Company insight
A bright future for cannabidiol ingredients
For nearly a decade, CBDepot has been a pioneer in the production of high-quality cannabinoid ingredients. Company founder and CSO Boris Banas, tells Ingredients Insight how the company has helped establish legal and quality standards within the industry and formulated cannabidiol derivatives in myriad sectors, including: food, cosmetics, pharmaceuticals and other health products.
When was CBDepot founded? Boris Banas: CBDepot originated in mid- 2014. At that time, the majority of current shareholders were well-established in segments of bulk wholesale supply of hempseed derivatives. It was in fall 2014 that we introduced the first CBD- containing ingredients and finished consumer products on the market using third party CBD isolate.
In early 2015 we collaborated with PhD chemists from the Czech Academy of Sciences in Prague, who had their lab-scale extraction and isolation set-up within the premises of this public institution – where our primary production stays to this date. This enabled us to commercialise the know-how and facilitate the upscale. We added CBG isolate into our offer in January 2017. In 2018 we also included Broad Spectrum distillates (CBD and CBG-types), with ultra-low THC levels (<0.0005%) as well as CBD produced by chemical synthesis. Throughout 2017-2020 we have been working hard on setting up a supply chain structure for EU GMP pharma-grade cannabidiol isolate. In 2018 we filed the first-ever CBD-specific novel food application. It’s important to note that our products do not stem from the “seed and stalk” of Cannabis sativa L. We only use the “green parts” of hemp cultivars listed in the EU Pant Variety Database cultivated in the GACP regime.
What is your background in the cannabinoid industry, and what role do you currently fulfil? CBDepot has played a substantial role in shaping the European cannabinoid landscape. I acted as a board member of the European Industrial Hemp Association, responsible for the CBD agenda. I
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represented EIHA during pre-review and critical review of cannabidiol at the 39th and 40th meetings of the WHO Expert Committee on Drug Dependence. I also appeared in talks with the European Commission, Standing Committee on Plants, Animals, Food and Feed, and EFSA and have co-authored several position papers available on EIHA’s website.
How have cannabinoid products changed over the past decade? The regulatory dynamics have been a roller- coaster ride. In October 2016, the first entry on CBD was published in the Novel Foods Catalogue. We can currently find the third updated version of the entry published in January 2019, which now includes cannabinoids and extracts in general. The entries in the CosIng Database are not helping to give too much clarity as we can see there are two listings for cannabidiol (isolated and synthesised – without restrictions), one for CBG (unrestricted) and CBN (restricted), as well as an entry cannabinoids (restricted). Luckily, cannabidiol has made its way into an official glossary of common ingredient names for use in labelling cosmetic products, as established by Commission Decision (EU) 2019/701. Pharma-grade CBD is finally widely used as an active ingredient in the manufacture of magistral formulas under prescription, in off-license drugs, and human clinical trials.
What are CBDepot’s legal and quality standards for cannabinoid ingredients and the formulation of cannabidiol derivatives?
Since day one, our manufacturing has been organised in a 100% legal manner. First, under the umbrella of handling license of
the Czech Academy of Science, and later under license of our 34% shareholder PharmaCan. This permission issued by the Czech Ministry of Health allows us to manufacture hemp extracts and tinctures legally, and handle and dispose of whatever THC is recovered during the extract purification steps. Our CBD comes with a non-objection letter from the Czech Inspectorate of Narcotic and Psychotropic Substances. We provide full compliance within the judgement of the EUCJ in the case C-663/18, which stresses the lawfulness of CBD production in an EU Member state. Yet another level of compliance comes from our pharmaceutical leg covered by a sister company CB21 Pharma. Their manufacturing certificate issued by National Competent Authority SUKL guarantees the principles of the Good Manufacturing Practice for Active Pharmaceutical Ingredients are met.
How has the company worked to obtain validity on novel food applications? We invested in industry-standard safety studies, such as in-vitro genotoxicity, 90-day oral toxicity, and toxicokinetics. We currently hold three validated applications under risk assessment: our synthesised CBD in the EU systems and in the UK, for both isolated and synthesised CBD. We also hold one EFSA suitable application for plant-based CBD and the other one under the pending EFSA suitability phase. Currently, safety studies are underway for pure Cannabigerol. We expect the submission of novel new food applications in the spring of 2022. ●
www.cbdepot.eu Ingredients Insight /
www.ingredients-insight.com
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