EFSA Concludes Safety of Synthetic Cannabidiol Cannot Be Established Due to Major Data Gaps

"The European Food Safety Authority’s (EFSA) Panel on Nutrition, Novel Foods and Food Allergens (NDA) has announced that it cannot determine the safety of synthetic cannabidiol (CBD) as a novel food under Regulation (EU) 2015/2283. The conclusion follows a request from the European Commission, which sought EFSA’s scientific opinion on chemically synthesised (−)-cannabidiol intended for use in food supplements at up to 150 mg/day for individuals above 6 years of age, excluding pregnant and lactating women. During its assessment, EFSA identified significant data gaps across multiple safety domains. These included missing or insufficient information on: Identity (including presence of small particles/nanoparticles) Production process Compositional data and specifications Stability Genotoxicity Reproductive and developmental toxicity Human clinical data EFSA issued several requests for additional information to the applicant, including a final request in June 2022, but the applicant either failed to respond or did not provide adequate data. Due to these unresolved information gaps, the Panel concluded that the safety of synthetic CBD as a novel food cannot be established. This opinion means the product cannot move forward toward EU market authorisation under the novel food framework."