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EFSA has published an updated statement on the safety of cannabidiol (CBD) as a novel food. The NDA Panel confirmed that the significant data gaps already identified in 2022 remain unresolved and that the available evidence continues to raise concerns, particularly for the liver, gastrointestinal tract, endocrine, nervous, and reproductive systems.
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In its updated statement, EFSA derived a provisional safe dose of 0.0275 mg/kg body weight per day, corresponding to approximately 2 mg/day for a 70 kg adult, but only for food supplement formulations containing CBD with a purity of at least 98%, without nanoparticles, and only where the production process is considered safe and genotoxicity has been ruled out.
At the same time, EFSA concludes that, based on all available data, the safety of CBD cannot be established for individuals under 25 years of age, pregnant or lactating women, or people taking concurrent medications. EFSA also points to continuing concerns regarding hepatotoxicity and CBD interaction with drug metabolism.
From a regulatory perspective, this publication does not represent a breakthrough towards a near-term authorisation of CBD as a novel food in the EU. On the contrary, EFSA’s updated position confirms a highly cautious scientific and regulatory approach to the oral use of CBD in foods and food supplements.
