The European Union Good Manufacturing Practice (EU GMP) Certification is similar to any other country’s GMP Certification, including the United States. It focuses on businesses that manufacture medicines, mainly the pharmaceutical industry, and sets the minimum standards they must meet to operate legally. These rules help governments to specify the quality of a medicine by the level of compliance the manufacturer meets under GMP criteria. 

The European Medicines Agency (EMA) qualifies cannabis as a medical product and therefore requires any cannabis product that’s distributed in the EU to be produced in an EU GMP Certified facility. This means forward-thinking operators interested in exporting cannabis to EU markets must be EU GMP Certified.

The certification reviews and documents nearly everything in an operation, including but not limited to:

• personnel
• supply chains
• building(s)
• clothing staff wears
• distribution chains
• storage setups
• documentation procedures

Because EU GMP for cannabis delves so deeply into the operation and ensures consistency across the board, securing the certification offers incredible benefits to businesses and consumers alike.

Check out the top three reasons why cannabis operators are getting EU GMP Certified below.

 2) EU GMP for Cannabis Opens Up New Markets

The EMA requires all medical products sold in the European Union to be manufactured in an EU GMP Certified facility. This means getting your operation EU GMP Certified opens up the entire EU market to your business.

This is an incredible advantage as the EU cannabis market is growing at a fast pace. At this point, over 20 EU nations have proposed medical cannabis legislation, with a few also working toward adult-use markets.

One emerging global player coming out of the EU is Germany. Germany’s medical market is expected to top €420 million in 2024, but the country cannot meet this demand on its own.[1] Only three federally approved suppliers are currently allowed to grow cannabis within the country; the rest of the demand is filled by imports mainly from the Netherlands, Canada, and Portugal, as well as Macedonia, Malta, Czech, and Colombia. In 2023 alone, Germany imported 30 tons of cannabis.

While US operators will have to wait for the plant’s federal status to change before they can export to Germany and other EU countries, securing an EU GMP Certification now will position them for exports in the future. Operators in other countries with federally legal markets, like Canada or Columbia, are currently able to export cannabis products, but if they didn’t start with EU GMP for cannabis, they’ll have to rework their entire business framework to meet EU GMP criteria before they can begin exporting.

If you’re a US operator planning to keep your business around for the long haul, earning your EU GMP Certification now means setting your business up for the future of global exports.

3) EU GMP Supports Long-Term Business Growth

With consistent operations in place, consumer trust earned, and new markets within reach, EU GMP for cannabis ensures long-term business growth.

Having a documented practice that’s EU GMP Certified allows manufacturers to easily mimic production in new locations, so businesses can expand and remain EU GMP compliant. It also allows operators to easily identify where changes or upgrades need to be made so they can continue to meet demand with a consistent product.

This is just the domestic side of things. With EU GMP for cannabis, operators are also positioned for long-term business growth with exporting opportunities. Instead of operating in a siloed state-specific or country-specific market, cannabis businesses can expand across oceans and establish a global presence. This can boost interest in a business’s brand and products both domestically and internationally.

Prioritize EU GMP for Cannabis Now, Reap the Rewards in the Future

The time to start working toward an EU GMP Certification is now. The process is long and detailed, especially if your operation and its SOPs are already established.

One major part of securing an EU GMP Certification for cannabis is the process you use for decontaminating your product before sending it to market. While the US doesn’t have specific requirements for decontamination in place, the EU does. Ionizing and non-ionizing radiation processes are both accepted, but using ionizing radiation (X-ray, gamma, and e-beam) comes with its own set of hoops to jump through outside of EU GMP criteria. Germany, in particular, charges exporters who use ionizing radiation around €4,500 per strain.

Radio Frequency (RF), the industry’s most popular non-ionizing radiation option, does not trigger any extra fees or licensing if used on products exported to the EU. Ziel’s RF technology, in particular, is already EU GMP Validated for microbial control and approved for organic operations by the U.S. Department of Agriculture (USDA) and the National Organic Program (NOP).

If you’re interested in learning more about securing your EU GMP Certification to prepare to export your cannabis products and are interested in leveraging the advantages of radio frequency microbial control, get in touch with Ziel today.

A mold outbreak in your cannabis grow can be devastating if gone unnoticed or left untreated. Not only is your entire crop at risk, but if moldy weed makes it out of your grow and onto dispensary shelves, your brand and business are at risk too.

