European Food Safety Authority (EFSA)

On 9 February 2026, the European Food Safety Authority (EFSA) published an update regarding the safety assessment of cannabidiol (CBD) as a novel food. The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel) established a provisional safe intake level of 0.0275 mg/kg body weight per day, corresponding to approximately 2 mg/day for a 70 kg adult.​​

This level was derived using a highly conservative approach that applied an uncertainty factor of 400 to the available toxicological data, reflecting the significant data gaps still present in the scientific literature on CBD safety.

Importantly, the proposed intake level does not represent a formal authorization for CBD as a novel food. Instead, it is a provisional safety benchmark intended to support ongoing risk assessments while additional scientific data are generated.
It is important to note that EFSA statement refers specifically to highly purified CBD preparations (≥98% purity) used in food supplement formulations, produced through well-characterized manufacturing processes and not containing nanoparticles.

Behind the assessment: precautionary regulatory process

The establishment of this provisional intake level is the result of a cautious and ongoing regulatory process within the EU novel food framework.

On November 3, 2025, EFSA assessed a novel food application concerning synthetic CBD. The NDA Panel concluded that the available evidence was insufficient to establish safety due to incomplete information on the substance’s identity, manufacturing process and toxicological profile.
No CBD ingredient – natural or synthetic – has yet received authorization as a novel food in the European Union.

Cosmetics sector reflections: the CMR substances knot

Although the EFSA opinion concerns ingestion, the European cosmetics sector follows developments closely.
In parallel, the Scientific Committee on Consumer Safety (SCCS) has been mandated by the European Commission to conduct a comprehensive safety assessment of cannabidiol used in cosmetic products. The evaluation aims to determine:

• the maximum concentration of CBD considered safe in cosmetics
• acceptable levels of THC as a contaminant
• potential safety concerns related to other cannabinoids.

In January 2026, the SCCS published a preliminary opinion.

At the same time, a harmonised classification proposal submitted to the European Chemicals Agency (ECHA) suggests classifying CBD as Reproductive Toxicity Category 1B (H360FD, H362) under the CLP Regulation.

If such classification were adopted, CBD could automatically fall under Annex II of the EU Cosmetic Products Regulation, which lists substances prohibited in cosmetic products, unless the SCCS concludes that its use is safe under specific conditions.

While the EFSA opinion relates to ingestion rather than dermal exposure, the toxicological concerns identified for systemic effects – particularly regarding the reproductive system – may influence the broader regulatory debate on CBD safety across different sectors.

Burden of proof: the crucial role of industry

One of the key messages emerging from EFSA’s statement is that the current evidence base for CBD remains insufficient to support a definitive safety conclusion.

The provisional intake level therefore represents a temporary risk-management tool, rather than a final regulatory endpoint. EFSA has explicitly highlighted the lack of robust data on several critical endpoints, including liver toxicity, endocrine effects, gastrointestinal impacts, and particularly reproductive toxicity.

Under the EU Novel Food Regulation, the burden of generating these data lies primarily with the applicants submitting novel food dossiers. Additional toxicological studies, well-designed clinical investigations, and improved characterization of CBD preparations will be necessary to address the current scientific uncertainties.

Until these gaps are adequately filled, the regulatory pathway toward authorization of CBD as a novel food in the EU is likely to remain highly cautious and evidence driven.

>>> Complife experts help companies generate and verify the scientific evidence required to bring products to the European market, supporting compliance in both nutraceutical and cosmetic applications.

 

SOURCES:
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2026.9862