The year 2020 has ended with two great news for the world of cannabis. On one side, a new judgment by the Court of Justice of the European Union (CJEU) on November 19 where the court ruled that CBD "cannot be regarded as a narcotic drug" and therefore the distribution and marketing of cannabidiol should not be prohibited within the EU territory.
On the other, last December 2, 2020, the United Nations voted on the recognition of the medicinal and therapeutic potential of cannabis and urged to remove this substance from Schedule IV of the Single Convention on Narcotic Drugs, which includes the most dangerous substances with limited or no medical value, such as heroin. Thus, from now on, cannabis should only be classified under Schedule I of the aforementioned Convention, which includes substances that are addictive, are not so harmful to health and have a therapeutic value.
However, this change in the classification will not a great impact in terms of legalization since this reclassification simply means that the UN recognizes the therapeutic benefits and uses of cannabis. According to specialized lawyer César García-Vidal Escola, the scenario for the commercialization of CBD in Spain will be different depending on the type of derivative in question.
In the case of hemp flowers containing cannabidiol (CBD) but very low levels of THC, this lawyer advises that its sale will be subject to the authorization of the Spanish Agency for Medicine and Health Products (or AEMPS).
On December 2, the health division of the European Commission notified the European Industrial Hemp Association (EIHA) their decision that CBD may qualify and be regulated under food category, as the association explained the next day in a press release. However, this change in the criteria has not been officially published yet on the EU Official journal website by the European Commission, and cannabidiol is still included in the new foods catalogue or ‘novel foods’, a list of products that require a safety evaluation and official control before they can be marketed. "This new consideration does not exempt CBD from compliance with the requirements set forth in the regulations for novel foods” explains the lawyer about the decision notified to the EIHA. "Actually, as of today, it is indicated that there are applications for 'novel foods' in process," he adds.
According to our specialized lawyer, in Spain the Comisionado para el Mercado de Tabacos (or Commission for the Tobacco Market) informed in a public statement of November 27 that there are already some hemp-derived foods authorized for marketing in the European Union since they already have a history of safe consumption. These foods must be made exclusively from hemp seeds in the form of oils, hemp proteins or flours made with sativa strains with less than 0.2% THC.
The lawyer points out that it is foreseeable that, according to the new decisions adopted by the CJEU and the UN, will reactivate new regulations and authorizations but for the moment these innovative food products can only be distributed and marketed following the current EU Regulation 2015/2283 on novel foods.
Cosmetics made with CBD or other cannabinoids as ingredient are subject to Regulation (EC) No 1223/2009, like most cosmetic products. There are prohibited substances listed in its Annex II (entry 306) classified under Schedule I and II of the Single Convention on Narcotic Drugs, the first of which is still cannabis sativa. Nevertheless, new regulations still prohibit cannabidiols derived from cannabis extracts, tincture or resins, including flowers, leaves, stems, distillates and oils, or any other substance under Schedule I, as specified by the Cosmetic Ingredients Database of the European Commission (also known as CoSign). In the same list, there is a type of extract resulting from a suspension of lysed cells and derived from the stem of cannabis sativa, the Cannabaceae, that is listed as a permitted substance, despite the fact it is made from extracts of the resin present in the buds and stems.
Finally, the lawyer points out that in the case of e-liquids, liquids for vapers or electronic cigarettes containing CBD, its sale will be allowed only if it has been legally marketed in another country of the European Union previously, so it is necessary to check the certification of origin of the product in order to legitimize its sell and distribution.
The Spanish Commission for the Tobacco Market did not take into account, despite the fact it was published a week prior their statement, the CJEU latest judgment after the sentence on the Kanavape Case C-663/18, November 19, 2020.