To return to the current frustration among industry figures at having to run the gauntlet of Novel Foods approval in the EU, a part of this may be to do with CBD having been categorised as ‘traditional’ for two decades, as Reeves explains. “So why is it now suddenly a ‘novel’ food?” he asks. The re-classification of CBD products as Novel Foods at the beginning of 2019 prompted EIHA to begin the process of seeking—and providing the evidence for—approval on this basis. The consortium of association members has budgeted up to €3.5m to spend on the relevant toxicology tests and on kinetic studies to demonstrate how cannabinoids pass through the body, Reeves says. Romanese at EIHA believes that the lack of clear EU regulations up to now has put the whole idea of a ‘single market’ for CBD products in jeopardy, and “barriers are growing,” she says. Those barriers start with the hemp plant itself. “Based on a major misinterpretation, that ‘hemp equals a drug’, decisions are left in the hands of Member States, which have very little knowledge—and too many prejudices—about this plant.” She adds: “The sector needs to stimulate the adoption of a comprehensive political agenda to address and overcome the full complexity of the Cannabis sativa L. plant.” As mentioned at the outset, these complex dimensions in which full-spectrum, hemp-derived CBD operates can be as much a liability as a blessing. Mariko Hill, global innovation manager at PEA supplier Gencor, says: “Typically, most countries permit the sales of CBD derived from hemp so long as it contains less than 0.2% THC. However, standardisation of CBD can be a challenge in itself, and numerous products on the shelf have been found to contain higher THC levels than the European Food Safety Authority (EFSA) permits.”
PEA: CBD alternative
At a time when CBD appears to offer huge potential, but also faces significant challenges in some areas, palmitoylethanolamide (PEA) is being presented as an alternative without the downsides.
But such issues and inconsistencies may not be a problem forever. “The EU is actually moving fairly quickly towards some sort of stability,” says Reeves. “And money is now coming into the industry because investors can see signs of that stability.” He adds: “At the end of April, EFSA is expected to outline its position on CBD, which is anticipated to assist in future Novel Food applications. This follows confirmation from the European Commission back in December 2020 that CBD qualifies as a food, and by definition is not a narcotic.” CBD-Intel takes the view that delays to the Novel Food process are not entirely the fault of the regulators. “We were told by the European Commission that many applications were thin, and they had to go back multiple times to companies to get more thorough responses,” reports managing editor Freddie Dawson. While decisions for the five validated applications are notionally due by the end of the year, this could easily slip to the second half of 2023, says Dawson; and, of course, it may be that no approvals are forthcoming at all, from this batch at least. “The impact of these delays is minimal for most of the sector, in reality,” he adds. “Broadly speaking, those that have spent significant time, resources, energy and capital in engaging with the Novel Food application process are angry about the delays.” The US has, in the recent past, often been seen as being more open in regulatory terms and more stable as a market, and Reeves is quite clear that globally, most innovation in CBD markets still originates in North America. “But from a regulatory perspective, the US has always been very complicated, with a certain lack of clarity from the Food & Drug Administration (FDA),” he argues. With varying requirements in different states, shipping CBD products from one to the other can be problematic. Reeves envisages a time, not so far off, where current relative positions either side of the Atlantic may be reversed, with the EU coming to represent ‘stability’ for CBD markets and the US playing catch-up—while still remaining the larger market, of course.
Shifts in the regulatory environment across Europe could offer great potential to the broader cannabidiol (CBD) industry