Regulatory compliance and quality assurance are paramount for operators seeking to establish themselves in the cannabis industry. In the United States, for example, each state with a medical or recreational program has its own standards around pesticides, mold content, and other compliance factors. In Europe, a more comprehensive approach to regulatory compliance that mirrors the pharmaceutical market has been implemented.

Although the discussion around recreational cannabis in Europe is still progressing, strict regulations already govern production and distribution across the continent. With this, the European Union Good Manufacturing Practice (EU GMP) Certification has emerged as a crucial asset for cannabis operators, especially those looking to export cannabis to Europe’s medical cannabis markets.

What Is EU GMP Certification?

EU GMP Certification establishes the minimum standard that all European medical manufacturers—including cannabis cultivators and manufacturers—must meet to legally distribute their products under the European Medicines Agency (EMA). This means any domestic cannabis operators in the EU and any companies outside the EU seeking to export to the EU must be EU GMP Certified.

Specific regulations can vary depending on the product type and intended use, but essentially, the certification considers factors such as:

• Premises and equipment
• Documentation and records
• Storage and distribution
• Complaints and product recall
• Production controls
• Quality control
• Audits and inspections

Germany, the largest importer of cannabis in the EU (30 tons in 2023), has taken it one step further, requiring an AMRadV license for all strains decontaminated with ionizing radiation (X-ray, gamma, and e-beam). This license can take 12 to 18 months to secure and cost around €5,000 per strain.

Current Legal Cannabis Markets in Europe

Over 20 EU nations have proposed some sort of medical cannabis legislation, with a few also laying groundwork for an adult-use market.[1] At this point, you won't find recreational markets like Canada's or the United States’, though adult-use cannabis is still available in certain countries with specific program measures in place, and in other EU countries, patients can secure cannabis for adult use with a prescription.

• Spain: Cannabis is decriminalized and personal consumption and private cultivation are legal in Spain; however, selling cannabis is illegal. “Social clubs” numbering more than 1,000 nationwide operate in a legal gray area.
• Netherlands: While recreational cannabis is technically illegal in The Netherlands, the sale and possession of small quantities are tolerated in licensed "coffee shops" under a policy of "de facto" legalization.
• Luxembourg: Last year, Luxembourg legalized the possession, consumption, and cultivation of up to three grams of cannabis, though public purchasing is still not allowed.
• Malta: In 2021, Malta became the first EU country to legalize cannabis for adult use using non-profit cooperatives instead of dispensaries.
• France: A three-year pilot medical program is now halfway complete. However, the government recently announced it’s discontinuing the use of cannabis flower in the program.

Germany is leading the way on proposed legislation changes that are expected to have a ripple effect across the EU and the globe. With the potential for their market to grow 7-10X in the next 18 months, the country’s AMRadV license requirement has cultivators with plans to export to Germany reconsidering their post-harvest decontamination technology choices.

Radio Frequency Decontamination Approved for EU GMP Facilities

For cannabis operators looking to earn or maintain their EU GMP Certification but in need of an effective mold remediation solution that won’t require AMRadV licensing, Radio Frequency (RF) solves both these needs.

RF decontamination is already used for food safety in established agricultural markets like nuts and dates. It’s recognized by the U.S. Food and Drug Administration (FDA) as an organic process. And, as of January 2024, Ziel’s RF technology has officially received its EU GMP Certification for microbial control.

This certification allows cultivators wanting to export, or currently exporting, to Germany to avoid AMRadV costs while still maintaining their EU GMP status.

Incorporate RF Decontamination into Your EU GMP Operation

Curious to learn more about RF microbial decontamination and how it can earn you more money without compromising your EU GMP Certification? We’ll walk you through the power of Radio Frequency and what it means to treat your flower organically, without the side effects of ionizing radiation. Get in touch with us today.

