Obligation to provide information under the Consumption Cannabis Act (KCanG)

What producers need to know about labeling now

In germany the cannabis legalization has been decided. However, the KCanG is only a first step; the compliant implementation is the next. One aspect is the obligation to provide information upon distribution, for which suitable labeling solutions will be indispensable.

Despite controversial discussions beforehand and ongoing debates about anticipated benefits and feared harm, the Consumption Cannabis Act (KCanG) was passed by the Bundestag on March 27, 2024, with the majority of the government coalition against the votes of the opposition from CDU/CSU and AfD. Considering the significance of a law that aims to end the long-standing practice of condemning drug use, regardless of differentiation between so-called hard and soft drugs, its provisions are complex. It is already clear that the entire process of legalization will not be completed with this one law. Rather, it is part of a multi-stage process and a legal framework that is intended to be based on several pillars. Even this implementation strategy must be considered provisional today, as it may change in many, even fundamental, details.

 

The 1st Pillar of Legalization in Two Stages

On April 1, 2024, the first stage of the KCanG came into effect. With it, both the consumption and possession of cannabis in limited quantities (25 g in public / 50 g at home) became legal. Furthermore, within the scope of personal cultivation to meet one‘s own needs, possession of up to three cannabis plants per adult individual is allowed.

As the second stage, starting from July 1, 2024, communal, non-commercial cultivation in so-called cultivation associations – also referred to as Cannabis (Social) Clubs – will be permitted. The cannabis cultivated here may be distributed to registered members in similarly regulated quantities (50 g per month). A cultivation association consists of a maximum of 500 (adult) members and is subject to detailed regulations.

Legalization of consumption, possession, and personal cultivation, as well as the rules regarding cultivation associations, together constitute the first pillar of cannabis legalization. The planned second pillar regulates the commercial future of cannabis legalization.

Pillar 2: Commercial Trade

In regional pilot projects, commercial supply chains are to be established to enable legal procurement of cannabis for personal consumption beyond personal cultivation and independent of membership in a cultivation association. Additionally, this aims to counteract illegal black market trading. The assumption behind this is that despite widespread interest in cannabis consumption, only a small portion of the population will join cultivation associations, and personal cultivation may not be a viable alternative for many. Hence, it is feared that while the first pillar may restrict illegal black market trading, it will hardly eliminate it.

According to current information, the second pillar is part of a separate legislative process. However, according to the German Hemp Association (DHV), it is already apparent that such a process may not even take place. Rather, it is presumed that the responsibility for commercial regulation will be transferred from the previously designated Federal Institute for Drugs and Medical Devices (BfArM) to the Federal Ministry of Food and Agriculture (BMEL). Since the latter is already responsible for granting permissions for the use of cannabis for research purposes, DHV officials speculate that commercial trade in consumption cannabis could also be regulated through provisions instead of a completely new law.

No Distribution Without Information

Regardless of the detailed questions regarding the design of cannabis legalization, the establishment of cultivation associations, as mandated by the law, already entails labeling and information obligations. According to the KCanG, when distributing cannabis to members, information – at least regarding the weight of the content, the type of cannabis contained, the harvest and expiration date, and the average THC content – must be provided directly on the packaging or on a label. Furthermore, information on dosage, application, and risks must be provided upon distribution, along with guidance on counseling services. According to current language, this information should be „made available,“ covering various implementation practices. The government‘s policy paper mentions both the provision of written information akin to a package insert and the possibility of applying a QR code to the packaging, enabling access to digital information.

The same or likely even more extensive regulations regarding information and labeling obligations will almost certainly apply to the planned commercial trade of cannabis. Additionally, the law allows cultivation associations to trade in seeds, even to non-members. Here, and with all other future providers of seeds and other propagation material, an obligation to provide information will exist, which can be implemented through suitable labeling solutions.

Professional labeling solutions will be indispensable

The first cultivation associations are permitted to commence operations as of July 1, 2024. For this to succeed, planning has been underway in many German cities since the details of the legislative initiative were announced.

As a prominent example, the Cannabis Social Club Berlin had already received over 6,000 registrations by early April 2024. How to manage the high demand within the context of the membership limit of 500 members in a cultivation association remains to be seen. However, regarding the labeling required by the law, it is evident that even with 500 members and a distribution of up to 50 g per month, a purely manual solution will hardly be practical. If, as planned, commercialization occurs, the effort for legal providers will be much greater.

