EFSA says the safety of isolated CBD could not be established

Safety of cannabidiol isolated from Cannabis sativa L. 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 safety assessment examined whether CBD isolated from Cannabis sativa L. could be considered safe as a novel food under European Union regulations. The proposed product contained ≥98% w/w CBD, was made through extraction and purification steps, and was intended for use in food supplements at a maximum intake of 60 mg/day for adults, excluding pregnant and lactating women. This was a regulatory risk assessment based on submitted evidence, not a clinical trial testing health benefits.

During its review, the panel identified missing information about the product’s identity, manufacturing process, composition, specifications, genotoxicity, reproductive and developmental toxicity, and human data. The applicant did not provide the requested additional information. Based on the available evidence, EFSA concluded that the safety of this CBD novel food could not be established. This abstract-based summary cannot determine whether the product is harmful or safe in practice; it reports that the available data were insufficient for a safety conclusion.

💡 Key Findings

1
The assessment concerned CBD isolated from Cannabis sativa L. as a proposed novel food for adult food-supplement use.
High
95%
2
The proposed product contained ≥98% w/w CBD and had a stated maximum intake of 60 mg/day.
High
95%
3
EFSA identified data gaps involving composition, production, genotoxicity, reproductive and developmental toxicity, and human evidence; the applicant did not provide the requested information.
High
98%
4
Based on the available evidence, the safety of the novel food could not be established. This does not by itself establish that the product is unsafe; it means the abstract reports insufficient evidence for a safety determination.
High
98%

📄 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) isolated from Cannabis sativa L. as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of ≥ 98% w/w CBD. The NF is produced via ethanol extraction, followed by winterisation, filtration, decarboxylation and crystallisation. It is intended to be used as an ingredient in food supplements at a maximum intake of 60 mg/day. The proposed target population is the adult population, excluding pregnant and lactating women. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, EFSA requested additional information on the identity, production process, compositional data, specifications, genotoxicity, reproductive and developmental toxicity, and human data of the NF. The applicant did not reply to these data requests. Based on the available data, the Panel concludes that the safety of the NF cannot be established.

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