Change moves slowly at the federal level, especially if cannabis is involved. Since the first recreational market opened in 2012, not much has been done for the industry or its financial situation, although some recent efforts have been made. For example, the U.S. House of Representatives passed the SAFE Banking Act seven times since 2019. The Senate Banking Committee passed its SAFER Banking Act in September 2023. Even the Department of Health and Human Services (HHS) recommended cannabis be rescheduled to Schedule III in August of 2023. Yet, cannabis cultivators are still struggling to find financial backing and continue to carry the weight of 280E, hurting cash flow.

Although there are proponents for and against the rescheduling recommendation, one major benefit the cannabis industry has acknowledged is the elimination of the 280E Internal Revenue tax code that’s currently burdening all plant-touching businesses. Under Schedule I, plant-touching businesses can only deduct costs of goods sold from their federal taxes, meaning things like rent, utilities, advertising, and payroll aren’t allowed as deductions. Schedule III substances don’t have to comply with 280E, so those businesses currently struggling under a federal tax rate that can sometimes be as high as 80 percent^[2] would have a greater chance of survival.

Relieving that tax burden is significant and necessary when considering the other changes that could come with cannabis rescheduling. For example, if the plant were to be rescheduled to Schedule III, medical marijuana goods would become subject to the same medical laws and requirements as other drugs in Schedule III like anabolic steroids and Tylenol with codeine. That means, for medical markets, there would be much greater oversight by the Food and Drug Administration (FDA). With no current FDA involvement or broad standards for the types of testing medical cannabis products must pass before being eligible to sell, regulatory laws across the country are likely to experience major changes.

One potential implication of FDA cannabis regulation could be standards around mold and yeast content, something that currently varies by state. While some states have fairly strict laws around mold and yeast counts, like Massachusetts and Louisiana, others, like Connecticut and Florida, have taken a more lenient approach. Although we don’t yet know how the FDA might change mold and yeast count regulations, businesses should be prepared for change around current state-level standards.

On that topic, the FDA’s potential involvement means eligible cannabis brands may finally be able to claim USDA Organic status. However, it’s important for brands to recognize that, as it currently stands, food products treated with ionizing radiation to reduce yeast and mold counts are ineligible to be USDA Organic by FDA standards. It’s fair to assume cannabis products treated with ionizing radiation, such as X-ray, will also be ineligible for USDA Organic status, especially medical products.

Instead, the FDA could implement its current rule for food products treated with ionizing radiation and require cannabis products treated with that technology to be labeled with the Radura, the international symbol that signifies a product has been irradiated. This label update could have a negative impact on a brand’s consumer trust and loyalty.

Time will tell whether the US federal government decides to reschedule marijuana as a Schedule III substance, but one thing that’s for certain is change at the federal level is coming, and cultivators need to have a plan in place for whenever federal oversight begins. For those concerned about passing regulatory compliance for mold and yeast content but not willing to compromise their product with ionizing radiation, non-ionizing radiation like Radio Frequency could be the answer.

Radio Frequency is already used to remediate foods like nuts and seeds, which are all regulated by the FDA. The technology is approved for USDA Organic operations as it has no impact on a product’s molecular structure. It simply uses long radio wavelengths to create an oscillating electromagnetic field around and within the product, causing moisture molecules to sync with the vibration and rotate in unison with it. The friction this generates creates enough heat to kill microbial pathogens without getting too hot to degrade or decarb THC, maintaining the chemical integrity of the plant.

Ziel is the cannabis industry’s leader in Radio Frequency remediation, having been granted the first-ever U.S. Patent for processes that include the treatment of cannabis with Radio Frequency in 2020. To learn more about what Ziel can do for your operation in preparation of federal change, contact us today.

Financing Ziel RFX

Financing your Ziel RFX allows you to own your machine on day one. Along with your machine, you’ll get our Service Plan free for a year which includes:

• Bumper-to-bumper warranty
• Online Dashboard that provides access to all your COA data and processing parameters
• Consults with our engineers and scientists to optimize your post-harvest operations

You have the option to extend both the Service Plan and warranty once your financing term is completed.

We will facilitate the financing with our partners for no extra charge. Learn more about what’s needed to finance your Ziel RFX here.

