EFSA suspends assessment of CBD orders as a “novel food”

The evaluation of applications for submission of cannabidiol (CBD) as a novel food at the European Food Safety Agency (EFSA) is suspended, after a note published by the entity. At stake will be the lack of robustness in the documentation of submissions. EFSA scientists are unable to establish the safety of CBD as a novel food due to data gaps and uncertainties about the potential risks related to CBD ingestion.

Last week, the industry learned about an EFSA opinion, long awaited and requested by the European Commission (EC), within the scope of assessments regarding the safety of the use of CBD as a novel food. The report, entitled “Statement on the safety of cannabidiol as a novel food: data gaps and uncertainties”, was written by the EFSA expert panel on nutrition, novel foods and food allergens (NDA), which received 19 applications for CBD as a novel food, with more applications in the pipeline.

The Chairman of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD ingestion and determined that the various data gaps on these health effects need to be corrected before these assessments can proceed. It is important to emphasize at this point that it has not been concluded that CBD is unsafe as a food.”

The agency claimed that there was insufficient data on the effects of CBD on people's liver, gastrointestinal tract, endocrine system, nervous system and psychological well-being. Animal studies show significant adverse effects mainly in relation to reproduction. It is important to determine whether these effects are also observed in humans.

The Panel identified several hazards related to CBD ingestion and pointed to deficiencies in experimental data in animals and humans.

The issues raised by EFSA regarding the data and uncertainties identified in the declaration must now be reviewed by applicants to provide the basis for the safety assessment of CBD as a novel food.

Industry reactions

The news of the suspension of evaluation requests caught some stakeholders by surprise, who recognize that the need for new assessments and tests with these products may arise from this report, in order to ensure that regulators are given the necessary safety guarantees. For now, the big change will be the need to include human trials in the toxicity and reproduction issues raised by the panel of experts, due to the fact that there have not been results with rodents satisfactory enough to assume that the consumption of CBD is safe.

If, on the one hand, some of the applicants reevaluate their projects and the costs associated with the redefinition of the tests, the EIHA - European Industrial Hemp Association, anticipating a similar situation and advanced to a more robust study that brought together more than 100 companies and with a view to providing the industry with solid and robust data on the use of CBD.

EFSA will provide a debriefing session for the various stakeholders and applicants

EFSA has received several requests for the use of cannabidiol (CBD) as a novel food. The large volume of requests and the statement issued regarding the risks of CBD, led EFSA to organize, for June 28, from 15 pm to 17 pm (Central European Time Zone), an information session regarding the data needs to proceed with the requests.

The event will take place online and registration is free, and must be held until the 17th of June at a web page made available for this purpose.

The information session aims to promote understanding of the NDA Panel statement on the uses of cannabidiol (CBD) as a novel food, focusing on data gaps identified in the scientific literature, provide guidance to candidates on how they can address data gaps identified, which mainly concern the potential effects of CBD on drug metabolism, liver, gastrointestinal tract, hormonal responses, nervous system and reproduction as well as answering questions from candidates and interested parties.