Products containing CBD now need a validated novel food application to remain on the shelves.
The Food Standards Agency (FSA) has released a list of UK CBD products linked to novel food applications. These applications were submitted before 31 March 2021 to meet new regulatory requirements.
In this article we explain the novel food authorisation process, what this means for CBD companies and what you need to do to comply.
What are novel foods?
Novel foods are foods that do not have a ‘history of consumption’ in the UK or EU.
This means the public did not consume them to a notable degree in the UK or EU before May 1997. This was when the EU Novel Food Regulation came into force.
Some examples of novel foods are:
- Foods consumed elsewhere in the world, like baobab fruit pulp and chia seeds.
- Foods made using new processes, like bread treated with UV light to increase vitamin D levels.
- New foods, like phytostanols and phytosterols in cholesterol-reducing spreads.
Products that are subject to the Novel Food Regulation are placed on the Novel Food Catalogue based on information provided by EU member states.
The Novel Food Catalogue added CBD to the list in January 2019.
What is novel food authorisation?
Novel foods must undergo a safety assessment and authorisation before they are legally marketed or consumed in the UK.
The food must also fall into one of the following categories:
- Animals or plants
- Fungi, algae, micro-organisms or cell culture
- Minerals or engineered nano-materials
- Ingredients that have a new or intentionally modified primary molecular structure
- Food produced using a new process that significantly alters the product either nutritionally or in terms of food safety risks
In order to get novel foods authorisation, foods must be safe and must not be misleading to consumers. In addition, they must not replace other foods in a way that would nutritionally disadvantage consumers.
How do I know if a novel food is authorised?
The Union list of novel foods comprises all authorised novel foods.
Want to sell an authorised novel food in a way that is not included in the Union list? You must obtain novel foods authorisation for this new use.
If you intend to sell a product, it’s your responsibility to know whether the Novel Foods Regulation applies to it.
What does the novel food classification mean for the CBD industry?
The CBD market in the UK has grown rapidly over the last few years. According to the Association for the Cannabinoid Industry (ACI), around 1.6 million people now consider themselves to be regular consumers.
However, the growth has happened with little regulation on the quality or safety of products available. This has resulted in confusion for businesses and lowered consumer confidence.
The new regulatory novel food regulations will pave the way for a safe, sustainable and legally compliant CBD market. This means in future, consumers can feel confident the products they’re buying are of high quality.
What does it mean for CBD companies?
You must have a validated novel food application for any product containing CBD.
On 13 February 2020, the FSA set a new deadline for all CBD companies to submit retrospective applications. By 31 March 2021, all products already on sale had to have a validated application for novel food authorisation in place.
After this, only products with a validated novel food application were legally allowed to stay on the market.
This deadline applied to products that were already on the market on the date of the announcement.
New CBD products that come to the UK market must have full novel food authorisation before their sale. To do this, you must apply for a regulated product authorisation for a novel food.
What does a novel food application involve?
Applying for novel foods authorisation involves preparing a dossier of manufacturing and product information.
You must submit this dossier to the European Commission (or FSA if submitting in the UK from 1 January 2021) through an electronic portal. The dossier must demonstrate that your product is safe for human consumption.
After submission, your application will be evaluated. If you’ve provided sufficient information, it will be validated – this usually takes 2-3 months. This is the stage your application needs to reach before the 31 March 2021 deadline.
Following validation, your application will move onto the authorisation process. The European Food Safety Authority (EFSA) will then review the application, carrying out a risk assessment over 9 months.
Once the EFSA approves the application, they will pass it on to the European Commission. They will then have 7 months to authorise the product and add it to the Union list of novel foods.
How do I prepare a CBD novel food application?
Preparing your dossier involves a variety of product testing and data gathering exercises. Some of these may take as little as 2 weeks, while others can take up to 9 months.