Leasing Ziel RFX

Leasing your Ziel RFX allows you all the benefits of owning a machine but with the flexibility to walk away at the end of your lease term. Additionally, leasing offers the advantage of conserving your cash upfront. The out-of-pocket spend on day one of leasing your Ziel RFX is a little more than 5% of the out-of-pocket spend that comes with purchasing the machine outright.

Our partners offer lease terms as short as two years and as long as five years, giving you the flexibility to set terms that work with your business goals and projections. If you do decide you want to continue using RF as your preferred microbial control solution, you have the option to purchase your Ziel RFX for $1.00 at the end of your lease term.

With your lease, you’ll also get our Service Plan included for the duration of the entire lease, so you can operate your business with confidence. Similar to our financing option, we’re happy to negotiate your lease terms for you at no extra cost. Click here to read more about what’s needed to lease the Ziel RFX.

Buying Ziel RFX

There is always the option to buy your Ziel RFX outright. Like our financing and leasing options, a one-year bundled Service Plan is included in the purchase price.

Purchasing your machine allows you to immediately incorporate it into your standard operating procedures (SOPs), plus you become eligible to be one of our Authorized Tolling Partners and provide microbial reduction services to smaller and mid-size operators in your area.

Which Option Is Best For Your Cannabis Business?

To help you determine the best payment terms for your situation, we’re also excited to announce the release of our updated Business Case Calculator that incorporates leasing and financing options. Use it to quickly and easily determine if you have a worthy business case to justify moving forward with an investment in the Ziel RFX.

Using our Business Case Calculator, you can input and adjust your:

• Current harvest volume per year
• Percentage of harvest that fails microbial testing
• Wholesale pricing for dried flower and trim

From there, you can select your inputs (interest rate, down payment, and term) to evaluate what your monthly out-of-pocket payment will be for either leasing or financing.

Financial Advantages of Working With Ziel

Apart from our financing and leasing options for cannabis cultivators, and the average $1.1 million each of our customers recovers in lost revenue each year, there is another potential bottom-line benefit to the Ziel RFX. You may be able to depreciate your machine each year to reduce your taxable income.

This will require review with your accountant and financial advisors, but with the Ziel RFX as a part of your SOPs, you may have the option to claim its depreciation under your costs of goods sold (COGs). This could reduce the amount of taxes your business must pay under 280E.

Get Started with Ziel RFX

Explore our Business Case Calculator to determine your optimum financial solution. If you have questions or are curious about how to get started with your financial application for the Ziel RFX, get in touch with us today. We’re happy to help you narrow down the right financing or leasing option for your operation.

In August 2023, the U.S. Department of Health and Human Services (HHS) formally recommended marijuana be rescheduled from a Schedule I controlled substance to a Schedule III controlled substance in a first move toward federal weed legalization.

In the federal government’s eyes, this would align marijuana with drugs like ketamine and testosterone, make it federally legal to get with a prescription, and define it as having “moderate to low potential for physical and psychological dependence.” As it stands in Schedule I, the plant is currently likened to heroin and viewed as having “no currently accepted medical use and a high potential for abuse.”^[1]

Even more momentous than the US federal government finally acknowledging the medical validity of the cannabis plant will be the effects the potential rescheduling has on the country’s 37 legal state cannabis markets (and counting).

Although there are proponents for and against the rescheduling recommendation, one major benefit the cannabis industry has acknowledged is the elimination of the 280E Internal Revenue tax code that’s currently burdening all plant-touching businesses. Under Schedule I, plant-touching businesses can only deduct costs of goods sold from their federal taxes, meaning things like rent, utilities, advertising, and payroll aren’t allowed as deductions. Schedule III substances don’t have to comply with 280E, so those businesses currently struggling under a federal tax rate that can sometimes be as high as 80 percent^[2] would have a greater chance of survival.

