EU Classifies CBD as a Novel Food
The EU has passed legislation classifying CBD products as Novel Food, meaning they cannot not be sold without proper evaluation and authorization. In other words, if you’re in the CBD business, you’re going to need pre-market authorization and licenses. The troubling thing is that all CBD businesses in the EU were required to submit their Novel Food application before March 31, 2021. These things can creep up on you.
The cannabis industry team at Mackrell Solicitors has said that this policy will have broad ramifications on how CBD is sold and marketed in the EU. Let’s start with the basics before we take a deep dive into the Novel Food application process.
Why CBD is Classified as Novel Food in the EU
Novel Food is defined as any food that had not been consumed to a significant degree by humans in the EU before May 15, 1997, when regulations were introduced.
Novel Food policies in the EU state that any prospective food needs to be safe for consumers and labeled correctly without misleading consumers.
Since cannabis is now legally classified as Novel Food, any and all cannabis products will need a pre-market authorization based on evaluation in line with these policies. In other words, your CBD products need to pass through a strict approval process and get the thumbs-up from the European Food Safety Authority (EFSA).
While hemp is not a Novel Food, the German government said that foodstuffs which contain cannabinoids from hemp are considered Novel. This is great news for German pharmaceutical companies but bad news for CBD companies and businesses, since they will have to go through a lengthy licensing process.
The Novel Food Process Application
Let’s face it: most application processes are costly and time consuming. Novel Food is no different.
From the date a CBD company files an application, it can up to two years before final approval is confirmed.
In this process, the CBD manufacturer or supplier is the applicant. Companies selling the finished products must ensure that their suppliers have applied for and received certification.
Furthermore, Dr. Parveen Bhatarah of the Centre for Medical Cannabis, stated that the incumbent brand must consider stability, bioavailability, intended use, and potential effects. These are all necessary because various methods of production can impact the absorption of CBD in the body. What’s more, the purity profile may be different across such products.
Bottom line is, if you are a CBD brand selling CBD products, you need to have a conversation with your supplier to understand the status of their Novel Food application. If they missed the March 31 deadline, you might want to look at finding another supplier.
This is all about safety. The authorities want to ensure that the product you are selling to consumers is safe. Not a bad thing.
UK CBD Novel Food Policy
The UK Food Standards Agency has classified CBD as a Novel Food, but the implications of this are still unclear. We do know that, in the UK, most CBD products will remain on the market for now. According to most experts, the UK is likely going to mirror the German situation soon, ie. a stable and favourable commercial setting.
The European Industrial Hemp Association, together with Cannabis Trades Association in the UK, is working day and night to resolve CBD’s ambiguous legal position in the UK. The two bodies are doing everything they can to have transparent discussions with relevant authorities using appropriate channels.
The most surprising thing is that many businesses will find it weird that a lot of hemp-based foods that have identical chemical profiles and have been used for thousands of years are classified as Novel by the regulators. There’s a lot of evidence that suggests CBD isn’t harmful, yet more research is needed to prove it and allow CBD products to be used in the EU and the UK without restriction.
This is an issue that has to be dealt with. Product safety certification restores consumer confidence and helps to stabilize the market. And it is something that we need to support.
Manufacturers of finished products should liaise with their suppliers. Make sure the data is submitted because it’s going to be a part of your supplier’s dossier. The Novel Food application process helps manage and control long-term safety issues that may occur because of CBD.
If you fail to comply with Novel Food policies and rules, you may be denied a license to operate your business. Most importantly, you could be fined or imprisoned. If you missed the deadline, there is no more time to waste—have your legal team figure out what steps you need to take to safeguard your business.