When industrial hemp first appeared on the regulatory radar in Europe, it was exempt from the scope of the UN’s Single Convention of 1961, meaning that, other than its relative, marijuana, it was not considered a drug per se. Neither was its constituent cannabidiol (CBD) considered a narcotic, in contrast to the other famous hemp compound, tetrahydrocannabinol (THC), which is contained in industrial hemp in very small amounts only (below 0.3%). Varieties that contain 0.2% THC or less are legal to be cultivated in the EU. Any hemp product that contains more than that is considered a narcotic, and can therefore not be sold as a food or food/dietary supplement.

Despite the use of hemp as a food plant prior to 1997, CBD, both the extract from hemp and the synthetic form, is considered novel food, which led to a number of novel food applications for marketing authorization. Such applications for synthetic CBD are ongoing. However, all applications for hemp extracts and cannabinoids, including CBD extracted from hemp, were frozen by the EU Commission at the end of July 2020.

The applications are halted while the EC decides whether such extracts should be considered narcotics, or psychotropics. If the EC decides that, yes, hemp extracts are narcotics or psychotropics, it would mean that they cannot be food, novel or otherwise.

Industrial hemp contains higher amounts of THC in the flowering and fruiting tops than in the rest of the plant, and it is difficult if not impossible to separate the blossoms and buds during harvest, so the crop as a whole might contain more THC than is allowed. This is one of the problems industry must solve—and it has about two months to respond before the decision will be final.

Market Fallout
This decision is of course a crushing blow to the burgeoning CBD industry. It affects over 50 Novel Food applications. Synthetic CBD, guaranteed free from THC, is not affected by this decision, meaning that synthetic CBD might eventually make it onto the market.

This makes no sense from an environmental point of view, as the production of this synthetic substance can never be carbon neutral. Neither does it contain any other secondary plant metabolites, some of which may contribute to the benefits of natural CBD extracts, which lowers its appeal to both science-savvy consumers and those who are attracted to “natural.”

Also, the EC itself confirmed in 1997 that food coming from any part of the industrial hemp plant is not novel. All of this leads to the suspicion that the EC’s decision might be
politically motivated.

Opportunity in the U.K.?
Be that as it may, investing in a novel food application for hemp extracts or for CBD derived from hemp is a risky proposition at present, since the final decision of the EC is uncertain—in the EU at least. In the U.K., however, which is currently in the process of distancing itself from EU legislation because of Brexit, the situation is different.

The British Food Safety Authority (FSA) has stated that CBD will not be considered a narcotic in the U.K. after Brexit, regardless of the EU’s final decision. Food business operators will have to decide whether the much smaller U.K. market will be worth the investment into a novel food application, or whether it is better to wait—either for a novel food approval for CBD in the U.K. by another stakeholder, or for further developments in the EU.

In any case, it is looking like the U.K. will establish itself as a global leader in the CBD market while the EU is wrestling with decisions.

In the meantime, the novel food approval process for synthetic CBD is moving ahead in the EU. Despite the environmental concerns, at present it seems to be the safer bet for players within the CBD space to secure market share and brand awareness to go with this alternative. Food business operators considering to take this route might want to seek advice from experienced consultancies such as analyze & realize GmbH. 

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com; Website: www.analyze-realize.com.