Last year, the European Union reclassified extracts of Cannabis sativa L. and derived products containing cannabinoids, including CBD, as a “Novel Food” under the EU Novel Food Catalogue. The reclassification was based on the lack of demonstrated history of human consumption of these extracts and of any product to which they might be added.
Indeed, pursuant to Regulation (EU) No 2015/2283 (the “Regulation”), a “novel food” is any food that was not significantly used for human consumption within the European Union before May 15, 1997. As such, a novel food must be approved by the European Commission (the “Commission”) and the European Food Safety Authority (“EFSA”), which is the Food and Drug Administration’s European counterpart, before it can be lawfully marketed.
Novel food includes newly developed food, innovative food, food produced through new technology and processes as well as food traditionally consumed outside of the European Union.
As of today, the EFSA has received no less than 45 novel food applications for CBD-infused products, coming from the Netherlands, the United Kingdom, Czech Republic, Slovenia, Switzerland and the United States.
It’s worth pointing out that the Novel Food Application process is time consuming and expensive. Every successful Novel Food Application