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.
The application process to ensure that products are compliant and are regulated as novel food products is fairly complex and is set out in retained EU Law under Regulation (EU) 2017/2468. Applicants will need to provide various information including (but not limited to):
- The product manufacturing processes
- Compositional data
- History of use
- Absorption, distribution, metabolism and excretion data
- Toxicological information, including studies undertaken or propose to undertake with clear details of the reasoning for the tests.
Each application for novel foods status is considered on its own merits.
In the UK, companies have only until 31 March to have such authorisation granted. Novel food applications will be subject to an eight day admin check and the FSA has indicated that it may take up to 30 working days for an application to be validated.
In cases where CBD products are sold from 1 April 2021 in UK without the requisite approval, local authorities will be responsible for enforcement of novel food regulations and will make specific enforcement decisions based on the facts of individual cases and circumstances. These may include a fine and/or in rare instances imprisonment.
Practical steps for companies selling CBD-containing food products in the UK
The imminent deadline for novel food applications for CBD-containing food products is significant for all companies selling relevant products in the UK.
Companies must act now by doing the following:
- Finalise UK applications: Whilst the deadline for UK CBD-containing food products is drawing closer, and companies are unlikely to meet this deadline given projected timelines, companies are encouraged to continue to press forward with applications on the basis a pending authorisation may be preferable to the position of not having begun the process at all.
- Apply for other relevant authorisations across Europe: Other European countries already have authorisation processes in place that must be complied with before marketing and these should be commenced as early as possible in the product launch process.
- Consider ongoing regulator relationship: Companies should be transparent and seek guidance and collaboration with the regulator as they navigate this transition.
- Reassess product portfolio: Companies should consider their product portfolio, identify affected products, and consider their forward-looking compliance plan.
- Consider future marketing strategy: The additional regulatory steps required for the sale of CBD-containing food products in UK should be taken into account in any future market strategy to ensure enough time is given to allow the process to run its course.
- Keep up to date on regulation of cannabis-containing products in Europe: In what signals a potential first step towards a much-anticipated harmonised approach across Europe, the CJEU case also stated that EU member states may not ban the marketing of CBD when extracted from the cannabis sativa plant in its entirety and not solely from its fibre and seeds. Article 34 and 36 of the Treaty on the Functioning of the European Union (TFEU) apply to allow the free movement of goods of CBD within the EU. Companies should continue to monitor the trajectory of the regulation to plan accordingly.
As the ever-changing regulatory landscape for cannabis products continues to evolve, we are seeing disputes and queries around regulatory issues, including corrective actions such as recalls. We anticipate that these issues will continue for months if not years to come as the UK, Europe and global policy makers seek to navigate this complex regulatory landscape.
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