Change of the THC limit as of 1 July 2018

Updated 01 March 2022

The executive order on euphoriant substances has been changed as of 1 July 2018. The change introduces a threshold limit which makes it possible to produce and sell cannabis-based products containing up to 0.2% THC without contravening the executive order on euphoriant substances.

The change of the THC limit in the executive order on euphoriant substances implies no changes to the Danish Medicines Act or the assessment of when a product is considered to be a medicinal product. This means that many products containing CBD will still be classified as medicinal products if, for example, the product is to be consumed or applied on the skin and produces a real effect in the body or if it is claimed to be a medicinal product.

It is still not allowed to sell medicines without permission from the Danish Medicines Agency, and CBD-containing medicines are still prescription-only medicines.

What does the 0.2% THC threshold actually change?

The rule change removes “a bump on the road” for companies wanting to produce or import and sell non-medicinal cannabis products with a low THC content. This could be food products such as hemp beer or cookies containing hemp.

Previously, these products were illegal even if they contained only measurable quantities of THC, the reason being that Denmark until now had a complete ban on the possession of THC-containing products for other than medical and scientific purposes.

As of 1 July 2018, this ban no longer applies in Denmark.

However, the law may still impose rules on food or cosmetic products that must be observed for you to legally sell products like hemp shampoo and hemp beer with a low THC content.

Products that contain CBD will most likely have to be assessed by the Danish Medicines Agency to determine if they are medicinal products. If they are, they cannot legally be sold in Denmark without permission from the Danish Medicines Agency.

What the 0.2% THC limit rule does not change

The rule change does not turn CBD-containing products into food supplements automatically. It requires a specific assessment of each individual product to determine if it is a medicinal product. You should expect that the vast majority of CBD-containing products are still medicinal products. The Ministry of Health is presently conducting a survey among our neighbouring countries to see how they handle CBD products as practices seem to differ between EU countries.

Assessment of CBD-containing products

The Danish Medicines Agency cannot say in advance if a given CBD-containing product will be classified as a medicinal product. We can only provide information about the products we have specifically examined.

When we are to determine if a specific CBD-containing product is to be classified as a medicinal product, we look at how it is presented and the function it has. The things we examine include the product's active substances, the quantities of active substances and the dosage, the product's physical form, text and images on the pack, and we compare it to already authorised medicinal products, etc. We cannot say in advance if for example an oil that is based on cannabis will be classified as a medicinal product or a food product. It would require a specific assessment of the active substances, the effect and the application of the specific product.

We have previously assessed products that are based on cannabis. See some of the cannabis products we have determined to be medicinal products.

For reasons of patient safety, medicinal products must go through an authorisation process before they can be sold in Denmark. In the case of cannabis products, you can also apply for admission to the medicinal cannabis pilot programme. Only pharmacies are allowed to sell cannabis-containing medicinal products and cannabis products of the pilot programme.

If a product is not classified as a medicinal product, but instead classified as, say, a cosmetic product or food product, companies must be aware that the products must comply with the food legislation or the cosmetics legislation.