What is CBD Regulation in Poland and UE?

Updated: 11.12.2024

The legal status of CBD (cannabidiol) in the European Union, including Poland, has been a topic of debate and regulatory uncertainty for years. As one of the main compounds found in the Cannabis sativa L. plant, CBD is gaining popularity across various industries. It is commonly used in dietary supplements, cosmetics, hemp products, and medical devices.

However, despite its increasing demand, CBD regulations remain complex. The legal classification depends on both the intended use of the product and its THC (delta-9-tetrahydrocannabinol) content, a psychoactive substance that determines how strictly it is controlled under law.

How is CBD Classified and Regulated in the EU and Poland?

A key legal question is whether CBD products fall under the „novel food” category. According to EU and national regulations, hemp-derived products can be legally sold if there is evidence of human consumption before 15 May 1997. This classification is crucial for producers and distributors, as it determines compliance with strict food safety and quality standards.

Additionally, products containing even trace amounts of THC are subject to strict legal control. The law differentiates between industrial (fibrous) hemp and non-fibrous hemp, a distinction that directly impacts the cultivation, processing, and sale of hemp extracts.

CBD is also subject to pharmaceutical regulations. In Poland and across the European Union, medicines containing CBD must meet rigorous safety, efficacy, and quality standards to ensure compliance with pharmaceutical law.

What This Article Covers?

In this article, we will examine the key legal regulations surrounding CBD in Poland and the EU. Topics include:

• The classification of CBD products as novel food
• The legal framework for hemp-derived products
• The regulation of psychotropic substances
• The requirements for medicinal CBD products
• Potential legislative changes affecting the CBD market

Understanding these legal aspects is essential for businesses, manufacturers, and consumers navigating the rapidly evolving CBD industry.

Marijuana and Hemp – What’s the Difference?

Although the terms „marijuana” and „hemp” are often used interchangeably, they refer to different types of the Cannabis sativa L. plant. Cannabis is a broad term for all plant-derived products containing cannabinoids – chemical compounds that interact with the human body.

The two most well-known cannabinoids are:

• THC (tetrahydrocannabinol) – the psychoactive compound responsible for the intoxicating effects of marijuana.
• CBD (cannabidiol) – a non-psychoactive compound known for its potential therapeutic benefits.

The primary distinction between marijuana and hemp lies in their THC content. Marijuana contains higher levels of THC, making it a controlled substance in many jurisdictions. In contrast, hemp has low THC levels (typically below 0.2-0.3%, depending on legal limits) and is widely cultivated for industrial, medical, and commercial uses.

Other Cannabinoids in Cannabis

The cannabis plant contains over 100 different cannabinoids, many of which are still being researched. In addition to CBD and THC, two other notable compounds include:

• CBG (cannabigerol) – often referred to as the „mother of all cannabinoids,” as it serves as a precursor to CBD and THC.
• CBN (cannabinol) – a cannabinoid with mild psychoactive effects, often associated with potential sedative properties.

While scientists continue to study these compounds, their exact effects and medical applications remain under investigation.

EU Law on CBD – Current Regulations

Regulations on cannabis and cannabinoids within the European Union are complex and vary between member states. In general, hemp-derived products are legal in the EU as long as they contain less than 0.2% THC (although Poland permits up to 0.3% THC).

A significant legal milestone occurred in 2021 when the European Court of Justice (ECJ) ruled that CBD is not classified as a narcotic. This decision allows for the free trade of CBD products across EU countries, provided they comply with applicable regulations.

Hemp and the Common Agricultural Policy (CAP)

Hemp (Cannabis sativa L.) is primarily cultivated for industrial purposes and is regulated under the EU’s Common Agricultural Policy (CAP). To be eligible for CAP-related benefits, hemp must contain low levels of THC, ensuring that it cannot be used for narcotic production. Currently, 75 hemp varieties that meet these criteria are registered in the EU plant variety catalog.

Importing Hemp into the EU

According to Article 189 of Regulation (EU) No. 1308/2013, importing hemp into the EU requires a special permit. Additional restrictions include:

• THC content in raw hemp (CN code 5302 10) must not exceed 0.3%.
• Hemp seeds for sowing must have a documented THC content below 0.2%.
• Hemp seeds not intended for sowing require national authorizations, and importers must provide proof that the seeds cannot be used for cultivation.
• EU member states may impose stricter regulations, as long as they comply with EU law.

Support for Hemp Farmers in the EU

Farmers cultivating hemp may qualify for financial support under the CAP, provided they meet specific criteria:

• The THC content of their hemp variety must be below 0.3%.
• The seeds used for sowing must come from certified varieties registered in the EU catalog.

Additionally, some EU countries, including France, Poland, and Romania, offer national subsidies to support hemp production. Farmers may also apply for rural development funding, which covers:

• Investments in hemp farming and processing,
• Training programs for farmers,
• Supply chain development,
• Environmental protection initiatives,
• Organic farming incentives,
• Innovation in hemp-based industries.

