The European Union flipflops and declares that the CBD is not a narcotic, but the cannabis compound remains subject to international controls. EFSA’s scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.
Europe’s CBD Conundrum
CBD is a regulator’s nightmare. Just the fact it comes from the cannabis plant means no amount of rebranding as a wholesome wellness supplement can shift the ingrained mistrust and hostility felt by regulators. Throw in the millions of consumers clamouring to buy every kind of CBD -infused product imaginable and it’s understandable why governments should want to bring some order and regulation to the party.
And Europe is no exception. Only Europe is not some homogenous mass, but 27 countries interpreting laws from an overarching political and economic union. However, when it comes to CBD , even European Union ( EU ) agencies such as the European Food Safety Authority ( EFSA ) haven’t been able to figure out how to regulate it.
Europe’s Wild West
Let’s take a step back to a time when CBD was a word whispered on the peripheries of society. In some European countries such as France, hemp farming was nothing new. But using the buds and flowers to make a sticky oil sold to customers over the internet certainly was.
A select few European CBD companies blazed a gentle trail. Before long, however, hundreds of new CBD companies, many with ‘green rush’ Euro signs in their eyes, had sprung up across the union. Just like the CBD -crazed madness that swept across the US , we had our own version of this cannabinoid Wild West.
But the European Union lives and breathes rules and regulations, and hundreds of thousands of Europeans were imbibing a hemp product, which hadn’t yet been classified. That situation needed regulating – fast.
Based on the fact that CBD (at least for the moment) was not considered a narcotic, it officially became classified as a food and as such came under the domain of the European Food Safety Authority ( EFSA ).
Novel or Not Novel?
A main driver in EFSA ’s modus operandi is to protect consumers from food-related risks, which includes the consumption of any ‘novel’ foodstuff that was not commonly consumed prior to May 1997. (That’s how the term ‘novel’ is applied in EFSA regulations.) Only novel foods that have been authorised and proven safe can be sold in the EU . But that process is both lengthy and costly.
The shockwaves throughout the European hemp industry were palpable with many predicting the end of hemp farming in Europe as we know it.
‘Well that’s OK ,’ you may be thinking. Hemp has been part of our diets for thousands of years, right? And for a while EFSA appeared to be in agreement.
However, all that changed in January 2019 when with very little fanfare EFSA added all cannabinoids to the novel food catalogue, including extracts, any products to which cannabinoids have been added, and synthetic cannabinoids in food.
The shockwaves throughout the European hemp industry were palpable. No more so than within the European Industrial Hemp Association ( EIHA ), which had tried unsuccessfully to prove the historic use of all parts of the hemp plant in food.
After howls of protest and a period of tactical adjustment, most players within the European CBD industry reluctantly started the costly novel foods authorisation process.
The KanaVape Case
To many CBD movers and shakers, this novel food episode felt like a temporary bump in the road that required some start-up style pivoting to get back on track again.
However, in France, a legal battle was rumbling on, which, depending on its eventual outcome, could throw more cannabinoid cats amongst the pigeons.
In January 2018, the founders of KanaVape, a company selling CBD vape products, were given a suspended 16-month sentence by a French tribunal and fined €10,000 after a four- year legal battle. Their crime? The CBD in their products was extracted from cannabis sativa flowers imported from the Czech Republic; in France using any parts of the plant other than fiber and seeds was illegal.
This case highlighted what was essentially the elephant in the room for the European CBD industry: that a literal interpretation of the 1961 Single Convention of Narcotic Drugs’ definition of cannabis (which included any resinous parts of the plant) could result in CBD products being classed as a narcotic.
While this decision effectively shut down the legal CBD market in France, most of the rest of Europe carried on selling their CBD products hoping the French view was just a local matter.
That seemed to be where things were headed. Just over a year later in May 2019, Evgeni Tanchev, the Advocate General in the European Court of Justice gave a preliminary non-binding ruling that CBD was not a narcotic and as such CBD oil products made from the whole hemp plant could be freely traded across EU member states.
Still, a secure future of the European CBD industry was not yet guaranteed as this preliminary view would have to be confirmed in a final ruling – although in most cases the Advocate General’s preliminary view is upheld. But the legal muddle around CBD is not like most cases.
European Commission Throws CBD Narcotic Curveball
By now hemp farmers, CBD oil suppliers and CBD companies were used to the European Commission and EFSA continually shifting the goal posts. But what happened next left everyone in the industry scratching their heads and considering their options.
A literal interpretation of the 1961 Single Convention of Narcotic Drugs’ definition of cannabis could result in CBD products being classed as a narcotic.
In July 2020, the European Commission ( EC ) notified around 50 companies that had applied for novel food authorization that their applications had been paused because the Commission believed CBD to be a narcotic. As a curious aside, novel food applications for synthetic CBD were not interrupted.
CBD industry insiders had erred in assuming that this whole narcotic issue had been clarified by the European Court of Justice ruling just two months earlier.
“If they had read the press releases from the Court of Justice properly, they would have known that there could be a problem shortly afterwards because the final decision [re: CBD ’s legal status] was expected in autumn 2020,” says lawyer Kai-Friedrich Niermann.
