Novel Food applications for natural CBD suspended by Europe

Requests for Enforcement Novel Food for CBD natural products have been suspended by the European Commission (EC), which expressed a «preliminary conclusion » that extracts from the flowering tops of hemp should be considered a drug within the meaning of the 1961 United Nations Single Convention on Narcotic Drugs.

Notification of the decision was sent to applicants who applied for Novel Food authorization, whose’EIHA, which had submitted four applications on behalf of a consortium of companies.

«Industrial hemp and its derivatives are not narcotic drugs or psychotropic substances, and are therefore clearly excluded from the scope of the Single Convention,» he declared the EIHA, adding that current European regulations on food and cosmetics clearly refer to this distinction.

«As a result of this opinion, submitting a Novel Food application will not be a viable option for operators in the hemp sector who are striving to demonstrate the safety and legality of their products,» the EIHA stated in the press release. «If confirmed, this illogical position is likely to deal a final blow to the sector and deprive farmers of a low-maintenance, profitable rotation crop with the potential to provide environmental benefits.»

European regulations on novel foods were established as a food safety mechanism to regulate new genetically or synthetically modified food products before they enter the market. A novel food is defined as a food that did not have a history of significant consumption in the European Union (EU) prior to May 15, 1997. If a food is considered «novel,» it must undergo a safety assessment by the European Food Safety Authority (EFSA) prior to being placed on the market before it can be legally sold in the EU. This process for the CBD has now been bypassed due to the EC's recent decision.

«This preliminary view defies all logic and is anything but fair,« said Lorenza Romanese, executive director of the EIHA. »Countries like the United States, Canada, China, and Switzerland are making progress. I wonder if Europe will be bold enough to seek truly sustainable solutions or, on the contrary, remain inactive, gaping in the face of a world that is moving forward. Is the spirit of the Green Deal dead before its time?”

While enriched and isolated extracts and traditional hemp extracts are covered by the EC’s preliminary decision, «applications for novel foods for the Synthetic CBD »which is not extracted from the plant, are still undergoing the approval process," the Commission said. Some applications for synthetic CBD have already been forwarded to the European Food Safety Authority for risk assessment, after the EC reviewed these cases as «valid.».

Allowing synthetic extracts but not natural ones is «absurd from a scientific and environmental standpoint,» argues the EIHA. «The final product derived from a synthetic or natural CBD extract is the same in terms of chemical composition,» the Association stated. The EIHA also argues that promoting synthetic extracts over natural ones «will deprive farmers and food industry operators of a market opportunity that is sure to generate significant revenue during these times of crisis.».

«If hemp extracts become a medicine, it won’t be farmers and small and medium-sized businesses that will benefit from the success of the hemp industry, but only large corporations that can afford to produce chemicals synthetically,» said Lorenza Romanese. «This is an absurdity that we can neither afford nor accept.»

«Not only is the hemp sector on the verge of losing a battle, but so is all of Europe,» said Lorenza Romanese. «As a European citizen, I am disappointed that the Commission is not working toward a constructive approach and is instead punishing a sector that, if given the chance, could help accelerate the transition to a zero-emission, organic, and sustainable model and provide additional income for our farmers, the backbone of the EU food market.»