In the draft statement, EFSA concludes the following:

• During the assessment of cannabidiol (CBD) as a novel food, in 2022 the NDA Panel identified significant data gaps. Concerns focused on potential adverse effects on the liver, gastrointestinal tract, endocrine, nervous, and reproductive systems. Literature searches to retrieve relevant animal and human studies have been conducted to cover the period from the previous statement until June 2024 and confirmed the persistence of these gaps, as many of the new studies suffer from methodological limitations, including non-standardized protocols, short durations, and concomitant treatment with medicine.
• Pharmacokinetic studies confirmed that CBD’s bioavailability is highly 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 effects emerging as sensitive endpoints. Human trials indicated hepatotoxic potential, especially 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 confirmed the concern for this endpoint.
• Neurodevelopmental effects following prenatal exposure were observed, suggesting long-lasting, sex-specific outcomes. Endocrine disruptions were noted, including altered thyroid hormone levels and adrenal histopathology. No studies directly addressed immunotoxicity, though CBD’s interaction with immune pathways warrants caution.
• To set a provisional safe dose, the Panel performed a benchmark dose modelling from GLP-compliant subchronic studies, deriving a provisional safe dose of 0.0275 mg/kg bw per day (2 mg/day for a 70-kg adult), by applying  an uncertainty factor of 400. This provisional safe dose applies solely to food supplement formulations  with CBD purity >95%, without nanoparticles and for which genotoxicity has been ruled ou
• The Panel  concludes that, based on all available data, the safety of CBD for individuals under 25, pregnant or lactating women, and those on concurrent medications, cannot be established.

EFSA - European Food Safety Authority

Siehe auch: nutraingredients.com