CBD In The Novel Food Regulation
Navigating the legal and regulatory landscape of CBD in Europe is critical for businesses looking to enter this growing market. At the heart of this is the CBD Novel Food Regulation, which governs the safety and authorization of CBD products as food or food ingredients within the European Union. Since its inclusion in the Novel Food Catalogue in 2019, CBD has faced rigorous scrutiny, requiring scientific evidence and compliance with EU standards. This article explores the evolving CBD Novel Food Regulation, the challenges businesses face, and how Essentia Pura is actively working to ensure compliance while maintaining the quality and safety of its CBD products.
2019
In January 2019, Member States’ representatives updated the Novel Food Catalogue. The entry for “Cannabis sativa L.” was revised, and a new entry for “Cannabinoids” was introduced, placing CBD under this category. Novel foods were defined as food and food ingredients not commonly consumed in the EU before May 1997. This meant CBD, categorized as a novel food, would require regulatory approval before being marketed in the EU. Applications had to include scientific evidence to prove safety, and approval involved EFSA’s safety assessment followed by authorization from the European Commission.
2021
The European Commission received numerous applications for CBD as a novel food, submitted by companies seeking market authorization. These applications included safety data intended to address EFSA’s requirements. However, the EFSA highlighted significant gaps in the data, particularly concerning CBD’s safety profile. Concerns arose regarding potential effects on the liver, gastrointestinal tract, endocrine system, nervous system, and reproduction. Without resolving these concerns, EFSA could not provide the necessary safety assessment, delaying progress on CBD-related novel food approvals.
2022 (June)
EFSA officially announced its inability to establish CBD’s safety as a novel food. It cited gaps in available data and uncertainties about potential health risks. Research raised questions about CBD’s effects on the liver, the gastrointestinal and nervous systems, and psychological well-being. Adverse effects on reproduction were particularly concerning, as indicated by animal studies. Due to these findings, EFSA paused evaluations of CBD novel food applications until applicants provided sufficient evidence to address these issues.
2022–2023
In response to EFSA’s concerns, stakeholders, including the European Industrial Hemp Association (EIHA), took action. They initiated studies to generate the required scientific data for CBD’s safety profile. These efforts aimed to fill the gaps in evidence and facilitate the regulatory approval process for hemp-derived CBD products. Despite these efforts, the regulatory process for CBD as a novel food remained lengthy and complex, adding challenges for businesses seeking market entry.
Present (2024)
The regulatory landscape for CBD-infused food products in the EU remains uncertain. The European Commission continues to wait for EFSA’s updated safety assessments before proceeding with novel food authorizations. Meanwhile, businesses interested in marketing CBD products face ongoing challenges due to regulatory delays. We advise companies to stay informed about updates, comply with both EU and national regulations, and proactively prepare for stricter requirements to meet EFSA’s safety standards.
Essentia pura and the novel food application for cBD
Essentia Pura does not dispute such a decision. We believe hemp extracts, without isolated cannabinoids, should not qualify as novel foods since they were present in Europe long before 1997. However, the CBD industry must implement additional regulations to ensure product quality, especially for those aimed at improving the health of our clients.
Quality controls from 3rd party laboratories are already an integral part of our mission and so is the compliance of our organically grown hemp
To comply with new regulations, Essentia Pura decided to submit the Novel Food application and will do so jointly with the European Industrial Hemp Association (EIHA). For this purpose, Novel Food Consortium has been established. Within it, 4 product formulations will be submitted to cover every possible CBD-related product..
We will jointly invest up to €3,5 million for financing all relevant and unprecedented toxicological studies on CBD and THC. Based on this research, we hope to establish the safety profiles of CBD and THC and their recommended daily intake. This will help us to get full-spectrum hemp extracts approved by the European Commission, and allow them to be used again as food ingredients.
NF 2020/2233
Novel Food Authorisation
Application Acknowledged
Perform Validity Check
EIHA Project GmbH
NF 2020/2233
Novel Food Authorisation
Application Acknowledged
Perform Validity Check
EIHA Project GmbH
Novel Food Authorization – A Long, Tedious And Expensive Process
The Swiss company Cibdol, a significant player in the CBD novel food regulation landscape, has offered insights into the length and complexity of the novel food process. They were among the first European companies to apply for novel food authorization with synthetic CBD. Currently, only applications for synthetic CBD have been validated by the EFSA. No hemp-derived CBD received validation so far.
The European Food Safety Authority (EFSA) typically takes around nine months to conduct a risk assessment for a novel food ingredient. Despite Cibdol’s synthetic CBD application being validated early in 2019, their final assessment is scheduled for March 8, 2022. This highlights the lengthy and detailed nature of the approval process.
If all CBD novel food applications undergo safety assessments individually, delays are inevitable. It may take years before ingestible CBD products, particularly those derived from hemp, are widely available in the market under the CBD novel food regulation framework.
CBD in The UK
As the UK is no longer part of the EU, EU novel food regulations no longer apply in the UK. Instead, the UK has adopted its novel food approach for registering CBD products.
Companies must submit applications based on safety evidence to the FSA (UK) to meet the deadline of March 31, 2021. The FSA has also published detailed guidelines on how to proceed with UK CBD novel food applications. These guidelines are available online for reference.
Essentia Pura has submitted Novel Food applications for CBD products. However, these applications are still under review. Our UK Novel Food applications are registered under numbers 427 and 438. Additionally, we have applied to register several product formulations through secondary applications.
While the FSA reviews Novel Food applications for CBD, it has also issued consumer advice on cannabidiol (CBD) extracts. This advice is based on recent studies. The FSA recommends a daily dose for healthy adults and provides specific guidance for vulnerable groups.
References
Baron, E. P. (2018). Medicinal properties of cannabinoids, terpenes, and flavonoids in cannabis and benefits in migraine, headache, and pain: An update on current evidence and cannabis science. Headache: The Journal of Head and Face Pain, 58(7), 1139–1186. https://doi.org/10.1111/head.13345
Boyaji, S., Merkow, J., Elman, R. N. M., Kaye, A. D., Yong, R. J., & Urman, R. D. (2020). The role of cannabidiol (CBD) in chronic pain management: An assessment of current evidence. Current Pain and Headache Reports, 24(4), 31. https://doi.org/10.1007/s11916-020-0835-4
Berger, A. A., Keefe, J. M., Winnick, A. M., Gilbert, E. B., Eskander, J. P., Yazdi, C., & Viswanath, O. (2020). Cannabis and cannabidiol (CBD) for the treatment of fibromyalgia. Best Practice & Research Clinical Anaesthesiology, 34(3), 617–631. https://doi.org/10.1016/j.bpa.2020.08.010
European Food Safety Authority. (2022). Cannabidiol novel food evaluations on hold pending new data. EFSA News. https://www.efsa.europa.eu/en/news/cannabidiol-novel-food-evaluations-hold-pending-new-data
European Industrial Hemp Association. (2021). Update on the novel food status of CBD. CBD Oil Europe. https://cbdoileurope.com/update-on-the-novel-food-status-of-cbd-updated-november-2021/
