ICBC
This week the European Food Safety Authority (EFSA) set what it considers to be a “safe” consumption level for cannabidiol (CBD), and by many measures, the dosage level is very low.
“In an updated statement, EFSA’s expert 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 (approximately 2 mg/day for a 70 kg adult).” EFSA wrote in a news release.
“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.” EFSA also wrote.
“This compares with a limit of 10 mg per day in Britain, 12 mg per day in Switzerland, and a range of 20-200 mg per day, for a maximum of 30 days, in Canada, provided users discuss the use of all other medications and substances used with their pharmacist.” pointed out Reuters in its coverage of the announcement.
Several peer-reviewed studies and reviews have examined CBD dosage levels, safety, and efficacy for treating a wide range of conditions. One such example from 2023 was conducted by researchers affiliated with the University of Sydney.
“The review includes interventional studies that measured the clinical efficacy in any health condition and/or safety and tolerability of oral CBD dosed at less than or equal to 400 mg per day in adult populations (i.e., ≥18 years of age). Studies were excluded if the product administered had a Δ9 -tetrahydrocannabinol content greater than 2.0%. Therapeutic benefits of CBD became more clearly evident at doses greater than or equal to 300 mg. Increased dosing from 60 to 400 mg/day did not appear to be associated with an increased frequency of adverse effects.” the researchers wrote.
“At doses of 300-400 mg, there is evidence of efficacy with respect to reduced anxiety, as well as anti-addiction effects in drug-dependent individuals. More marginal and less consistent therapeutic effects on insomnia, neurological disorders, and chronic pain were also apparent.” the researchers concluded.
Ultimately, there are still other bureaucratic hurdles, decisions, and processes set to take place before CBD industry regulations are finalized for the wider European market, so only time will tell what impact the announced EFSA standard will have.
Provisional safe level for cannabidiol as a novel food
EFSA’s scientists have established a provisional safe intake level for adults for cannabidiol (CBD) as a novel food 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, 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 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, 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 of each CBD novel food application based on the data made available by each applicant.
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https://www.efsa.europa.eu/en/news/provisional-safe-level-cannabidiol-novel-food








