Scientists from the EFSA have established a provisional safe intake level for adults for cannabidiol (CBD) as a novel food, but have highlighted persistent data gaps.
The European Commission considers that CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods.
In the new, updated statement, EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) has set a provisional safe intake level for CBD of 0.0275 milligrams per kilogram of body weight per day (approximately 2 mg/day for a 70 kg adult).
When the available evidence is incomplete, EFSA’s scientists may set provisional safe intake levels.
The level includes an added safety factor (or uncertainty factor) to protect health despite uncertainties in the available data.
EFSA’s scientists will review the provisional safe level when the required toxicological and/or human data become available, either from applicants or in published research.
Food supplements
The provisional safe level applies solely to food supplement formulations containing CBD with a purity of at least 98%, without nanoparticles and for which the production process is deemed safe and genotoxicity has been excluded.
For individuals under 25 years old, pregnant and lactating women, as well as those on medication, EFSA’s scientists concluded that the safety of CBD cannot be established.
EFSA confirmed data gaps highlighted in its previous statement published in 2022, including for possible effects of CBD on the liver and endocrine, nervous and reproductive systems.
Applicants are responsible for filling data gaps. To support applicants in providing the missing information, EFSA held an information session in June 2022 and is now planning a follow-up webinar to take place in April of this year.
EFSA will proceed with the risk assessment of each CBD novel food application based on the data made available by each applicant.
