Provisional safe level for cannabidiol as a novel food
EFSA’s scientists have established a provisional safe intake level maximum amount that can be confidently concluded to pose no risk of adverse effects in the population for adults for cannabidiol (CBD) as a novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997 but 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.
Provisional safe level
In an updated statement, EFSA’s expert Panel on Nutrition The science of how diet relates to the body's need for sustenance, 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 (approximately 2 mg/day for a 70 kg adult).
When the available evidence is incomplete, EFSA’s scientists may set provisional safe intake The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet levels. The level includes an added safety factor - or uncertainty Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment 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 Foodstuff containing concentrated amounts of nutrients or other substances that are intended to supplement the normal diet formulations containing CBD with a purity of at least 98%, without nanoparticles, and for which the production process is deemed safe and genotoxicity When a substance is capable of damaging the DNA in cells has been excluded.
For individuals under 25 years old, pregnant and lactating women, and those on medication, EFSA’s scientists concluded that the safety of CBD cannot be established.
Data gaps
EFSA confirmed data gaps highlighted in its previous statement published on 7 June 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.
Next steps
EFSA will proceed with the risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation of each CBD novel food application based on the data made available by each applicant.
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