With CBD Poised To Become A Novel Food In Europe, Industry Must Think Ahead To Gain Advantage
Executive Summary
Europe's dynamic CBD market could soon see tighter regulation, after the European Commission (EC) last month added the ingredient to its Novel Food Catalogue. Regulatory expert Janet Worrell argues that the time is now for CBD industry players to act to get ahead of this potentially transformative development.
Cannabidiol (CBD) could soon be classified as a novel food within the European Union (EU) following a revision by the European Commission (EC) to its ‘Novel Food Catalogue’.
The Novel Food Catalogue is a database maintained by the EC that provides guidance on novel foods and ingredients for EU member states and serves as an orientation as to whether a product will require authorization under the EU’s Novel Food Regulation.
Although yet to be confirmed, the EC’s catalogue revision at the end of January – which suggests that all cannabinoids, including CBD, should now be considered novel foods – provides a framework across the EU for each member state to translate into national legislation.
The UK’s Food Standards Agency (FSA) told HBW Insight that it was now “considering the way forward in light of this clarification at EU level” and would be “meeting with relevant industry representative bodies, local authorities and other stakeholders to clarify how to achieve compliance in the marketplace in a proportionate manner.”
The updated Catalogue entry for ‘Cannabinoids’ states that “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),” the entry continues. “This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.”
Prior to the update, CBD was only considered novel if it was present in levels exceeding that naturally occurring in hemp oil. At naturally occurring levels, CBD products can be sold as food supplements within the EU, as long as no health claims are made for such products.
European CBD Market Booming
In the last few months, the market for CBD products in Europe has exploded, with CBD supplements available in a variety of retail outlets, including supermarkets and petrol stations.
While the US Food and Drug Administration (FDA) has recently decided to prohibit the use of ingredients derived from the cannabis plant in supplements and food, such practices have until now remained legal within the EU. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)
Except for Austria, that is. In December, the country’s health ministry, BMASGK, decided to ban the sale of CBD-containing foods, including dietary supplements.
As CBD was a novel food, BMASGK argued, it required authorization under the EU’s Novel Food Regulation.
Since no CBD product had received such an authorization, it continued, the placing of such products on the Austrian market was not permitted, and CBD products could not be sold in the country.
Strangely, the EC at the time had not yet entered CBD into its Novel Food Catalogue, so the Austrian government was anticipating a rule change that seemed to come out of the blue for most operators.
Speaking exclusively to HBW Insight, Janet Worrell – regulatory specialist at OTCexperts – suggested that Austria’s decision “mirrored the prevailing mood in Europe.”
Away from Austria, countries like Germany, Italy, France, Netherlands and the UK – where it is still legal to sell CBD as a food supplement – “would like more certainty” than what they have currently on CBD, she explained.
“It is a classic borderline product,” Worrell pointed out. “With such borderline products, it is inevitable that some distributors may associate a health benefit with CBD, where no health claims exist.”
“This is a concern for all EU members states wishing to protect consumers from misleading claims,” she added.
Industry Players Can Gain Advantage
Worrell anticipated that CBD trade associations – such as the UK’s Cannabis Trades Association – would now be “fighting for their members’ rights on two fronts.”
On the one hand, they will likely begin “lobbying hard” to maintain the position prior to the change in the Novel Food Catalogue and, on the other, support applications from member companies to gain novel food status for their products.
Key to this process would be establishing CBD extraction processes common to the largest cross-section of member companies, Worrell explained.
“All novel foods are closely linked to the process of extraction or production,” she continued. “A novel food application needs to provide data on the specification of the product, its production process, use and intakes, nutrition, microbiology, toxicology and allergy information.”
Under the EU’s Novel Foods Regulation – which came into effect in 2018 – each production process results in a distinct approval, which is then valid across all EU member states.
“Therefore, any manufacturer that has seized the opportunity to initiate the novel food process may, with the right data package, be in a unique situation to be able to supply the European market with the only approved novel food source of CBD,” Worrell pointed out.
“This would then give CBD firms which have successfully negotiated the EU novel food application process the chance to corner the market for one or two years,” she maintained.