EFSA journal. European Food Safety Authority · 2026
Safety of cannabidiol isolated from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283.
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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, De Henauw Stefaan, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Cubadda Francesco, McArdle Harry J, Trezza Viviana, Albert Océane, Beneventi Elisa, Laganaro Marcello, Nuin Garciarena Irene, Rossi Annamaria, Berrío Cruz Sebastián, Seminati Francesca, Magani Maura, Hirsch-Ernst Karen Ildico
Аннотация
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.