The EU marketing authorisation of cannabidiol oil (CBD) as novel food has been put on hold by the EU’s food safety agency (EFSA) as more data on the effect of this lighter chemical compound extracted from hemp plants on human health is needed.
On Tuesday (7 June), the EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) said the data collected so far is considered either insufficient or inadequate in order to draw conclusions on the safety of CBD as a novel food.
CBD is a lighter chemical compound extracted from hemp plants containing less than 0.2% of the active substance tetrahydrocannabinol (THC), which can be obtained from Cannabis sativa L. plants and be synthesised chemically as well.
In particular, EFSA experts stressed that there is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, and nervous system, as well as on people’s psychological well-being.
The assessment also pointed out that studies in animals show significant adverse effects in relation to reproduction, adding that it is important to determine if these effects are also seen in humans.
According to Ana Afonso, EFSA head of nutrition and food innovation, “stopping the clock on a novel food assessment is not unusual when information is missing”.
Novel food is defined as food that was not consumed to any significant degree in the EU before 15 May 1997, when the first novel food legislation entered into force.
This food category refers either to newly synthesised compounds derived from new sources or produced using new technologies, or food traditionally eaten outside of the EU.
A scientific assessment carried out by EFSA is a requirement for the EU marketing authorisation of the new food.
An updated EU novel food regulation came into force in January 2018 in a bid to make it easier and quicker for food businesses to bring new and innovative foods to the EU market while maintaining high levels of food safety.
Unauthorised novel foods may not be placed on the market within the EU as such, or used in or on foods, while member states have the main responsibility for the complete and correct application of the EU legislation.
CBD can be found in several food products and supplements outside the EU including sweets, confectionery, baked goods, beverages, and oils.
Another stop in an already long process
Since January 2019, when CBD was included in the novel food catalogue, EFSA has received 19 applications for CBD as a novel food, with more in the pipeline.
However, after the CBD inclusion in the novel food catalogue, the European Commission decided to put the marketing authorisation process on hold because of uncertainty surrounding the possible classification of CBD as an extract of cannabis.
The General Food Law, the EU regulation governing the marketing authorisation of foodstuff in the single market, excludes from the definition of ‘food’, narcotic or psychotropic substances within the meaning of the two United Nations Conventions on psychotropic substances and on narcotic drugs.
In December 2020, the UN Commission on Narcotic Drugs (CND) voted to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs, solving the CBD issue at its root.
Only one week before, the European Court of Justice (ECJ) ruled that CBD did not appear to have any psychotropic effect or any harmful effect on human health, according to the current state of scientific knowledge.
After the ECJ ruling and the UN decision, the European Commission concluded that CBD should not be considered a drug and can therefore be listed in the novel food category, de facto reopening the authorisation process in December 2020.
But EFSA’s stop may deal another severe blow to the nascent EU industry of hemp-derived products.
“It is important to stress at this point that we have not concluded that CBD is unsafe as food,” commented Dominique Turck, the chair of the EFSA expert panel.
Currently, the EFSA is engaging with applicants to explain how the additional information can be provided to help address the uncertainties, EFSA’s Ana Alfonso explained.
Products containing CBD may also be considered medicinal ones in accordance with the rules laid down in the Medicinal Products Directive, while CBD has already been authorised as a drug to treat some epilepsies that do not respond to usual drug treatments.
[Edited by Zoran Radosavljevic]