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 goes through three phases over the course of 3 to 4 years and require a hefty budget of €300,000 to €400,000. These three phases include:
- Phase 1 – Application Assessment
An applicant must submit an online application that complies with the requirements of Article 10 of the Regulation. Once received, the application is reviewed and assessed for completeness. All applications must be accompanied by a toxicological opinion confirming the substance is safe for human consumption.
- Phase 2 – Safety Assessment
Once the application is deemed valid, the EFSA carries out a risk or safety assessment of the substance. The European agency then has 9 months to carry out its evaluation and issue an opinion to the Commission.
- Phase 3 – Marketing Authorization
Within 7 months of the publication of the EFSA opinion, and assuming the opinion is favorable, the Commission will submit to the Standing Committee on Plants, Animals, Food and Feed (the “Standing Committee”) a draft of an implementing regulation approving the substance as a novel food and authorizing it be added to the list. Once the Standing Committee approves the regulation and publishes it in the EU Novel Food Catalogue, the substance can be lawfully placed on the European Union market.
It’s important to know that the approval of one CBD-infused product will not authorize the sale and market of all CBD-infused products. Indeed, any product that differs from the one(s) approved also will need to go through the Novel Food Application process.
Moreover, any approved “Novel Food” must comply with general labeling requirements listed in Regulation (EC) No 1169/2011 as well as with any special labeling requirements the EFSA and the Commission may impose on this newly approved substance.
Given the cost and time required to secure a Novel Food approval, and given the non-binding nature of the Regulation, many business are deterred from pursuing Novel Food classification. However, several countries (e.g., Austria, Belgium and Spain) have banned the sale and marketing of CBD products without a Novel Food classification. These states have taken frequent enforcement actions against non-compliant local businesses. Consequently, stakeholders should seriously consider these risks before venturing into the European CBD market without securing a Novel Food authorization.