Placing on the market and retail regarding Cannabidiol (CBD) consumer products is currently subject to a highly controvertible discussion of the respective interpretations of the regulatory background. Compliance with the complexity of German narcotic regulations in addition to European originating regulations for Medicinal Products, Food and Dietary Supplements, Cosmetic products as well as Tobacco products poses currently certain difficulties for marketers as well as German authorities.
The status quo for CBD food products is a perfect example for the complexity of the regulatory background in Germany:
1. The Novel Food Regulation - CBD food products, esp. dietary supplements potentially not marketable in Germany without CBD entry in Novel Food Catalogue
CBD-consumer products currently placed on the market as food products, especially as dietary supplements, fall – at least according to most of German authorities´ perspectives – within the scope of the Novel Food Regulation. Therefore, in a nutshell: As CBD is not included in the Novel Food Catalogue yet, most German authorities are currently classifying CBD-food as not marketable in Germany.
Food products and dietary supplement are generally not subject to a formal authorization requirement. However, according to Sec. 6 (2) Novel Food Regulation (Regulation (EU) 2015/2283), "[o]nly novel foods authorised and included in the Union list may be placed on the market within the Union […]". Therefore, the question whether or not food products and dietary supplements containing CBD are novel within the meaning of this regulation is crucial with regards to the respective placing of the market.
Whether a food product is novel depends on several criteria: Inter alia its significant degree of consumption within the Union before 15 May 1997, its molecular origin and also the respective propagating practices are key elements for the classification.
Manufacturers have to classify food products with regards to the European and German regulations. Therefore, manufacturers have to decide whether a CBD food product is novel or not within the meaning of the Novel Food Regulation. However, authorities, Public Prosecutors Offices and courts are not bound to the manufacturer´s classification. Therefore, manufacturers, marketers and other parties involved within the respective business process have to clear uncertainties prior to the marketing in order to mitigate financial and criminal risks.
Several guidelines regarding such classification exist. One crucial factual indication with respect to CBD food products is currently European Novel Food Catalogue. The European Commission changed the entry with regards to Cannabinoids, including CBD in January, 2019. It states now that:
[…] 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
Even though the Catalogue´s entry is not binding under German law, authorities tend now to act against food products/dietary supplements, emphasizing the strong indication (evidentiary effect) of the Novel Food Catalogue. Therefore, most of German authorities tend to classify its placing on the market as illegal.
2. Further criminal risk – Thin line between classification of a potential food product as Medicinal Product
Furthermore, manufacturers, importers and marketers have to assess on the sometimes very thin line between the classification as food/dietary supplement/cosmetics or medicinal product. According to the German Medicinal Products Act (Arzneimittelgesetz, "AMG"), i.a. basically every substance that has a pharmacological effect or is presented as such has to be classified as a medicinal product. Marketing a medicinal product without supporting marketing authorization is a serious crime under German law. Therefore, the comprehensive product manufacturing and marketing process (e.g. composition, marketing claims, wording for the customer´s instructions etc.) of CBD consumer products has to be designed accordingly in order to avoid a classification as medicinal product.
3. Narcotic Restrictions remain applicable for all products containing THC – The potential 0.2 percent limit has to be carefully assessed
Every consumer product containing the Cannabinoid tetrahydrocannabinol (THC) is also subject to the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG). Basically, Marihuana, plants and parts of plants of the cannabis genus are generally prohibited within consumer products by the BtMG. However, products that contain less than 0.2 per cent whilst their movement (except the cultivation) serves exclusively commercial/industrial or scientific purposes that exclude an abuse/misuse for intoxication issues, are excluded from this prohibition, Annex I to BtMG, subsec. "Cannabis", lit. b) alt. 2.
As there is currently no stable interpretation regarding the mandatory exclusion of abuse/misuse condition, consumer products, esp. with ingest purpose, containing any amount of THC put at (criminal) risk to the manufacturer, importer or marketer under German law.
Finally, the potential tolerance of products containing up to 0.2 percent THC under German narcotic regulations does involve all products legally manufactured elsewhere (e.g. products manufactured of hemp within the meaning of the US Farm Bill are still comprehensively subject to the aforementioned prohibitions when imported and/or placed into the German market).
4. Further proceedings
We emphasize that it is crucial to thoroughly assess on the complex regulatory background if it comes to CBD consumer products in order to mitigate both financial and criminal risks.
The issues resulting from the interpretation of the Novel Food Regulation in Germany could change in Q 1/Q 2 2020 as the European Commission is currently deciding (again) whether or not to include CBD in the Novel Food Catalogue.
For other CBD consumer products, e.g. cosmetics, the Novel Food Regulation does not apply. The relevant German regulatory background for such products is not as hostile as sometimes advertised by German authorities.