To avoid exposing your customers to the health risks of smoking moldy weed and subjecting your brand to a recall scandal, use this 6-step guide to implement preventative measures, identify potential mold risks and outbreaks, and decontaminate your grow by incorporating a mold remediation process into your standard operating procedures (SOPs).

PREVENT

 1) Monitor Your Humidity Levels

Like your cannabis plants, mold spores need moisture to grow. Maintaining consistent humidity levels that nurture your crops without encouraging pathogen growth is crucial to preventing mold.

Some stages of the cannabis growth cycle require higher humidity levels than others, so finding the sweet spot will depend on where you are in the cycle. Generally, the vegetative and flowering stages—where mold makes itself most known—are dryer than the seedling stage, which gives you a bit of an advantage.

Maintaining consistent, proper humidity levels can help to keep mold at bay in more ways than one because pests also multiply with high humidity levels and/or the presence of standing water. As they buzz around your operation, they can spread mold spores and compound the problem.

2)  Install Compartmentalized Ventilation

Mold spores can attach themselves to insects, clothing, and equipment.

Installing and maintaining compartmentalized ventilation for the different rooms in your operation helps to avoid cross-contamination in case of a mold outbreak, and it also helps to maintain the proper humidity levels in each room as discussed above in step one.

IDENTIFY

3) Inspect Your Bud

Unfortunately, mold on weed is hard to identify until it or its impact on your plants is visible. But once it makes itself known, it’s fairly easy to spot moldy weed.

Look for identifiers like:

• Dark, near-black spots on the flower
• Yellow or gray fuzz coating the bud or leaves
• A white powdery substance on the bud or leaves (don’t confuse your trichomes with this; they may look similar but this mold tends to have more of a sawdust texture)
• Leaf tips turning yellow and brown
• The presence of slime on plants

4) Use Different Light Techniques

There are a couple of lighting techniques you can use to identify moldy weed in your grow. If you’re going to try these, we suggest removing one plant from your grow room and testing it in a separate area. This will avoid disrupting the rest of the crop’s growth cycle and can help to stop the spread of mold in case you find some.

First, you can put the plant in a dark room and shine a black light on it. Mold glows under a black light, so if it’s there, you should be able to see it easily.

Second, you can put the plant in a dark room and shine a flashlight beam at it. Tap or shake the plant—if a white, dusty cloud shakes off, it’s likely mold.

DECONTAMINATE

5) Choose Your Cannabis Mold Remediation Process

Discovering moldy weed in your operation does not have to be a death sentence if you have the right mold remediation process in place. There are several options available to cannabis cultivators, though as the legal cannabis market matures across the globe, some are being considered inferior to others.

Ionizing Radiation

Ionizing radiation irradiates cannabis flower, penetrating the bud from the outside with short, high-energy wavelengths. Though effective, ionizing radiation changes the molecular structure of the flower and compromises the plant’s natural chemical makeup. Ionizing radiation options include:

• Gamma radiation
• Electronic beam (E-beam) radiation
• X-ray radiation

Non-Ionizing Radiation

Non-ionizing radiation, on the other hand, does not alter the plant’s molecular or chemical structure and is generally considered a safer decontamination process for moldy weed by regulators and consumers alike.

There are two types of non-ionizing radiation processes available to cannabis:

• Cold plasma
• Radio frequency (RF)

Cold plasma kills mold on the surface of the bud by using excess energy to cause oxidative reactions that poke holes in mold spore membranes.

RF uses long, lower-energy wavelengths to decontaminate flower from the inside out by generating friction amongst the plant’s water molecules that creates enough heat to kill mold and pathogens without harming the plant’s sensory compounds.

6) Incorporate Cannabis Remediation Into Your SOPs

Cannabis remediation should not be a strategy deployed only in the instance of moldy weed. It should be a major part of your SOPs.

Consider other agricultural industries, like nuts or dairy. Both must pasteurize their products before they’re sent to market regardless of whether or not mold or pathogens were detected in initial production. In order to be sold, they must be cleaned.

The same holds true for other medicinal products and supplements—both are heavily regulated before they’re allowed to enter the market.

