In recent years, a lot has changed worldwide for preparations of hemp (Cannabis sativa L.).
In November 2020, the European Court of Justice ruled that a Member State cannot prohibit the marketing of cannabidiol (CBD) legally produced in another Member State if it is extracted from the entire Cannabis sativa plant and not just from the fibers and seeds. It did not classify CBD as a narcotic because it has no psychotropic effect.[1]
In December 2021, the UN Commission on Narcotic Drugs voted to remove “cannabis and cannabis resin” from Schedule IV of the 1961 Single Convention on Narcotic Drugs, based on a scientific assessment by the World Health Organization.[2]
Consequently, CBD could qualify as food in Europe.
However, hemp extracts fall under the Novel Foods Regulation in the EU.[3] They must therefore be assessed for safety by EFSA before they are placed on the market. EFSA’s Expert Panel on Food, Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food with more in the pipeline.
However, in the summer of 2022, EFSA announced that its scientists cannot confirm the safety of cannabidiol (CBD) as a novel food for the time being due to data gaps and uncertainties about potential dangers associated with CBD intake.[4] This leads to a so-called clock stop of the requests until the applicants provide the required data.
In particular, EFSA experts stressed that there is insufficient data on the effect of CBD on the liver, the gastrointestinal tract, the endocrine and nervous system, as well as on people’s psychological well-being. The review also pointed out that animal studies show significant adverse effects related to reproduction, adding that it is important to determine whether these effects are also seen in humans.
To fill data gaps, at least 90-day animal toxicity studies would be required for the specific ingredient used in the products. These are quite complex and time-consuming studies that require a significant investment. As a result of the EFSA statement, some of the applications were therefore withdrawn.
According to a recent study[5], the available scientific literature allows calculation of a benchmark dose (BMD) and, via BMD response modeling, a lower confidence limit of BMD (BMDL) of 20 mg/kg body weight/day for hepatotoxicity in rats. Human data in healthy volunteers found elevations of the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA as a lowest observed adverse effect level (LOAEL).
The authors of the study suggest that those CBD products that are still available on the EU market despite the lack of a license should be considered “unsafe”. Products exceeding a reference dose of 10 mg/day should be considered “unfit for consumption”; while products exceeding the lowest observed adverse effect level (LOAEL) should be considered “harmful to health”. So it remains to be seen whether the applicants will succeed in collecting the necessary data and whether extracts containing cannabidiol will be authorized. In the meantime, all hemp extracts remain banned in the EU.
[1] https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-11/cp200141en.pdf, 14/03/2023
[2] https://en.wikipedia.org/wiki/Removal_of_cannabis_and_cannabis_resin_from_Schedule_IV_of_the_Single_Convention_on_narcotic_drugs,_1961, 14/03/2023
[3] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283, 14/03/2023
[4] https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.7322, 14/03/2023
[5] https://www.mdpi.com/2813-1851/2/1/5, 14/03/2023
[1] https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-11/cp200141en.pdf, 14/03/2023
[2] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283, 14/03/2023
[3] https://www.mdpi.com/2813-1851/2/1/5, 14/03/2023
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