|2020 Market Size
|Key Distribution Channels
Denmark entered into the regulated CBD space recently, but the country's policies and guidelines – while still highly restrictive – are clearer and more well-defined than those of other European countries when it comes to the cannabinoid. CBD products are technically considered legal for use if they contain <0.2% THC content, though products themselves cannot be legally grown or marketed unless authorized by corresponding Danish government agencies. This is because CBD, whether smoked, ingested or applied topically, is considered to have an effect on the body and thus falls under the Danish Medicines Agency’s purview – alongside all medical cannabis products. The few products that fall outside this definition, such as pet treats, are subject to regulation by either the Danish Veterinary and Food Administration or Danish Environmental Protection Agency. In addition, Agency-sanctioned CBD food supplements must comply with the European Commission’s Novel Food policy. It is expected that this clear and well-defined legal landscape will lead to a stable and successful Danish CBD market over the longer term, though today there is no legal avenue through which to produce or sell product outside Denmark’s medical cannabis program.
The Danish Agricultural Agency regulates and reviews the applications for commercial cultivation of industrial hemp. If approved, licensed growers can cultivate, process, and sell industrial hemp for commercial purposes; including hemp seeds, hemp seed oil, hemp flour, grains and hemp protein powder. Notably, however, growing hemp for the purpose of extracting CBD is not permitted under this license category. Instead, this requires the issuance of a medicinal cannabis permit by the Danish Medicines Agency as CBD is considered medical due to its effects on the body.
On July 1st 2018, the possession and sale of CBD without a prescription became formally legal, so long as products maintain a THC content of 0.2% or less and are appropriately authorized by Danish government agencies. Three separate institutions are tasked with overseeing the authorization and sale of CBD products: The Danish Medicines Agency, The Danish Veterinary and Food Administration (DVFA), and The Danish Environmental Protection Agency (EPA).
The first, the Danish Medicines Agency (Lægemiddelstyrelsen) grants licenses for the cultivation of medicinal cannabis and is the authority for cannabis products sold in the country. Any product that contains CBD or THC which produces an effect in the body (virtually any ingestible, topical or smokable product) or claims to have a medical application should be classified as medicine and must be authorized by the Agency or apply to join the cannabis pilot program in the country.
If the Medicines Agency determines a CBD product is not considered medicinal, it can be classified as a food or cosmetic, in which the case company’s manufacturing conditions must comply with applicable food or cosmetic laws.
If a company brought a low-dose CBD ingestible product to market, and the Medicines Agency determined it to be non-pharmaceutical, then the product could be registered as a food supplement. However, the Agency has not yet published its safe-threshold dose and no CBD products are currently registered as food supplements. In addition, ingestibles containing CBD must comply with Novel Food regulations.
In Denmark, CBD is prohibited in cosmetic products if generated from the extracts, tinctures or resins of cannabis – effectively banning all CBD cosmetics. The one exception, because it is not listed by the UN Convention on Narcotic Drugs, is synthetically-produced CBD. Hemp extracts produced from plant stems or leaves not associated with the flower are permitted to be used in cosmetic products as long as they comply with other Danish cosmetic regulations, though these do not contain any significant CBD content.
Thus, despite that CBD is technically legal in Denmark, the various state agencies’ policies toward these products have effectively prohibited CBD’s legal mainstream sales. Legal products must align with existing regulations regarding medicines, food products, and cosmetics – and while all CBD falls under one or more of these umbrellas, over the course of two years, only medical products have been authorized for sale. Therefore, while on paper the legality of a CBD product depends only on its THC content, labeling, and its category’s governing agency, in practice no non-medical product can comply so a viable and legal Danish CBD market does not yet exist.
Though there is no legal channel outside the Danish medical market (ie through pharmacies with a prescription) through which to market or purchase CBD, consumers in possession of CBD products with THC content below 0.2% - which they may obtain online or through various other gray market channels - are considered compliant with the law.
Non-synthetic CBD-infused topicals and cosmetics are not permitted by Danish law, which defers to the the United Nations Convention on Narcotic Drugs’ (CND) policy toward the substance. Should the late 2020 CND vote on de-scheduling CBD end favorably, CBD-infused topicals would then be legally permitted on the Danish market, so long as they comply with applicable Danish cosmetics regulations.
Ingestible products - such as tinctures, capsules and food - that have not been authorized are prohibited by Novel Foods policy unless being purchased through the country’s medicinal pilot program, and no CBD products are currently registered as a food or supplement in the country. These products will likely trickle into the legal mainstream market once they have successfully complied with Novel Foods, making them more likely to receive approval from the Danish Medicines Agency.
All other CBD products for human use (eg vapes, flower) are considered medicine due to their effects on the body, and thus remain limited to the medical market unless otherwise authorized by the Danish Medicines Agency. Products outside this realm, such as pet products, are also under tight regulatory agency control and have thus not yet entered the legal market.