What substances will be regulated by the psychomodulation law and what about CBD?

Author of the article: Mgr. Barbora Dlabolová, ARROWS advokátní kancelář (office@arws.cz, +420 245 007 740)

As of 1 January 2025, a new Psychomodulation Act came into force, which newly introduces into the Czech legal system the conditions for regulating the handling of psychomodulatory substances and so-called classified psychoactive substances. What does this mean for manufacturers, importers, distributors and other businesses and which substances will be affected by the new regulation? Prepare for new obligations and legislative changes that may affect your business.

Psychomodulation law - what is new?

As we have informed you several times in our previous articles, the new Psychomodulation Act, which amends a number of legal provisions, represents a major step in the regulation and control of psychomodulatory substances. Its aim is to protect public health and ensure safety in the market for these substances.

The main changes introduced by the law are:

• 3 new categories of substances: a) addictive, b) psychomodulatory (not posing a serious risk to public health) and c) classified psychoactive (serious health and social risks cannot be ruled out in the light of current scientific knowledge).
• Obligation to obtain a permit: Businesses wishing to handle psychomodulants, from manufacturers to distributors, must obtain a permit to handle psychomodulants. An important part of the authorisation procedure is the payment of an administrative fee, which ranges from CZK 200,000 and upwards. Such a fee will then have to be paid each year as a kind of maintenance fee.
• Stricter conditions for production and distribution: good manufacturing practice requirements, possibility to sell only in specialised outlets to persons over 18 years of age, ban on sales in vending machines or near schools, mandatory labelling of products, restrictions on advertising, ban on exports, registration obligation, etc.
• Prohibition on the disposal of scheduled psychoactive substances: Exemption for research purposes only under a licence for the disposal of scheduled psychoactive substances.
• Extension of powers of control authorities: the State Agricultural and Food Inspectorate and other authorities will be authorised to carry out random checks, both at the place of business and during the transport of goods.

Lists of psychomodulatory and scheduled psychoactive substances - what do they include?

So what substances will fall under the new statutory regulation? The amendment foresees the adoption of a government regulation on the list of psychomodulatory and scheduled psychoactive substances as well as other implementing legislation.

The Government Regulation on the list of classified psychoactive substances was adopted under No. 11/2025 Coll. with effect from 17 January 2025. HHC and its derivatives (HHCP, HHCH, HHC-C8, HHCB), and THC derivatives such as THCP, THCH, THC-C8, THCB and others. Therefore, it is not possible to handle these substances, or it is only possible to do so on the basis of an authorisation to handle scheduled psychoactive substances for research purposes.

The Ministry of Health should assess the risks of the substances within 2 years of their inclusion in the list of scheduled psychoactive substances and then the Government, in cooperation with the Ministry of Health, the State Institute of Health and the Office of the Government of the Czech Republic, should decide on their further fate, i.e. either their inclusion in the list of psychomodulatory substances, addictive substances or their retention on the list or their complete removal from the regulated area.

What about the list of psychomodulatory substances? The Government was due to consider the Psychomodulatory Substances List Order today, 19/2/2025. However, the discussion of this item was suspended, as the technical notification by the European Commission is still pending.1 According to the information available after the Government meeting, the Regulation should be notified by 20.5.2025 at the latest, and subsequently it should enter into force as planned on 1.7.2025.

For the time being, it seems that if the draft regulation is indeed approved by the European Commission under the notification procedure, then the following substances should be included among the psychomodulatory substances:

1. Kratom (Mitragyna speciosa) - a plant compound native to the leaves of the Mitragyna speciosa plant containing the alkaloids mitragynine and 7-hydroxymitragynine;
2. Kratom extract - a preparation made from kratom;
3. Cannabis containing up to 1 % THC - includes plant material containing a canopy with a THC content of up to 1 %, intended for human consumption or for processing for human consumption, excluding source material for processing into food or cosmetics.
4. Cannabis extract and tincture up to 1 % THC - Extract or leachate obtained from cannabis up to 1 % THC, intended for human consumption or for processing for human consumption, except as a source material for processing into foodstuffs or cosmetics, and preparations thereof.

Once approved by the European Commission and once the Government Regulation on psychomodulants has entered into force, these substances, if the Regulation is approved as proposed, can only be handled under the terms of the Psychomodulants Act on the basis of a licence.

The implementing regulations for the Psychomodulation Act should be adopted by 1 July 2025.

What about CBD?

If we proceed from the current draft Government Regulation on the list of psychomodulatory substances and Government Regulation No. 11/2025 on the list of scheduled psychoactive substances, CBD and products containing CBD do not fall under psychomodulatory or scheduled psychoactive substances. However, this only applies to those products that do not contain any THC, i.e. pure CBD isolate with a THC content below the level of detection.

However, if there are CBD products, extracts, etc. (e.g. CBD drops) that contain some detectable amount of THC, then such substances and products should fall under psychomodulants and their management should fall under the regulation of psychomodulants.

If you have any questions in relation to the new regulation of psychomodulants or cannabis law, please do not hesitate to contact us. We would be happy to learn more about your case and provide you with appropriate legal assistance.