Cannabis under different controls
On 2 December 2020, the UN Economic and Social Council’s Commission on Narcotic Drugs voted on recommendations from the World Health Organization Expert Committee. This has made some changes in the classification of cannabis, but not as far-reaching as producers and suppliers of cannabis products had hoped.
Reclassification of cannabis and cannabis resin
Cannabis and cannabis resin are narcotic drugs covered by the 1961 United Nations Single Convention on Narcotic Drugs (as amended by the 1972 Protocol). So far, they have been included as “cannabis and cannabis resin” in Schedule IV to the Single Convention, alongside such drugs as highly addictive opioids. Thus they were subject to all the control measures provided for in the convention, like other narcotic drugs, and to special controls laid down in the convention which any state-party to the convention may introduce in accordance with its assessment of the seriousness of the danger inherent in the properties of a narcotic drug, as well as with a view to protect public health and well-being. As a result of the approved reclassification, cannabis and cannabis resin were removed from Schedule IV. Now they will be included in the general list of narcotics, i.e. Schedule I.
Justifying his support for this reclassification, the German representative, who expressed the position of the 27 EU countries (the EU has observer status in the commission), stated that while remaining in Schedule I cannabis will be controlled in accordance with the requirements of the Single Convention, but at the same time it will be more accessible for research into its medical use in accordance with the practice of an evidence-based drugs policy.
Status of products containing CBD
Extracts and tinctures from cannabis and cannabis resin have been removed from Schedule I. Thus, they are no longer classified as narcotic drugs and are no longer subject to controls foreseen by the Single Convention. However, this does not mean that products containing them are left completely uncontrolled. Now, in many countries, they will be controlled exclusively by agencies responsible for food safety, such as the Food and Drug Administration in the US and the European Food Safety Authority in the EU, and relevant agencies in the member states—agencies that have been overseeing these products for some time.
In EU member states, hemp seeds (of approved species), oil from such seeds, seed flour, and shelled hemp seeds are freely traded, as these products were considered to have a consumption history dating back before 15 May 1997. Products derived from other parts of the plant, in particular extracts including hemp extracts, have been deemed “novel foods” and can be placed on the market after undergoing a registration procedure. These products contain cannabidiol (CBD) in their composition, the effect of which is considered relaxing, but scientific research has not yet provided indisputable grounds to exclude adverse effects of CBD on the organisms of healthy people. This precautionary stance has been adopted consistently for several years by the sanitary inspectorate in Poland. It has ordered the withdrawal of products containing CBD from the market, and those decisions have been upheld in complaints to the administrative courts (e.g. judgment of the Province Administrative Court in Białystok of 12 October 2020, case no. II SA/BK 388/20).
In their analyses and work on CBD-containing products, regulators around the world have yet to adopt a fairly uniform position on the medically allowable quantity of CBD for daily consumption. Currently, the EFSA is processing an application for registration of a supplement with a recommended maximum daily intake of 130 mg as a novel food. The Food Standards Agency in the UK indicates that a healthy adult should not consume more than 70 mg of CBD per day, which would translate into e.g. 28 lozenges with 5% CBD content, and the South African regulator allows a dose of 20 mg of CBD per day. It is clear that when determining the level of daily CBD consumption in foodstuffs, individual countries will take into account not just medical aspects, but also sociological or cultural factors, so there will probably be differences in this respect.
International control over narcotics
The commission also voted in favour of a recommendation to move two forms of THC from the UN Convention on Psychotropic Substances of 1971 to Schedule I of the Single Convention, thus reclassifying them as narcotic drugs controlled under the Single Convention. On the other hand, a recommendation was voted down that would have excluded preparations with a predominant amount of cannabidiol (CBD) and no more than 0.2% dronabinol (THC) from international controls by adding a footnote to that effect under the entry “cannabis and cannabis resin” in Schedule I. Among other things, the commission members pointed out that there was no scientific evidence to support the appropriateness of setting a 0.2% limit for THC in such products, and criticised the different treatment of cannabidiol compared to other cannabinoids that are also non-psychoactive agents. They called for further consultations with a view to establishing appropriate international controls for such products within the existing framework, while ensuring protection of public health and welfare.
The drafting of the WHO recommendations and the debate over them, within the member states of the Commission on Narcotic Drugs and at the December session, have undoubtedly contributed to a better knowledge of cannabis and the effects on the human body of the substances it contains, in particular cannabidiol. However, this has not led to the presentation of scientific evidence justifying a general liberalisation of controls over these substances. Hopefully, food approval authorities will obtain studies allowing them to register and admit food products containing CBD while maintaining the required level of food safety.
Court of Justice rules on scientific evidence
In its judgment of 19 November 2020 in C-663/18, HS, the Court of Justice of the European Union indicated that the assessment of the harmfulness of cannabis-derived products to human health is closely related to the state of scientific knowledge and therefore changes with the development of such knowledge. In criminal proceedings, a number of charges were brought against the directors of a French company, including unauthorised possession of narcotics. The product was a cannabidiol (CBD) liquid used in electronic cigarettes, with a trace amount of THC, always below the legal limit. The liquid was produced in the Czech Republic in compliance with local law and constituted an extract from the entire Cannabis sativa plant.
Among other issues, the court analysed the concept of narcotic drugs under French and international law. Applying a purposeful interpretation of the Single Convention, i.e. with a view to protecting the physical and mental health of humans, and in light of scientific reports finding that CBD is not a psychoactive substance, the court concluded that the whole-plant extract cannot be included in the definition of narcotic drugs. As a result, the court held that the ban on sale of the CBD liquid was unjustified and, under Art. 34 of the Treaty on the Functioning of the European Union, was a measure equivalent to quantitative restrictions.
Drawing on its extensive case law, the Court of Justice also formulated the premises to be met by a member state when applying a measure restricting the free movement of goods on grounds of public health protection. Among other things, it pointed to the need to refer to the state of scientific research to demonstrate uncertainties regarding certain substances used for human consumption, and to refer to the scientific results available at the time of issuing the decision to prove the necessity of prohibiting the sale of the products concerned as posing a real risk to public health. The risk assessment should establish the likelihood of harmful effects of the use of the prohibited products on human health and the seriousness of those potential effects. These cannot be purely hypothetical considerations.
The court did not deny member states the right to apply the precautionary principle, in the form of adoption of protective measures in a situation of high scientific and practical uncertainty. However, this must be preceded by a thorough understanding of potential negative health effects and a comprehensive health risk assessment based on the most reliable scientific data and the latest research findings. Thus the court set a high bar for restricting the free movement of non-narcotic cannabis products.
The principles formulated by the Court of Justice to be applied in relations between member states in assessing the admissibility of hemp products on their markets are unlikely to be directly applicable to the activities of national regulators. This is hampered by binary food safety rules and the precautionary principle, applied with equal rigor to products used daily by an overwhelming majority of consumers as well as products selectively chosen by consumers with a much higher level of awareness.
Perhaps the work on registration of cannabis products as novel foods, based on a growing understanding of the effects of the substances contained in cannabis, will lead the EFSA to review its position and narrow the category of novel foods with respect to such products.
Dr Ewa Butkiewicz, attorney-at-law, Life Science & Regulatory practice, Wardyński & Partners