Cannabis decontamination should not be a reactive step taken in response to moldy weed. It should be a proactive step taken to avoid moldy weed ever making it into the hands of a consumer in the first place.

Explore Radio Frequency for Moldy Weed

Although there are several mold remediation processes available to cannabis cultivators, radio frequency mold remediation is proving to be the top choice for operators looking to plan for the future and expand abroad.

RF is so safe for treating mold and pathogens that it’s already an approved technique under the USDA Organic label, and it’s so effective it can guarantee a >99.9% pass rate when it comes to cannabis regulatory compliance.

Ziel’s RFX and APEX 7 radio frequency machines, in particular, are safe for organic operations when that designation becomes available to cannabis, they’re approved for EU GMP-certified operations, and they can be incorporated into an existing operation within a week.

If you’re interested in learning more about radio frequency mold remediation or have questions about preventing or identifying moldy weed, get in touch with us today.

As the cannabis market continues to evolve and mature, so too do approaches to cannabis operations. For example, when it comes to regulatory compliance for mold and other pathogens, a current, popular strategy among cannabis cultivators is to roll the dice and send untreated product to the lab in hopes that it passes microbial testing.

However, any product that fails microbial testing must be remediated, a process that is negatively perceived by consumers, who view remediated cannabis as inherently flawed. Some states, such as Pennsylvania, have banned this remediation approach altogether because of the risks associated with moldy product unintentionally getting to market. If flower in Pennsylvania fails microbial testing, growers may choose to have it re-tested without remediating it. If it fails again, the flower must be thrown out, or in specific circumstances, may be used to create topical products only.[1]

Remediation Doesn’t Need to Be Reactive

To avoid these issues, many operators are changing their approach to meeting regulatory compliance. Instead of reactively remediating failed flower, they’re incorporating a microbial contamination control solution into their Standard Operating Procedures (SOPs) before sending their product out for testing. This proactive approach is similar to the milk industry, which pasteurizes all milk prior to sale out of an abundance of caution. For cannabis operators, this strategy avoids failing tests, reduces the added expense of retesting, and ensures a predictable, safe product hits the shelves.

With rescheduling in the US on the horizon, there is now an even more compelling reason to proactively incorporate a microbial control solution versus reacting with remediation. The FDA and USDA will soon gain access to states’ medical marijuana programs, in turn bringing the industry one step closer to the eventual federal oversight of recreational cannabis markets.

The reactive approach to regulatory compliance through remediation runs in opposition to how the FDA and USDA currently regulate manufacturers and protect consumer safety. When the federal government does decide to regulate cannabis, it’s likely they’ll approach it like any other agricultural commodity or medical product and will require cultivators to treat their flower for mold and pathogens before sending it out for testing.

If cultivators want to prepare for the future of the cannabis market, they must adjust their approach to regulatory compliance and embrace a proactive decontamination strategy.

Microbial Contamination Control Solutions

There are several microbial contamination control solutions available to cannabis cultivators, though not all are ideal when considering what federal oversight may entail, including labeling requirements and organic certification.

With this looming federal oversight in mind, microbial control solutions that use ionizing radiation to treat mold and pathogens should be avoided. Ionizing radiation can change the molecular structure of the flower, as well as its moisture and terpene content. Because of this, products treated with ionizing radiation may become subject to specific labeling requirements, like adding the Radura—the international symbol for radiation—to their packaging.

That molecular change also means any product treated with ionizing radiation is not eligible for USDA Organic status, a label that could become available to cannabis once it’s rescheduled to Schedule III.

Ionizing Radiation Microbial Control Solutions:

• Gamma radiation
• E-beam radiation
• X-ray radiation

Non-Ionizing Radiation Microbial Control Solutions

Non-ionizing radiation, on the other hand, does not alter the molecular structure of what it’s treating, making it the front-running microbial control solution for cannabis cultivators. The most readily available and reliable non-ionizing solution for cannabis cultivators is Radio Frequency (RF).

RF has been used to treat nuts and dates for decades and has already been approved by federal authorities for USDA Organic operations.

The Benefits of Being Proactive With Radio Frequency

Incorporating an RF microbial control solution into your SOPs now is the fastest and easiest way to efficiently run your business and start preparing for federal change.