Nierman found the EC position perplexing. “If I were the European Commission, I would have waited until the end of this proceeding, as I know that the European Court of Justice can interpret the EU law at the final stage.”
While rumours abounded about backhanders from pharmaceutical companies keen to shut down the European CBD market, Nierman himself believes it was simply a question of the left hand not knowing what the right was doing.
“No one knows how the European Union works at this level. There are some services in the background of the Commission, legal services not located in Brussels, but somewhere in Luxembourg. It’s like a black box… And they are working on these legal opinions, trying to help the EU Commission’s different departments in their view and in their assessments. And so, there was some sort of mistake, I guess.”
Another likely factor: the upcoming Dec. 2 vote of the United Nations Commission on Narcotic Drugs ( CND ) on whether to amend the cannabis entry in Schedule 1 of the 1961 Single Convention and remove CBD preparations with less than 0.2% THC (recommendation 5.5).
Marijuana Business Daily reported how at a virtual CND meeting in June 2020 EU member states had remained ominously silent when discussing this particular recommendation. Could the EC view that CBD was a narcotic be some kind of hint on how European countries might vote in December?
Whatever the rationale, the EC announcement about CBD sent shock waves around the hemp industry with many predicting the end of hemp farming in Europe as we know it.
Common Sense Prevails
A glimmer of hope rested on the final decision of European Court of Justice in the KanaVape case on the 19th November.
On this occasion the Court didn’t disappoint. It ruled: “The provisions on the free movement of goods within the European Union are applicable, since the CBD at issue in the main proceedings cannot be regarded as a ‘narcotic drug’.”
Rumours abounded about backhanders from pharmaceutical companies keen to shut down the European CBD market.
In what appeared to be a victory for good old fashioned common sense, the Court found that a literal approach to interpreting the 1961 Single Convention “in so far as it is a cannabis extract, would lead to the classification of CBD as a narcotic drug, [and] such an interpretation would be contrary to the general spirit of that convention and to its objective of protecting ‘the health and welfare of mankind’.”
Also highlighted was CBD ’s lack of psychotropic effect and good safety record, as well as the inconsistencies from a public health standpoint of classifying cannabis-derived CBD as a narcotic, while allowing the sale of synthetic CBD products.
A collective sigh of relief echoed around the European hemp industry when this news was announced, with key stakeholders calling on the European Commission to amend its position on CBD so that companies can resume their applications for novel food authorization.
And while it ain’t over until the fat lady sings, from a legal point of view Kai-Friedrich Niermann didn’t doubt that the Commission would eventually follow suit and classify CBD as a food once again.
“The European Court of Justice definitely said that hemp extracts are legal commodities, and the interpretation of the European Court of Justice is final. It’s a so-called precedent and the other EU institutions and courts in the member states have to follow that interpretation.”
A Bumpy Ride
The European Commission officially reversed its position, declaring that CBD is not a narcotic, after all, on Dec. 2, the same day the UN ’s CND voted to reschedule cannabis in recognition of the plant’s therapeutic utility.
However, there was still the issue of whether to remove CBD products containing less than 0.2% THC from international control, as recommended by the WHO . Here Niermann was less confident of a positive outcome, but this time not because of any disagreement over whether or not CBD is a narcotic.
Only a few weeks before the UN vote, the European Parliament had increased the threshold for THC in industrial hemp from 0.2% to 0.3%, in line with levels in the United States. So already, the WHO recommendation was out of step with the EU ’s position, making a collective ‘no’ vote likely. Which is exactly what happened, as EU countries all voted against recommendation 5.5, citing a lack of scientific evidence for the 0.2% THC limit and insufficient legal certainty in the drafting of the amendment as reasons for their decision.
It seems, then, while a more coordinated approach to Europe-wide CBD regulation is on the horizon, we remain a long way from the holy grail of global CBD harmonization. And this means that the CBD industry could still be in for rather a bumpy ride.
Mary Biles, a Project CBD contributing writer, is a journalist, blogger and educator with a background in holistic health. Based between the UK and Spain, she is committed to accurately reporting advances in medical cannabis research. Visit her website here.
Copyright, Project CBD . May not be reprinted without permission.
Cannabidiol novel food evaluations on hold pending new data
Cannabidiol is a substance that can be obtained from Cannabis sativa L. plants and be synthesised chemically as well. The European Commission considers that CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods. Following the submission of numerous applications for CBD under the novel food regulation, the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans.
Data gaps and uncertainties
EFSA’s expert Panel on , Novel Foods and Food Allergens (NDA) has received 19 applications for CBD as a novel food, with more in the pipeline.
Chair of the NDA Panel, Prof. Dominique Turck said: “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”
There is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being.
Studies in animals show significant adverse effects especially in relation to reproduction. It is important to determine if these effects are also seen in humans.
Support to applicants
Ana Afonso, Head of Nutrition and Food Innovation at EFSA, stated: “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”
As part of the follow-up, EFSA is holding an info-session, open to applicants and other groups or individuals with an interest in this issue and novel food more generally. The online event takes place on 28 June – register to attend!