Despite all the ramifications of Brexit, when it comes to CBD, the EU ruling will stand. This means that since 1 January 2021, CBD has been officially classified as a novel food. But what does that mean for UK producers and manufacturers of CBD products?
Essentially, it means that they all must start the process of Novel Foods Application. In terms of novel food regulation, CBD has some specific requirements.
In this article, we’ll elaborate on the concept of novel food and discuss what the future holds for both CBD businesses and consumers. Plus, we’ll
answer some of the most common questions pertaining to the process.
What Is Novel Food Exactly?
To the average consumer, the concept of “novel foods” might not be as clear. What does it mean? All the foods and ingredients that were not significantly used before 15 May 1997 within the Union are considered novel foods.
The European Commission must approve every food or food supplement introduced after this date. All the foods that were created using cloning or nanotechnology are also considered novel.
However, it’s important to differentiate functional food from novel food. Functional foods existed prior to the set date but contained added ingredients that are beneficial for overall human health. An example would be bread companies that use UV light to convert ergosterol into vitamin D.
CBD Novel Food Status
For the European Commission, CBD novel food status is confirmed, but that doesn’t mean every CBD product currently on the market will be approved as an official novel food.
But it does mean that every manufacturer or supplier will have to submit their CBD product for authorisation. If they don’t, or if their application is rejected, these CBD products will have to be removed from shelves and online stores.
There is another essential element in the authorisation of CBD as a novel food. When it comes to EU Novel Food Catalogue, CBD is officially added. However, the catalogue itself is not yet fully authorised, so it doesn’t change the application process.
Before applying, CBD producers should consider taking advantage of Article 4 of Novel Food Regulation. Basically, this is a consultation process that doesn’t impact the application itself in any way.
It’s an excellent opportunity to make sure the CBD product is eligible to become novel food. This step can provide a lot of guidance for CBD manufacturers and suppliers who need to first address the quality of their product.
Authorising CBD as Novel Food – The Application Process
The route for compliance can only be taken via UK’s Food Standards Agency (FSS) or Foods Standards Scotland (FSS.) CBD suppliers will have to apply directly via these two agencies only.
It’s also crucial to point out that CBD products that enter the application process have the right to remain on the market until the final verdict.
Those whose applications are rejected will eventually have to remove the products, though. Also, the EU’s decision doesn’t impact CBD products that have previously complied with regulatory standards, and their authorisations will remain valid.
The complete application of a CBD product as a novel food is comprised of three crucial elements. All three are equally important and require attention and resources from the supplier.
The first portion of the application to FSA is of an administrative nature. The applicant should submit accurate personal and business information such as date of formation and other details.
In many ways, this is the part of the application process which requires the most attention. First, applicants must identify the type of novel food and describe the production process.
This means highlighting the details regarding CBD extraction. Further details are also needed, such as the compositional data, the hemp source, and the history behind it. Manufacturers and suppliers must also propose uses of CBD product and what the anticipated intake should be.
Compiling this dossier will also require addressing all toxicological information and any content of allergens. Finally, the nutritional information of the CBD product will also impact its approval for novel foods.
The final step in the application process is probably the longest and most expensive. There are zero FSA fees, but CBD brands will still have to pay to complete the application.
Here’s why. They’ll need to acquire complete study reports that will support the claim they’re making about the product. That also means asking for scientific opinions on national and international regulatory bodies.
The third step will involve creating a glossary of the terms and abbreviations presented in the dossier. All the accreditations from the laboratory and analysis certificated should be included as well. Lastly, all the copies of relevant scientific data (both unpublished and published) go into the dossier.
The approval will likely take at least a year, with confirmation of the second part being the lengthiest part of the process. Meanwhile, suppliers that have applied for the authorisation can still sell their CBD products on the market.
What Type of CBD Product Is Exempt From the Novel Foods Authorisation?
All the CBD food supplements are included in the Novel Foods authorisation. But not all CBD products are. While tinctures, pills, and gummies, all must be approved, CBD skin products do not. Since consumers don’t ingest them, they don’t require regulation from the FSA.
What Are the Pitfalls of the Process?
The biggest standing issue in Novel Foods Authorisation is not providing consistent CBD levels in the product.
That can be particularly challenging because CBD content has natural variability in the hemp plant as well. It’s the reason reputable suppliers invest in the extraction process and follow all the necessary protocols.
The Goal of CBD Products Regulation
The new rules regarding the approval of CBD food supplements as novel foods only bring positive changes for the future of CBD products. The consumer will welcome not having to decide if a particular CBD supplement is up to the standards of the EU or not.
If they’re available, it means they are. For the suppliers, this represents a chance for a broader market. The absence of manufacturers that provide low-quality CBD products gives them more opportunities.
Finally, food should be well-regulated, regardless of how safe some proclaim it to be, which applies to CBD products.