Regulation of HHC and THC

The End of the Grey Zone: What Does the New Act on Psychomodulatory Substances Bring?

The Act introduces two entirely new, key categories of substances, the understanding of which is crucial for your business:

1. Listed Psychoactive Substances: This category can be thought of as a strict "quarantine" list for new, unresearched, or high-risk substances. Any handling of these substances (production, sale, import, storage) is prohibited. The only exception is scientific research based on a special permit from the Ministry of Health. This is where previously freely sold substances like HHC now fall.

2. Psychomodulatory Substances (PML): This is a new category for substances that have been assessed as less risky. Their sale is legal, but only under very strict conditions similar to the regulation of alcohol and tobacco, and in some respects even stricter. It is expected that this list will include, for example, kratom or cannabis with a THC content of up to 1%, once the government issues an implementing regulation and the process is approved by the European Commission.

This new legislative framework gives the state an effective tool to react quickly to new synthetic substances appearing on the market. Whereas previously a substance was legal until explicitly banned, now any new substance can be immediately placed on the restrictive list, making it essentially illegal until its relative safety is proven. For entrepreneurs, this means a fundamental change in risk assessment when launching new products.

HHC, THCP and their derivatives: Why is their sale now a criminal offence?

Since March 2024, when Government Regulation No. 52/2024 Coll., came into force, substances such as hexahydrocannabinol (HHC), HHC-O, and tetrahydrocannabiphorol (THCP) have been officially included on the list of addictive substances. This step was a direct response to the growing number of intoxication cases, especially among children and adolescents who consumed these substances in the form of sweets.

Continuing to sell, produce, import, or store these substances exposes you to extreme legal risk. The penalties are severe and can have ruinous consequences for both your company and you personally.

• Sale and other handling: Any handling of these substances is now the criminal offence of illicit production and other handling of narcotic and psychotropic substances and poisons under Section 283 of the Criminal Code. Perpetrators face a prison sentence of up to eight years, or longer in more serious cases.

• Possession for personal use: Even mere possession of a small quantity for personal use is an offence punishable by a fine of up to CZK 15,000.

Some sellers are trying to circumvent the ban by offering chemically similar but as yet unregulated alternatives (e.g., 10-OH-HHC, THC-R).

However, this strategy is extremely risky, as the new act allows the government to very quickly add these new derivatives to the list of banned substances.

At ARROWS, we strongly warn against such a course of action and are ready to provide you with a legal opinion on the legality of your existing and planned portfolio. For an immediate solution to your situation, write to us at consultation@arws.cz.

 New Rules for the Legal Market: What Conditions Must You Meet to Sell Psychomodulatory Substances?

Entering the legal market for psychomodulatory substances (PML) is not simple. Act No. 321/2024 Coll. sets high barriers and strict operating conditions that require careful legal preparation.

Key requirements for the legal sale of PML include:

• Handling permit: For any form of handling PML (production, import, distribution, sale), it is necessary to obtain a non-transferable permit from the Ministry of Health.

• High administrative fees: Market entry is associated with significant costs. The fee for initiating proceedings for a distribution or production permit is CZK 200,000, for each specialised shop CZK 20,000, and for each e-shop CZK 200,000. In addition, annual maintenance fees of the same amount must be added.

• Restriction of points of sale: Sales are permitted exclusively in specialised brick-and-mortar shops and via e-shops with strict age verification (18+). Vending machines are completely prohibited.

• Absolute ban on advertising: The Act introduces a blanket ban on any form of advertising, sponsorship, or promotion of psychomodulatory substances. This fundamentally limits marketing opportunities.

• Strict packaging requirements: Each product must be clearly labelled on the packaging with the text "Psychomodulatory substance" and meet other technical requirements for composition, appearance, and quality, which will be specified in an implementing decree.

The ARROWS team specialises in administrative law and is ready to guide you through the entire licensing procedure, from preparing the application to communicating with the authorities. Our lawyers are ready to help you – write to us at consultation@arws.cz.

The Future of CBD Products: When Does the New Strict Regulation Apply to You?

Sellers of CBD products must be alert. The new legislation brings a fundamental change that may unexpectedly affect a large portion of them. The Act distinguishes between pure CBD isolate and products that also contain trace amounts of THC.

If your products (e.g., full-spectrum or broad-spectrum CBD oils, drops, or flowers) contain any detectable amount of THC, they will now most likely fall into the category of psychomodulatory substances. This means you will be obliged to meet all the strict conditions described in the previous chapter – including obtaining a licence, paying high fees, and an advertising ban.

In addition, the problem persists with the classification of edible CBD products as so-called "novel foods" by the European Food Safety Authority (EFSA) and the Czech Agriculture and Food Inspection Authority (SZPI). This status requires a complex and costly approval process, without which there is a risk of products being withdrawn from the market.

Expansion Abroad: How to Navigate the Different Regulations in Germany, Austria, and Poland?

If you plan to expand into foreign markets, you must be aware that each country has its own, often very different, rules. A single European market does not exist in this area, which poses a significant legal risk for international trade.

• Germany: Since April 2024, it has liberalised the possession and cultivation of cannabis for personal use (up to 3 plants, 25g in public) and is planning the creation of so-called cannabis clubs. However, commercial sales are still restricted. HHC was banned in Germany in June 2024.

• Austria: HHC has been banned since March 2023. While possession and consumption are not penalised, production and sale are illegal. A strict limit of 0.3% THC applies to legal CBD products.

• Slovakia: As of November 2024, it has joined the Czech Republic in banning the sale of HHC, HHC-P, and HHC-O, thus aligning its approach with ours.

• Poland: It applies some of the strictest anti-drug laws in Europe. Recreational cannabis is completely illegal, and even possession of a small amount of THC can lead to criminal prosecution. Legal CBD products here must meet a 0.3% THC limit.

Thanks to the ARROWS International network, built over ten years, we handle these cross-border cases on a daily basis. We are able to ensure that your business, whether it involves importing raw materials, exporting finished products, or operating an e-shop, is in full compliance with local legislation in each target country.

How Can ARROWS Help You Protect Your Business and Ensure Compliance with the New Legislation?

The new legislative environment is complex, but manageable with expert legal guidance. At ARROWS, we understand that for our clients, which include more than 150 joint-stock companies and 250 limited liability companies (s.r.o.), legal certainty and risk minimisation are key. Our goal is to protect your investments and allow you to focus on growing your business.

We provide comprehensive legal services tailored to your needs:

• Legal advice on obtaining permits and licences for handling psychomodulatory substances.

• Preparation and revision of contracts with suppliers and distributors that reflect the new legal regulations.

• Drafting of internal directives and compliance programmes to protect your company from misconduct.

• Expert training for employees or management with a certificate, so your team understands the new rules.

• Representation before courts and administrative authorities (SZPI, Police of the Czech Republic, Ministry of Health) in case of inspections or proceedings.

For our clients, we are not just lawyers, but also business partners. We enjoy connecting companies with interesting business opportunities and listening to innovative ideas.

Don't wait for a problem to knock on your door. A proactive legal strategy is the key to protecting your investment and ensuring peace of mind. For a no-obligation consultation and analysis of your situation, write to us at consultation@arws.cz.