Regulatory aspects of the production and sale of medicines, cosmetics, dietary supplements and hemp-based foods in Germany
It is worth considering Germany as a potential market for specifically cannabinoid products created on the basis of technical hemp varieties of a therapeutic orientation. However, this issue will become relevant when the by-laws in Ukraine provide an opportunity to legally work with leaves and inflorescences of technical hemp.
More than two years ago, the German legislature regulated the cultivation, processing and sale of hemp. Cannabis containing tetrahydrocannabinol no higher than 0.2% is no longer banned in the country. With the adoption of the relevant law in March 2017, the legal basis for the sale of this plant was regulated, as well as the possibility of using hemp for medical purposes. The important thing is that for consumer products such as cosmetics and food, including food additives, you can use exclusively technical hemp. The part of the plant used and the purpose depend on whether this type of activity for the production and sale of hemp products in Germany is permitted.
In the pharmaceutical sector, cannabis can be used both in finished medicines and in prescription drugs. Finished products come directly from pharmaceutical companies to pharmacies. Prescription drugs are made individually by pharmacists on prescription (or by order of the patient). A license to manufacture or approve the drug is not required in both cases. However, a prerequisite here is that the main stage of production in the pharmacy be completed. At this stage, it is not easy for large pharmaceutical companies to provide evidence of the effectiveness needed to approve cannabis-based finished medicines. For this reason, there are currently only two drugs containing cannabinoids on the German market. The use of hemp flowers for inhalation is also problematic. There is still legal uncertainty as to whether the main and final stages of drug production are actually carried out by the pharmacist. Nevertheless, the corresponding medicines are already presented in the assortment of many pharmacies.
In addition to the specific regulatory requirements for the corresponding product category, the law governing the circulation of hemp and its therapeutically active substances - cannabinoids, applies. For example, cosmetics that are usually freely available should not contain psychotropic tetrahydrocannabinol. Manufacturers must also adhere to the UN Single Convention on Narcotic Drugs, which covers cannabis, its extracts, tinctures and resins. The seeds and leaves of a hemp plant are not regulated by this convention and therefore, in principle, can be used to produce cosmetics such as creams, shampoos, lotions or soaps. Thus, the permissibility of the use of hemp in cosmetics depends mainly on the component of the plant from which cannabidiol is obtained, which is the main active ingredient in this category of goods.
Even food and nutritional supplements should not contain tetrahydrocannabinol so as not to endanger the health of the consumer. In Germany, this issue is regulated by the Law on Illicit Traffic in Narcotic Drugs. For example, since the seeds of hemp plants are not covered by this law, if they are not intended for unauthorized cultivation, then they can be used for food. On the shelves of supermarkets you can now find many cereals enriched with hemp seeds. The remaining components of cannabis, especially flowers, can be used if the plants were grown from certified seeds, and tetrahydrocannabinol in the dried straw of the latter does not exceed 0.2%. Thus, for the manufacture of food products, only technical hemp can be used. In addition, any use of these components for commercial or scientific purposes should completely exclude abuse in order to obtain drug intoxication.
On the other hand, it is believed that hemp varieties, even with a low content of tetrahydrocannabinol, should be used as raw materials for the production of textiles, cosmetics or insulating materials, but not for cooking or food. Consequently, the use of hemp in foods, including dietary supplements, in the near future is likely not to be covered by the exclusion clause.
Products containing cannabidiol, including dietary supplements, are not yet sold in Germany. From the point of view of the Federal Office for the Protection of Consumer Rights and Food Safety, the high content of cannabidiol in food should undergo additional research on the safety of consumption and the absence of side effects, although there is no clear regulation. In the near future, lawmakers, authorities and the courts should bring more clarity to this issue.
Commentary of the Ukrainian Technical Hemp Association
Health products and cannabis-based consumer products are becoming more and more popular in economically developed countries due to the obvious usefulness of the therapeutic properties of cannabinoids and other substances contained in the plant. Nevertheless, suppliers of hemp products in Europe are subject to many different rules, as well as a huge number of legal uncertainties, which negatively affects the development of hemp business, including in Germany.
The therapeutic cannabis varieties created in Ukraine can also be a source of non-narcotic cannabinoids in the manufacture of hygiene and medicines, cosmetics and food products, in addition, they are characterized by the absence of psychotropic tetrahydrocannabinol, which makes them extremely safe for human health. Therefore, it is worth considering Germany as a potential market for specifically cannabinoid products created on the basis of technical hemp varieties of a therapeutic orientation. However, this issue will become relevant when the by-laws in Ukraine provide an opportunity to legally work with leaves and inflorescences of technical hemp.