In January 2019, the European Union (EU) reclassified extracts of Cannabis sativa L. and products derived therefrom that contain cannabinoids, including CBD, to the EU catalog for novel foods. The reclassification was based on the lack of a proven history of human consumption of these extracts and any products to which they could be added.
As one would of course suspect, the novel food application process is time consuming and expensive. Every successful novel food application goes through three phases (the “Application Assessment”, the “Safety Assessment” and the “Marketing Authorization”), which last three to four years and require a large budget of EUR 350,000 to EUR 500,000.
To reduce the high costs of a single novel food application, the European Industrial Hemp Association (EIHA), which represents and advocates the interests of European hemp producers and processors, has set up a novel food consortium (the Consortium). The consortium was set up to submit joint novel food applications and to share the cost between its members, most of which are small and medium-sized enterprises (SMEs) that could not bear the cost of a single application.
So far, EIHA has submitted three novel food categories, including one for CBD isolate-based products, one for synthetic CBD-based products, and a third for products infused with full-spectrum hemp extract. For each of these uses, the EIHA has to submit toxicological studies that show that the substances are safe for human consumption. However, the organization appears to be particularly concerned with hemp extract based products on a full spectrum basis.
In a recent interview with Cannabis Health, managing director of EIHA, Lorenza Romanese stated that the challenge lies in the presence of tetrahydrocannabinol (THC) in the full-spectrum hemp extract.
As in the United States, Europe lacks sufficient reliable scientific data to ensure the safety of products infused with full-spectrum hemp extract, including the safety of THC, one of the 100+ cannabinoids found naturally in the extract. Therefore, through its combined efforts, EIHA is taking the lead in investing in the kind of in-depth research the industry so desperately needs to operate freely, by spearheading the largest human study to date on the safety of trace amounts of THC consumption.
EIHA hopes that this toxicological study, in which 200 participants will take part within 30 days, will familiarize regulators with the concept of full-spectrum hemp extract and enable EIHA members to continue manufacturing these products in the European market and overseas for sale .
However, there is still a possibility that European regulators will reject the validity of the study during the evaluation phase of the novel food use process. In this case, EIHA is ready to appeal.
After submission, the European Food Safety Authority (EFSA), the European counterpart of the Food and Drug Administration, has 9 months to carry out the safety assessment of the EIHA’s toxicological study. At this point in time, EFSA will submit a statement to the EU Commission. If this is favorable, the EU Commission will submit a draft implementing regulation to the Standing Committee on Plants, Animals, Food and Feed for the approval of products with hemp extract from the entire spectrum, which will then include these products in the EU’s new food catalog.
Needless to say, such approval would fundamentally change the industry. We will continue to monitor and report on the development of this groundbreaking study. So stay up to date!