Products containing cannabidiol (CBD) such as CBD biscuits, CBD muesli, CBD soap or CBD skin creams are also becoming increasingly popular in Germany. CBD, like tetrahydrocannabinol (THC), is a cannabinoid contained in the cannabis plant, but according to current scientific knowledge, it is not psychoactive or intoxicating, unlike THC. Nevertheless, the national legislator classifies cannabis and therefore any products containing CBD under section 1 (1) in conjunction with Annex I of the German Narcotics Act (BtMG) as non-marketable narcotics, subject to some exceptions. However, if the THC content of the CBD products is below 0.2% and the marketing of these products (with the exception of cultivation) serves exclusively commercial or scientific purposes that exclude abuse for intoxication purposes, CBD products are marketable in Germany. Depending on the product, however, further regulatory requirements apply when it is placed on the market, in particular as a food or cosmetic product. For example, Regulation (EC) No 178/2002 (Regulation on the General Principles of Food Law) and, in the case of new foodstuffs, Regulation (EC) 2015/2283 (Novel Food Regulation) form the regulatory framework. For cosmetic products, on the other hand, Regulation (EC) No. 1223/2009 (Cosmetics Regulation) and other national laws apply.
In order to place foodstuffs on the European internal market, all foodstuffs must first meet the general safety requirements in accordance with Article 14 of the Regulation on the General Principles of Food Law.
In the case of foods containing CBD, the next step is to examine whether the food is a specially regulated novel food. This means all foods that were not used for human consumption to any significant extent in the European Union before 15 May 1997 and that fall into at least one of the categories listed in Article 3 (2) (a) Novel Food Regulation. The non-binding Novel Food Catalogue of the European Commission serves as orientation. According to this, “classic” parts of the cannabis plant such as seeds and oil are not to be classified as novel foods, as their history of use, for example in biscuits or hemp seed muesli, goes back further. Since 2019, on the other hand, naturally obtained extracts of the cannabis plant or products made from it that contain cannabinoids such as CBD are classified as novel foods. The same applies to synthetically produced cannabinoids like synthetic CBD. National courts and authorities have overwhelmingly agreed with the above classification, which means that, given the common extraction process, almost all foods containing CBD should be considered novel.
For novel foods - with the exception of flavourings - a detailed authorisation procedure must also be carried out according to Article 10, 11, 12 Novel Food Regulation. In contrast to the previous authorisation procedure, the European Commission alone is responsible for the authorisation procedure with the participation of the European Food Safety Authority (EFSA). The application for the authorisation procedure with its essential data can be viewed publicly, whereby according to the official website several procedures on CBD-containing novel foods are currently pending. However, the CBD-containing novel food will only be approved if it does not pose a safety risk to human health and does not mislead consumers. The application must therefore be accompanied by extensive documentation and expert opinions on the characteristics of the product. In July 2020, the European Commission had in the meantime considered all CBD-containing novel foods to be narcotics within the meaning of the UN Single Convention on Narcotic Drugs and suspended the proceedings on the grounds of incompatibility with Article 2 (g) Regulation on the General Principles of Food Law. However, according to the CJEU (judgment of 19 November 2020 - C-663/18 - Kanavape), CBD-containing products that contain only a completely insignificant amount of a psychoactive substance (less than 0.2% THC) do not constitute narcotic drugs. The European Commission endorsed the CJEU’s position in December 2020 and resumed the authorisation procedures. So far, no authorised novel food containing CBD exists on the European market. However, the results of the first authorisation procedures are eagerly awaited in the near future. If the novel food is approved, the corresponding implementing regulation of the European Commission also regularly specifies conditions under which the novel food may be used and sets out labelling requirements.
According to Article 3 of the Cosmetics Regulation, cosmetic products must also comply with the general safety requirements. Furthermore, according to Article 5 of the Cosmetics Regulation, the responsible person ensures that the other provisions are complied with. However, placing cosmetic products containing CBD on the market is simpler than for (novel) foods. Cosmetic products do not have to undergo an official authorisation procedure, but only have to be notified to the competent authority according to national law. According to Article 14 (1) (a) in conjunction with Annex II No. 306 Cosmetics Regulation, natural and synthetic narcotics within the meaning of the UN Convention on Narcotic Drugs are prohibited for cosmetic products. However, after the CJEU in the Kanavape case has denied CBD extracts with minimal THC content the property of being an addictive substance, the market is opening up here as well, analogously to the novel foodstuffs. In this context, the European Commission expanded its CosIng (cosmetic ingredients) database in February 2021 - although it is not binding - to include an entry on natural CBD as an ingredient with antioxidant, skin-protecting, skin-caring and sebum-fighting functions. The previous CosIng database explicitly considered only synthetically derived CBD as a permissible ingredient in cosmetics. Whether CBD-containing oils and creams may be marketed as cosmetic products, however, depends on a precise case-by-case examination of the respective product.
Authors: Christoph Behm, Dr. Daniel Tietjen
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