Cannabidiol (CBD) as a Novel Food in the European Union

Under Regulation (EU) 2015/2283, any food that was not consumed in the European Union before 15 May 1997 is classified as a novel food. This means that CBD and other cannabinoids must undergo an authorization process before they can be legally marketed.

The European Commission has confirmed that certain hemp-derived products, such as CBD oil, hemp seed flour, and defatted hemp seeds, were consumed before 1997 and therefore do not require additional classification. However, CBD extracts, other cannabinoid extracts, and hemp resin from Cannabis sativa L. must still go through the novel food approval process.

Regulatory Status of THC in the EU

In contrast, THC (tetrahydrocannabinol) is strictly regulated. It falls under the German Narcotics Act and is controlled by the 1971 United Nations Single Convention on Psychotropic Substances. Under EU law, THC is not considered a food ingredient, and its presence in hemp-derived products is tightly regulated to ensure compliance with permissible THC concentration limits.

CBD Authorization Process and Safety Concerns

To be legally marketed as a novel food, CBD products must undergo evaluation by the European Food Safety Authority (EFSA). The EFSA has highlighted concerns due to insufficient data on how CBD affects the human body, particularly its potential impact on the liver function, endocrine system and nervous system.

As a result, CBD manufacturers must provide scientific evidence demonstrating the safety of their products before they receive regulatory approval.

Impact on Producers and Consumers

The classification of CBD as a novel food has significant consequences for both producers and consumers:

• For producers: Compliance with strict legal requirements and lengthy approval processes, which can take several years, delaying CBD product availability.
• For consumers: More certainty that CBD oils, dried CBD, and hemp-based food products meet EU food safety standards. However, due to differences in national laws, the possession of cannabis-derived products may still be restricted or penalized in certain EU jurisdictions.

Cannabinoids in Hemp: A Broader Perspective

Cannabis sativa L. contains over 100 different cannabinoids, including:

• CBD (cannabidiol) and its precursor CBDa (cannabidiolic acid)
• CBG (cannabigerol)
• CBN (cannabinol)
• CBC (cannabichromene)
• Δ9-THC (delta-9-tetrahydrocannabinol) and its precursor Δ9-THCa

Of these compounds, only THC is classified as a psychotropic substance.

In Case C-663/18, the European Court of Justice (ECJ) ruled that CBD is not a narcotic under the 1961 United Nations Single Convention on Narcotic Drugs, as it does not have psychoactive effects. Following this ruling, the European Commission recognized CBD as a potential „foodstuff”, provided it meets the requirements outlined in Article 2 of the General Food Law.

How is CBD Regulated in Poland?

In Poland, the CBD regulation framework is primarily based on the Act on Counteracting Drug Addiction and the Minister of Health’s regulations. While CBD products are legal, their production, import, storage, and sale require official permits. The amendments to the Anti-Drug Act introduced industrial hemp cultivation with a THC limit of 0.3%, aligning with drug policy to differentiate industrial hemp from controlled substances.

The amendment also permits research institutes to cultivate cannabis and harvest resin with a higher THC concentration exclusively for medical cannabis use. This change aims to enhance access to medical marijuana, reduce treatment costs, and provide pharmaceutical raw materials for licensed physicians and healthcare providers. Since THC is a psychoactive substance, its use in pharmaceutical products is subject to strict regulatory oversight under cannabis law.

Regulations on Hemp and CBD Products

Recent court rulings in Poland have liberalized regulations on hemp-derived products. Although CBD extracts are classified as „novel food” under EU law and require marketing authorisation, whole hemp plants (Cannabis sativa L.) do not fall under these restrictions. This means that hemp-containing food products can bypass the novel food approval process.

However, the production and distribution of THC-containing products remain highly regulated, requiring special authorizations. Additionally, products are subject to safety assessments to evaluate adverse effects and public health risks in compliance with the Public Health Service Act.

Hemp Cultivation and Trade Regulations in Poland

In Poland, activities related to the import, production, processing, and distribution of CBD products and THC-containing products fall under strict legal control. Industrial hemp cultivation is only permitted for specific commercial, medical, and research purposes, with THC content restricted to 0.3%.

Each end product containing THC undergoes a risk assessment, considering the acute reference dose, currently set at 1 g D-THC/kg. Furthermore, all hemp varieties cultivated in Poland must be registered in the European Union’s agricultural plant variety list to ensure compliance with quality and THC content standards.

Permitted Uses of Industrial Hemp in Poland

The cultivation of fiber hemp is strictly regulated, with legal applications limited to:

• Textiles, chemicals, cellulose, and paper production,
• Cosmetics, pharmaceuticals, and energy production,
• Hemp seed oil and plant extracts for food, veterinary, and beekeeping use,
• Scientific research and clinical trials,
• Construction materials and plant-based protective products,
• Land reclamation and environmental remediation.

For private individuals, fiber hemp cultivation is restricted to 1 hectare per year for personal use.

