EFSA Establishes Provisional Safe Level for Cannabidiol (CBD) Intake in Adults

On February 9, 2026, the European Food Safety Authority (EFSA) updated its safety statement regarding cannabidiol (CBD) as a novel food. The update establishes a provisional safe intake level for CBD with a defined scope of application, outlines data gaps in its safety research, and confirms that EFSA will continue to advance the risk assessment of CBD.

The European Commission considers CBD to qualify as a novel food, provided it complies with the relevant EU novel food regulations. When existing safety evidence is incomplete, EFSA may apply an additional safety factor (or uncertainty factor) to set a provisional safe intake level to protect consumer health. Should applicants or newly published studies provide additional toxicological or human trial data, EFSA will reassess the provisional safe level accordingly.

In this update, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) established a provisional safe level of 0.0275 mg CBD per kg body weight per day. For a 70-kg adult, this corresponds to an intake of approximately 2 mg/day.

Conditions for the provisional safe level: This provisional safe level applies only to healthy adults aged 25 years and above, consuming food supplements containing ≥98% pure CBD, free of nanoparticles, and produced via processes deemed safe with genotoxicity risks excluded. For individuals under 25 years of age, pregnant or breastfeeding women, and those taking medications, the provisional safe level is not applicable, as the safety of CBD in these populations remains uncertain.

EFSA had previously highlighted data gaps regarding CBD in its statement on June 7, 2022. The current update confirms those findings and evaluates newly published studies. EFSA noted that the pharmacokinetics of CBD and the long-term effects of CBD on the liver, nervous system, reproductive system, and immune system remain uncertain. Applicants are responsible for filling these data gaps. To assist applicants in providing the necessary data, EFSA held an information session in June 2022 and plans to host a follow-up webinar in April 2026.

EFSA emphasized that it will continue to assess the risk of CBD in each novel food application based on submitted data, ensuring that CBD products are safe and reliable.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

References

Provisional safe level for cannabidiol as a novel food

Update of the statement on safety of cannabidiol as a novel food