CBD Food Product Approval In The EU
The legal landscape in the Cannabidiol (CBD) sector is changing quickly
The legal landscape in the Cannabidiol (CBD) sector is changing quickly, especially for CBD-infused food products. Companies looking for business opportunities involving CBD-infused food products are well advised to keep an eye out to new developments. In the European Union one can notice a change in perspective regarding CBD, its danger and use. This can be traced back to a long-awaited judgment by the Court of Justice of the European Union (ECJ) in 2020.
ECJ rules on the classification of CBD as narcotic drug
In November 2020 the ECJ concluded that CBD extracted from the Cannabis sativa plant in its entirety — and not solely from its fiber and seeds — cannot be regarded as a narcotic drug. Corresponding to currently available scientific data it “does not appear to have any psychotropic effect or any harmful effect on human health” (Case C-663/18).
This decision conflicted with the earlier classification of CBD by the United Nations (UN). Until recently, the UN placed cannabis and cannabis resin in the highest danger class of narcotic drugs established by the 1961 UN Single Convention on Narcotic Drugs. Following the ECJ ruling and a recommendation of the World Health Organization (WHO), the UN Commission on Narcotic Drugs downgraded cannabis and cannabis resin from the highest to the lowest danger class in December 2020 (to see how the sausage was made here, check see our earlier posts: The United Nations is FINALLY Taking a Hard Look at Cannabis and The World Health Organization Steps Up on Cannabis).
CBD in Europe after the ECJ ruling
The European Commission (EC) also reacted to the ECJ ruling and signaled that it will no longer classify CBD as a narcotic drug in the future. It stated:
“in light of the recent Court’s judgment in case C-663/184, the Commission has reviewed its preliminary assessment and concludes that cannabidiol should not be considered as drug within the meaning of the United Nations Single Convention on Narcotic Drugs of 1961 in so far as it does not have psychotropic effect.”
These developments are expected to open the European market to CBD. However, prior to selling a CBD-infused food product in the European Union, each product requires pre-market authorization under the EU novel food regulation.
The EU novel food regulation (Regulation (EU) 2015/2283) lays down rules for placing novel foods on the market in the European Union. These rules provide heightened protection for human health and consumers’ interests. CBD is classified as a novel food and therefore falls within the scope of application of the regulation. Any food product containing CBD therefore needs authorization by the EC before placing it on the European market.
The procedure under the EU novel food regulation is time consuming and involves several institutions. Primarily responsible is the EC as competent EU authority. Here are the steps:
- An application for approval of a novel food is submitted to the EC.
- The EC assesses whether the product meets all requirements set out by the regulation, e.g. no safety risk to human health based on available scientific data or no misleading of consumers by the intended use of the food.
- The EC then assigns the application to the European Food Safety Agency (EFSA) to conduct a scientific evaluation of the product, which concludes with a recommendation on whether the product should be approved.
- The EC submits its final evaluation regarding the approval of a novel food to the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee).
- If PAFF Committee approval is granted, the product is added to the list of approved products within the EU Novel food catalogue.
For further information on the novel food application process see our latest post on European CBD Sales: Securing a Novel Food Authorization.
Sale of a CBD food product remains prohibited until approval as novel food
To date, CBD has not been approved as a novel food. All applications had been halted to await the above mentioned ECJ’s decision. The EC has now resumed the application process, and several applications for approval of synthetic CBD are pending.
In the light of the EC’s re-evaluation, it can be expected that CBD will be added to the list of approved products. However, it is uncertain when a final decision will be issued in the pending cases. Generally, it takes 3 to 4 years for an ingredient to gain novel food status.
Note that the approval of one CBD-infused product does not mean authorization of all CBD-infused products. Any product that differs from the one(s) approved will need to go through the novel food application process. Moreover, any approved novel food must comply with general and special labeling requirements the EC may impose on the approved substance.
Without approval, it is prohibited to place a CBD-infused food product on the European market. Still, enforcement is up to each EU member state. Enforcement is not uniform, with some countries being more stringent in the process than others. However, several European countries such as Spain, Belgium and Austria have taken enforcement actions against CBD products on the basis of being novel foods.
Despite the change in perspective regarding CBD within the EU, the formal requirements to market a CBD-infused product are being tightened. Businesses interested in marketing CBD-infused food products on the EU should carefully consider these new developments and risks prior to offering their products.
Further considerations for CBD food products in the EU
The new Common Agricultural Policy (CAP) was adopted on December 2, 2021 by the European Council. This introduces the possibility for farmers to receive Direct Payments for hemp varieties registered in the EU Catalogue. Critically, the CAP also elevates the authorized THC level for hemp varieties from 0.2% up to 0.3%. The new legislation takes effect in 2023.
This decision incentives a potential development of more specialized varieties of fiber, grain and flowers for CBD production. Eventually, this may translate in new CBD-infused food products.
We will continue to update as to the European Union and CBD here on the Canna Law Blog. In the meantime, check out these prior posts:
- Exporting CBD Food Just Got Harder: The EU Makes a Move
- The EU May Designate CBD Foods as “Narcotics” (Yes, You Read that Right)
- The EU Concludes CBD Foods are Not Narcotics After All
- European CBD Sales: Securing a Novel Food Authorization
Source: Canna Law Blog