To be fully authorized (and sold) within EU member states, a CBD product must have a novel food application with the European Food Standards Agency (EFSA).
But now the EFSA has paused the processing of all CBD novel foods applications.
The decision, which was announced on June 7, was made because the 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.”
Before the announcement, the European agency had been processing 19 applications for CBD products, all of which are now in limbo.
Remarking on the pause of novel food applications, Dominique Turck, chair of the EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens, 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.”
According to the accompanying press statement, these data gaps include a lack of information on the effect of CBD on the liver, the gastrointestinal tract, endocrine system, nervous system, and on people’s psychological well-being.
The EFSA’s official statement on the matter also cites the adverse events associated with Epidyolex, a CBD medication used to treat epilepsy, as a cause for pause. These side effects, according to the EFSA, may be a price to pay for medications but they are “not acceptable when considering CBD” as a novel food.
To help address these data gaps, the EFSA will be holding an online info-session, open to all 19 novel food applicants and other individuals, that will take place on June 28.
“Stopping the clock on a novel food assessment is not unusual when information is missing,” Ana Afonso, head of Nutrition and Food Innovation at EFSA, said in a statement.
“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.”