Natural CBD Applications Still in Limbo in the EU

Lack of progress with the applications and launch of the INCB’s Cannabis Initiative has caused growing concerns in the European CBD industry.

On December 2, 2020, the same day that the UN decided to remove cannabis and cannabis resin from the list of most dangerous drugs, the European Commission confirmed that CBD is not a narcotic.

Following the ruling of the highest European court, the Commission confirmed that CBD should not be considered a drug within the meaning of the United Nation Conventions. On an online press briefing on December 3, the European Commission’s spokesman for public health and food safety Stefan de Keersmaecker announced that the Commission started resuming their verification of the validity of the Novel Food applications.

Yet, more than 11 months later, there is still no approval for any of the 130-plus natural CBD applications. The Commission approved further synthetic CBD applications, amounting to the total of five that are in the risk assessment phase by the European Food Safety Authority.

The lack of progress with the applications is causing concern in the industry, with some representatives worried the Commission could take an u-turn on the status of CBD. These fears are fueled by the International Narcotics Control Board (INCB) launch of the Cannabis Initiative, aimed to ”set standards for the control of the cultivation, manufacture, and utilization of cannabis for medical and scientific purposes.”

No official position on CBD

Leading European cannabis industry expert Boris Baňas, founder and Chief Sales Officer of Czech company CBDepot expressed his concerns to BusinessCann.

“Last summer the EC switched their position saying they viewed CBD as a Schedule I narcotic drug within the meaning of the UN Single Convention. Then following the KanaVape decision, they concluded cannabidiol cannot be considered a drug if manufactured lawfully in another EU Member state.”, he said.

“However, this has yet to be ratified by the EC executive branch. So almost one year on there is still no official position on the status of CBD. Whether hemp/CBD products are narcotic drugs has yet to be confirmed or refuted and some promised EC discussions with the industry on this – known in EC language as a Civil Dialogue – have now been postponed on two occasions.”, he added calling the present state of the industry ‘a limbo’.

Mr. Baňas added: “In the eyes of the INCB any extract of cannabis is a narcotic drug unless from the pure seeds and therefore such extracts – those from the green parts of the plant – are a controlled substance, and should only be reserved for medicinal use.

“The hemp sector made itself heard during the WHO review of Cannabidiol in 2017 and 2018 that all hemp derivatives should be considered as exempt from the scope of the Single Convention.”

The EC has confirmed to BusinessCann that it has received ‘over 130 Novel Food applications for hemp-derived products including CBD’.

“The Commission took note of the Court ruling in the (KanaVape) case and is carefully assessing the reasoning and conclusions it has reached, including on whether the judgment could apply to other cannabinoids as well.”, they stated.

“We are following carefully the discussions in the context of the INCB’s ‘Cannabis Initiative’ and we attended the intergovernmental meetings organized by INCB on the draft ‘Guidelines on the international drug control requirements for the cultivation, manufacture, and utilization of cannabis for medical and scientific purposes.

“We consider that it is important to maintain the coherence and compatibility of international law with the EU acquis and we are taking into account in our own assessment the work carried out by INCB. Our work is however independent from the INCB initiative, including as far as timing is concerned.”, a ‘Commission Official’ told BusinessCann.

INCB as a ‘secretive organization’

Speaking to the same media outlet earlier this year Lorenza Romanese, Managing Director of the European Industrial Hemp Association called the INCB a ‘secretive organization’.

“The proposals refer to CBD as still being ‘under control’, but completely ignore the ruling by the European Court of Justice last year in the KanaVape case.

This judgment clearly states that CBD extracted from cannabis plants should not be regarded as a narcotic drug in the light of the spirit and letter of the 1961 Convention.”, she said.

The Commentary of the Single Convention 1961

Sasha Bajilo, the founder of Ilesol Pharmaceuticals commented on the subject with the following statement: ”The hemp industry has for decades been held hostage to a misinterpretation of the UN Single Convention 1961. The government’s arbitrariness concerning hemp regulation and ignoring the Convention commentary published in 1962 has led to the practical closure of the hemp processing industry, along with a dozen different processing industries.

Twenty years ago, the hemp processing industry was slowly returning to various market niches. As industry participants and activists, we have put a lot of effort into educating governments and EU institutions step by step, all to increase industrial production and create new value.
The rule of law is a fundamental tenet of the EU. Any deviation or non-implementation of the decisions of the court of justice will not be tolerated by the industry.”

In the Commentary of the Single Convention 1961, page 322, article 28 Control of Cannabis, paragraph 2 of the Convention, stating ‘This Convention shall not apply to the cultivation of the cannabis plant exclusively for industrial purposes (fibre and seed) or horticultural purposes’ is explained in the following words:

This paragraph, however, only emphasizes what follows in any case from paragraph 1 prescribing the control regime applicable only to the cultivation of the cannabis plant for the production of cannabis or cannabis resin. Cultivation of the plant for any other purpose, and not only for the purposes mentioned in paragraph 2, is consequently exempted from the control regime provided for in article 23.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.