The Ziel RFX and APEX 7 are the industry’s only non-ionizing solutions that boast a 99.9% regulatory compliance pass rate. Operators who use them are set up for success in a few ways:

• RF is already approved for USDA Organic operations, so when that certification becomes available to the cannabis industry, cultivators who use the machine and meet the rest of the National Organic Program (NOP) requirements will be eligible for the USDA Organic label.
• Ziel’s RF technology has been EU GMP validated, a requirement for all processors seeking to bring product to market in Europe. Additionally, using RF enables processors to more easily sell in Germany, Europe's largest and fastest-growing market, which has a restrictive stance on the use of ionizing radiation.
• Both the Ziel RFX and APEX 7 can be set up on-site without building modifications and be working within a week.
• Both machines can decontaminate 160 pounds of raw cannabis flower per eight-hour shift.
• RF technology does not alter the molecular structure of the flower, so brands with a health-conscious customer base can continue to provide their consumers with a clean product.

“We’ve already seen cultivators in states like New Mexico, where the only pathogen tested for is Aspergillus, adding the Ziel RFX to their SOPs to prepare for change at the federal—and even state—level,” Ziel CEO and Co-Founder, Arthur de Cordova, noted recently. “The same thing is happening in Mississippi, where cultivators are preparing as the state makes moves to expand their testing requirements from only E-coli and Aspergillus to a full panel similar to Colorado’s. State programs are making changes as the federal reschedule draws nearer.”

Start Preparing Now

The cannabis industry is changing across the world. Standard testing procedures are in the industry’s future not just at the federal level, but also at the global level as cross-border trade increases, especially throughout Europe.

Operators must start preparing for a more regulated and standardized industry if they want to survive these changes, and that starts with reframing their attitude toward remediation. It’s no longer about reactively killing mold—it’s about proactively ensuring your product hits the market shelves.

To future-proof your business with the Ziel RFX or APEX 7, get in touch with Ziel today.

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. Other regular business expenses, which can usually be deducted to lower taxable income, like rent, utilities, advertising, and payroll, are specifically excluded under 280E. Depreciation of capital investments, such as facilities and improvements, are also excluded.

Without the ability to deduct business expenses and depreciation, the federal tax rate for plant-touching businesses can sometimes be as high as 80 percent[2], jeopardizing the chances of financial survival.

However, even without rescheduling, several MSOs have successfully challenged the 280E regulation and have begun to receive significant refunds from the IRS for previous tax periods.  Rescheduling would codify the elimination of 280E for good, boosting the bottom line of all operators.

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 under the National Organic Program (NOP). 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 NOP and 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 the USDA’s 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 USDA and 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.

Germany’s Future Cannabis Supply

Starting April 1, domestic production of cannabis in Germany is legal for anyone to partake.

For the last seven years, domestic cannabis cultivation for the country’s medical market has been limited to three federally approved suppliers. Because of this production cap, a supply gap of as much as 80% has been filled with imports primarily from Canada, Portugal, and the Netherlands.

Scaling domestic production to support this new market is expected to take years. In the meantime, the adult-use market is projected to increase product demand 7-10X, creating further reliance on imports. This demand will continue to be filled by imports from the Netherlands, Canada, and Portugal, emerging players in Macedonia, Malta, and Czech, as well as low-cost suppliers from Colombia.In keeping with its intention of building a pharmaceutical-grade system in the EU and the United Kingdom, all cannabis flower in Germany, whether imported or grown domestically, is required to be grown in GACP-validated facilities and processed post-harvest in GMP-validated facilities.

Germany Cannabis Exporting/Importing Requirements

Operators exporting cannabis flower to Germany, as well as domestic producers, have principally relied on ionizing radiation technologies like X-ray, gamma, or e-beam to meet the strict microbial compliance regulations detailed in the European Pharmacopoeia, which currently governs the EU cannabis regulatory framework. Not only are these treatments expensive, but they alter the molecular structure of the plant, creating free radicals and potentially unknown medical consequences.

Germany has taken a strong stance against both domestic and imported cannabis flower that has been treated with ionizing radiation. Producers that do use ionizing radiation are required to secure an AMRadV license for each strain treated with ionizing radiation. This license can take up to 12 months to receive and costs €4,500 per strain.

Separate from this license, the country also requires all exporters and domestic producers to follow EU GACP (Good Agricultural and Collecting Practice) and EU GMP (Good Manufacturing Practice) guidelines.

