In recent years, there has been a huge shift regarding cannabis, with many countries all over the globe legalising CBD for medicinal use.
The global CBD market is expected to reach £9.68 billion (USD 13.4 billion) by 2028, and there is an ever-increasing demand for CBD products.
Cannabidiol (CBD) is a non-psychoactive ingredient derived from the Cannabis sativa plant widely known for its calming benefits. It is considered a novel food by European and UK regulators, and selling CBD-infused products requires pre-market authorisation.
We understand that the Novel Food Application and its process are extremely complicated and may get confusing, especially those new to the market.
Because of that, we’ve made this comprehensive guide to help you through the NFA process, including the information required for the application, the testing recommended, and what steps you need to take to get pre-market authorisation and start selling your product.
CBD as a Novel Food
According to the European Food Safety Authority (EFSA), a novel food is one that was not used to a significant degree in the EU or UK before 15th May 1997. In 2019, the EFSA determined that CBD was a novel food. Because of this, it’s now mandatory to gain pre-market authorisation before selling it in the United Kingdom.
FSA Novel Food Application
At the start of 2020 (February 13, 2020), it was announced that those selling CBD in the UK market must submit a Novel Food Application (NFA) to the UK Food Standards Agency (FSA) to do so legally.
Both UK manufacturers and imported products require this authorisation. However, this didn’t prove very easy because there was already an unregulated CBD market in the UK before this. Therefore, the FSA allowed products already on the market before 13th February 2020 to remain on the market as long as they submitted their novel food applications by 31st March 2021.
This does not extend to new products, and thus, all manufacturers and importers now have to submit a full NFA to be eligible for sale in the UK. While this is necessary for safety and trust in the growing UK CBD market, the process is extremely costly and time-consuming. According to some estimates, it can take up to two years for approval to be granted.
CBD Novel Food Application Process
The CBD novel foods application requires the submission of information about the manufacturing process and other relevant product information to the Food Standards Agency (FSA). This includes composition analysis, stability information, toxicology information, nutritional content, i.e., absorption, distribution, metabolism, and excretion content (ADME), and more.
It should be noted that information should be specific to the product and public information alone is not grounds for authorisation.
Step 1: Gathering Data
The first step in your CBD Novel Food Application is gathering non-testing administrative data, including information about you, the applicant.
Next, it’s important to gather information about the product itself, including the production process, history, proposed uses, usage levels, anticipated intake, and more. During this step, it’s important to perform various tests and gather the following data:
- Compositional data
- ADME (absorption, distribution, metabolism, and excretion) data
- Nutritional information
- Toxicology and genotoxicology information
- Stability assessment
- Product manufacturing data for at least five batches (all five batches have to be manufactured separately and then independently tested)
- CBD exposure and usage
- Full chemical analysis including terpenes, pesticides, mycotoxins, residual solvents, and heavy metals
It’s also important to include all references.
In addition to a risk assessment and risk mitigation plan, you will require a glossary of terms used throughout the application and dossier, certificates of analyses as well as the laboratories’ accreditation, all published and unpublished scientific data, reports on studies, and all scientific opinions by other regulatory bodies.
Step 2: Submitting the Dossier
After filling out an application form, you must submit both the form and the relevant data gathered in the first step.
Step 3: Evaluation
This is when the FSA will evaluate the information you have submitted, which can take more than nine months.
Step 4: Questions
The regulatory authority (FSA) may ask questions about safety, effectiveness, and more, which you have to answer.
Step 5: Approval
It’s only when the FSA is completely satisfied with the product’s safety that it will be approved. Then, your product can be marketed in the UK.
Since the FSA’s application is based on the EFSA’s novel food application, you can find thorough information on it here.
Get a Reliable Testing Partner for Your CBD Novel Food Application
To complete your novel food application, you must run the required tests and submit accurate results to the FSA. A reliable laboratory is integral for this process to be completed successfully. That’s where IFS Laboratories comes in. Not only are we UKAS-accredited, but our analytical testing services include everything you’ll need for your CBD novel food application.
As previously mentioned, the testing process is quite complex and costly. The application process also takes a lot of time. Therefore, it’s imperative to get it right from the start to avoid the need for additional testing, re-submitting evidence, and waiting even longer for approval. With all of this at stake, you simply cannot take a chance by choosing an untrustworthy laboratory.
We have a foothold in the cannabidiol industry and are experienced in all things related to CBD testing. Therefore, in addition to providing testing, we can also help you determine which tests are needed, what you need to aim for, and more. If you want a thorough and timely job, you can rest assured that we provide just that.
IFS Laboratories uses state-of-the-art equipment to conduct all of our tests and ensure regulatory compliance. We can offer you expertise in:
- Cannabidiol profiling
- Terpene analysis
- Residual solvent testing
- Heavy metals testing
- Mycotoxin analysis
- Shelf life and stability testing
These are only some of the tests we provide. To complete and submit your novel food application successfully, contact us here.
Disclaimer: This sponsored content was written by IFS Laboratories