CBD & Novel Food Regulations
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Novel Food Regulations & The CBD Industry
Not even a decade ago, CBD was a complete unknown to consumers fond of food supplements and alternative medicine. Even consumers of illicit cannabis, whether they relied on the plant for medical or recreational reasons, pretty much overlooked cannabidiol. Throughout human history, the cannabis plant was highly praised for the beneficial effects it has on our health. But because of prohibition in the previous century, access to cannabis became almost impossible, so its health qualities were also forgotten. The cultivation of cannabis was only legal through hemp varieties which contained less than 0.2% THC. (the compound responsible for intoxication). And could be cultivated only for industrial purposes, mostly for fiber and seed oil production. In 1998, hemp flowers and leaves became allowed to be used in the food industry and the plant suddenly became much more interesting. Hemp started gaining attention from farmers and consumers alike. With more countries joining the European Union, hemp cultivation and consumption kept increasing. Although hemp only contains trace amounts of THC, other cannabinoids like CBD (cannabidiol) are found in abundance. And it was cannabidiol, the pebble that started the avalanche. It singlehandedly put cannabis back on track as one of the best medicinal plants. From 2015 onwards the CBD industry really took off. Hemp extract rich in CBD and other cannabinoids started show everywhere, from online shops to pharmacies. Up until January 2019, CBD industry in Europe was booming, everyone predicted a bright future ahead. Until out of the blue, starting 2019, European Comission decided to add a new section in their Novel Food Catalogue for cannabinoids. With this manoeuvre, the booming CBD industry took a U-turn. Since the addition to the Novel Food catalogue, hemp extracts and products containing them cannot be marketed as products safe for human consumption. Even if products contain zero THC and heaps of healthy cannabinoids they are deemed unsafe until proven otherwise.What Are Novel Foods?
The first Novel Food regulation was introduced in 1997 by Regulation (EU) 258/97 with the aim of establishing a food safety mechanism to control newly developed, synthetic, or genetically produced food. An updated version of the regulation came into force on 1st January 2018 (Regulation (EU) 2015/2283). This basically means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997.
In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % (w/w). Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities.
The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.
EFSA novel food application process requirements
And we can only speculate how long it is gonna take to process EFSA novel food applications. To obtain a novel food license it might take anywhere from 16-60 months (avarage is 35).- It is gonna be especially long if every single cannabinoid will have to go through the following lab tests:
- If every single cannabinoid will need to have the following parameters set:
- And if following data needs will need to be set for every single cannabinoid: