Following the submission of numerous applications for cannabidiol (CBD) under the novel food regulation (19 received by EFSA, but more than 150 sent to the Commission), the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans.

According to its statement published on 7 June 2022, EFSA cannot currently establish the safety of cannabidiol as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake. 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.

That’s why Cannabidiol novel food evaluations are now on hold pending new data (clock-stop). It’s now the responsibility of applicants to fill data gaps. 

EFSA organized an online information session for applicants on “The safety of cannabidiol as a novel food: data gaps and uncertainties” on 28 June 2022. The recording of this session is available on the EFSA”s website, the Presentation and the FAQ document of the session will be available on 8 July.