Relieving that tax burden is significant and necessary when considering the other changes that could come with cannabis rescheduling. For example, if the plant were to be rescheduled to Schedule III, medical marijuana goods would become subject to the same medical laws and requirements as other drugs in Schedule III like anabolic steroids and Tylenol with codeine. That means, for medical markets, there would be much greater oversight by the Food and Drug Administration (FDA). With no current FDA involvement or broad standards for the types of testing medical cannabis products must pass before being eligible to sell, regulatory laws across the country are likely to experience major changes.

One potential implication of FDA cannabis regulation could be standards around mold and yeast content, something that currently varies by state. While some states have fairly strict laws around mold and yeast counts, like Massachusetts and Louisiana, others, like Connecticut and Florida, have taken a more lenient approach. Although we don’t yet know how the FDA might change mold and yeast count regulations, businesses should be prepared for change around current state-level standards.

On that topic, the FDA’s potential involvement means eligible cannabis brands may finally be able to claim USDA Organic status. However, it’s important for brands to recognize that, as it currently stands, food products treated with ionizing radiation to reduce yeast and mold counts are ineligible to be USDA Organic by FDA standards. It’s fair to assume cannabis products treated with ionizing radiation, such as X-ray, will also be ineligible for USDA Organic status, especially medical products.

Instead, the FDA could implement its current rule for food products treated with ionizing radiation and require cannabis products treated with that technology to be labeled with the Radura, the international symbol that signifies a product has been irradiated. This label update could have a negative impact on a brand’s consumer trust and loyalty.

Time will tell whether the US federal government decides to reschedule marijuana as a Schedule III substance, but one thing that’s for certain is change at the federal level is coming, and cultivators need to have a plan in place for whenever federal oversight begins. For those concerned about passing regulatory compliance for mold and yeast content but not willing to compromise their product with ionizing radiation, non-ionizing radiation like Radio Frequency could be the answer.

Radio Frequency is already used to remediate foods like nuts and seeds, which are all regulated by the FDA. The technology is approved for USDA Organic operations as it has no impact on a product’s molecular structure. It simply uses long radio wavelengths to create an oscillating electromagnetic field around and within the product, causing moisture molecules to sync with the vibration and rotate in unison with it. The friction this generates creates enough heat to kill microbial pathogens without getting too hot to degrade or decarb THC, maintaining the chemical integrity of the plant.

Ziel is the cannabis industry’s leader in Radio Frequency remediation, having been granted the first-ever U.S. Patent for processes that include the treatment of cannabis with Radio Frequency in 2020. To learn more about what Ziel can do for your operation in preparation of federal change, contact us today.

Similar to other agricultural commodities, cannabis must pass regulatory compliance testing for microbial pathogens before it can be legally sold to consumers. Currently, cannabis cultivators have a few options to treat their flower, the most common being: ionizing radiation technology like gamma, X-ray, and e-beam or non-ionizing radiation such as radio frequency.

Although the cannabis industry is new across the globe, a trend in cannabis decontamination tech is already emerging. While both ionizing and non-ionizing tech are equally successful in reducing mold and pathogens, the similarity ends when evaluating the impact on the original product quality. So much so that regulators in Canada and Germany have implemented extra rules for product treated with ionizing radiation to warn consumers of its usage, and states in the United States are discussing the same.

Cultivators have also taken note of the current regulations and ongoing conversations around cannabis decontamination. Seeing the writing on the wall, forward-thinking operators are future-proofing their business and electing non-ionizing solutions for their post-harvest operations.

Ionizing vs. Non-Ionizing Radiation

The difference between ionizing and non-ionizing radiation goes down to the molecular level..

Ionizing radiation such as gamma, X-ray, and e-beam use high energy wavelengths to penetrate cannabis flower, simultaneously killing mold and pathogen DNA while removing electrons from the atoms and molecules of the flower. This molecular change of electrons essentially nullifies the natural integrity of the flower, eliminating the enzymatic properties of the plant that are responsible for its unique characteristics.

