CBD is the first of over 100 cannabinoids from the hemp plant to enter the mainstream as a lifestyle product. It has been used in medicine for quite some time. It occurs naturally in hemp tea, dissolved in oils, in extracts or in isolates and is now found in a wide variety of products - from food, cosmetics and other products. However, the thing with CBD is not that simple. One issue that cannabis companies cannot avoid in this context is the so-called Novel Food Regulation. This is primarily concerned with the safety of the products for end consumers and the safe marketing of the products.

CBD as a single substance has not yet been approved for use in food and is considered novel. Therefore, companies wishing to sell isolated CBD as for use in food must have a corresponding approval. The FSA in UK has recently issued a regulation for CBD products used in food: CBD extracts and CBD isolates may only be sold as novel foods after 31.03.2021 provided they have a valid novel food application.

In continental Europe, the EIHA reports that products containing cannabidiol (CBD) are not necessarily subject to approval as novel foods. However, EIHA is clearly positioned on the issue of CBD isolates (see PM EIHA of 03.03.2020) and considers isolated cannabinoids to be novel.

For this interview we spoke to Boris Baňas from CBDepot in the Czech Republic, who with his team is currently the only company that has a validated application for approval by the European Commission as a novel food for synthesized (-)-trans-cannabidiol. What does this all mean for the market? What role does the safety of the product play in the protection of end consumers? Boris answered these and other questions in the following interview.

krautinvest.de: Boris, CBDepot is the first company to achieve a validated status for a novel-food application. Can you tell us something about why this is such an important achievement for you as a company and what this means for the industry? Can you tell us something about the status of the application and about other applications by CBDepot?

Boris Baňas: CBDepot’s approach has always been to lead by example. Validation of the application dossier means it has passed a three-tier process performed by the EU Commission and the EFSA. The first round is a basic administrative control by staff at Unit E2 at DG SANTE. It ends by publication of the Public Summary at EC website:

https://ec.europa.eu/food/safety/novel_food/authorisations/summary-applications-and-notifications_en

We completed this step on Nov 26, 2019. After this the EU COM sends the dossier to EFSA for a so-called Suitability Check when it is checked if all information provided complies with EFSA’s guidelines. In our case this step was finalized on March 23, 2020 when EFSA declared our dossier as Suitable. Suitability Complete, however, does not yet mean the application is valid. Only EU COM can validate any novel food application. Validation practically means if the substance/ingredient in question can be assessed as potential authorized novel food. Implication for the industry is EU COM does not consider pure Cannabidiol as exempted from a definition of food within the meaning of the General food law regulation EC 178/2002. However, it still needs to be authorized. And a basis for this authorization is the outcome of the Risk Assessment by EFSA. In our case, this process formally began on March 31.

For the post-Brexit UK, a condition was set by the UK FSA in February that a Valid application has to be submitted between January 1 – March 31, 2021 for the products to lawfully remain on the market.

krautinvest.de: Was the European Commission hesitant to take the mandate?

Boris Baňas: EU COM or EFSA have not caused any undue delays, except for the objective slow-down during the Christmas period. I can confirm this process was rather smooth.

krautinvest.de: Your company has different products in their range. Can you tell us something about your portfolio? What products can your ingredients be used in?

Boris Baňas: We also feature various ingredients for the cosmetics, vaping and pharmaceutical sectors for the European and export markets. We follow guidelines of the good manufacturing practice applicable for various industrial segments, apply robust in-house and accredited 3rd party quality control starting from the raw materials we purchase.

krautinvest.de: Currently, you have two Novel Food Applications in the process: isolated (–)-trans-Cannabidiol with Cannabis Pharma s.r.o. and synthesized (–)-trans-Cannabidiol with CBDepot s.r.o.. Was it clear to you from early on that Novel Food is the way to go and there is no way around it for single cannabinoids?

Boris Baňas: It was evident to us since 2015 that highly purified or synthesized cannabinoids do fall under the scope of the novel food regulation. Our first NF application was already submitted in 2016, still by Czech authorities under procedures of the “old” novel food regulation (EC) 258/97.

krautinvest.de: Why is risk-evaluation such an important part of the novel food application? Can you tell us something about the recommendations you made for daily maximum intake? Why is a moderate level (50 mg per average adult) important for food and in the end consumer safety? Will your application, once it is finished and fully approved, be the start to the daily dose of CBD in an array of everyday food products?

Boris Baňas: It is important to establish a safe, long-term daily intake for the healthy population.

Also, consumption of food supplements must not exert any pharmacological action. Supplements can only provide physiological effects to support, optimize and maintain the homeostasis. Such effects can be reached somewhere between No Observed Effect Level (NOEL) and the lowest pharmacological dose. And we believe 50 mg / day for an average healthy adult is the upper threshold of the recommended intake.

But, for instance, the UK FSA suggested that daily intake should not be higher than 70 mg / day.

We really look forward to the outcome of the EFSA risk assessment.

krautinvest.de: There are many different cannabinoids products coming to the market: water-soluble CBD, Nano-technology CBD, CBG, CBN, etc. Where do you think our industry is heading? What is the real deal and what areas do you personally see as the most promising from your experience as an entrepreneur in the Cannabis Industry?

Boris Baňas: While the safety profile of the CBD itself has been studied for decades, very little is known about toxicity profiles of other phyto-cannabinoids. More research is needed before industry can be confident about its safe consumption by humans outside non-medicinal applications.

In our group we believe CBD, CBG and CBN will play roles in the skin-treatment segments in products falling under the category of medical devices or OTC products. We already see interest in CBG and CBN from the clinical trials segment.

As to engineered nano-materials (particle size less than 100 nm), they automatically fall under the definition of novel food and business operators need to grasp this from the right end.

krautinvest.de: Thank you very much for the insightful interview. We are also looking forward to the results of the risk assessment by EFSA and wish you a smooth process for the approval.