Safety of cannabidiol isolate from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on cannabidiol (CBD) isolated from Cannabis sativa L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced via ethanol extraction, followed by decarboxylation and crystallisation. It is a white to off-white powder consisting of ≥ 97% w/w CBD. Other cannabinoids are present at a total concentration below 2.5% w/w. The NF is intended to be used in food supplements at 21 mg/day. The proposed target population is the adult population, excluding pregnant and lactating women. Uncertainties remain concerning the type of formulations that the applicant intends to market, and consequently on the possible presence of small particles - including nanoparticles - in such formulations. The Panel therefore cannot conclude as to whether the selected test items and ADME and toxicological testing strategies were appropriate to adequately assess the safety of the NF. Based on the available data, the Panel concludes that the safety of the NF under the proposed conditions of use cannot be established.