What does Novel Foods legislation mean for CBD manufacturers?
Since the start of 2019, all CBD food products have been regulated as novel food products in the EU (European Union) following a ruling made by the European Commission.
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.
The UK Market
In the UK, CBD products are regulated by the Food Standards Agency and are enforced by Trading Standards and Environmental Health Officers. All applications will be submitted to the European Commission for approval in the form of a dossier containing the following information:
- Administrative information
- Technical information, including the product manufacturing process, and the product composition.
- Safety information, including risk assessment and risk management data.
All applications must also include the following:
- Accompanying letter
- Dossier summary
- Public dossier summary
It must also be noted that authorisation of an application may take in excess of 9 months.
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
The first step of our CBD novel foods process involves us working closely with you to complete our submission form which has been carefully designed to capture all administrative information that will enable us to kickstart the production of your dossier.
Step Two - Data Gathering
At stage two we will gather all the technical and scientific data required to characterise your novel food that will be at the heart of your successful submission. This will be a mixture of production data, literature data wherever relevant, and the results of the chemical and biological analysis that we conduct.
- Non-testing data
- A technical description of your novel food and the production process
- Testing data
- Full chemical analysis
- CBD and other cannabinoids
- Terpenes and other ingredients
- Pesticides and Mycotoxins
- Residual solvents
- Heavy metals
- Stability testing
- Microbiological testing
- Toxicological evaluation
- Only where necessary for raw material. It is expected that finished products will make use of data from the raw material manufacturer. Data already in the public domain will be used whenever possible.
- ADME evaluation
- To determine the absorption profile and bioavailability of finished products in a rodent model
- Full chemical analysis
Step Three - Submission
The third and final stage of our process is the submission of your dossier through the FSA portal (from 1st January 2021) and/or the EFSA portal, and to subsequently work with regulators to achieve a successful market authorisation for your product.
- Validation: 1 month
- Once validated, your product can legally remain on the market post 31st March 2021
- Risk assessment phase: 9 months
- Risk management phase: 7 months
- Market authorisation received
*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.