CBD and the Novel Foods Directive- An Introduction
[Editor’s note: This article by Kight Law attorney Philip Snow is the first in a series of articles about the EU’s Novel Foods Directive and how it applies to CBD. As Philip discusses, a Novel Foods authorization must be obtained in order to sell CBD foods in the EU. -Rod Kight]
With the market for cannabidiol (CBD) rich products rapidly expanding in the United States and across the world, I am frequently asked by clients how they can distribute their CBD products in Europe. Unfortunately, the sale of CBD products in all European Union (EU) Member States is prohibited unless the CBD product has been authorized for sale following a risk assessment conducted under what is known as the Novel Foods Directive. This article is the first in a series of posts discussing the relationship between CBD products and Novel Foods, how they are authorized, and what you and your company can be doing in order to distribute your products in the EU.
A Novel Foods is defined as food or ingredient that has not been consumed to any significant degree in the European Union before May 15, 1997. Novel Foods can be newly developed or innovative foods, food produced using new technologies or production processes, or even food that was traditionally consumed outside of the EU prior to May 15, 1997.
Cannabinoids were confirmed as Novel Foods in January 2019 and were subsequently entered into the EU’s Novel Foods Catalogue. The European Commission’s Novel Food Catalogue lists products from plant and animal origins, as well as other substances which are subject to the Novel Food Regulation based on information provided by EU Member States. This list, which is non-exhaustive, describes whether a product will need authorization under the Novel Food Regulation.
Based on CBD’s designation as a Novel Food, manufacturers of food products containing CBD and other cannabinoid derivatives must submit a Novel Foods application in line with the Novel Food Regulation. The primary focus of the application is a safety determination of the food or ingredient. The safety of a food or ingredient is based on clinical studies and an investigation of the manufacturing process. Manufacturers can place a Novel Food on the market in the EU only after the Commission has processed the application for the authorization of a Novel Food and has adopted an implementing act authorizing the placing on the market of a novel food and updating the Union’s list.
In our next blog post covering Novel Foods, I discuss how certain CBD products in the EU, and in the United Kingdom in particular, are able to be sold while the Novel Food application is being reviewed by the relevant Food Safety Agency. This gives existing manufacturers of CBD products an advantage over others, as it could provide them an opportunity to conduct sales during the entire 2-3 year period while their risk assessment is being conducted.
June 5, 2020
This article was written by Kight Law attorney Philip Snow. Kight Law represents hemp and CBD businesses in the US and throughout the world. To schedule a consultation with Philip, please click here and mention this article.