Regulatory Review

Updated January 7, 2021

International Regulatory Environment  

The dark consequences previously associated with cannabis use have been rendered largely inaccurate or exaggerated, with successful and well-regulated cannabis programs operating throughout the world – casting doubt on the validity and efficacy of the antiquated and excessively restrictive approach the international community continues to take toward cannabis. Thus, international bodies are beginning to revisit the topic under increased pressure from member states – especially those in Europe. In recent years, many medical cannabis markets have come online in Europe, and some countries have included CBD tinctures or CBD-dominant flower products in their medical programs or allowed for its sales outside formal cannabis channels altogether.  

World Health Organization (WHO) Rescheduling Recommendations   

In January 2019, the World Health Organization (WHO) formally recommended the rescheduling of cannabis and descheduling of CBD within the 1961 Convention on Narcotic Drugs, which currently sets global standards for drug policy. The recommendations were addressed to UN Secretary-General Antonio Guterres – who served as Prime Minister of Portugal when universal drug decriminalization took place in the country – and were broken down as follows:

  • Whole-plant cannabis and cannabis resin would remain Schedule I but removed from Schedule IV – the most restrictive category of the Single Convention on Narcotic Drugs (1961). Compounded pharmaceutical cannabis preparations, such as Sativex, would be placed in less restrictive Schedule III of the 1961 Convention.

  • Cannabidiol (CBD) and CBD-focused preparations containing no more than 0.2% THC would no longer be subject to international control.

This latter policy change would have permitted for the formal cultivation, production, sales, etc. of CBD products outside cannabis supply chains, without qualifying medical conditions as a prerequisite, and without international oversight, which would facilitate international commerce.  

United Nations Commission on Narcotic Drugs (CND)

In their 62nd session, on March 19, 2019, the UN Commission received the note from the Secretariat on changes in the scope of control of substances, which contained the scheduling recommendations by WHO on cannabis and CBD. The Commission decided to postpone voting twice to give states time to consider the complex recommendations. When the vote finally took place in December 2020, the Commission elected to reschedule cannabis, but did not remove CBD from international control. Various concerns about the approach of the CBD descheduling recommendation were cited, for example that it might introduce legal ambiguities or unintentionally authorize THC extracts.

Novel Foods Policy

Under European Commission regulations, any food that was not consumed “significantly” prior to May 1997 is considered to be a Novel Food. The category covers new foods, food from new sources, new substances used in food as well as new ways and technologies for producing food.”

Although they are not legally binding, authorities of European countries use Novel Foods regulations as a reference to enforce health and safety laws inside their borders. Following the January 2019 re-classification of extracts of cannabis as Novel Foods, the corresponding regulations on CBD were reinforced by a European Food Safety Authority (EFSA) determination that CBD was an extraction of the hemp plant that had not been largely consumed prior to 1997. As a result, European states were increasingly pressured to uphold the Novel Foods regulatory framework and make it unlawful for companies to bring any CBD ingestible (note: not cosmetic or inhalable) product to market without first applying for and receiving authorization from the European Commission. In fact, the largest economies in the region have enacted Novel Foods policy for CBD, though the UK case has been atypical. The UK Food Standards Agency (FSA) announced in early 2020 that those looking to legally market ingestible CBD products would have to submit a valid application for Novel Food authorization to the FSA (which will work in collaboration with the Novel Foods Commission and follow similar procedures) prior to March 31, 2021 in order to keep product on shelves beyond that date.

Before placing a novel food on the European market, the applicant must submit to the Commission an online application for authorization in line with the requirements of Article 10 of the Regulation. After the Commission adopts an implementing act authorizing the placing of the product on the market and updating the Union list, food business operators can place their product on the European market. If the product is liable to have an effect on human health, the Commission will request the European Food Safety Authority (EFSA) carry out a risk assessment. Theoretically, the EFSA is able to adopt an opinion on each application within 9 months, and within the following 7 months, the Commission should submit a draft implementing act authorizing placement on the market and updating the Union list – though no product has yet received marketing authorization. Once the act receives a favorable vote from the Standing Committee and is adopted and published by the Commission, the novel food can be lawfully placed on the market.

However, to date, greater than 40 applications have been received by the European Commission requesting Novel Foods authorization for CBD products, and no product has been authorized for commercialization. Details of only a small handful of CBD authorization applications have made their way onto the EFSA and European Commissions' websites.

To further complicate matters, in July 2020, the European Commission surprised applicants by suspending all Novel Food applications for plant-based CBD products – announcing that since CBD extract is derived from hemp, the ingredient should be labeled as a narcotic (citing the UN Single Convention of Narcotic Drugs) and not be used as a consumable ingredient. At the time, given the UK’s distinct approach to Novel Foods, a rush to apply for Novel Foods/FSA authorization and get products on UK shelves ensued, as this was the first viable formal path to mainstream CBD legalization seen in the region.

However, following a subsequent CJEU ruling (detailed below), the Commission walked back its declaration, beginning to process EU Novel Food applications once again in December 2020.

European Court of Justice Ruling (Kanavape)

A significant ruling by the European Court of Justice (CJEU) was finalized on November 19, 2020, impacting not only the French market for CBD - which had been non-existent due to a blanket ban placed in 2019 - but all other EU Member States’ CBD markets. Kanavape (the defendant and CBD company prosecuted by French authorities) had claimed that under the EU’s Free Movement of Goods Policy, so long as product was legally sourced, it could be legally sold in another member state. The CJEU sided with the defendant, finding that it would be ‘contrary to the purpose and general spirit’ of the 1961 UN Single Convention to consider CBD a narcotic, despite that the cannabinoid is technically an “extract of cannabis”. This ruling invalidated the French ban, though it allowed for the possibility that authorities restrict CBD sales in the future if based on scientifically backed public health concerns. As the CJEU’s ruling on CBD’s classification is binding on EU institutions, including the European Commission and its Novel Foods Committee as well as the Member States - irrespective of the UN CND’s recent decision not to deschedule CBD - the move essentially legitimized European CBD across the region, put the onus on countries to justify regulatory moves before enacting them, and opened the door for a thriving market.

While there are many factors at play, in the immediate term, inhalable and topical (cosmetic) products types, and the companies excelling in these segments, are likely to increase their share of market in the region, with ingestibles – primarily tinctures and capsules – temporarily taking a backseat everywhere except the UK. These are expected to make a comeback when Novel Food-authorized products begin to circulate in the wider European market.

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