Cbd oil as novel food

The first of May last year (2021) was an important day for anyone interested in cannabis. Slovakia was also the last country in the European Union to remove CBD cannabidiol from the list of psychotropic substances, which brought many opportunities for the production of hemp products. This means that we can legally sell and buy products containing CBD extract such as CBD drops, CBD oils, mastic and other products, but only as a product for further processing or as a cosmetic product. Not as food or dietary supplements. In order to be sold and consumed as food, CBD products must first be individually approved as novel food.

In this article you will learn what a novel food is, how it relates to CBD, how the approval process works, and what will change once CBD is approved or not approved as a novel food.

What is novel food

Novel foods, also called novel foods, are all foods that were not approved in the European Union before May 1997 and fall into at least one of the defined categories, such as foods isolated from or made from plants and parts of plants. Novel foods have in the meantime already included, for example, sage seeds or dried fly larvae (1). CBD extract and its products are still awaiting approval by the European Novel Foods Council. To be approved as a novel food, a product must meet strict criteria. It must be non-toxic, completely safe to consume and correctly labelled.

Applications for approval of CBD as a novel food

The European Novel Food Council has received 19 applications for the inclusion of CBD extract, CBD oil or CBD drops in novel foods. Usually these applications for approval of a product as a novel food are concluded within 9 months, but for cannabinoid this is different again and the Council suspended its decision-making process in June this year (2022) due to insufficient evidence and research (2).

It held an online meeting for all applicants, which mainly include manufacturers of such products, where it explained its decision and provided further information on the aforementioned shortcomings in the evidence. Nevertheless, the applicants expressed their disappointment with the decision. Several of the companies, i.e. the applicants, had collectively contributed EUR 3,5 million to the toxicological research, hoping that this would be sufficient for the European Council to make a decision on the safety of CBD and its daily recommended dose (3). However, the Council requires further toxicological studies, including specifically on humans, which is not a common practice for the registration of new foods, but rather for pharmaceutical applications. While it is obvious why toxicological results are important, the applicants believe that the existing evidence on the safety of CBD is abundant and sufficient to approve CBD as a novel food (2). However, the Council has stressed that it certainly does not consider CBD to be unsafe, it is just cautious with the process.

What scientists have to say

Researchers have reviewed all available studies on the safety of CBD use and concluded that the recommended dose of CBD drops should not exceed 10 mg/day (4). The authors of the study think that there is enough evidence, and the board has a decision to make. However, they stress that CBD products currently available on the market should certainly be inspected to see if they meet their recommended dosage. They have also suggested procedures for the European Council to follow when deciding on CBD as a novel food.
They mentioned the approval of CBD products that meet the recommended dosage as new foods, the inclusion of both low and high CBD products in the medical products. With such an ever-increasing market and demand, it is unlikely that sales and purchases will be discontinued for additional studies to be carried out; on the contrary, the authors call on the Council to act immediately to protect the health of users (5).

What are the current procedures?

The European Union is preparing a directive that should bring uniform rules for the production of hemp products and facilitate both the production and distribution of these products throughout the European Union. It wants to prevent all Member States from taking a particular approach to the matter and failing to regulate these products on the shelves. However, as we have mentioned, the European Council requires further studies and tests in order to be able to introduce such rules.

What would the approval of CBD as a novel food mean?

If the European Council comes up with a single directive to regulate the production of CBD products and classifies CBD products that meet its criteria as new foods, we will be able to buy CBD drops labelled as a food supplement or CBD oils as a food. However, it may be a few years before we see CBD drops sold as a dietary supplement or food, given the time and money needed to conduct additional studies. However, there is a silver lining, and that is that this time it is not Slovakia that is lagging behind in the rankings for the adoption of the effects of CBD into everyday life, but change must come from the European Union level. In the meantime, we can only hope that it will be soon!

(1) The Public Health Service of the Slovak Republic. Novel food. Online at:
https://www.uvzsr.sk/web/uvz/nove-potraviny-novel-food

(2) Leo Bear Mc-Guinness. (2022) European CBD Company Reacts to the EFSA’s Decision to Halt Novel Foods Process. Analytical Cannabis. Online at:
https://www.analyticalcannabis.com/news/european-cbd-company-reacts-to-the-efsas-decision-to-halt-novel-foods-process-313998

(3) CBD In The Novel Food Regulation. EssentiaPura. Online at:
https://essentiapura.com/cbd-in-the-novel-food-regulation/

(4) Lachenmeier, D. et al. (2022) Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the EFSA Clock Stop Regarding Novel Food Authorisation. Preprint. Online at:
https://www.preprints.org/manuscript/202208.0232/v1

(5) Alexander Beadle. (2022). CBD Products Still Available in the EU Must Be Considered Unsafe, Say Researchers. Analytical Cannabis. Online at:
https://www.analyticalcannabis.com/news/cbd-products-still-available-in-the-eu-must-be-considered-unsafe-say-researchers-314112

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