In recent years, the CBD industry has seen tremendous growth. However, when it comes to CBD extracts and isolates in food and beverages, businesses must follow a strict regulatory process. This ensures compliance with EU and UK regulations.
This process is known as the Novel Foods Directive, and it is the only authorised route for bringing CBD food products to market in both regions. In this blog post, we’ll delve into the Novel Food application process and how our laboratory can assist you every step of the way.
Understanding the Novel Food process step by step
The Novel Food application process is a comprehensive and structured approach to obtaining authorisation for CBD extracts and isolates in food and beverages. It involves several key steps, all of which are crucial to ensuring the safety and compliance of these products.
- Characterisation
This step involves a technical and scientific data review to understand the composition and properties of the CBD extract or isolate.
- Verification of Novel Food identity
Confirming the identity of the novel food is essential for regulatory compliance.
- Naming conventions confirmation
Ensuring that the product is labelled and named correctly according to regulatory standards.
- Description of plant parts
Providing a detailed description of the plant parts used in the manufacture of the novel food.
- Geographical origin
Determining the geographical origin of the plant used in the product. - History of use
Documenting the historical use of the novel food or its source. - Production process description
Providing a detailed description of the production process for the CBD extract or isolate. - Stability testing
Conducting real-time and accelerated stability testing in accordance with ICH Harmonised Tripartite Guidelines to assess the product’s stability over time. - Proposed uses and intake levels
Determining the intended uses and recommended intake levels based on guidance from the Food Standards Agency (FSA). - Absorption, Distribution, Metabolism, and Excretion (ADME)
Reviewing available or generating new data on the product’s ADME to assess both its toxicological and nutritional impact. - Toxicological data review
Assessing available or generated data related to toxicology, genotoxicity, and subchronic toxicity. - Study report conclusions
Drawing scientific conclusions from study reports and data. - Dossier preparation
Compiling all the necessary data and documentation into a comprehensive dossier. - Application to FSA or EFSA
Finally, submitting the application to the Food Standards Agency or the European Food Standards Agency for review, processing and authorisation.
The role of the lab
As the UK’s leading development, testing, and regulatory laboratory for cosmetics, nutraceuticals, biocides, household, and food products, ADSL is committed to assisting businesses throughout the entire Novel Food application process. Our team of chartered chemists, toxicologists, microbiologists, and regulatory experts specialise in providing formulation and testing services across various sectors–including cosmetics, pharmaceuticals, supplements, and household products.
Compliance reviews
Our experienced compliance team conducts thorough reviews of your products, ensuring they align with the relevant territorial regulations. We also assess toxicological aspects, assist with product registrations, and help build comprehensive dossiers.
Analytical capability
We offer exceptional analytical capability, including High-Performance Liquid Chromatography (HPLC). Gas Chromatography-Mass Spectrometry (GC-MS), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), and Fourier Transform Infrared Spectroscopy (FTIR) for heavy metal analysis, residual solvents, cannabinoids, and preservation checks.
Regulatory expertise
Our regulatory experts are well-versed in navigating the complex landscape of CBD regulations in the EU and UK. We provide guidance on labelling compliance and help you meet the necessary regulatory standards.
The only route to market
The Novel Food application process is the only authorised route to compliance for CBD extracts and isolates in food or beverage form in the EU and UK. It involves a series of meticulous steps and comprehensive documentation. With laboratory expertise and the support of organisations like Greenbridge Gateway, you can navigate this process with confidence, ensuring that your CBD products meet all regulatory requirements and can be safely marketed to consumers in these regions.