RFX Radio Frequency Microbial Treatment

Choosing non-ionizing technology like Radio Frequency (RF) to achieve microbial compliance is the most cost-effective solution for those looking to export cannabis to Germany. Radio Frequency is a non-ionizing radiation technology that ensures cannabis flower meets microbial compliance, doesn’t change the molecular structure of the plant, and therefore does not require AMRadV certification. Ziel’s RF technology has achieved EU GMP validation as a microbial control solution for cannabis flower and operating commercially in Europe. As a post-harvest treatment, RF can seamlessly integrate into EU GMP-certified operations. 

Ziel’s RFX machine has the largest throughput of any microbial control solution on the market today, making it ideal for cultivators looking to process large volumes. Using Ziel’s Business Case Calculator, cultivators can determine how much revenue the RFX will recover for their business by increasing harvest yields, avoiding compliance failure, and eliminating the need to send contaminated product off to extraction. This, in turn, also eliminates the subsequent costs for retesting. Cultivators interested in exporting to Germany are also 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 Ziel’s RF technology.

To better understand just how much money the RFX can save a cultivation, explore the example below. Using a wholesale selling price of €4,000/kg, if a processor failed 20% of their annual harvest, they would be forced to retest, treat again, or offload the failed product to a manufacturer for a deep discount—as much as 90%, or €400. This snapshot shows the revenue a cultivator will recover within the first year of using the RFX, based on recovering 20% of the harvest that fails microbial testing on 1,000 kgs of dry flower harvested per annum.

In this example, more than €720,000 of revenue is recovered in the first year alone—more than double the cost of the RFX!

The Future of Germany’s Cannabis Market

As Germany spends the next five years monitoring its new adult-use market and the limited number of dispensaries it’s anticipated to 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 operating in alignment with EU GMP processing guidelines.If you’re looking to streamline your product’s entry and position in the German cannabis market, let’s talk. Ziel’s RFX offers the largest throughput of any technology currently available and boasts a >99% pass rate for regulatory compliance. Together, we can get you set up to leverage what’s anticipated to be one of the largest cannabis markets in the world. Get in touch with Ziel today.

Ionizing Radiation Technologies

Ionizing radiation reduces microbial contamination by irradiating the product. While these are popular technologies that many producers in agriculture use, they’re not always considered safe as they alter the molecular structure of whatever they’re irradiating. In cannabis, irradiation has been shown to alter terpene and moisture content[1], and in some cases, it’s also altered the anti-proliferative compounds of the plant[2] i.e. those that may fight against certain cancer cells.

In certain countries, like Canada for example, any product treated with ionizing radiation must be labeled with the Radura, the international symbol for irradiation. In the US, the FDA requires whole foods that have been irradiated to be labeled with the Radura. This requirement may extend to US cannabis once the reschedule is in effect. US states like Nevada have also been considering the same requirement for cannabis.

Gamma Radiation

Gamma radiation has been used in agriculture for decades, particularly with meats, fruits, and vegetables. It’s also a well-established method used for sterilizing medical supplies. This technique employs high-energy photons to penetrate deep into materials, disrupting the DNA of mold, bacteria, and other pathogens to render them inactive. However, some evidence shows that this disruption leaves enough DNA intact for those microbes and pathogens to revive themselves.

Using gamma radiation in cannabis can be expensive as the process must be done entirely off-site, costing operators time and money.

Electron Beam (E-beam) Radiation

Like gamma radiation, E-beam radiation utilizes high-energy particles to eradicate microbial contamination. The primary difference lies in the particle type; E-beam uses electrons instead of photons. This method is known for its rapid processing times, but it doesn’t penetrate the flower as deeply as other remediation solutions, so there’s no guarantee it eliminates pathogens within the core of the bud. This can be an issue when dealing with pathogens like Botrytis, AKA “bud rot,” because it typically starts on the stem at the bud’s core.

Treating microbial contamination in cannabis with E-beam must also be done offsite, so it comes with similar added costs as gamma radiation.

X-ray Radiation

X-ray radiation falls between gamma and E-beam in terms of penetration depth and energy. This modality is advantageous for its ability to uniformly treat cannabis products whether or not they’re packaged, but it still doesn’t guarantee the core of the flower has been treated.

