According to European regulations, CBD is considered a novel food. To be precise, that only applies to CBD products that had their path of compliance authorised by the appropriate authorities.
Officially, CBD became a part of the Novel Food Catalogue in January 2019, a meaningful step for many CBD brands and manufacturers.
However, given that the deadline for filing all applications for CBD products expired at the end of March 2021, many are unsure of what comes next.
In this article, we’ll talk about novel food products and CBD’s place among them. We’ll also answer some of the most important questions consumers may have regarding CBD and it regulations.
What Constitutes as Novel Food?
We immediately accept the term “novel food” when it comes to the CBD category of products, but what does it mean exactly?
All foods and ingredients that were not used for human consumption to a significant degree before 15 May 1997 are considered novel foods. Everything produced in the EU market after this date is known as novel food and needs approval by the EU Commission and EFSA prior to being marketed.
The most important factors of novel food are that it’s safe for consumption and correctly labelled. Also, if it’s meant to replace another food product, it mustn’t be nutritionally disadvantageous, which is a challenge for some novel food processing technologies.
What Is the Difference Between Novel Food and Functionals Food?
It’s important to note the disambiguation between functional food and novel food. The functional food product may contain additional nutrients for both physiological and psychological benefit.
An example would be probiotic yoghurt with bacterial cultures. It has added nutrients, but it’s n
ot considered novel food.
Where Does CBD Fit In?
As mentioned, CBD products received the status of novel foods,
and the Novel Foods Catalogue has been updated to reflect that.
However, the catalogue itself is still to receive full legal status. Essentially, this means that there are no fully authorised CBD extracts on the market.
This doesn’t mean that the products found in stores and online are illegal, just that the brands have to apply for authorisation.
This means that manufacturers and suppliers will have to look at their CBD ingredient list and the CBD raw materials they use in their products.
It’s bad news for brands that have not taken novel technologies in food processing seriously and have been offering low-quality CBD product until now. On the other hand, CBD brands that have consistently produced high-quality CBD products will receive fast track authorisation.
How to Apply for Authorisation?
The only route for CBD product authorisation is via Food Standards Agency (FSA) or Food Standard Scotland (FSS.) Manufacturers and suppliers will have to submit their application which consists of three parts.
The first part needs to have all the administrative data, such as all the relevant information regarding the applicant.
The second part pertains to CBD as a novel food. Applicants will have to provide all the necessary information regarding the production process, compositional data, and nutritional information.
The novel food technology used to produce CBD extracts is crucial as well. In this second part of the application process, brands will also have to state the history of the products and their source.
Furthermore, they’ll have to list all the proposed uses and the exact levels of the anticipated take. Finally, toxicological information and allergen content are critical.
The third and final part of the application process of CBD for authorisation revolves around several essential factors. The application must contain a glossary of terms and abbreviations used to describe the product.
It needs to have all the certificates, such as accreditation from laboratories, as well as analysis certificates. All the pertinent scientific data manufacturers can gather should also be submitted, including the scientific opinions of national and international regulatory bodies.
Important note: Manufacturers and suppliers that have submitted their application before 1 January 2021 and have not yet completed them will have to re-apply. Also, all the existing authorisations of CBD as novel food before this date will remain valid.
How Long Does the Application Process Take?
There are no exact guidelines on how long the application process will take, but a rough estimate of at least one year is to be expected.
The validation process will take around one month, and then the risk assessment element takes up to nine months. The subsequent risk management and other considerations can also take up to seven months.
What Is Article 4 of the Novel Food Regulations?
Brands that sell CBD products should be acquainted with Article 4 of the Novel Food regulations before applying for authorisation.
This is a consultation process that allows businesses to check if their product is even eligible to become novel food or not. This is not the route to compliance, merely a helpful step to take before complying.
It’s also crucial to reiterate that submitting your product to Article 4 consultation doesn’t permit it to stay in the market, the same as the application process does.
Is the Application Process Expensive?
FSA doesn’t charge any fees for the application and authorisation, so that’s good news. The bad news is that when gathering the ingredient dossier, the expenses will likely pile up.
The relevant regulatory experts need to be involved in the process and the cost of running additional studies to support the application.
This is why the brands need to ensure they have everything in terms of ingredients, extraction methods, and hemp sources before collecting the documentation.
Only the Best CBD Products Will Remain
This is the goal of regulating CBD as a novel food. Consumers won’t have to worry about choosing the wrong product due to misleading marketing.
They can spend their time and money researching dosages, flavours, and other factors. For manufacturers, this is also a significant process. The CBD products of lower quality will not receive EU authorisation. Hence, there will be less competition in the market.
CBD products have many proven benefits, but it’s imperative to be realistic about what they can do and never jeopardise your health or finances with a poorly regulated product.