The regulatory domain of cannabis has been lately impacted by a number of international developments. Focusing particularly on the EU perspective, let us have a look at the most recent updates that have happened in the last six months.
The EU Parliament voted to increase the limit to 0.3 % THC
The European Parliament has voted in October 2020 to increase the permissible THC limit for industrial hemp in the EU. This amendment will follow the ordinary legislative procedure and become official EU law during 2021.
The increase was widely motivated by the industry in order to bring the sector up to the same level as in most countries around the world, such as, for instance, in theUSA and China..
Besides, there are supporters of an even higher tolerance of THC in hemp, since higher permissible levels of THC would enable higher yields of other cannabinoids of interest in consumer products. This would bring benefits to both manufacturers and consumers with lower costs of production and raw materials.
ECJ C-663/18, Kanavape judegment
A life-defining moment for the whole hemp and CBD sector was provided by the so-called Kanavape Judgement in November 2020. As already explained, the European Court of Justice clarified that CBD cannot be defined as a narcotic substance based on the current scientific knowledge, and it is not subject to the discipline set out by the United Nation Single Convention on Narcotic Drugs of 1961. The ECJ has further explained that any literal interpretation deeming CBD a narcotic substance would contravene to the spirit of the Convention.
In addition, the Court also pointed out that all parts of hemp plants can be used in an extract, provided that the limit on THC content is fulfilled.
Cannabis removed from schedule IV of 1961 UN SC
Few days after the delivery of C-663/18, another historic even took place: the UN Commission on Narcotic Drugs voted, on the December 2, 2020, to remove Cannabis from schedule IV of the UN SC. However, cannabis remains listed in schedule I of the Convention, as such, it remains subject to the international level of control reserved to narcotic substances.
Although, from a regulatory perspective the vote does not really have a significant impact on consumer products, it does have a specific weight from a policy and political perspective: schedule IV was only reserved to the most dangerous substances with no intended medical use; as such, the vote was strongly needed to correctly update the scientific understanding of cannabis and its compounds on the international policy level. The change will allow wider possibilities for important scientific studies and investigations to help patients and the general development of cannabis-based medicines.
CosIng update reflecting the outcome of C-663/18
Following the Kanavape judgement, the CosIng (Cosmetic Ingredient Database by the European Commission) was updated to incorporate the clarifications provided by the European Court of Justice. As it was/The Court made clear that whole-plant hemp extracts are allowed for use, CosIng has finally listed CBD whether derived naturally or synthetically as unrestricted. This is an important clarification, considering the previous stance from some Competent Authorities prior to C-663/18 judgment, which indicated only synthetically produced CBD was allowed for use in cosmetics.
Additionally, CosIng also provides a general Cannabinoids restriction that applies in those cases where manufacturers are interested in using any other cannabinoids in cosmetic products: it is pointed out that cannabinoids shall be prohibited for use when derived from controlled substances in schedule I of the UN SC. This simply means that cannabinoids cannot be derived from drug type cannabis plants with higher levels of THC, but can be derived exclusively from hemp plants fulfilling the limit on THC content, while any applicable national narcotic legislation must be taken into account.
Finally, another ingredient that is gaining more and more interest for manufacturers and consumers is Cannabigerol, a minor non-psychoactive cannabinoid for which CosIng has a dedicated entry. This cannabinoid is also referred to as ‘Mother of all cannabinoids’, as it serves as a precursor molecule from which the other cannabinoids in the plant get converted to. From a regulatory perspective, the same considerations we made for CBD and the other cannabinoids applies to Cannabigerol.
Alessandro Polimeno
Regulatory Affairs Expert Consultant
R&D Department
23/04/2021
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