CBD as a New Type of Food (Novel-Food)

News on the approval of CBD products as food

Together with the EIHA, the European Industrial Hemp Association, we, along with other companies, are striving for approval and safety assessment of CBD products. We jointly finance the necessary toxicological examinations 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
• Of these, 71 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• 42 applications were withdrawn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 evaluated to meet the standards for novel foods of the FSA. Thus, cannhelp was also included as a manufacturer with the then already market-available CANNEXOL products on the CBD- list. This means that our products can continue to be sold while awaiting full approval.

This step also has the effect of increasing the attractiveness of CBD for investors and guaranteeing consumers the safety of the products accordingly. The inclusion in the CBD- List  is an important milestone on the way to full approval, which is expected in 2023.

Both applications for the different CBD oils have now been successfully validated and the FSA has already made a related 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 may remain on the UK market until the approval decision is made. Thus, we can also CANNEXOL Full Spectrum CBD Oils now again as dietary supplements 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 ("Novel Foods") are generally all foods that were not used to a significant extent 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 have been isolated from plants and plant parts 
• consist of or have been 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 " in Austria.CBD Decree" led us also to stop selling our products as dietary supplements since then.