Applications for hemp extracts and natural cannabinoids under the EU’s Novel Food rules have been suspended by the European Commission, which has expressed a “preliminary conclusion” that extracts from the flowering and fruiting tops of the hemp plant should be considered a drug under the United Nations Single Convention on Narcotic Drugs of 1961.
Notification of the decision, delivered to current Novel Food applicants, drew a swift and strong rebuke from the European Industrial Hemp Association (EIHA), which criticized the move as “political, rather than legal, and absolutely not based on the latest scientific literature nor inspired by the current debate at the United Nations level.” EIHA’s comments came in a statement released today.
“Industrial hemp and its downstream products are not narcotic or psychotropic drugs, and therefore are clearly exempted from the scope of the Single Convention,” EIHA said, adding that current EU regulations on food and cosmetics make clear reference to that distinction.
“As a consequence of this opinion, submitting a Novel Food application will not be a viable option for operators in the hemp sector that strive to demonstrate the safety and legality of their products,” EIHA said in the statement. “If confirmed, this illogical position is likely to strike a final blow to the sector and deprive farmers of a low maintenance and profitable rotation crop with the potential for bringing environmental benefits.”
In a decision reached through a Commission inter-service consultation, the Novel Food approval process was halted over concerns about “CBD extracted from the flowering and fruiting tops of the hemp plant (Cannabis sativa).” The EC said the stoppage is a step in the process of providing EU Member States clear guidance on hemp extracts, particularly the highly popular and potentially lucrative CBD. “The Commission’s preliminary view is that CBD extracted from the flowering and fruiting tops of the hemp plant should be considered as a narcotic falling under the United Nations Single Convention,” the EC said.
Defining Novel Food
Europe’s Novel Food rules were created as a food safety mechanism to control new, genetically or synthetically produced food products before market entry. Under the guidelines, Novel Food is defined as food that was not consumed to a significant degree in the EU before May 15, 1997. If a food is considered “novel” it must undergo a pre-market safety assessment under the European Food Safety Authority (EFSA) before it can be legally marketed in the EU. That process has now been short-circuited as a result of the EC’s recent move.
“This preliminary view stands against any logic and is nothing but unfair,” said Lorenza Romanese, Managing Director at EIHA, which recently formed a consortium to consolidate various CBD ingredients into one Novel Food application covering a wide range of hemp food and extract products. The Association has planned a €3.7 million investment to commission studies on THC and CBD under its application, “in full transparency and under the monitoring of EFSA (the European Food Safety Association),” Romanese added.
EIHA clearly states that traditional hemp extracts, which have been consumed for centuries in the EU and worldwide, should therefore be considered as traditional food according to food regulations. Hemp extracts processed by new extraction methods should be subject to the respective legal frameworks of the Novel Food Regulation (EU) 2015/2283.
Although EIHA is consistent in their position that traditional hemp extracts should not fall under Novel Food rules at all, it started the consortium to give its members planning security and a path to get their products to market legally, and affordably.
Can Europe be bold?
“Countries such as the U.S., Canada, China and Switzerland are making headway,” Romanese said. “I wonder whether Europe will decide to be bold enough to pursue solutions that are really sustainable or, instead, choose to stand idle, gaping at the world moving ahead. Is the Green Deal spirit dead before its time?”
EIHA has repeatedly affirmed that industrial hemp is exempted from UN drug treaties, whose authors made a clear distinction between cannabis grown for the production of drugs, which falls under the scope of the treaties, and that grown for other purposes, which are exempt. The Association said its position paper on the Single Convention, first drafted last year, will soon be updated to reflect a common position supported by hemp associations from around the world.
Only for aliens?
After industrial hemp started to be regulated and subsidized by the European Economic Community Council (EEC) (precursor to the EC) in the 1970s, the European Commission in 1997 confirmed that parts of the hemp plant were defined as not being “novel,” according to EIHA. Inexplicably and suddenly, Novel Food rules were changed early in 2019 to re-classify hemp leaves and flowers as well as extracts derived from those plant parts – including CBD – as Novel Food.
The recent EC ruling is yet another blow to hemp food and extract producers in Europe, EIHA noted. Mused EIHA president Daniel Kruse: “What comes next? Industrial hemp gets classified as extraterrestrial, and only aliens but not our European farmers are allowed to grow and process it? And only other nations and ETs but not Europeans are allowed to consume it?”
Synthetics move ahead
While enriched and isolated – or traditional hemp extracts – are targeted in the EC’s preliminary decision, “Novel Food applications for synthetic CBD which is not extracted from the plant, continue in the approval process,” the Commission has said. Some applications for synthetic CBD have already been forwarded to the European Food Safety Authority for risk assessment, after the EC signed off on those dossiers as “valid.”
EIHA has agreed in an official position paper that synthetic and isolated CBD, as well as enriched extracts should be considered Novel Food, but the Association has strenuously argued that all extracts with natural composition of substances found in the industrial hemp plant should be exempt from the Novel Food approval process. The Association has repeatedly provided historical examples of such substances having been in the European diet for centuries.
EIHA said classifying natural extracts as drugs will inevitably damage the whole industrial hemp sector and lead to proliferation of a grey market for substandard products that do not adhere to food safety standards and labeling regulations.
“In an ideal world, the Commission would work hand in hand with the hemp sector and other institutions to ensure, in full transparency, a fair market for operators, as well as safe and quality products for consumers,” Romanese said. “The debate should not be around whether hemp extracts are a drug or food, but rather on coming up with scientific data to establish the maximum levels of daily intake and how to comply with safety standards.”
Authorizing synthetic, but not natural extracts, is “nonsense from a scientific and environmental point of view,” EIHA contends. “The final product that is obtained from a synthetic or natural CBD extract is the same in terms of chemical composition,” the Association said. Also, because the chemical processes carried out to produce synthetic extracts require energy, they are not as environmentally friendly as those derived from natural extracts, which minimize carbon as a byproduct.
More importantly, EIHA argues that promoting synthetic over natural extracts “will deprive farmers and food business operators from a market opportunity that is bound to generate an important revenue in these times of crisis.”
“If hemp extracts become a drug, it will not be the farmers and SMEs benefiting from the success of the hemp industry, but only those big companies that can afford the synthetic production of chemicals,” said Romanese. “That’s an absurdity we cannot afford nor accept.”
Effect on other hemp sectors
Giving up the most profitable commercial hemp application will also prevent the parallel development of value chains for the valorization of co-products (hemp fiber and shivs) that can be used for the production of paper, construction material, textiles, cosmetics and bio-based plastics, EIHA said.
“Not only is the hemp sector on the brink of losing a battle, but so is all of Europe,” Romanese said. “As a European citizen, I am disappointed that the Commission is not working for a constructive approach and is instead punishing a sector that, if given a chance, could contribute to speed up the transition towards a zero-emission, bio-based and sustainable economy and represents an additional revenue for our farmers, the backbone of the EU food market.”