On behalf of the Association of Responsible Distributors, z.s., which brings together experts and
entities involved in the distribution of products containing natural substances, we express our
strong opposition to the Czech Republic’s proposal to include cannabis with THC content up to
1% (including CBD products) in the list of psychomodulatory substances.
We would like to draw attention to the following key points:
1. CBD is not a psychoactive substance.
According to expert opinions from the World Health Organization (WHO) and the United Nations
Commission on Narcotic Drugs (CND), CBD does not exhibit psychoactive or addictive properties.
Therefore, its use does not pose a health risk that would justify its inclusion among
psychomodulatory substances.
2. European Union position.
The European Union has classified CBD as a “novel food” – a type of food that does not have a
significant history of consumption or is produced by a method that has not previously been used
for food – and not as a psychotropic or illegal substance. National inclusion of these products
among psychomodulatory substances would directly contradict the principles of harmonization
of the internal market and equal access for entrepreneurs within the EU.
3. Legal interpretation confusion.
The proposed measure blurs the distinction between industrial hemp and high-THC cannabis.
Such generalization may lead to confusion among the public, businesses, and regulatory
authorities.
4. Procedural deficiencies.
The notification process is marred by a series of uncertainties – such as repeated deadline shifts,
the absence of a final version of the regulation, and uncertainty about the legal regime in force
from July 1, 2025. This situation threatens legal certainty and the stability of the business
environment.
5. Violation of the principle of proportionality.
The draft introduces disproportionately strict restrictions for a substance whose health risks
have not been scientifically demonstrated. Such an approach is contrary to the principle of
proportionality, which is a fundamental pillar of EU-level regulation.
6. Unjustified regulation with respect to road safety.
Low-potency cannabis with THC content up to 1%, as confirmed by expert analyses, does not
have psychoactive effects and does not impair perception, reaction time, or cognitive functions.
The use of such a substance, if treated as a psychomodulatory substance, would fall under Act
No. 361/2000 Coll., on Road Traffic, specifically Section 5(2)(b), which prohibits driving a vehicle
or riding an animal immediately after consuming alcohol or other psychoactive substances. In
this respect, there is no reason to regulate it based on road safety, since cannabis with THC
content up to 1% does not impair the ability to drive a motor vehicle.
7. Contradiction with superior legislation.
According to Section 29(2) of Act No. 167/1998 Coll., on Addictive Substances, handling cannabis
containing no more than 1% THC is not considered handling psychomodulatory substances if it is
intended for industrial, food, cosmetic, technical, or horticultural purposes. The draft regulation
is therefore in direct contradiction with this legal provision, which constitutes a fundamental
legal flaw and a strong argument for rejecting the notification.
In light of the above, we respectfully request that the European Commission reject the Czech
Republic’s proposal in its current form. We also urge that it be revised based on scientific
evidence, compliance with the legal framework, and with regard to the integrity of the European
internal market.