The End of Free Sale of CBD Products in Europe?
Dentons / Germany
Peter Homberg of Dentons Germany examines the regulatory status quo around the free sale of products containing cannabidiol (CBD) across Europe. Although deregulation efforts are underway, Homberg argues that the trade in these products is not as free and unregulated as it may initially seem.
CBD products that are marketed in Gemany as pharmaceutical products must comply with the strict provisions of the Medicinal Products Act of Germany (Arzneimittelgesetz), as a CBD pharmaceutical product is categorized as a prescription drug
Products containing cannabidiol (CBD) are in high demand throughout Europe. An increasing number of suppliers are trying to satisfy customer demand in all product categories. In any case, these are CBD products with a tetrahydrocannabinol (THC) content below 0.2 percent.
In Europe, CBD products are governed by various laws, both European and national. The applicable law depends on the respective final product containing CBD and its categorization. CBD products may be categorized as medicine, food supplements or cosmetics, depending on how the product is marketed.
In order to place CBD products legally on the European market, they must comply with the applicable European and national legislation.
In Germany, CBD products containing a concentration of THC of less than 0.2 percent are generally not subject to the Narcotic Drugs Act (Betäubungsmittelgesetz), due to the fact that it has no psychoactive effect in comparison to a product containing more than 0.2 percent THC, provided that trading is exclusively for commercial or scientific purposes, which precludes any misuse for intoxication purposes. CBD products that are marketed in Gemany as pharmaceutical products must, however, comply with the strict provisions of the Medicinal Products Act of Germany (Arzneimittelgesetz), as a CBD pharmaceutical product is categorized as a prescription drug.
In addition, there are various European regulations that standardize the handling of CBD products throughout Europe. This applies in particular to the area of food supplements and cosmetics.
Regarding food supplements containing CBD, the Novel Food Regulation has to be taken into account. Novel foods are subject to harmonized rules throughout the European Union (EU) in order to achieve a high level of protection of human health on the one hand and to ensure the functioning of the internal market on the other. Therefore, novel foods must undergo a risk assessment before they can be placed on the market. This is regulated in Regulation (EU) 2015/2283 (Novel Food Regulation).
CBD is currently not included in the EU Community list, which positively lists such foods that are already authorized to be placed on the European market without prior additional examination.
Information on whether a product might need an authorization under the Novel Food Regulation can be found in the Novel Food catalogue of the European Commission, available online. In the past, the classification of CBD was initially not clearly assessable for market participants, as the entry of CBD in the Novel Food catalogue only classified as Novel Foods those CBD products “in which CBD levels are higher than the CBD levels in the source Cannabis sativa L”. However, due to recent changes of the Novel Food catalogue, the entry for CBD now states “extracts of Cannabis sativa L and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.” By now, the Novel Food Catalogue explicitly states that all food supplements containing CBD are subject to an approval even with a THC content of less than 0.2 percent.
There is currently one novel food application for CBD under consideration with the European Food Safety Authority (EFSA), to authorize the use of CBD in food supplements for adults with a daily intake of up to 130 mg. In case the application is successful, the European Commission must draft an implementing act authorizing the use of the product within seven months. However, the opinion of EFSA has not yet been published.
The essential requirements and obligations for cosmetics containing CBD are governed by Regulation (EC) 1223/2009 (“Cosmetics Regulation”). According to Article 14 in conjunction with Annex II of the Cosmetics Regulation, cosmetic products may not, in principle, contain prohibited substances, including in particular, according to Table I of the Single Convention on Narcotic Drugs of 1961, the flower and fruit buds of the cannabis plant from which the resin has not been removed. Seeds and leaves not mixed with such strands are excluded. Consequently, the prohibition does not cover CBD obtained from the seeds and leaves of the cannabis plant which have not been mixed with the flowers or fruit from which the resin has not been removed. CBD, which is synthetically produced, is also not prohibited in cosmetics. Hence, it is essential for the retailer to have precise knowledge of the exact production of the respective CBD and the harmlessness of the product before selling cosmetics containing CBD.
The Austrian authorities have adopted an even stricter position. The Austrian Ministry of Health has issued a decree banning the sale of food and cosmetic products containing the cannabis ingredient CBD. The prohibition does not apply to pharmacies if CBD products are offered as so-called “presentation drugs” which are subject to strict controls and may only be sold in pharmacies.
In conclusion, the trade of CBD is not as free and unregulated as it seemed at the beginning. The regulations around CBD have always been quite strict. Moreover, they are handled and enforced more restrictively from time to time. It remains to be seen whether deregulation efforts, such as the attempt to include CBD in the list of approved novel foods, will be successful.