The distribution of recreational cannabis, according to the law, is to be done in neutral packaging without promotional design. This formulation also allows for much flexibility. Plastic bags as well as glass or plastic containers with screw caps are conceivable. It can be assumed that different systems will be used within a cultivation association, as not every member will always take the full 50 g – an amount with considerable volume – and different packaging sizes will be required.

As an established label machine manufacturer with relevant experience in producing machines for the pharmaceutical and food industries, b+b offers various models for labeling the required product formats, such as tubes for pre-rolled joints, PET cans, or jars with cannabis flowers, as well as small bottles with CBD oil that need to be labeled either wrap-around or on the side. Fully automatic machines are suitable for commercial trade, while there are also more affordable semi-automatic or manual solutions available for smaller product batches.

Documentation requirement and monitoring

In a sensitive area like the distribution of legal but still strictly regulated intoxicants like cannabis, the legislator cannot rely solely on legal regulations and assume that these will be fully complied with. Especially in such a controversial and likely still debatable topic in the long run, control is of particular importance. Accordingly, the new law already imposes strict documentation requirements on cultivation associations. This includes, in addition to evidence of purchased seeds and harvest quantities, primarily documenting distributions. Individual data capture is indispensable just to adhere to the specified maximum quantities and is likely to be regularly checked or kept transparent for the relevant authorities through a reporting system. Even here, manual systems will quickly reach their limits. In conjunction with labeling, software-assisted documentation similar to common ERP systems is conceivable and easily implementable. With suitable standards or even interfaces, automated data transfer is also feasible. Whether this is justified for simple cultivation associations remains to be clarified. Commercial legalization will hardly be possible without such systems.

The greatest flexibility in labeling is provided by automated labeling systems. Printing and applying paper labels offer various options for applying information as needed. Printers and applicators provide the capability to label different packaging geometries. This allows pre-printed labels to be applied to packages with identical content as well as, with the help of suitable software and printers, for similar containers to be printed with variable information during a labeling process.

Solution1: Model VRM

Solution 2: EDS

Solution 3: Model VRM

Solution 4: Model RML

Solution 5: Model FMpharma

Solution 6: Model TNC-F

Leading solution providers are ready to go

Whether it‘s cultivation associations or legal commercial trade: When it comes to finding the right solution for the required labeling, decision-makers don‘t have to rack their brains for long. Professional solution providers with extensive experience in the development and customer-specific implementation of labeling solutions, such as b+b Automations- und Steuerungstechnik GmbH from Oberzent, Hesse, not only possess the necessary know-how but also have proven solutions that can be easily adapted to the requirements of cannabis labeling. Especially systems predominantly used in the food industry or pharmacy work under similar conditions and with similar requirements profiles, such as packaging geometries. With a flexible combination of suitable label printers and applicators, b+b offers a wide variety of applications. Semi-automatic labeling of cans with wrap-around labels or the labeling of tubes commonly used in pharmacy, both variants that could also be used as packaging for cannabis in various quantities.

Solution 7: Also, tamper-evident labels, as used in cosmetics and pharmaceutical products, are important to provide consumers with tamper-proof protection and thus guarantee the integrity and quality of the product.

For the design of required labels, including the described option of providing information by applying a QR code, the label software Labelsplatform 5 offers a simple solution that can reliably implement legal requirements through an integrated guidelines module.

Additionally, bb-trace offers both standard systems and customer-specific solutions for the serialization and aggregation of cannabis products. This enables manufacturers to handle track & trace tasks through labeling and to document and trace supply processes. Here, too, relevant experience from the pharmaceutical sector can be drawn upon to ensure that supply chains are traceable seamlessly during distribution or later trading with cannabis and cannabis products as part of quality control.

Model RML is designed for labeling lying, cylindrical products. Pre-rolled joints, for example, are packaged in similar tubes for individual distribution. Compared to semi-automatic systems, a higher quantity can be achieved here. With the labeler, the tubes can be labeled both lengthwise and wrap-around.

---

Key Mandatory Information at a Glance

Information on the packaging or label:

• Weight of the content

• Contained cannabis strain

• Harvest and minimum shelf life date

• Average THC content

Additional mandatory information upon distribution:

• Dosage information

• Application instructions

• Risk disclosure

• References to counseling services

Implementation Practices:

• Written information as a package insert

• Possibility of applying a QR code on the packaging for digital access to information

PR-03-2024-Cannabis-EN

.pdf

Download PDF • 1.81MB