In recent years, the CBD industry has seen tremendous growth, with various products flooding the market. However, when it comes to CBD extracts and isolates, businesses must follow a strict regulatory process.
This ensures compliance with European Union (EU) and United Kingdom (UK) regulations. This process is known as the Novel Food Application, and it is the only authorised route for bringing CBD products to market in these 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 Application Process
The Novel Food Application process is a comprehensive and structured approach to obtaining authorization for CBD extracts and isolates. It involves several key steps, all of which are crucial to ensuring the safety and compliance of these products:
- Characterisation of the Novel Food:
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 labeled 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:
Finally, submitting the application to the Food Standards Agency for review and authorisation.
How Our Laboratory Can Help
As the UK’s leading development, testing, and regulatory laboratory for cosmetics, nutraceuticals, biocides, household, and food products, we are committed to assisting businesses throughout the entire Novel Food Application process. Our team of Chartered Chemists, Toxicologists, Microbiologists, and Regulatory experts specialises 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.
Summary
The Novel Food Application process is the only authorised route to compliance for CBD extracts and isolates in the EU and UK. It involves a series of meticulous steps and comprehensive documentation. With our laboratory’s expertise and support, 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. From concept to manufacture and fulfilment, we offer an unrivalled level of industry knowledge and expertise to help your business succeed in the CBD market.
Take the next steps
Let ADSL support you with navigating your CBD Novel Food Application. Please speak to our compliance team today. Please call +44 (0) 1803 520 048 or book a free video consultation with us using the Get Started link.
