CBD or cannabidiol is obtained from the leaves of useful hemp plants. Also flowers containing this ingredient are offered. Many people associate hemp mainly with the intoxicating effects of marijuana and the illegal use of drugs.
It is overlooked that hemp and hemp products also have a long history as legally consumed foods and are also used as medicines.
How are cannabidiole to be classified in these border areas of different legal categorizations? Can you acquire them in Germany without legal restrictions? We have answers for you here.
Hemp plants with different characteristics
What we commonly know as cannabis refers to a group of different plants. The so-called useful or industrial hemp has been known for a long time in commercial use. It is used to make hemp products such as hemp oil or hemp flour, which are freely available for sale as food.
Cannabidioles are also extracted from hemp. These are hemp species with the addition "sativa" in their botanical name (see Cannabis Sativa). These plants are very poor in THC (Tetrahydrocannbinol). This is important for the legal classification and properties of hemp.
Tetrahydrocannbinol is responsible for the intoxicating and addictive effects of cannabis extracts and is mainly found in species bearing the addition 'indica'.
In the EU, there are certified seeds with low contents of tetrahydrocannbinol, which are not restricted in their marketability according to the Narcotics Law (BtMG).
Why are cannabidiols interesting for consumers?
In recent years, both globally and in Germany, we have begun to conduct more intensive scientific research into this group of substances. It has been established that it could potentially have many health-promoting effects in the human organism.
This is because cannabidiole can occupy certain receptor sites in the human brain, among other things. Their surface matches the surface of these receptors. The body's own substances normally combine with these substances, which, for example, pass on stimuli during the development of pain.
If the receptors are occupied instead by cannabidiols, unpleasant symptoms such as pain or nausea can be positively influenced by humans.
Among other things, the attachment to these receptors by CBD releases further substances produced by the body, which for example alleviate pain or lighten the mood.
Scientific research in this area on the specific mode of action of cannabidiols is not yet complete.
According to the current state of knowledge, there are hardly any or no side effects within a certain spectrum of dosage, whereby further scientific research is also necessary here.
What exactly is CBD?
Hemp crops contain more than 100 active substances known to date, including cannabidiole. These substances are initially contained in the plant in an original, inactive form as CBDa. This is also known as the "acid precursor" of cannabidiol because it is a carboxylic acid.
Carboxylic acids are very common in nature. Acetic acid, for example, can also be classified here.
CBDa can be converted into an active form by certain extraction processes. The process is referred to as decarboxylation because it involves the removal of a specific building block from the CBDa molecule. The extracted extract is later usually added to oil or offered in crystal form.
CBD can be extracted by heating, using a certain form of CO2 or solvents such as butane, hexane, isopropyl alcohol or ethanol. The legal classification of a plant extract may also depend on the chosen extraction method.
What is the legal background in Germany?
Plant extracts of any kind can be legally classified into different product categories. These have very different prerequisites.
Products containing or consisting of herbal extracts may be foodstuffs (including the food supplementsubcategory) or medicinal products. In the case of food, a distinction is also made between novel foods, which we will discuss later.
Different product categories are assessed differently in legal terms
If the legislator restricts the use and sale of certain plant extracts, it is usually a question of averting dangers from the population. In this context, it seems reasonable, for example, that noise and addictive substances cannot all be legally acquired.
In the field of cannabis articles, extracts rich in THC are therefore not easily legally available for purchase. They are subject to strict restrictions in the area of the Narcotics Law (BtMG) and may only be legally marketed with a limited medical prescription as a drug.
Such restrictions on legal marketability are also considered important at supranational and international level. The UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances lists products with a certain content of tetrahydrocannabinol; CBD as a substance is generally not.
The legal classification of plant extracts can become very complex if an extract can and will be assigned to two or more different categories. This is the case with cannabis extracts. It also depends on whether CBD is isolated as an extract or is contained in hemp oil as a full spectrum oil with all its constituents.
Limited tetrahydrocannabinol content
On the one hand, there are the extracts that are assigned to the BtMG. In Germany, the definition is currently at a THC content of 0.2 percent. This restriction is important in order to distinguish extracts containing both cannabidiols and tetrahydrocannabinol from narcotics.
However, many experts believe that the 0.2 percent limit applies to the extract itself. The Federal Office for Risk Assessment (BfR) recommends various guideline values for the end product that you as a consumer can buy in an oil, for example. These refer to the product and mg/per body weight for food.
