EFSA finds synthetic CBD safe at proposed dose, with medication caveat
Safety of synthetic cannabidiol as a novel food pursuant to regulation (EU) 2015/2283.
AI Summary
This EFSA opinion assessed whether chemically synthesized CBD could be marketed as a novel food under EU regulations. The product contains at least 98% CBD, is intended to be dissolved in medium-chain triglyceride (MCT) oil, and would be used in food supplements at a maximum daily amount of 2 mg for adults over 25, excluding pregnant and breastfeeding women. The assessment found no safety concerns from the reported production process, composition, specifications, nutritional characteristics, or genotoxicity information.
A 90-day oral toxicity study in rats identified the liver as the key target organ, with female rats more sensitive than males. Based on the available evidence and remaining uncertainties—including gaps in reproductive and developmental toxicity data—EFSA derived a safe intake level of 0.026 mg/kg body weight per day, equivalent to 2 mg/day for a 70-kg adult. The panel concluded that the product is safe under the proposed conditions of use, but safety could not be established for people taking medication. This is an abstract-based summary; it cannot determine the product’s long-term safety, effects in humans, or safety during pregnancy or breastfeeding.
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