Novel Foods: Validation and the UK Deadline

[Editor’s note: This article by Kight Law attorney Philip Snow is the second in a series of articles about the EU’s Novel Foods Directive, which requires approval of an application in order to sell CBD foods in the EU. As Philip explains in this article, the UK has extended the deadline for obtaining validation of Novel Foods applications, creating a crucial opportunity for companies wanting to sell their products there. -Rod Kight]

As previously discussed here in my introductory blog post about Novel Foods in the European Union (EU), the sale of cannabidiol (CBD) products in all EU Member States is prohibited unless the product has been authorized for sale following a risk assessment conducted under the Novel Foods procedure. This procedure, set forth in Regulation (EU) 2015/2283, governs the lengthy process a company must follow in order to have its food and/or ingredient product approved for distribution in the EU.

Despite the necessity of having a product approved under the Novel Food Regulation by means of a risk assessment, a glimmer of hope has emerged as the United Kingdom (UK) and its Food Standards Agency (FSA) have created a “window of opportunity” for CBD food products to be sold in the UK without a risk assessment under the Novel Foods process having been completed. (Click here for an excellent article on this point by The Canna Consultants.)

What is required under the FSA scheme is for a product manufacturer to submit a Novel Food application and have it “validated” by March 31, 2021. Generally speaking, in this context “validation” means that the application has been properly submitted and contains all of the required elements, though it does not mean that the application has been approved. If a manufacturer’s application is validated prior to March 31, 2021, its CBD products can be lawfully sold in the UK throughout the whole period of the risk assessment (2-3 years). As you might imagine, it would be extremely beneficial for a manufacturer to submit an application and have it “validated” prior to March 31, 2021. This because it provides the company the ability to sell its product until at least 2023 and possibly 2024. Keep in mind this ability to sell the product during the window of opportunity applies regardless of whether the product is finally authorized or rejected.

Manufacturers whose Novel Foods applications have been validated are able to keep selling their products in the UK, which allows them to realize profits necessary to keep manufacturing operations up and running. More importantly, this can help pay for the costs of submitting a Novel Food application in the first place. In contrast, those who do not obtain a validation prior to March 31, 2021 are unable to sell their products until the entire risk assessment is complete. Therefore, they miss out on the opportunity to receive any income related to the product subject to the Novel Food application.

At this point in time it is important to note that this opportunity is unique to the UK and does not apply to the EU in general. The EU has not provided a similar window of opportunity and those seeking to sell CBD products in the EU must undergo the Novel Foods application process. For more information on what a Novel Foods application consists of, tune in to my next blog where I discuss the requirements for a Novel Food application.

June 10, 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.