The Act will make it possible to regulate the market for new psychoactive substances (kratom, low-potentcannabis, etc.) and control them in order to minimise public health risks without including them in the list ofnarcotic drugs and psychotropic substances.

Draft Act amending Act No 167/1998 on addictive substances and on amendments to certain other acts, asamended, and other related acts

There is currently a single regime for the control of psychoactive substances established by the UNConventions on Narcotic Drugs and Psychotropic Substances, which is reflected in the current form of theAddictive Substances Act. New psychoactive substances are then added to the list of prohibited narcotic drugsand psychotropic substances and are thus subject to strict control, including enforcement primarily at the levelof criminal law (similar to heroin, cocaine, pervitin, etc.).

The submitted proposal represents the missing alternative solution. The inclusion of a new substance that hasnot yet been sufficiently studied in the list of so-called Scheduled Psychoactive Substances will enable a rapidresponse, thus preventing its free import or export or other disposal.
The placing on the market of the listed psychoactive substances will be prohibited, but at the same time theirusers will not be unnecessarily persecuted. This regime already provides sufficient tools to control the importand supply of new psychoactive substances.
A risk assessment of the substance will then be carried out. It will be transferred to the list of psychomodulationsubstances (and thus subject to strict regulation) or to the list of addictive substances (and thus banned asnarcotic and psychotropic substances) or it will be retained on the list of scheduled psychoactive substancesand further investigated or removed from the list.
Within the category of psychomodulation substances, a strictly regulated market is introduced for substancesfor which a risk to public health and a risk of social impacts on individuals and society has been identified, butnot of a serious nature. Substances included in the category of psychomodulatory substances under thepresent proposal will be subject to strict statutory conditions in the area of disposal.
The proposal regulates measures related to reducing the risks of negative effects associated with theconsumption of psychomodulatory substances, namely: a ban on advertising psychomodulatory substances,sales through vending machines and sales outside specialised shops.
Furthermore, measures aimed at protecting the health of minors include a ban on the sale ofpsychomodulation substances to persons under the age of 18, severe restrictions on on-line sales, a ban onminors entering specialised stores for these substances, or a ban on selling in schools and other specificallylisted places. More stringent regulation is therefore chosen than for tobacco products or alcohol.
As opposed to alcohol and tobacco, it is not possible to sell psychomodulation substances in grocery stores ortobacco shops. Furthermore, the use of psychomodulation substances may be restricted by a municipalordinance.
Violations of the statutory conditions for handling psychomodulatory substances or classified psychoactivesubstances correspond to the new offences.
The proposal introduces a strict control regime whereby entities handling substances on the list ofpsychomodulation substances (except for statutory exceptions) must have a permit issued by the Ministry ofHealth.

Keywords: psychoactive substances, psychomodulation substances, Narcotic substances, psychotropic substances

reference to:
- - Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 onmaterials and articles intended to come into contact with food and repealing Directives 80/590/EEC and89/109/EEC
- ČSN EN ISO/IEC 17025
Conformity assessment – General requirements for the competence of testing and calibration laboratories,Catalogue No 504810;
reference is made to the proposed draft Act and Basic Act No 146/2002, which is attached to the supportingdocuments under ‘Other text’.
- ČSN EN ISO 19011-2019
Guidelines for auditing management systems
Catalogue No 506469
makes reference to Act No 258/2000.