EU Sets Provisional Safe Level for CBD as Novel Food
The European Food Safety Authority (EFSA) has established a provisional safe intake level for adults for cannabidiol (CBD) as a novel food, but data gaps remain.
CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods. The newly established provisional safe level applies only to food supplement formulations containing CBD with a purity of at least 98 percent, without nanoparticles, and for which the production process is deemed safe and genotoxicity has been excluded.
Specifically, EFSA’s Panel on Nutrition, Novel Foods, and Food Allergens (NDA) set a provisional safe intake level for CBD of 0.0275 milligrams per kilogram of body weight per day (mg/kg BW/day), equating to approximately 2 mg/day for a 70-kg adult.
For individuals under 25 years old, pregnant and lactating women, and those taking medication, EFSA’s scientists concluded that the safety of CBD cannot be established.
Provisional safe intake levels are set when there are gaps in the available scientific evidence. EFSA will reassess the provisional safe level when the required toxicological and/or human data become available, either from novel food applicants or in published research.
Existing data gaps include possible effects of CBD on the liver and the endocrine, nervous, and reproductive systems, which EFSA noted in its previous safety assessment of CBD as a novel food in 2022.
EFSA emphasizes that novel food 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 planning a follow-up webinar to take place in April.
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EFSA will proceed with the risk assessment of each CBD novel food application based on the data made available by each applicant.
The full update of the statement on the safety of CBD as a novel food can be accessed here.
