On 27 May 2026, the European Food Safety Authority (EFSA) published a scientific opinion concluding that cannabidiol (CBD) isolate from Cannabis sativa L. is safe for use as a novel food under Regulation (EU) 2015/2283. The opinion, which assesses the safety of purified CBD with a purity of at least 98%, marks a significant step toward potential EU-wide market authorisation for CBD isolate as a food ingredient, impacting manufacturers, consumers, and regulators.
The document, prepared by EFSA's Panel on Nutrition, Novel Foods and Food Allergens (NDA), evaluates data on toxicology, genotoxicity, and human exposure. EFSA established an acceptable daily intake (ADI) of 0.15 mg per kg of body weight, based on a no-observed-adverse-effect level (NOAEL) from a 90-day rat study. The opinion notes that CBD isolate does not raise concerns for genotoxicity or carcinogenicity at the proposed use levels, but highlights potential risks of liver toxicity and drug interactions at higher doses, recommending that maximum levels be set to ensure consumer safety.
As a scientific opinion, the document is not legally binding but serves as a risk assessment that the European Commission and Member States will consider in the authorisation process under the Novel Food Regulation. The opinion applies specifically to CBD isolate, not to full-spectrum extracts or other cannabinoids, which remain under separate evaluation.
EU food and supplement manufacturers of CBD products face a clearer regulatory pathway if the Commission adopts the opinion, potentially opening a harmonised market across Member States. However, the ADI may limit product concentrations, affecting product formulations and marketing claims. EU consumers gain assurance of safety for authorised products but may see reduced availability of higher-dose CBD supplements. National food safety authorities will have a scientific basis for enforcement, reducing fragmentation in the internal market. The novel food industry, including CBD producers, benefits from regulatory clarity but must comply with strict purity and labelling requirements.
The European Commission will now draft an implementing regulation to authorise CBD isolate as a novel food, likely including specific purity criteria, maximum levels, and labelling requirements. Member States will vote on the proposal in the Standing Committee on Plants, Animals, Food and Feed (PAFF). The process is expected to take several months, with potential authorisation in 2027.