Greece has sharply narrowed its legal market for hemp-derived cannabinoid products, effectively forcing full-spectrum CBD oils and some other natural extracts off shelves under rules that demand virtually no THC and restrict which cannabinoids may be sold.
The crackdown follows a Sept. 15 circular from the Greek Ministry of Health providing enforcement guidance under legislation adopted in July. The rules are forcing Greek hemp businesses to withdraw or reformulate products that had been legally sold for years.
The restrictions add another layer of difficulty for CBD in Greece, a European Union member state where ingestible cannabinoid products already face the EU’s restrictive novel foods regime – and are being sharply criticized.
“The Minister of Health is setting Greece back 15 years in terms of regulating the legal cannabis market, while creating conditions of unfair competition and monopolistic exploitation for the benefit of specific business interests,” said Michalis Theodoropoulos, a longtime Greek hemp industry leader and founder and CEO of organic hemp producer KANNABIO.
Redefining what’s permitted
The new law, adopted in July, rewrote Greece’s definition of permitted cannabis products. The law recognizes qualifying cosmetics and food supplements and a separate category of products that contain “exclusively cannabidiol (CBD).”
That language creates problems for natural hemp extracts, which typically contain multiple cannabinoids. Full-spectrum CBD oils contain trace THC along with CBD and minor cannabinoids such as CBG, CBC and CBN. Broad-spectrum formulations generally remove THC while retaining some of those other cannabinoids.
The previous Greek definition was considerably broader, covering, simply, products derived from Cannabis sativa varieties containing up to 0.3% THC and products containing CBD.
The new law also strengthened inspections and requires cannabis retailers to certify that their products comply with the revised framework.
‘Brutal’
The Ministry of Health followed is also providing guidance to regulators and businesses on identifying prohibited cannabis products.
Kannabio said products containing THC appear to be prohibited regardless of concentration.
Kannabio said its full-spectrum extracts typically contain less than 0.2% THC, while broad-spectrum products can retain quantifiable traces below 0.05%. It said some formulations will now have to be changed, including replacing natural full-spectrum extracts with CBD isolate.
Even highly purified plant-derived CBD can retain minute traces of other cannabinoids, potentially creating uncertainty over how literally regulators will apply the requirement that products contain CBD “exclusively.”
“The result is a brutal redistribution of the market: small and medium-sized industrial hemp producers are losing the products in which they invested, while large, vertically integrated medical cannabis companies are placed in a distinctly more advantageous position to fill the resulting gap,” Theodoropoulos said.
Prescription cannabinoid medicines remain governed under the medicinal framework. That includes pharmaceutical CBD such as Epidyolex and Greece’s broader prescription medical-cannabis system.
Minor cannabinoids
The law also appears to threaten products based on minor cannabinoids even when they contain no measurable THC.
Greek legal analysis of the legislation says broad-spectrum extracts and products containing CBG and other minor cannabinoids fall outside the new definition because they contain cannabinoids other than CBD. That potentially removes an emerging class of cannabinoid products that companies have developed as the conventional CBD market weakened.
The restrictions apply separately from Greece’s rules for foods and food supplements, which are tied to EU food law.
EU clampdown
The European framework had already left CBD businesses with an increasingly narrow path.
Cannabidiol and other cannabinoids are considered novel foods under EU rules, and require authorization before they can legally be marketed as foods. Greek authorities have previously stated that no EU authorization has been granted for cannabinoids used as foods or food ingredients.
The commercial outlook became even more difficult this year when the European Food Safety Authority established a provisional safe intake level for CBD of just 0.0275 milligrams per kilogram of body weight, equivalent to roughly 2 milligrams per day for a 70-kilogram adult.
That level is far below doses traditionally offered by the CBD wellness industry and has raised questions over whether authorized products could be commercially meaningful.
The drawn-out novel foods process has already helped shrink Europe’s CBD sector, eliminating or weakening many companies that entered during the market’s earlier boom.
‘Power to survive’
Theodoropoulos argues that the changes in Greece favor larger, highly capitalized pharmaceutical and cannabinoid companies capable of meeting increasingly stringent production and regulatory requirements, while squeezing out smaller hemp businesses selling natural extracts.
“This is the Greek formula: first, you allow a market to develop; then, you strip smaller businesses of the products they created; and finally, you leave the field open only to those with the financial, technological and political power to survive,” he said.