Below is the list of required assessments for CBD products, along with estimates on how long each stage takes:
- Full toxicology assessment: 8-9 months, comprising 7-8 months for the assessment followed by one month to produce the data report
- Stability assessment: At least 6 months. This should assess a minimum of 6 months’ accelerated stability to support the product’s shelf life. This would be in addition to continued real-time stability testing
- Product manufacturing data for a minimum of 5 batches: 5 months. You must independently manufacture and test each batch. Total ADME assessment: 2-3 months
- Genotoxicology studies: 6-7 weeks, comprising initial Ames testing
- Detailed information on typical CBD exposure and usage: 2-3 weeks
- Risk assessment and risk mitigation plan: 2-3 weeks
- Submission of additional supporting data: 2-3 weeks
These activities can happen simultaneously, so in total this process should take around 9 months. However, timescales can vary depending on the complexity of your product.
Recent developments in toxicology data requirements
The UK government’s Committee on Toxicity (COT)’s ongoing review of CBD safety highlights the need for that new toxicology data.
The study will address the missing information identified by the COT. This will include whether CBD can cause liver toxicity or drowsiness, or if it interacts with other drugs. Providing this data will be a key requirement for a successful novel foods dossier.
In line with the EFSA’s guidance on preparing a novel food application, the ACI-led study will include a 90-day rodent study according to OECD 408 parameters.
To minimise animal usage, the study will use a single 90-day rodent study. The resulting data will be available to all participating companies. Companies interested in joining the study can contact the ACI.
Meeting the deadline
All CBD products that were on the market in the UK prior to 13 February 2020 needed to have a validated novel food application by 31 March 2021 to remain on the shelves.
From the submission date, it takes 2-3 months to validate a novel food application. Therefore, to meet the deadline, you should have submitted your dossiers by October 2020 and by December 2020 at the very latest.
Given the timeline above, your data gathering activities should have begun by the end of January 2020 to allow 9 months before submission.
If you’re yet to begin the novel food application process, you should follow the novel food application guidance and CBD guidance from the FSA. You should also make sure the novel food application covers the formulation and usage of your product.
If they aren’t doing this or are unlikely to meet the deadline, you could source a supplier that has already done so to avoid supply chain disruption.
Latest guidance post-Novel Foods deadline
As of 26 April 2021, the FSA has a published list of all the CBD products which are not authorised, but can stay on sale. This list was recently updated on 22 February 2022.
The list can help local authorities enforce regulations on the sale of unregulated foods. It’s also useful for retailers to know the status of suppliers.
The list includes applications which:
- Are validated and in the initial stage of the process before going on to the safety assessment
- Are ‘on hold’, meaning applicants have started the risk assessment process but haven’t supplied all the information needed
The FSA are regularly reviewing applications made before 31 March to update the list, so it’s worth keeping an eye on.
How will Brexit affect the Novel Food Regulation?
The Novel Food Regulation is an EU regulation. However, the FSA will still require novel foods in the UK to be authorised after the end of the Brexit transition period on 31 December 2020.
Currently, the European Commission and EFSA are responsible for evaluating and authorising novel food applications for the UK.
From 1 January 2021, the FSA and Food Standards Scotland took over responsibility for assessing UK applications. They provide advice to ministers, who then decide if they will authorise novel foods.
For existing authorisations, if your product has been authorised by the European Commission and the appropriate legislation is in place before the end of the transition period, then your authorisation will remain valid in the UK.
However, if you want to make changes to an existing authorisation after 31 December 2020, you’ll need to use the FSA’s authorisation procedure.
For ongoing applications, the FSA states:
“We are finalising procedures for the applications submitted to the EU before the end of the transition period for which the assessment process has not been completed. We will provide guidance in due course.”
How much does a novel food application cost?
There is no fee payable for the application itself, but the cost of testing and reports can be significant.
It could cost just £20,000 if your product uses raw materials that already have a validated novel food application. However, it could cost as much as £350,000 for a complex product that needs a full application.
Novel foods authorisation for CBD products
Worried about novel food regulations or applying for a novel foods authorisation? Leaf Sciences can help. We offer a range of both CBD raw materials and white label products, all covered by a novel food application.
Putting together a full CBD novel food application could involve lots of hassle – and a steep cost. Use our raw materials and white label products to save yourself this difficulty while staying true to your brand.
We also offer consultancy and market intelligence services – something few other wholesale distributors provide. This means we’re a one-stop-shop for new and pre-existing companies looking to expand.