Germany Cannabis Resources + Regulations
Germany Set To Replace Canada as Largest Legal Cannabis Market in the World
Updated: May 2023
In April 2023, after talks with EU lawmakers, Germany announced its plans for cannabis legalization. Though these plans are not as accelerated as many hoped, they pave a clear pathway for Germany to replace Canada as the largest legal cannabis market in the world within the next decade.
Included in this first round of recreational legislation are state-controlled, non-profit social clubs that can cultivate and sell cannabis to a limit of 500 members, similar to Spain’s current adult-use structure. Individuals are also allowed to grow up to three plants of their own.
Germany also included plans to authorize a limited number of dispensaries in certain cities for the next five years. During that time, officials and regulators will study the impact of these shops on the country’s consumption habits and black market activity before determining the next step in nationwide cannabis legalization.
Germany Cannabis Exporting/Importing Requirements
The country’s medical program, which was legalized in 2017, already imports the majority of its product from Canada and the Netherlands due to caps on domestic commercial cannabis production. With the addition of adult-use sales and the subsequent increase in demand, exports of cannabis into Germany are expected to continue to increase.
Current EU cannabis regulatory framework is guided by existing European Pharmacopoeia. However, Ph. Eur. Standards were not designed to address all the formulations and characteristics of cannabis, leaving requirements around microbial compliance up for interpretation.
If, as experts predict, Germany’s import/export regulations surrounding microbial compliance follow those of Canada, the country will start with the stricter policies listed in column 5.1.4. of the below chart before taking the more realistic approach of column 5.1.8.
Operators exporting cannabis flower to Germany have principally relied on ionizing radiation technologies—X-ray, gamma, or e-beam—to meet the strict microbial regulatory compliance detailed in the European Pharmacopoeia. However, not only are these treatments expensive and alter the molecular structure of the plant, but they also require exporters to secure additional licensing that costs extra money and time, resulting in delays to market. The AMRadV license required for each strain treated with ionizing radiation technology can take up to 18 months and cost EUR 5,000 per strain. This is on top of the requirements to follow EU GACP (Good Agricultural and Collecting Practice) and GMP (Good Manufacturing Practice) guidelines.
The AMRadV licensing requirement is an expensive barrier to entry, can keep the market from evolving, and can keep both medical and recreational consumers from accessing new strains and products. Choosing non-ionizing technology like Radio Frequency to achieve microbial compliance is the most cost-effective solution for those looking to export cannabis to Germany.
| Ph. Eur. 5.1.4.1 | Ph. Eur. 5.1.4.2 | Ph. Eur. 5.1.8 – Table B | Ph. Eur. 5.1.8 – Table C |
|---|---|---|---|
| Acceptance criteria for microbiological quality of non-sterile dosage forms | Acceptance criteria for microbiological quality of non-sterile substances for pharmaceutical use | Herbal medicine products with or without recipients, where the method of processing (pre-treatment) reduced the levels of organisms | Herbal medicine products with or without recipients, where the method of processing (pre-treatment) cannot reduce the level of organism to table B requirement |
| TAMC <100 CFU/g TYMC <10 CFU/g BTGN BTGN not detected in 1g Pathogenic E.coli not detected /g Salmonella not detected /g S. aureus not detected /g P. aeruginosa not detected /g | TAMC <1,000 CFU/g TYMC <100 CFU/g BTGN not detected in 1g Pathogenic E.coli not detected /g Salmonella not detected /g S. aureus not detected /g P. aeruginosa not detected /g | TAMC <10,000 CFU/g TYMC <100 CFU/g BTGN <100 CFU/g Pathogenic E.coli not detected /g Salmonella not detected /g | TAMC <100,000 CFU/g TYMC <10,000 CFU/g BTGN <10,000 CFU/g Pathogenic E.coli not detected /g Salmonella not detected /g |
Radio Frequency Treatment Cost-Effective Solution to Germany’s AMRadV Barrier
Radio Frequency (RF) mold treatment is a non-ionizing radiation technology that brings cannabis flower within microbial compliance (whether the 5.1.4 or 5.1.8 margins), doesn’t change the molecular structure of the plant, and therefore doesn’t require AMRadV certification.
Instead of irradiating the product, RF is a thermal process that activates the water molecules within the flower, causing them to oscillate and create enough heat to kill microbes and pathogens. The result is a compliant product with near-zero THC or terpene loss.
Ziel’s APEX 7 is the leading Radio Frequency mold treatment solution and provides cultivators a clear, cost-effective path to begin cannabis exports to Germany.
APEX 7 Radio Frequency Microbial Treatment
The APEX 7 has the largest throughput of any technology on the market today, making it ideal for cultivators looking to export large amounts. As a post-harvest treatment, it can be seamlessly integrated into GMP-certified operations and falls under the FDA’s current organic guidelines for food products.
Using Ziel’s APEX Business Case Calculator, cultivators can determine how much revenue the APEX 7 will bring back into their business by increasing harvest yields, stopping compliance failure, and eliminating the need to send contaminated product off for extraction, in turn avoiding the subsequent costs for retesting. Additionally, cultivators interested in exporting to Germany are encouraged to add up how much they’d spend in time and money on AMRadV licenses for each of their strains treated with ionizing radiation, an expense that’s nonexistent with the APEX 7.
To better understand just how much money the APEX 7 can save a cultivation, explore the example below. We use a wholesale price of €4,000/kg for wholesale with failed product discounted to €400/kg and sold as trim. The snapshot shows the savings a cultivator will accrue within the first year using the APEX 7, based on recovering 20% of the harvest that fails microbial testing on 1,000 kgs of dry flower harvested per annum.
The Future of Germany’s Cannabis Market
Cannabis activists were hoping for broader legalization in Germany this year, as all of the EU is watching the country and expected to follow suit on whatever legislation it rolls out. Although the new laws unveiled this month aren’t as comprehensive as hoped, they’re a solid step toward full legalization.
As Germany spends the next five years monitoring the limited number of dispensaries they license, microbial compliance regulations are expected to become clarified with the release of a German monograph designed specifically to address cannabis.
Cannabis cultivators looking to join Germany’s market must have a mold treatment solution in place. Radio Frequency is the safest and most cost-effective option on the market, requiring no additional licensing and keeping in line with EU GACP- and GMP-certified guidelines.
Ziel’s APEX 7 offers the largest throughput of any technology currently available and boasts a >99% pass rate for regulatory compliance. To learn more about APEX 7 and how it can help you break into Germany’s cannabis market, get in touch with Ziel today.
About Ziel
Ziel is a leading developer of Radio Frequency (“RF”) solutions for the reduction of microbial pathogens. The food and cannabis industries across North America, Europe, South America, and Australia rely on RF technology to safely remediate products intended for human consumption or ingestion. Ziel’s devices utilize non-ionizing radiation to pasteurize products like almonds, cashews, macadamias, sesame, and chia.
The RF technology has been adapted for the cannabis industry to successfully remediate bacterial and fungal pathogens. These devices help cannabis cultivators ensure that they are providing a safe product that meets the highest safety and quality standards. Moreover, Ziel’s technology allows licensees to satisfy these standards through a method that is compatible with the requirements for organic certification.
Contact Ziel to learn more about our innovative cannabis processing system for Colombia-based growers.