Greece has severely restricted its legal market in hemp-derived cannabinoid-derived products. Full-spectrum CBD oil, and some other natural extractions are effectively forced off the shelves due to rules that demand virtually zero THC and restrict what cannabinoids they may be sold.
The crackdown comes in response to a circular issued by the Greek Ministry of Health on September 15, which provided enforcement guidelines under legislation passed in July. The rules are forcing Greek hemp companies to remove or reformulate products they had legally sold for many 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 for Health is setting Greece 15 years back in terms of regulation of the legal cannabis market while creating conditions of unfair competitiveness and monopolistic exploit to the benefit of certain business interests,” Michalis Theodoropoulos said, a Greek hemp industry veteran and the founder and CEO KANNABIO, an organic hemp producer.
Redefining what is permitted
The new law adopted in Greece, in July, redefined the definition of allowed cannabis products. The law recognizes qualified cosmetics and food supplement products, as well as a separate category of CBD-only products.
This language can cause problems with natural hemp extracts that typically contain multiple cannabis compounds. Full-spectrum CBD oil contains trace THC, along with CBD and other minor cannabinoids like CBG and CBC. Broad-spectrum formulations remove THC, but retain some cannabinoids.
The Greek definition of cannabis sativa was much more expansive, and covered products with THC up to 0.3%, as well CBD-containing products.
The new legislation also strengthens inspections. Cannabis retailers must certify that the products they sell comply with revised guidelines.
‘Brutal’
The Ministry of Health is providing information to businesses and regulators on how to identify cannabis products that are prohibited.
Kannabio stated that products containing THC are prohibited, regardless of the concentration.
Kannabio stated that its full spectrum extracts contain typically less than 0.2% of THC while broad-spectrum can retain quantifiable trace amounts below 0.05%. The company said that some formulations would have to change, such as replacing full-spectrum natural extracts with CBD isolator.
It is possible that even highly purified CBD derived from plants can contain minute traces other cannabinoids. This could create uncertainty about how regulators will interpret the requirement for products to only contain CBD.
The result is a harsh redistribution of market share: small and mid-sized industrial hemp companies lose the products they invested in, while large vertically integrated medical marijuana companies are in a much more advantageous position to close the gap,” Theodoropoulos stated.
Prescription cannabinoid medications remain under the medical framework. This includes prescription-only medical cannabis in Greece and pharmaceutical CBD like Epidyolex.
Minor cannabinoids
Even when products contain no THC, they are still subject to the law.
According to Greek legal analysis, products that contain CBG or other minor cannabinoids and broad-spectrum extracts do not fall under the new definition as they contain cannabinoids besides CBD. The new definition could remove a class of products that has emerged as the CBD market weakened.
These restrictions do not apply to the EU’s food laws or Greece’s food and supplement rules.
EU crackdown
CBD businesses had a very narrow path to follow in Europe.
Cannabidiol, along with other cannabinoids, are considered novel food under EU regulations and need authorization to be legally marketed as food. Greek authorities previously stated that EU authorization had not been granted to cannabinoids being used as food or ingredients.
Commercial outlooks became more difficult in 2014 when the European Food Safety Authority set a safe CBD intake level of 0.0275 mg per kilogram body weight. This is equivalent to 2 mg per day for an adult weighing 70 kg.
The CBD industry has traditionally used much higher doses, which raises questions as to whether the products approved by the FDA could have any commercial value.
The long novel food process has already contributed to shrinking Europe’s CBD industry, eliminating or weakening a number of companies that entered the market during its earlier boom.
‘Power to survive’
Theodoropoulos claims that changes in Greece favour larger, well-capitalized pharmaceutical and cannabinoid firms capable of meeting ever more stringent production requirements and regulatory requirements while squeeze out smaller hemp businesses which sell natural extracts.
He said: “This is the Greek Formula: First, you let a market develop, then you take away the products created by smaller businesses, and finally you only allow those with financial, technological, and political power to succeed.”
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