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Pharmacokinetic studies confirmed that CBD's bioavailability is variable, influenced by delivery matrix and food intake. Its ability to cross the placenta and accumulate systemically raises further safety concerns. Animal studies revealed consistent liver toxicity, with liver weight and histopathological changes emerging as sensitive endpoints. Human trials indicated hepatotoxic potential, particularly when CBD is used in combination with other medications. Gastrointestinal effects were reported at higher doses, while neurological and psychiatric safety data remain insufficient. Animal studies on reproductive toxicity reinforced the concern regarding this endpoint. Neurodevelopmental effects following prenatal exposure were observed, suggesting long\u2010lasting, sex\u2010specific outcomes. Endocrine disruptions were noted, including altered thyroid hormone levels and adrenal histopathology. No studies addressed immunotoxicity, though CBD's interaction with immune pathways warrants caution. The Panel performed benchmark dose modelling based on GLP\u2010compliant subchronic studies to identify a toxicological reference point. By applying an uncertainty factor of 400, a provisional safe dose of 0.0275 mg\/kg bw per day (approximately 2 mg\/day for a 70 kg adult) was derived. This provisional safe dose applies solely to food supplement formulations with CBD purity \u2265\u200998%, without nanoparticles, for which the production process is considered safe and genotoxicity is ruled out. The Panel concludes that, based on all available data, the safety of CBD for individuals under 25\u2009years of age, pregnant or lactating women, and those on concurrent medications, cannot be established.<\/jats:p>","DOI":"10.2903\/j.efsa.2026.9862","type":"journal-article","created":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T09:19:38Z","timestamp":1770628778000},"source":"Crossref","is-referenced-by-count":13,"title":["Update of the statement on safety of cannabidiol as a novel food"],"prefix":"10.2903","volume":"24","author":[{"name":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Turck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torsten","family":"Bohn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monta\u00f1a","family":"C\u00e1mara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"Castenmiller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefaan","family":"De Henauw","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1ngeles","family":"Jos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Maciuk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inge","family":"Mangelsdorf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Breige","family":"McNulty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Androniki","family":"Naska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Pentieva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfonso","family":"Siani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Thies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Cubadda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helle Katrine","family":"Knutsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harry J.","family":"McArdle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Moldeus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Neuh\u00e4user\u2010Berthold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josef Rudolf","family":"Schlatter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandros","family":"Siskos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviana","family":"Trezza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oc\u00e9ane","family":"Albert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Beneventi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene Nuin","family":"Garciarena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George E. 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