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EFSA has published a scientific opinion on a carbon dioxide extract from industrial hemp varieties of Cannabis sativa L. submitted as a novel food for use in food supplements. The NDA Panel concluded that, based on the data provided, the product’s safety could not be established.
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The opinion concerns an extract obtained using carbon dioxide (CO₂). In practice, this means that plant constituents were extracted using supercritical CO₂ rather than conventional solvents such as alcohol or isopropanol. T
A key issue was that a substantial part of the composition remains uncharacterised, while the stability and toxicological studies were conducted with a material different from the novel food under assessment and produced using a different extraction process. EFSA also pointed to the lack of adequate data on the product’s safety for the proposed general population aged 3 years and above.
From a regulatory perspective, the opinion confirms that for hemp extracts, the mere presence of CBD is not sufficient to support a positive safety assessment. Full compositional characterisation, representative test material, and adequate stability and toxicological data remain essential elements of a novel food dossier.
