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.

EFSA journal. European Food Safety Authority • • Highly Relevant
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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.

💡 Key Findings

1
The EFSA panel concluded that synthetic CBD is safe under the proposed conditions of use, at a maximum of 2 mg per day for the specified adult population.
High
90%
2
In a 90-day oral toxicity study in rats, the liver was identified as the key target organ, with female rats more sensitive than males.
High
90%
3
The assessment found no concerns regarding genotoxicity based on the information provided.
High
85%
4
Safety could not be established for people taking medications, and important data gaps remained for reproductive and developmental toxicity.
High
95%

📄 Original Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on cannabidiol (CBD) obtained by chemical synthesis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of ≥ 98% (w/w) CBD and is intended to be marketed exclusively dissolved in medium-chain triglyceride (MCT) oil in food supplements at a maximum daily dose of 2 mg. The proposed target population is the general adult population over 25 years old and excluding pregnant and lactating women. The safety of CBD in individuals taking medications cannot be established. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The NF is not considered to be nutritionally disadvantageous, and no concerns were identified with respect to genotoxicity. The applicant submitted a 90-day subchronic oral toxicity study with the NF in which the liver was identified as the key target organ, with female rats being more sensitive than males. A BMDL10 of 10.5 mg/kg bw of CBD per day was derived for increased liver weight relative to body weight in female rats. In view of the remaining data gaps, including those related to reproductive and developmental toxicity, the uncertainty factor proposed in the Updated Statement on the safety of CBD published by EFSA in 2026 (i.e. 400) was applied to derive a safe intake level for cannabidiol of 0.026 mg/kg bw per day (2 mg/day for a 70-kg adult). The Panel concludes that the NF is safe under the proposed conditions of use, except for people taking medication, for whom safety could not be established.

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