs per severity (severe, moderate, mild) and Serious Adverse Events (a specific category involving Death, Life-threatening, Hospitalization (initial or prolonged), Congenital Anomaly/Birth Defect);
Number of AEs per body system;
Number of AEs potentially linked to the product.
Some specific questionnaires can be used also, as for example for assessing the impact of the consumption of the novel food in the gastrointestinal area. The Bristol Stool Scale can be used to assess the consistence of stools in order to evaluate potential impact on transit modifications (3).
Figure 1 : Bristol Stool Scale from Maruyama et al. 2019 (1)
Specific gastro-intestinal symptoms scoring can be performed during the consumption of the novel food and compared to a placebo, for example by the following Likert scale: (2)
“Please rate your score of abdominal pain for the passing day?”
Finally, into the EFSA GUIDANCE it is also specified that the highest level of scientific evidence should be presented first. Meaning that Randomized, double blinded and placebo Controlled Clinical Trials (‘RCT’) methodology will be encouraged to conduct. The use of international guidelines regarding clinical trials, as the International council for harmonization (ICH) is required.
Clinical studies can be conducted in order to assess the safety of a novel food application, and additionally, design combining safety and efficacy can also be performed at the same time.
– Hélène Chevallier, Clinical Methodologist, Biofortis –
(2) EFSA : https://doi.org/10.2903/j.efsa.2021.6555
(3) Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920–4.
(4) Maruyama M, Kamimura K, Sugita M, Nakajima N, Takahashi Y, Isokawa O, et al. The Management of Constipation: Current Status and Future Prospects. In 2019.