Author: Peter Homberg
Peter Homberg is a partner in the Dentons Berlin office. He focuses on life sciences, IP, corporate law and M&A transactions in the life sciences and high-tech sector as well as in R&D and cooperation agreements, cross-border IP licensing and IP strategies. Furthermore, he has extensive experience providing legal advice on compliance issues. Additionally, he is the head of the European Cannabis sector group. Peter advises companies in the pharmaceutical, diagnostics, biotechnology, medical device and medical cannabis industries—from startups to large publicly listed companies and has broad transactional experience in Southeast Asia. Peter is member of the Licensing Executive Society (LES), the German Association for Intellectual Property and Copyright (GRUR), the German Institution for Arbitration (DIS) as well as the Pharma-Lizenz-Club Deutschland e.V. Furthermore, he is chairman of the board and heading of the Regulatory Working Group at the European Cannabis Association (ECA) and regularly holds lectures at seminars and conferences and a monthly deep-dive webinar on current topics of medical cannabis law and the German and international medical cannabis market. He is also the author of numerous professional articles and other publications regarding corporate or IP law in the field of life sciences.
The popularity of the cannabis plant has grown enormously in recent years. Thus, cannabis found its way into medical care as a medicine under strict conditions in some EU member states. While cannabis for recreational purposes is still banned in many countries, and this is especially due to the regulations in the UN Conventions on Drugs and the EU laws.
The market for cannabidiol (CBD) is booming not only in Germany, but also in many European countries. CBD, as a component of the cannabis plant, is said to have a variety of health-promoting effects. At the same time, however, regulatory hurdles make it difficult to market such products. There are still no final regulations for CBD products and there is also no uniform legal framework for all member states of the European Union. The regulatory framework in Germany for such products is largely influenced by regulations at the European Union (“EU”) level.
The marketability of CBD products in the European market largely depends on the category in which the product is sold. The uses of CBD range from food supplements and cosmetics to smoking products and pharmaceuticals.
Food and dietary supplements
The European Commission has determined that cannabidiol is considered a novel food under the Novel Food Regulation (Regulation (EU) 2015/2283). Thus, several manufacturers of CBD-containing foods (including food supplements) have applied to the European Commission for such novel food approval. Currently, only 19 applications of over 50 filed applications are being evaluated at the European Food Safety Authority (EFSA). However, to date, no applicant has been granted an authorization. According to EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA), when evaluating these applications, it became clear that there were gaps in knowledge regarding the effects of CBD that would need to be addressed before a final assessment of CBD’s safety could be made (CBD-containing foods and dietary supplements are considered “novel foods” under the Novel Foods Regulation. Therefore, they may not be marketed without a corresponding authorization). Consequently, no food products containing CBD are currently marketable in the European Union – although they are de facto widely available.
In 2021, the European Commission included CBD derived from extracts, tinctures or resins of cannabis as a cosmetic ingredient in the cosmetic ingredients database (CosIng database). This revision to the CosIng database follows a ruling by the European Court of Justice (ECJ) of 19 November 2020, that CBD derived from the whole cannabis plant is not a narcotic as defined by the 1961 UN Single Convention on Narcotic Drugs (“Single Convention”). The entry is not linked to references to legal restrictions under Regulation (EC) 1223/2009 on cosmetic products or the Single Convention. However, entries in the CosIng database are not binding law. Just because an ingredient is listed in CosIng does not mean that it is permitted or approved for such use in cosmetic products. Although CosIng is not legally binding, this database serves as a guide for EU member states to adopt national regulations for cosmetic products. It aims to harmonize EU national legislation on cosmetic products to facilitate the free movement of goods. Regulatory classification and legal requirements for the product will continue to be decided by national competent authorities on a case-by-case basis, taking into account all characteristics of the product.
Following the ECJ’s 2020 ruling, pure CBD extract from the cannabis plant is no longer classified as a narcotic. It may therefore be used in cosmetic products in accordance with the EU Cosmetics Regulation (EC) No. 1223/2009. However, in Germany a cannabis extract containing not only CBD but also other parts of the cannabis plant is considered a narcotic and is therefore prohibited unless it is produced on the basis of seeds and leaves or flowers and inflorescences from which the cannabinoid-rich resin has been extracted. CBD that has not been extracted from the cannabis plant but has been produced synthetically may also be added to cosmetic products.
Products for smoking
CBD flowers are not marketable in Germany for the time being. German regulators take the clear position that when smoking cannabis flowers containing CBD, abuse for intoxication purposes can never be ruled out.
Cannabis flowers are generally considered narcotics in the sense of the German Narcotics Act (Betäubungsmittelgesetz – “BtMG”) and are only marketable for medical and research purposes. However, exception b) of Annex I to the BtMG states that cannabis is not considered a narcotic if it is either obtained from special EU-certified industrial hemp or the THC content of the plant/plant parts is below 0.2% and the trade and distribution of such cannabis exclusively serves commercial or scientific purposes that exclude abuse for intoxication.
However, it is debated whether flowers with high CBD content and low THC content can fall under this exemption or not. So far, it has been argued that the extraction of THC from cannabis flowers always remains possible, even if the THC content is below 0.2%, and that consequently abuse for intoxication purposes is never excluded. As a result, all cannabis flower products are subject to the Narcotics Act, regardless of the actual THC content. However, there is an ongoing court case in Germany before the Higher Administrative Court of Lower Saxony challenging this indiscriminate ban on CBD flowers and aiming to offer them instead as regular herbal smoking products subject to the provisions of the Tobacco Products Act (TabakerzG).
To date, CBD flower products are not marketable in Germany.
Electronic cigarettes, refill containers and e-liquids
Electronic cigarettes and refill containers containing CBD are marketable in Germany.
Electronic cigarettes as well as their refill containers (regardless of whether they contain nicotine or not) must not contain additives that create the impression that the product has health benefits or lower health risks. Whether the addition of CBD creates this impression is disputed. EU member states, which all implement the same EU directive, come to different conclusions.
However, Germany has not included CBD in the list of prohibited additives in Annex 2 of the Tobacco Products and Related Products Ordinance (Tabakerzeugnisverordnung – TabakerzV).
CBD is not per se a prohibited ingredient for animal feed. Rather, the product must meet general safety and quality standards.
Other non-medicinal products
Sometimes other products can be found on the market that contain CBD or are advertised as containing CBD. Here, the actual intended use (rather than the name) of the product is critical in determining the applicable legal regime. In practice, both courts and administrative agencies generally hold that a product containing CBD and advertised as such is intended to be ingested into the human body in one way or another.
The legal situation in the European Union regarding CBD is visibly confusing and highly dependent on the use of the products. However, this situation is of course also significantly related to the regulatory patchwork on cannabis in general. The creation of a uniform regulatory framework would significantly simplify the handling and thus also do justice to the ever-growing market.
- Statement on safety of cannabidiol as a novel food: datagaps and uncertainties, EFSA Journal, 2022, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7322
- Judgement of the ECJ, 19 November 2020, https://curia.europa.eu/juris/document/document.jsf?text=&docid=233925&pageIndex=0&doclang=en&mode=req&dir=&occ=first&part=1&cid=2389570
- Administrative Court (Verwaltungsgericht) Würzburg, Court Order of 16 November 2021 – W 8 E 21.1399, https://webgate.ec.europa.eu/cpnp/public/tutorial.cfm