In a newly published statement, the European Food Safety Authority (EFSA) presents the knowledge gaps and uncertainties regarding cannabidiol (CBD) as a novel food. The European Commission has concluded that CBD may be considered a novel food, and 19 applications are currently under risk assessment by EFSA. However, by way of the risk assessments of these applications, EFSA found that data is unavailable in multiple areas, and any adverse effects of CBD as a novel food are therefore not known. This significant uncertainty results in EFSA currently being unable to establish the safety of CBD as a novel food.
Cannabidiol as a novel food?
Following the decision made in case C-663/18 in November 2020 in which the Court of Justice of the European Union concluded that CBD should not be considered a narcotic drug, the European Commission has concluded that CBD may be considered a novel food, provided that the other conditions regarding the definition of food in Regulation no. 178/2002 are also met.
19 applications pending before EFSA
As of mid-March 2022, the European Commission has received more than 150 applications for CBD as a novel food, and 19 applications are currently under risk assessment by EFSA. Most of the said applications include CBD extracted from hemp plants. However, several applications include chemically synthesized CBD.
One of the applications dates as far back as 2019, but with the new statement made by EFSA, expectations are that this application, along with the other applications, will remain pending for the foreseeable future. While assessing the data disclosed in the applications, EFSA came across multiple significant data gaps creating uncertainty as to the safety of CBD as a novel food. Consequently, EFSA released a statement on 7 June 2022 in which the lack of data is explained along with a summary of the state of knowledge of the safety of CBD as a novel food.
Safety cannot be established
In its statement, EFSA highlights multiple areas of data gaps and uncertainties forming the basis of the conclusion that the safety of CBD as a novel food cannot currently be established. Among the areas with significant data gaps are the effects of CBD on the human metabolism and the possible evidence of liver toxicity. Another important area with data gaps is the interaction between CBD and other drugs due to common metabolic pathways that could impact the kinetics of CBD. In the statement, EFSA highlights multiple areas with significant data gaps making the safety of CBD as a novel food uncertain.
For CBD to be considered as safe as a novel food, the said data gaps need to be filled in as part of the safety assessment and authorization process. In the conclusion of the statement, EFSA stresses that the data gaps and uncertainties identified in the statement need to be addressed by the applicants in order to provide sufficient basis for the safety assessment of CBD as a novel food.
Therefore, the applicants are responsible for filling in the data gaps and, until the gaps have been filled in, CBD cannot be expected to be considered safe enough to constitute a novel food.
Read the full statement here. If you would like to know more about CBD in foods, please contact the Bech-Bruun team.