For some time, the regulatory framework applicable to cannabis products in Europe has been widely recognised as being particularly complex. As a result of this, companies frequently struggle with successfully navigating the regulatory regimes applicable in each country in which they sell. This looks set to continue as new UK requirements come into force on 1 April 2021.
- It is a patchwork system – regulated nationally and without a pan-European approach that is a hallmark of the EU legal system.
- Cannabis-containing products trigger the application of both sector-specific product regulatory frameworks and criminal law frameworks across Europe, and the interaction between the two systems is often unclear and disparate.
- The legal allowable limits of THC across European jurisdictions varies greatly, is not immediately apparent, and often (especially where a 0% limit strictly applies) does not necessarily consider the technical limitations of harvesting CBD from cannabis plants by allowing (even non-detectable) trace presence of THC.
- Absent a clear legal position regulators across Europe have taken very different approaches to enforcement of regulations.
Authorisation required to sell CBD-containing foods in the UK from 1 April 2021
Cannabis-containing food, in addition to being subject to these regulatory complexities, has also be the subject of specific judicial focus and a particularly disparate approach from food regulators across Europe.
Since January 2019, CBD has been listed as a ‘novel food’ under EU Regulation 2015/2283. If a food product, ingredient or the manufacturing process is classified as novel, then safety assessments must be undertaken and the product must be authorised before entering the EU market.
Food regulatory bodies across Europe chose to act on this classification in different ways. Spain and Austria removed CBD food and drink products from their markets entirely until they receive the requisite novel foods authorisation, whereas the UK permitted the ongoing sale CBD products that existed on the UK market in January 2019 until 31 March 2021.
However, in July 2020, the European Commission announced all pending applications for CBD products to be regulated as novel foods should be paused. There were concerns that, regardless of compliance with applicable regulatory frameworks, such products would violate criminal laws - CBD may constitute ‘an extract of cannabis’ and may therefore be considered a ‘drug’ as defined by the UN Single Convention on Narcotic Drugs 1961.
On 19 November 2020, the CJEU ruled that CBD cannot be regarded as a narcotic under the 1961 UN Convention given that the current scientific knowledge does not suggest that CBD contains psychoactive ingredients.
Following the ruling, and the regulators’ resumption of processing applications, over 50 companies that had applied to register their products as novel foods within the EU were able to resume their applications to market their CBD products.