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.