CBD as a Novel Food

News on the approval of CBD products as food items

Together with the EIHA, the European Industrial Hemp Association, we are working with other companies to achieve approval and safety assessment of CBD products. We jointly finance the necessary toxicological tests and studies for approval. In 2021, the EIHA already submitted applications for several product formulations at the EU level to EFSA and separately in the United Kingdom (UK) to the FSA.

The numbers of FSA approval and list

• Around 900 applications were submitted before the deadline
• 71 of these were pursued further
• 680 applications were rejected
• 42 applications were withdrawn

Validation of applications by FSA in the UK:

CANNEXOL available again as a dietary supplement!

The application documents were assessed as meeting the FSA's novel food standards. Thus, cannhelp as the manufacturer, along with the CANNEXOL products already on the market at that time, were included in the CBD- list. This means our products can continue to be sold while awaiting full approval.

This step also increases the attractiveness of CBD for investors and guarantees consumers the safety of the products accordingly. Inclusion in the CBD- list  is an important milestone on the path to full approval, expected in 2023.

Both applications for the different CBD oils have now been successfully validated and the FSA already has a list published, showing these brands and companies. The UK is taking a slightly different approach than the rest of Europe. Products found on this list are allowed to remain on the market in the UK until a decision on approval is made. Thus, we can also continue our CANNEXOL Full Spectrum CBD Oils now again as a dietary supplement isold in the UK.

What does Novel Food mean?

As a rule, foods may be placed on the European market without prior approval. An exception is novel foods, as there is insufficient experience regarding their safety and tolerability. They include newly developed foods as well as foods produced using new methods. Foods traditionally consumed in other parts of the world but not in Europe may also fall under this classification. According to EU law, novel foods are generally all foods that were not significantly consumed for human consumption in the European Union before May 15, 1997, regardless of the accession dates of member states. They must fall into at least one of the following categories:

• new or deliberately modified primary molecular structure
• obtained from microorganisms, fungi, or algae
• consist of materials of mineral origin 
• consist of or are isolated from plants and plant parts 
• consist of or are isolated from animals or their parts 
• cell and tissue cultures from animals, plants, microorganisms, fungi, or algae
• produced using a new, unusual manufacturing process
• consist of technically manufactured nanomaterials 
• Vitamins, minerals, and other substances 
• that were used exclusively in dietary supplements

Since novel foods must undergo a uniform safety assessment before they can be marketed in the EU, this also applies to CBD and products containing cannabinoids according to the EU Commission. The only exceptions are hemp products such as hemp seeds, hemp seed oil, hemp proteins, or products made from them. Novel foods must not pose a risk to consumers and must not contain unauthorized "claims." This assessment by the EU Commission led in 2018 to the well-known " CBD Decree" which also led us to stop selling our products as dietary supplements since then.