Whenever there is confusion about whether or not a food is considered Novel Food, business operators can file a novel food application, and the EU Commission will eventually address the question on a case-by-case basis by either declaring that food non-novel—meaning it can be marketed in the EU without restriction—or by including the food in the Novel Food Catalogue. The Novel Food Catalogue lists products of animal and plant origin and other substances that are subject to the Novel Food Regulation, based on information provided by EU Member States.
Even though the new Novel Foods Regulation ((EU) 2015/2283) went into effect last year, these basic principles have not changed.
In this context, cannabidiol (CBD), the non-psychoactive constituent of the Cannabis plant that has been linked to a number of health benefits, has now come under the radar of regulators, with unsurprising results.
The market for CBD-containing products has been booming in Europe, although the regulatory environment around these products was not exactly well-defined. Specifically, it was not clear whether extracts from leaves, flowers, and seeds of the Cannabis sativa plant could be used as or in foods. This led to a lot of uncertainty among manufacturers of CBD-containing products.
The only thing that seemed fairly certain was the fact that, as long as the content of the psychoactive tetrahydrocannabinol (THC) remains below a certain amount, then the food products derived from Cannabis can be sold legally.
The CBD contents alone are not critical in that context. This led to the assumption that products made from industrial hemp, a variety of Cannabis sativa that contains hardly any THC, are legal to sell.
The European commission has now addressed these issues and, as a result, has recently updated the Novel Food Catalogue regarding CBD and cannabinoids. In the current version of the Novel Food Catalogue, extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods, on the grounds that 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). It also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered to be “novel” as a matter of course.
In other words, nearly all products consisting of or containing hemp extracts are now considered novel foods and will require Novel Food Authorization. Hemp seeds and hemp seed oil as well as medicinal products made from Cannabis sativa are not affected by this ruling.
The implications of this decision for the CBD business are enormous, as many of the products already on the market might become illegal. Many CBD products are sold over the Internet, and it will remain unclear if and when they might be attacked by the health authorities, even when they are officially regarded as illegal. That is the risk which needs to be taken into account.
A successful Novel Food Authorization for a CBD-containing product might bring a little clarity. As of the time of this writing, there is one novel food application pending for trans-cannabidiol. However, this application only concerns food supplements, so its approval would not relate to other food applications. No further information is publicly available on the status of this application or on the exact composition of the extract.
In the meantime, at least one novel food application for a food use of CBD has been filed with a decision expected soon. The results of this and other currently pending applications will send a signal for the industry’s future strategy—either, in case of a rejection, by pushing food business operators to other categories such as cosmetics or drugs, or, in case of acceptance, to intensifying business with CBD products in foods.
As of right now, industry is in a sort of holding pattern, as further investments into food applications for CBD seem unwise as long as there is a considerable risk that the resulting products could then be disallowed from sale in the EU markets. The signs are there, though, that this will be resolved with the decision on the first pending novel food application.
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: firstname.lastname@example.org; Website: www.analyze-realize.com.