Levels of tetrohydrocannabinol (THC) levels have been established for certain hemp foodstuffs, which may later govern the amount of THC allowed in ingestible cannabinoid products, experts working for the European Commission have confirmed.
Meanwhile, work also continues on the novel food status of CBD and implementation of the European Court of Justice (CJEU) ruling in the Kanavape case into EU and member state regulations.
The Expert Group for Agricultural Markets met in March in a Civil Dialogue Group (CDG) meeting that placed particular emphasis on hemp. The group discussed the permitted THC levels for hemp seed foodstuffs established by a 28th February meeting of the Standing Committee on Plants, Animals, Food and Feed (SCOPAFF) on Novel Food and Toxicological Safety.
The CDG discussed the Commission’s amendment of Regulation n. 1881/2006, increasing the maximum level of THC to 3 mg/kg for dry products, such as flour, seeds, and snacks and 7.5 mg/kg for hemp seed oil and how this could impact regulation of the sector. This is a binding regulation for all EU members, which will come into force 20 days after its publication in the Official Gazette.
The Commission also announced that it will work to further clarify a so-called “tolerance index” for THC levels in hemp seed foodstuffs. This is a range by which THC contaminants can exceed the limit established by the regulation without penalty.
“I think that such tolerance index for THC level on foodstuff could be between 40% and 50%,” said Giacomo Bulleri, an Italian lawyer specialising in cannabinoid-related issues and representing Italian association Agrinsieme at the CDG. “This would mean, for instance, that it would bring the maximum THC level in hemp seed foodstuffs up to 5 mg/kg for dry products and 10.5 mg/kg for hemp seed oil.”
Bullieri told CBD-Intel that this was a significant step forward as EU member states would eventually have a standard methodology for measuring THC contaminants in foodstuffs.
It could also lead to a permitted level of THC contaminants for products containing CBD or other cannabinoids currently considered novel—once a novel food application has been approved. Initially this would likely apply to foodstuffs containing CBD isolate. Applications for foodstuffs containing spectrum CBD would take longer and be more complicated, Bullieri said.
Addressing safety considerations
However, while an incremental THC limit for foodstuffs is good news for the sector, the THC limit does not apply currently to CBD as a food ingredient and this is an issue.
Companies submitting novel food applications must provide data showing that any trace amounts of THC are safe. This is particularly an issue with full-spectrum applications, according to Ludovic Rachou, president of the Union of Industrialists for the Valorisation of Hemp Extracts (UIVEC).
But without the incremental levels of THC contaminants applying to CBD products, at this stage there remains a lack of clarity on how much of those trace amounts of THC would be deemed safe, Rachou told CBD-Intel.
“Everyone is waiting for the EIHA [European Industrial Hemp Association] dossier on the study of the safe limit of THC on humans as it will be the first big study, but it will take time,” he said. He said it did not make sense to use the THC limits adopted for foodstuff for CBD products in the form of supplement.
EIHA managing director Lorenza Romanese also emphasised the work that remains to be done. “Today’s considerations will be useful to allow the Commission to respond when the operator asks questions or when the European Commission has to position itself,” she said.
However, there will be no written documents on the CDG’s considerations until the European Commission requests a decision by the College of Commissioners, which is not yet on the agenda, Romanese told CBD-Intel.
Nonetheless, she highlighted the continued work at all levels to implement the CJEU judgement on the Kanavape case, which confirmed that CBD was not a narcotic. This must still be fully integrated by the Commission but work was progressing, she said.
Rachou told CBD-Intel that the Kanavape ruling was the best thing ever to happen in Europe in the CBD realm. He said that during the CDG meeting the Commission reminded all the EU member states that they must follow the CJEU’s ruling and change their regulations to treat CBD as non-narcotic.
“Because it is a ruling from the highest court of the European Union and has primacy over national law, it has an automatic application to national law,” he said. “However, the ruling can have repercussions in EU law. The Commission is still trying to assess the Kanavape case’s impact on each regulation, for instance in the cosmetics sector or agricultural policy.”
Although the situation of CBD in cosmetics has not changed, Romanese highlighted the openness of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) on CBD. “It seems it has come to a well consolidated conclusion as it reaffirmed that CBD is not narcotic and operators are allowed to extract cannabinoids from certified hemp varieties,” she said.
She added that the EIHA was continuing to work on a toxicological study on CBD isolate and full spectrum on rats that it began in January in 2021 in partnership with French labs group Eurofins to assess the Tolerable Daily Intake (TDI) of CBD in foodstuffs.
In June the EIHA will also start a clinical trial involving 400 people to assess the Acute Reference Dose (ARfD) of THC in humans. It hopes to show a safe limit of 7μg/kg of body weight (BW) to match the levels established in Switzerland and help convince the European Food Safety Authority (EFSA) to raise its current 1 μg/kg BW limit.
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