Legal Requirements for Hemp Farmers

To cultivate fiber hemp, individuals must be registered in the fiber hemp register, managed by the National Centre for the Support of Agriculture (KOWR). However, individuals or entities that have previously engaged in illegal cultivation of poppies, cannabis, or coca bushes, or have been convicted of drug-related crimes, are prohibited from growing hemp.

To ensure quality control, only elite or certified hemp seeds can be used, unless the grower is engaged in:

• Breeding new hemp varieties
• Scientific research
• Seed production

Additionally, farmers not processing fiber hemp themselves must sign a contract with a registered buyer, except for those involved in seed production, research, or breeding.

Is CBD Legal in Poland?

In Poland, CBD regulation aligns with EU standards, permitting CBD-based cosmetics as long as they are derived from industrial hemp and contain less than 0.3% THC. However, sellers cannot make unsubstantiated health claims, as cosmetic product advertising must comply with applicable law. These CBD products are not classified as new psychoactive substances and are widely available for purchase in Poland.

Hemp dry (CBD flowers) is classified as a „herbal product for smoking”, making it legal but subject to regulations under the law on health protection against the effects of smoking and tobacco products. As a plant-derived product that does not contain tobacco, it can be consumed through combustion, but manufacturers and importers must meet specific packaging requirements and submit an ingredient list to the Office for Chemical Substances.

CBD vape cartridges, on the other hand, remain in a legal grey area. Poland lacks clear regulations governing their sale and distribution. However, these products fall under rules for refill containers and disposable cartridges outlined in the Act on Health Protection Against the Effects of Tobacco and Tobacco Products. In 2021, the European Commission highlighted the lack of regulation surrounding synthetic CBD in e-liquids, suggesting that future amendments to Polish law may introduce stricter controls.

Marketing CBD dried flowers and CBD cartridges is highly regulated. Advertisements must not compare them to psychoactive substances, and labels cannot contain misleading claims such as „rejuvenating,” „energizing,” „therapeutic,” or other health-related benefits.

Legal Status of Medical Cannabis in Poland

Medical cannabis has been legal in Poland since 2017, but its use is strictly regulated. Patients can access medical cannabis therapy only with a medical prescription issued by a licensed physician. This legal shift has been crucial in treating epilepsy, chronic pain, multiple sclerosis, and other medical conditions.

A significant breakthrough occurred in 2017 when amendments to the Act on Counteracting Drug Addiction and the law on reimbursement of medicines allowed the use of:

• Non-fibrous cannabis
• Hemp extracts and pharmaceutical tinctures
• Hemp resin as a pharmaceutical raw material

Despite these changes, the cultivation of non-fibrous hemp in Poland remains heavily restricted, requiring special authorization from federal agencies.

Changes in Hemp Cultivation Regulations (May 2022)

On 7 May 2022, Polish law introduced new definitions of hemp, distinguishing between:

• Fibre hemp (Cannabis sativa L.) – contains less than 0.3% THC
• Non-fibre hemp – contains more than 0.3% THC

Since May 2022, the cultivation of non-fibre hemp has been permitted but is strictly controlled. The harvesting and processing of non-fibrous cannabis for pharmaceutical raw materials require a special permit from the Chief Pharmaceutical Inspector. Only scientific research institutes under the Ministry of Agriculture are authorized to cultivate, harvest, and process this type of hemp.

Patients in Poland can access medical cannabis via pharmacies, either as:

• Prescription drugs prepared in pharmacies
• Ready-made medicinal products derived from Cannabis sativa L. (Two such FDA-approved products are currently available in Poland.)

New Rules for Medical use of Cannabis (2024 Update)

The Ministry of Health has announced changes to medical cannabis prescriptions set to take effect in autumn 2024:

• General practitioners may prescribe medical cannabis online only as part of a treatment continuation for up to three months.
• Patients must verify their identity during teleconsultations.
• For first-time prescriptions, an in-person doctor’s visit will be required.

These proposed regulations have sparked controversy in the medical community, with experts warning that stricter rules may limit patient access to treatment. Since the bill has not been published yet, the exact legal framework remains unclear.

Cannabis Legalization and Criminal Liability in Poland

Despite ongoing discussions about cannabis legalization, Polish law remains strict. Possession of narcotics, including cannabis, is a criminal offense, punishable by imprisonment. However, courts may choose to dismiss cases involving small quantities of cannabis for personal use.

Selling cannabis, including recreational cannabis, remains illegal under Polish law. Even public possession or intent to distribute is classified as a criminal act. In contrast, alcohol laws in Poland are significantly more relaxed, raising questions about future cannabis law reforms.

Will Poland Move Towards Cannabis Legalization?

The future of cannabis law in Poland remains uncertain. While public debate continues, any move toward legalization will depend on political developments, legislative changes, and evolving regulations within the cannabis space.

Poland’s cannabis industry is still in its early stages, with strict regulatory oversight governing CBD products, medical cannabis, and industrial hemp. However, private equity investments, clinical trials, and scientific research may play a key role in shaping the legal framework for cannabis-derived compounds in the coming years.

FAQ – Cannabis law in Poland