Last week the European Commission (the “Commission”) withdrew its preliminary position on the treatment of hemp-derived cannabidiol (“CBD”) and other extracts from the flower tips of the Cannabis sativa L. plant as narcotics under the UN Convention on Medicinal Products 1961 Narcotics (the “Single Convention”). We were relieved to see this development; Loyal readers of this blog may recall how problematic the Commission’s preliminary position really was.
The change in the Commission’s position resulted from the recent decision of the Court of Justice of the European Union (the “ECJ”) – Europe’s highest court – that CBD, which comes from the entire hemp plant, is not a narcotic within the meaning of the Single Convention. and should therefore be freely traded between the member states of the European Union (“EU”).
Although the ECJ has admitted that “a literal interpretation of the provisions of the Single Convention could lead to the conclusion that […] CBD […] extracted from a plant of the genus cannabis […] represents a cannabis extract [….]”, The court also noted that:
Since, according to the current state of scientific knowledge, CBD does not contain a psychoactive component, it would be contrary to the purpose and general spirit of the Single Convention to include it under the definition of “drugs” for the purposes of this Convention as a cannabis extract. ”
The judgment of the ECJ was significant because it became binding for all EU member states as well as for the Commission, which decided this summer to review around 25 existing applications for approval of new CBD foods on the basis of a literal and therefore incorrect Interpretation of Interrupting the United Convention.
This positive twist means that CBD products will not be banned from the EU market and that European regulators have resumed the review of these existing applications for approval of novel CBD foods.
If you recall, the EU revised its food catalog as early as 2019, classifying all new food products infused with the cannabis plant or its derivatives, including CBD, as “novel foods”. According to Regulation (EU) No. 2015/2283, a “novel food” is a food that was not used essentially for human consumption in the European Union before May 15, 1997. Therefore, a novel food must be approved by the Commission and the European Food Safety Authority (“EFSA”) – the European counterpart of the Food and Drug Administration – before it can be lawfully marketed.
Although hemp extracts have been consumed in Europe for centuries, EFSA stated that there is no evidence that hemp-derived cannabinoids, including CBD, were consumed prior to the 1997 date. As a result, such products must undergo the novel food authorization application process.
The landmark decision of the ECJ as well as the decision of the Commission to treat CBD products as legitimate goods should help to clarify and harmonize the fragmented CBD laws and regulations of the EU member states. Shortly after the ECJ ruling was published, the EU member states, including a group of German legislators, expressed the need to regulate the manufacture, sale and marketing of CBD products in the EU without delay.
It goes without saying that these recent developments represent a huge step towards creating a more competitive European CBD market that may even facilitate the dismantling of international trade barriers.
If you’d like to learn more about this issue, join us next week for a free one-hour webinar.