What does Novel Foods legislation mean for CBD manufacturers?
At the beginning of 2020 it was announced that all manufacturers of food containing CBD must submit a novel food application in the UK prior to sale. It was also stated that foods and supplements already on the market will require a validated application by 31st March 2021.
What is a CBD Novel Foods Application?
Simply put, it is the mechanism for registering a new food product or supplement that will then enable businesses to market CBD foods in the UK.
Manufacturers and importers may also be required to submit a CBD novel foods application as part of the premarket authorisation. This is defined under EU Regulation 2015/2283, and subsequent legislation.
What is involved?
The CBD novel foods regulation requires manufacturers to submit information about the manufacturing process and further product information to the Food Standards Agency (FSA).
Eos Scientific CBD Novel Foods Submission Process (Complex Mixtures)
approximately 24 months*
£40k – £100k per SKU†
Step One - Onboarding
We will provide you with a number of submission forms to allow us to gather information regarding the production of your product(s) and other requirements of the dossier that do not require testing.
Duration: 1 – 2 weeks
Step Two - Data Gathering
This step is for gathering all testing related data, including that associated with accelerated storage and performing toxicological research on the product(s).
Duration: 6 – 16 weeks (dependent on the nature and amount of samples provided)
As part of your submission, we may be required to perform additional testing in order to satisfy the ADME requirements of the novel food submission. This will cover the safety of the Absorption, Distribution, Metabolism and Excretion of your product.
Duration: 3 – 6 months
Step Three - Submission
Once all data has been gathered we will compile it and create your dossier which we will then submit for approval via the FSA/EFSA portal.
Duration: 1 week
Step Four - EFSA/FSA Evaluation
The EFSA/FSA will evaluate all information submitted via the online portal. The duration for this stage has been provided by the EFSA/FSA themselves.
Duration: 9 months
Step Five - Questions from the FSA
After evaluation, should any additional information be required by the governing bodies, we will prepare our response to these questions. This stage may not be required at all.
Duration: Dependent on the number and nature of questions as well as company response time.
Step Six - Approval
Once the EFSA/FSA are satisfied that your application is complete, your product(s) details will be uploaded to the union list of permitted novel foods. This means your product can now be marketed within the UK.
Duration: Approximately 3 – 6 months
*Timeframe approximation is based on the total duration required for real-time stability testing (product shelf-life). Accelerated stability testing will be used for your submission.
†Costs will vary based on product specification and formulation, as well as the number of submissions required.
How Eos Scientific can help with your CBD Novel Foods submission?
If you are a manufacturer of CBD extract, CBD infused drinks or CBD foods and supplements, we can help you to prepare and submit your novel food application to the EFSA and FSA.
At present, our process is designed to assist manufacturers of finished products that contain CBD (complex mixtures), however, our team is working tirelessly to define a process for CBD raw material suppliers (single compounds).
Our experience with submitting regulatory applications, such as 21,000 successful TPD submissions, means we are well placed to ensure your application has the best possible chance of being successful.
Request a Quote
To enable us to provide you with an accurate novel food application quote we require some information about your business and the products you wish to submit.