Safety of synthetic cannabidiol 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 synthetic cannabidiol as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is subject of the application is the (-)-cannabidiol (CBD) produced by chemical synthesis and proposed to be used in food supplements at a maximum use level of 150 mg/day. The target population is the general population above 6 years of age, 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. EFSA's request for additional information was sent to the applicant. The requested data concerned the identity, the production process, the compositional data, the specifications, the genotoxicity, the reproductive and developmental toxicity and the human data of the NF. The applicant did not reply or provide sufficient information on the identity (small particles and/or nanoparticles), stability, genotoxicity, reproductive and developmental toxicity and the human data for the NF. The applicant did not reply to the latest EFSA's request (in June 2022) for additional data. Based on the available data, the Panel concludes that the safety of the NF cannot be established.