Safety of cannabidiol isolated 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 consists of ≥ 98% w/w CBD. The NF is produced via ethanol extraction, followed by winterisation, filtration, decarboxylation and crystallisation. It is intended to be used as an ingredient in food supplements at a maximum intake of 60 mg/day. The proposed target population is the adult population, excluding pregnant and lactating women. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, EFSA requested additional information on the identity, production process, compositional data, specifications, genotoxicity, reproductive and developmental toxicity, and human data of the NF. The applicant did not reply to these data requests. Based on the available data, the Panel concludes that the safety of the NF cannot be established.