As previously discussed here in this blog, in January of 2019 the European Commission (EC) classified cannabinoids, including CBD, as novel foods. This means that in order to sell a CBD product in the European Union (EU) a manufacturer must submit a Novel Food Application dossier, which demonstrates the product’s stability and its safety for consumers. The EC is responsible for conducting a preliminary review of the dossiers and validating them for final review by the European Union Food Safety Authority (EUFSA). To date, at least fifty (50) of these applications have been submitted to the EC, and none of them have been validated for review by the EUFSA.
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.
THE EU COMMISSION HAS DETERMINED THAT CANNABIS-DERIVED CBD IS A NARCOTIC UNDER THE SINGLE CONVENTION
As previously discussed here in this blog, in January of 2019 the European Commission (EC) classified cannabinoids, including CBD, as novel foods. This means that in order to sell a CBD product in the European Union (EU) a manufacturer must submit a Novel Food Application dossier, which demonstrates the product’s stability and its safety for consumers. The EC is responsible for conducting a preliminary review of the dossiers and validating them for final review by the European Union Food Safety Authority (EUFSA). To date, at least fifty (50) of these applications have been submitted to the EC, and none of them have been validated for review by the EUFSA.
Recently, the EC paused its assessment of all Novel Food Applications if the CBD contained in the product was derived from the hemp plant or its flowers. In fact, due to recent internal discussions, the EC has stated it would reject all such applications on the basis that under the United Nations Single Convention of Narcotic Drugs in 1961 (Single Convention), CBD is a narcotic if derived from cannabis.
More specifically, the Single Convention defines the cannabis plant as: “any plant of the genus Cannabis.” Further, cannabis itself is defined as: “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted by whatever name they may be designated.” As you can see, there is no distinction in these definitions permitting the legality of low THC cannabis (hemp) and high THC cannabis (marijuana).
Pursuant to the Single Convention, “extracts and tinctures” of the cannabis plant are considered narcotics, regardless of whether the cannabis plant in question is hemp or marijuana. CBD is not directly specified in the Single Convention; however, the phrase “extracts and tinctures” is included. Because of their prohibition under the Single Convention, CBD derived from them is deemed a narcotic and its prohibition is clearly implied. Interestingly enough, when it is derived from synthetic sources, CBD is not considered a narcotic. As such, the EC has not paused the review of Novel Food Applications where the subject matter is synthetic-derived CBD.
UNDER EU LAW NARCOTICS CANNOT BE APPROVED AS NOVEL FOODS
The EU General Principles and Requirements of Food Law (in which the EUFSA is established) states that “Food shall not include: narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971.” This is the root of the EC’s argument that CBD, when derived from hemp flowers, is prohibited and cannot be classified as a novel food.
UN MAY VOTE TO REMOVE “EXTRACTS AND TINCTURES” LANGUAGE
Fortunately for the European CBD industry (and those Novel Food applicants seeking entry into the European CBD industry), the United Nations (UN) is considering removing “extracts and tinctures” from the language of the Single Convention. It is also considering setting a threshold for THC, thereby making any preparations below that threshold legal. Unfortunately, however, is the fact that the UN will not vote on these changes until the end of the year, leaving existing Novel Food Applicants in limbo.
This clearly puts companies who have already submitted their Novel Food Applications to the EC in a bind. By suspending the review of these applications, the EC has essentially created an insurmountable barrier to entry for companies looking to sell CBD products in the EU.
IS APPLYING FOR NOVEL FOOD STATUS IN THE UK A SOLUTION?
Fortunately, all is not lost. Anyone familiar with the European market for CBD products (or frequent readers of this blog) knows there is a separate and unique opportunity to distribute CBD products in the United Kingdom (UK).
As you may recall from this previous post, the UK’s Food Standards Agency (FSA) has stated that if a company has an existing CBD product on the market in the UK and also has a validated Novel Food dossier by March 31, 2021, the product can be distributed in the UK until the Novel Food dossier is reviewed. Given that the EC is no longer reviewing Novel Food dossiers, it stands to reason that companies are concerned they will not have a validated application by the end of the year, or in a worst-case scenario by the deadline next March.
The FSA cannot act independently of the EC until Brexit occurs. Practically speaking, this means the FSA cannot begin accepting Novel Food dossiers until January 1, 2021 at the earliest. Until then, companies seeking to introduce CBD products to the EU are forced to submit their dossiers to the EC. The FSA has stated, however, that it can accept Novel Food dossiers on an informal basis prior to Brexit. This is beneficial to companies because it essentially gives them the ability to have their dossier pre-reviewed by the FSA. The FSA has stated it will provide feedback as to whether the dossier would be validated as is, or if it needs additional information or data in order for it to be validated.
As a manufacturer or company seeking to introduce CBD products into the UK you might be asking yourself whether the UK adheres to the same policy as the EC (i.e. treating CBD as a narcotic), and if so, is there any point in submitting an informal Novel Food dossier to the FSA only to have its review suspended due CBD’s classification as a narcotic.
Fortunately, the UK’s policy on cannabis and cannabinoids is different than that of the EC. This policy, which is set by the UK’s Home Office, determines whether something is a narcotic based on whether it contains detectable levels of controlled cannabinoids (THC). Additionally, the UK makes no distinction between CBD derived from cannabis and CBD derived from synthetic sources. Most importantly, the FSA has stated it is going to follow the policy of the Home Office as it relates to the classification of CBD. In light of the foregoing, anyone looking to enter the CBD product market in the UK can submit their Novel Food dossiers on an informal basis without fear of having the review of their dossier suspended.
CONCLUSIONS
Despite the fact that hemp derived CBD is classified as a narcotic under the Single Convention, as a practical matter anyone seeking to introduce CBD products to the EU should submit their Novel Food dossier to the EC. This acts as a placeholder for the application, and it gives the applicant peace of mind knowing that if the EC changes its mind regarding the classification of hemp-derived CBD, the applicant is ahead of anyone else who jumps on the EU CBD bandwagon.
More importantly, any company seeking entry into the UK’s CBD market should submit its Novel Food dossier to the FSA. The FSA does not view hemp-derived CBD as a narcotic, paving the way for the successful introduction of CBD products to the UK. This gives the applicant the ability to receive valuable feedback regarding its dossier, allowing it to correct any deficiencies. Moreover, it gives the applicant confidence that when it formally submits its dossier it will be validated by the FSA.
We have had numerous discussions with law firms, testing services, laboratories, and industry consultants to determine how to position our clients for a successful Novel Food application. Contact us to discuss your Novel Foods strategy.
