Germany is likely to issue licenses for the cultivation of medical cannabis, but so far, no one knows the rules for cultivation.
The licenses are set by the Cannabis Agency, which will begin its work this year. This agency is essentially the German version of the Dutch “Office for Medical Cannabis” (OMC), which has regulated and supervised the cultivation and distribution of medical cannabis in the Netherlands since 2003.
In order to be able to grow cannabis in the Netherlands for the cannabis office, you can apply for a fee of 1,225 Euro. But due to the strict conditions, applicants must invest a lot of money in advance. As there is no other model for building rules within the EU, the German rules are expected to differ only slightly.
The Cultivation Rules
Consistency is strictly enforced, the active substance of the final product may not even fluctuate by 0.1%, and the entire environment must be as sterile as possible. In addition, the entire production process must be monitored and documented so that no cannabis gets into the wrong hands. For all these reasons, the Dutch medical cannabis regulations are more stringent than those for opium produced in Tasmania for the world market.
The production site must be located in a secret place that is unrecognizable as a greenhouse or gardening facility from the outside. The ventilation and filter systems of the building must not only prevent odors but also ensure that, despite the continuous fresh air supply, no contamination such as mold spores or harmful insects enter the plant rooms. To provide protection from birds, insects, rodents and pets, the entire terrain must be secured with lures, traps and electric insect killers. A special alarm system in bathrooms and lounges prevents unauthorized persons from entering plant rooms. Even if someone does not wash his hands after going to the toilet, the alarm will be triggered.
The entire building must be protected against burglars by lattices, fences and other construction measures; watchmen must be hired to guard the building. The staff must wear sterile working clothes and change in a room designed to keep contaminants out of the main facility. Personal items such as mobile phones, handbags or backpacks are not permitted in the production areas. In order not to contaminate the plants or get the employees high, protective gloves and suites are compulsory at all times so that the workers do not come into contact with the plant material at any stage of the production process.
Non-operating persons such as suppliers, tradesmen or visitors must register themselves, even for the delivery of a pizza. The whole building needs to be monitored with open and hidden cameras, but without violating the privacy rights of the employees. It is advisable to coordinate the security concept with local police officers.
For the cultivation of cannabis there is no in-company training, because in Europe, it has been an illegal activity for the most part. This history of illegality explains the lack of experienced personnel available. Cultivation companies must invest time and money in the training of an employee and then oblige the entire team to absolute secrecy. For reasons of secrecy, employees are not even allowed to tell their family where they are working. In addition to qualified growers, additional harvesters as well as at least one trained pharmacist who is responsible for the safety of the medicinal product and who is responsible for the laboratory must be hired for compliance.
In the Netherlands, 600 watts of high-pressure sodium are used in state-controlled cannabis breeding, as is the case with most illegal growers in Europe. LEDs do not (yet) play any role. The optimal climate is generated by computer-controlled filter exhaust air systems, creating a stable air humidity of approximately 50% with a temperature between 24-27 Celsius degrees throughout the grow facility. The irrigation is computer controlled and fully automated. The growing medium is sterilized rockwool, only certified organic nutrients are permitted. For the production of medicinal cannabis flowers, at least five to six different types of rooms have to be equipped:
– For the vegetative phase of the plants, at least two rooms are required, each illuminated for 18 hours. One serves the production of cuttings and mother plants, while seedlings are raised in the other.
– At least one large flowering-room for each strain. The size depends on the desired production capacity. On a square meter you can produce two to three kilograms of cannabis flowers per year.
– A room for processing the finished plants.
– At least one large room for each variety for flowering. The size depends on the desired production capacity. On a square meter you can produce two to three kilograms of cannabis flowers per year
– A room for processing the finished plants
– A drying room
– A laboratory that meets all required standards. Here, plants are tested for all required botanic and scientific parameters. Also the THC-, the CBD-content, the moisture and the presence of mold spores of every batch are examined carefully. In addition to small trials for quality control, the development of new strains and phenotypes are accomplished in these laboratory.
