EFSA’s scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.

Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. The European Commission considers that CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods. Following the submission of numerous applications for CBD under the novel food regulation, the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans.

Data gaps and uncertainties

EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline.

Chair of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”

There is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being.

Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans.  

Support to applicants

Ana Afonso, Head of Nutrition and Food Innovation at EFSA, stated: “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”

As part of the follow-up, EFSA is holding an info-session, open to applicants and other groups or individuals with an interest in this issue and novel food more generally. The online event takes place on 28 June – register to attend!

• Statement on the safety of cannabidiol as a novel food: data gaps and uncertainties
• Plain-language summary: Statement on the safety of cannabidiol as a novel food: data gaps and uncertainties