Operators can install their own X-ray remediation equipment on site, but additional chiller equipment is needed so there are added costs associated with this option.

Non-Ionizing Radiation Technologies

Non-ionizing radiation is considered safer than ionizing technologies because it does not alter molecular structures.

Radio Frequency

Radio Frequency (RF) treatment is a non-ionizing radiation technology that uses long, low-energy wavelengths to penetrate the cannabis flower to its core. These wavelengths create an oscillating electromagnetic field around and within the flower that generates heat, effectively destroying microbial contaminants without destroying the chemical makeup and potency of the plant.

RF treatment is particularly suitable for organic cannabis operations. Although cannabis cannot be officially designated as organic at this point, the reschedule will make this label available to cannabis operations. The USDA has already recognized RF treatment as an organic solution for other agricultural markets.

Ziel’s RFX machine has also been validated for EU GMP operations and can easily be integrated into operations looking to export cannabis to the EU. Ziel can install the RFX on-site, so you don’t have to worry about additional transportation or administration costs.

Cold Plasma

Though cold plasma radiation is non-ionizing, it’s not considered to be as safe as RF because it generates free radicals which may create health risks for consumers.

Basically, a high-voltage electrical charge is initiated within a gas. This charge then creates a cloud of electrons, ions, photons, and free radicals that poke holes in the membranes of pathogens and damage their DNA. Like E-beam radiation, it is mostly a surface-level treatment, so there is a risk that microbial contamination within the core of the flower won’t be treated.

UV-C Light

Ultraviolet-C (UV-C) light remediation uses a spectrum of non-visible, short-wavelength light to disrupt the DNA of pathogens. It attacks the core of a pathogen and prevents it from replicating. Because its wavelengths are short, it treats mostly the surface of cannabis flower and doesn’t tend to penetrate the flower’s center.

UV-C remediation can be used to treat loose flowers or fully packaged products. Additionally, because it’s chemical-free and non-ionizing, it can be incorporated into organic food operations and will likely be allowable for organic cannabis operations as well, once the USDA opens that designation to cannabis.

Chemical Remediation Technologies

There are a few chemical remediation technologies available, including ethanol, CO2, and ozone. We’re only going to touch on ozone here as it’s the most common chemical option for cannabis operators.

Ozone

Ozone treatment leverages the strong oxidizing properties of ozone gas to eliminate microbial contaminants. It can be incorporated into organic cannabis operations and has a GRAS (Generally Recognized as Safe) designation with the FDA, but it does have the potential to leave residue behind on your cannabis products.

Ozone remediation treatment can vary depending on the machine you use. Many ozone generators do not allow you to control the concentration of ozone, and too much of it can be extremely damaging to cannabis flowers. Even with a more customizable machine, it is mainly a surface-level treatment that doesn’t guarantee the core of the flower has been decontaminated.

Choosing the Right Microbial Control Solution for Your Operation

As the FDA prepares to regulate cannabis operations following its federal rescheduling, incorporating effective microbial control solutions into your SOPs is going to be essential for compliance and product safety. Understanding the various microbial remediation technologies available to you is crucial for making the right decision for your operation’s future.

Among these remediation solutions, Radio Frequency stands out as the best choice for cannabis operators. RF treatment offers an organic, non-ionizing, and cost-effective method of microbial control without compromising the quality and integrity of your product.

In particular, Ziel’s RFX can set your business up for a successful future as an organic, GMP-validated operation ready to sell in the US or export across the globe. Get in touch with us today to find out more about incorporating radio frequency remediation into your business.

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 around 12 months to secure and cost around €4,500 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. Department of Agriculture (USDA) 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.

To address this situation and help cannabis cultivators boost their bottom line with minimal upfront cash outlay, Ziel is pleased to announce partnerships with multiple financial institutions that have an established presence in the cannabis industry. Zie identified these direct lenders to provide our customers with a cost-effective means to finance or lease the safest cannabis remediation technology on the market—the Ziel RFX.

Using Radio Frequency (RF), the Ziel RFX decontaminates whole flower and trim to deliver a greater than 99% regulatory compliance pass rate. On average, the Ziel RFX recovers $1.1 million annually for each of its clients.

Read on to see how much revenue the Ziel RFX can recover for you and how you can secure yours with the help of our financial partners.

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.