Only Certified Genetics
The basis for breeding is the seed, which must be registered beforehand at the OMC. Unregistered seeds from Dutch seed companies or the black market are not accepted by the OMC. As a result, Jack Herer is called Bedrocan when it comes to medical use. The motherplants are selected from the seed in a multi-month process. Seeds will not be used directly for the production of medical cannabis because the risk of different phenotypes with different active substance value would be too high.
Automated systems control parameters such as nutrients and room climate, as well as floor and air humidity and grow lamp positioning. Insecticides or pesticides are prohibited, but they may be used and documented in exceptional cases. Unlike in the Netherlands, similar treatments in Germany are completely forbidden when it comes to production of medicinal herbs. The water, the medium and everything else that comes into contact with the plants must be carefully controlled before their use in the laboratory and be free from bacteria, pollutants and heavy metals. The harvesting of the plants from one room must occur within one day, so that the THC content of all harvested plants is consistent.
The flowers are pruned in a sterile room immediately after harvesting. Afterwards, the herbs come into a drying chamber for several weeks. The former Dutch producer S.I.M.M., who lost his license 12 years ago, has even dried the flowers for three months. Only then can a complete decarboxylation can take place, where the THC acid of the fresh plant is converted into active THC (THCa). Leaves, stalks and other harvesting waste must be weighed, documented and shredded before they are composted. If the waste exceeds 80 kilograms, it must be destroyed by the municipality. Finally, the cannabis, like all fruit and vegetables in the Netherlands, is exposed to UV radiation in order to destroy possible mold spores. Because S.I.M.M. had refused to irradiate their medical cannabis, the Dutch government refused to extended the license. Since there are still many national directives within the EU, the irradiation of “Cannabis made in Germany” would not be mandatory.
Every step, from the first seed to the waste disposal, must be carefully documented. The strain, the age, the fertilizer used, the location and the expected harvesting time, THC content and other details are recorded using a scannable batch number on each plant. The data must be kept for at least ten years and must be presented to the Cannabis-Agency immediately upon request. Even the natural loss of weight must be measured by weighing the plants and the trim before and after the drying process. The loss has to be documented precisely.
The State is the Dealer
In 1973 a commentary on the UN-Single Convention from 1961 states:
“Countries or territories which produce, opium, cannabis or cannabis resin are in a different position. As so far as they permit private farmers to cultivate plants from which those drugs ate obtained, they cannot establish with sufficient exactitude the quantities harvested by individual producers. If they allowed the sale of the crops to private traders, they would not be in the position to ascertain with reasonable exactitude the amounts which enter the controlled trade. The effectiveness of their control régime would thus be considerably be weakened. In fact experience has shown that permitting private licensed trades to purchase the crops results in diversion of large quantities of drugs into illicit channels. Those who, under the auspices of the League of Nations and of the United Nations, planned the control régime of the production of opium, coca leaves, cannabis and cannabis resin, as well as the authors of the 1953 Protocol and of the Single Convention, therefore came the conclusion that the acquisition of the crops and the wholesale and the international trade in these agricultural products cannot be entrusted to private traders, but must be undertaken by governmental authorities in the producing countries. Article 23, article 26, paragraph 1 and Article 28, paragraph 1 therefore require a government monopoly of the wholesale and international trade in the agricultural product in question in thea country which authorizes the production.”
Different from Health Canada, that does not buy the crops, the Dutch cannabis agency takes over the sale and resale to domestic pharmacies and abroad. The producer receives a fixed price and sells the whole harvest to the cannabis agency. Only the state-purchase of the harvest will meet the requirements of the UN single convention 100% until it might be adapted to reality one day.
The fingerprint of a batch is determined by the producer by taking ten one-gram samples of each, the analysis of which determines the percentage of individual cannabinoids such as THC, CBD and CBN. In addition to the active substance content, the samples are tested for pesticides, bacteria and residual moisture. For verification, the state cannabis agency can repeat these tests in its own laboratories. If the THC or CBD content falls short of the specifications, the OMC will provide the doses with a label that states: “Please note that the active ingredient content of this batch is only 18 instead of the usual 22 percent.”
This brief summary of the Dutch regulations mentions only the most important provisions, among which there are many others to make the production of medical cannabis even more complicated than the Canadian’s medical program. A Canadian production site that is already very secure, would never be licensed in the Netherlands or Germany – for security reasons.