The 0.2 percent is initially meaningful for a differentiation from the narcotics range.
Note: Currently, CBD extracts containing not more than 0.2 percent tetrahydrocannabinol are not considered narcotics in Germany.
Cannabidiole - are they medicines?
In September 2016, cannabidiol was added to Annex 1 of the Prescription Drug Regulation. CBD is therefore a drug substance.
Annex 1 describes prescription substances. Regularly the sale would only be legal if the cannabidiol was prescribed by a doctor.
Nevertheless, various products containing cannabidiols are currently sold in Germany without official complaint, mainly via the Internet. The legal situation remains uncertain. We cannot infer from this whether and how the authorities will deal with it in the future.
The Federal Office for Food Safety and Consumer Protection currently does not consider CBD products without drug approval or approval as a novel food to be legally marketable in Germany.
These aspects are also interesting for the legal evaluation:
- The classification as a prescription extract has been carried out without a limitation of the dosage. This is initially unrestricted. However, as the sale of CBD products seems to be tolerated at present, the question arises whether sellers can invoke this tolerance here.
When CBD 2016 was added to the list of prescription substances in 2016, a transitional period applied to products that were already on the market. Some legal experts doubt the classification of foods containing CBD as medicinal products.
- The distinction between medicinal products and food supplements is also made in the advertising of products. Therefore, products containing cannabidiol are currently not allowed to be advertised with statements that indicate a disease-related effect.
Is this about novel food?
The Novel Food Regulation of the European Union classifies certain foods as novel and subjects them to an approval procedure before they can be legally sold in the EU. The Regulation is aimed less at consumer protection than at controlling economic activities and market access in the EU.
If a food was not consumed on a significant scale in the EU before May 1997, it is considered novel. CBD is currently classified in this area. The evaluation as novel food can also start with the extraction methods used, especially the solvents.
Note: CBD is considered a novel food in the form of an isolated extract. The CBD Full Spectrum Oil should be excluded, since hemp oil was already known and made available on the market in 1997.
Flowers are not legally marketable?
The legal classification of CBD flowers in Germany and other European countries is particularly complicated. As plant parts, they are not subject to the Novel Food Regulation and are not a medicinal product either, because this is not a separately obtained extract. This applies as long as hemp flowers are not additionally supplied with isolated cannabidiole.
However, many authorities are of the opinion that the flowers are subject to the Narcotics Act because Annex 1 to the BtMG lists cannabis as follows:
"Parts of plants whose tetrahydrocannabinol content does not exceed 0.2 per cent and whose circulation is exclusively for commercial or scientific purposes, which preclude abuse for intoxication purposes are excluded from a sales ban. "
The Higher Regional Court in Hamm ruled in 2016 that the abuse for intoxication purposes was not so easy to deny. (OLG Hamm, judgment of 21 June 2016 - 4 RVs 51/16). Many authorities refer to this and prohibit distribution.
Conclusion: The legal situation regarding cannabidiol and CBD is unclear.
In Germany and the EU, the legal situation for products containing cannabidiols is very confusing. In addition to hazard prevention aspects, the interests of the pharmaceutical industry, which have discovered cannabidiols as a potentially profitable pharmaceutical substance, also play a role.
At present, products are still being sold in Germany as food with CBD. You don't take any chances here as a consumer. We cannot estimate how official practice will develop. Reports of prohibitions and restrictions at the level of trade are becoming increasingly frequent.
We will keep you up to date and have summarized the topic in the following table for the current situation in Germany:
|Product||Legal classification (Germany)|
|Full spectrum oil||As a food probably legal, if less than 0.2 percent THC|
|Products with isolated extracts||Medicinal products and/or novel food|
|Flower original||Often rated as an anaesthetic|
|Flower mixed with extract||Covers BtMG, Pharmaceuticals and Novel Food|
We assume that the legal situation will be clarified in the near future, also with regard to novel food aspects. It is currently not clear whether products containing cannabidiols will be completely withdrawn from the market.
However, in Germany and at EU level it is likely that at least further specifications will have to be made for dosages in order to find clear boundaries.
Note: In this article we report on prescription cannabis, prescription CBD or over-the-counter or legal CBD. This Article does not make any proposal as to the possible purpose of the proposal and is for information and education purposes only. Promises of healing and benefits are excluded.