At present, foods containing cannabidiol (CBD) and other cannabinoids are internationally being widely advertised and sold in increasing quantities. In the European Union (EU), these products require pre-marketing authorisation under the novel food regulation, so that all available CBD oils and CBD-containing food supplements in the EU are currently placed on the marked with an infringement of the food laws.

Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, EFSA located several knowledge gaps that need to be addressed before the safety evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Literature was searched and reviewed, but no observed adverse effect level (NOAEL) could be identified in both animal and human studies. However, lowest observed adverse effect levels (LOAEL) were available in animal studies, with the lowest LOAEL of 10 mg/kg bodyweight (bw) for liver toxicity being reported in a 39-week study in dogs with highly purified CBD. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day [1]. The EFSA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data.

Meanwhile, the authors suggest that CBD products still available on the EU market despite the lack of authorisation must be considered as being a serious health risk. At least products in exceedance of the human LOAEL of 4.3 mg/kg bw/day should be considered as being unsafe (Article 14(1) and (2) (a) of the Basic Regulation [2]).

References:

[1] EFSA NDA Panel. Statement on safety of cannabidiol as a novel food: data gaps and uncertainties. EFSA J. 2022, 20, 7322. https://doi.org/10.2903/j.efsa.2022.7322

[2] European Parliament and Council. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Off. J. EC, 2002, L031, 1-24.