Non-ionizing radiation such as Radio Frequency uses longer, lower energy wavelengths to penetrate the cannabis flower. These wavelengths create an oscillating electromagnetic field around and within the flower, causing its moisture molecules to vibrate in unison with it. This rapid oscillation creates just enough thermal heat to kill mold and pathogens without harming the flower’s molecular structure or chemical or enzymatic content.

This distinction is why regulators remain concerned about cannabis flower treated with ionizing radiation. While states in the US can currently make their own determinations about cannabis decontamination requirements, bellwether countries such as Germany are making decisions on a grander scale. Regulations enacted in Germany are influencing policy regulators in the emerging EU market and having ripple effects in more established markets like Canada.

Current Regulations Against Ionizing Radiation

Germany’s medical marijuana program was launched in 2017 and its recreational program in 2023. Despite both programs being limited, the country still has to import the majority of the cannabis it sells from Canada, the Netherlands, Australia, Portugal, Macedonia and Malta because of domestic production caps on the three licensed cannabis producers in Germany. To help protect their consumers from imported cannabis that’s been treated with ionizing radiation, the country has implemented AMradV regulations. These rules require cultivators to obtain a license for each strain treated with ionizing radiation, costing € 5,000 and 8-10 months in processing time per registration.

Likewise, in Canada, cultivators using ionizing decontamination to clean their cannabis must label each product with the Radura, the international symbol that indicates a product has been irradiated.[1] Recent trends show Canadian consumers starting to steer clear of cannabis labeled with the Radura because, by Canadian law, if cannabis has been treated with ionizing radiation, it cannot be considered or labeled as organic.

In the United States, cannabis regulators in Nevada have been in discussion for two years about whether or not to label cannabis products that have been treated with ionizing radiation with the Radura symbol. They’re considering the FDA’s current guidelines on labeling food treated with ionizing radiation, which requires the Radura symbol, though a final decision has yet to be made.

Since the cannabis plant remains federally illegal in the United States, cultivators currently can’t qualify as organic operations like Canadian cultivators can. But once the plant is legalized at the federal level, and if the FDA sticks with the same guidelines they currently have for food products treated with ionizing radiation, any cultivator using ionizing radiation will be ineligible for organic status and will have to label their products with the Radura symbol.

Essentially, across the globe, ionizing cannabis remediation costs the cultivator more money in labeling, licensing, and consumer satisfaction.

Other Costs of Ionizing Radiation

Ionizing cannabis remediation has other associated costs outside of regulations. For example, e-beam and gamma remediation must be done off-site, costing cultivators time and money for transportation, insurance, and administration.

X-ray equipment can be installed on-site, though it does require the installation of additional chiller equipment, adding cost and an additional layer of initial permitting and annual renewals.

Radio Frequency remediation, on the other hand, doesn’t call for any extra licensing, labeling, or facility upgrades. It can be done on-site, and the technology has already been screened by the FDA in other applications—a strong proxy for when the FDA inherits the cannabis portfolio.

Ziel Leads the Way for Radio Frequency Remediation

Ziel is the global market leader in non-ionizing radiation treatment with Radio Frequency. Our RFX is easily integrated into an existing operation, requiring zero facility changes. Unlike X-ray equipment, which must be cooled, the RFX can run 24/7, processing 1-6 pounds of cannabis every 14 minutes.

Cultivators who choose Ziel’s Radio Frequency remediation technology have the ability to monitor every batch treated so they can dial in specific treatment recipes for each of their strains. The RFX compliance pass rate is >99%, saving cultivators an average of $1.1 million each year in lost revenue.

*CAPEX - Capital Expenditure *OPEX - Operational Expenditure 

Leverage Radio Frequency in Your Operation

As countries around the world continue to dive into the cannabis industry, regulators are prioritizing cannabis remediation laws to protect their consumers. Those cultivators that choose to meet regulatory requirements via ionizing radiation are quickly learning that the associated costs aren’t worth the risk.

Radio Frequency is the safest and most cost-effective cannabis remediation option for cultivators and consumers. Contact Ziel today to learn how to incorporate the Radio Frequency solution into your SOPs, increase your yields, and future-proof your business.