Statement on safety of cannabidiol in food and pharmaceutical contexts

A statement on safety of cannabidiol [1] by EFSA defines the scientific and regulatory framework that governs the use of cannabidiol (CBD) in foods and pharmaceutical products in the European Union. In the pharmaceutical field, authorities assess CBD as an active substance with defined dosing, purity standards and clinical evidence. In contrast, food regulators evaluate CBD as a novel food ingredient intended for the general population. Therefore, the safety threshold must reflect chronic exposure and vulnerable groups. At the same time, manufacturers explore CBD as a functional ingredient in beverages, confectionery and supplements. Consequently, the discussion links toxicology, risk assessment and consumer protection with market innovation.

EFSA assessment and scientific background

The EFSA publication builds on the earlier scientific statement issued in 2022. At that time, EFSA concluded that significant data gaps prevented a full safety assessment of CBD as a novel food. In particular, the Panel identified uncertainties regarding liver toxicity, endocrine effects, neurological development, reproductive toxicity and potential drug interactions. Moreover, many available studies relied on pharmaceutical doses that exceeded typical dietary exposure. As a result, EFSA could not establish a clear no-observed-adverse-effect level for long-term intake through foods.

In its 2026 update, EFSA refined its risk assessment and proposed a provisional safe intake level for adults of 0.0275 mg per kilogram of body weight per day. Thus, a 70 kg adult would reach a provisional limit of roughly 2 mg per day. However, EFSA limited this value to highly purified CBD isolates that meet strict specifications. In addition, the Panel excluded vulnerable groups such as pregnant or breastfeeding women, people under 25 years of age and individuals taking medication. EFSA derived the intake level from human data that showed increases in liver enzymes at higher doses. Therefore, the authority applied conservative uncertainty factors to protect consumers.

Nevertheless, EFSA emphasised that this value remains provisional. Further toxicological, reproductive and long-term studies must reduce the remaining uncertainties. Consequently, the scientific evaluation continues, and applicants must provide robust data packages.

Regulatory status, critical debate and market perspectives

Currently, the novel food applications for CBD remain under evaluation in the EU. Although companies have submitted numerous dossiers, EFSA has paused several assessments because applicants have not yet closed key data gaps. Therefore, no fully authorised CBD food ingredient exists at EU level to date.

At the same time, some scientific bodies and national authorities express strong reservations. Critics argue that the current evidence base does not justify broad market access. In particular, they point to potential liver effects, endocrine modulation and drug interactions. Consequently, some stakeholders call for strict limits or even a ban on CBD in foods until long-term data become available.

However, if regulators confirm safety under defined conditions, CBD-containing foods could offer structured and quality-controlled options for adult consumers. For example, clearly specified low-dose products could replace unregulated grey-market offerings. In addition, harmonised EU rules would increase transparency, product quality and consumer confidence. Therefore, a science-based authorisation pathway may improve market order and legal certainty without relying on health claims.

Looking ahead, EFSA will reassess its conclusions once new studies address the identified uncertainties. Subsequently, applicants may update their dossiers with refined toxicology, human data and exposure modelling. If the evidence supports safety, the European Commission could grant novel food authorization with defined conditions of use. Thus, the regulatory process remains dynamic and evidence driven.

High-Quality Ingredients Ready for Product Development

High-quality ingredients such as CBD Powder 6% can play a decisive role in responsible product development. When manufactured under controlled conditions, with defined cannabinoid specifications, validated analytical methods and full laboratory batch testing, such an ingredient supports precise dosing and reproducible formulation. Consequently, manufacturers can design products that align with the provisional intake guidance set out in the statement on safety of cannabidiol. Standardized concentration, purity control and contaminant screening also reduce variability and help mitigate the risk of unintended excessive intake. Therefore, rigorous quality assurance at ingredient level forms a key foundation for safe consumer products in the evolving CBD novel food market.

Conclusion and outlook

Statement on safety of cannabidiol marks a pivotal step in the European risk assessment of CBD in foods. EFSA now provides a provisional intake level, yet it maintains a precautionary stance. Although interest in CBD as a functional ingredient continues to grow, scientific rigour must guide market access. Therefore, future progress depends on high-quality data, transparent risk assessment and consistent regulatory enforcement. If stakeholders close the current knowledge gaps, CBD food solutions may develop within a clearly defined and consumer-protective framework.

References

[1] EFSA Journal 2026;24(3):9862 doi: 10.2903/j.efsa.2026.9862