Message 001
Communication from the Commission - TRIS/(2024) 1304
Directive (EU) 2015/1535
Notification: 2024/0265/CZ
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20241304.EN
1. MSG 001 IND 2024 0265 CZ EN 17-05-2024 CZ NOTIF
2. Czechia
3A. Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
Biskupský dvůr 1148/5
110 00 Praha 1
tel: 221 802 216
e-mail: eu9834@unmz.cz
3B. Ministerstvo zdravotnictví České republiky,
Palackého náměstí 4,
128 01 Praha 2
tel: 224 971 111
e-mail: mzcr@mzcr.cz
4. 2024/0265/CZ - C00C - CHEMICALS
5. Draft Act amending Act No 167/1998 on addictive substances and on amendments to certain other acts, as amended, and other related acts
6. The Act will make it possible to regulate the market for new psychoactive substances (kratom, low-potent cannabis, etc.) and control them in order to minimise public health risks without including them in the list of narcotic drugs and psychotropic substances.
7.
8. There is currently a single regime for the control of psychoactive substances established by the UN Conventions on Narcotic Drugs and Psychotropic Substances, which is reflected in the current form of the Addictive Substances Act. New psychoactive substances are then added to the list of prohibited narcotic drugs and psychotropic substances and are thus subject to strict control, including enforcement primarily at the level of criminal law (similar to heroin, cocaine, pervitin, etc.).
The submitted proposal represents the missing alternative solution. The inclusion of a new substance that has not yet been sufficiently studied in the list of so-called Scheduled Psychoactive Substances will enable a rapid response, 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 their users will not be unnecessarily persecuted. This regime already provides sufficient tools to control the import and supply of new psychoactive substances.
A risk assessment of the substance will then be carried out. It will be transferred to the list of psychomodulation substances (and thus subject to strict regulation) or to the list of addictive substances (and thus banned as narcotic and psychotropic substances) or it will be retained on the list of scheduled psychoactive substances and further investigated or removed from the list.
Within the category of psychomodulation substances, a strictly regulated market is introduced for substances for which a risk to public health and a risk of social impacts on individuals and society has been identified, but not of a serious nature. Substances included in the category of psychomodulatory substances under the present 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 the consumption 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 of psychomodulation substances to persons under the age of 18, severe restrictions on on-line sales, a ban on minors entering specialised stores for these substances, or a ban on selling in schools and other specifically listed 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 or tobacco shops. Furthermore, the use of psychomodulation substances may be restricted by a municipal ordinance.
Violations of the statutory conditions for handling psychomodulatory substances or classified psychoactive substances correspond to the new offences.
The proposal introduces a strict control regime whereby entities handling substances on the list of psychomodulation substances (except for statutory exceptions) must have a permit issued by the Ministry of Health.
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 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/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 supporting documents under ‘Other text’.
- ČSN EN ISO 19011-2019
Guidelines for auditing management systems
Catalogue No 506469
makes reference to Act No 258/2000.
9. The law will allow public authorities to regulate the market for new psychoactive substances (kratom, low-potent cannabis, etc.) and their effective control to minimise public health risks, without including substances in the list of narcotic drugs and psychotropic substances with a related criminal impact.
Given the perceived low risk of public health or social impacts on individuals and society, some psychoactive substances already have users. If the substances in question were included in the list of narcotic drugs and psychotropic substances, users would be exposed to the risk of criminal prosecution and, at the same time, the illegal market would be stimulated or the search for more dangerous, but more readily available alternatives on the illegal market would be stimulated.
The following supporting documents are sent along with the draft and uploaded to the TRIS-TBT:
Act No 110/1997 on foodstuffs and tobacco products and on amendments and additions to certain related acts (with split efficacy) – reference to previous notification 2023/0516/CZ
Act No 65/2017 on the protection of health against the harmful effects of addictive substances – reference to previous notification 2023/0019/CZ
Act No 40/2009, the Criminal Code
Act No 167/1998 on addictive substances and on amendments to certain other acts – reference to previous notification 2023/0230/CZ
Act No 132/2010 on on-demand audiovisual media services and on amendments to certain acts
Act No 258/2000 on the protection of public health and on amendments to certain related acts (within divided effectiveness) – reference to previous notification 2023/0516/CZ
Act No 146/2002 on the State Agricultural and Food Inspectorate and on amendments to certain related acts
Act No 40/1995 on the State Agricultural and Food Inspectorate and on amendments to certain related acts – reference to previous notification 2023/0436/CZ
Act No 634/2004 on administrative fees (with split efficacy) – reference to previous notification 2020/0341/CZ
Act No 231/2001 on operation of radio and television broadcasting and on amendments to other acts
Act No 242/2022 on video-sharing platform services and on amendments to certain related acts (Video-sharing Platform Services Act)
10. References to basic texts: 2020/0341/CZ, 2023/0230/CZ,2023/0516/CZ,2023/0019/CZ,2023/0436/CZ
The basic texts were forwarded within an earlier notification:
2020/0341/CZ
2023/0230/CZ
2023/0516/CZ
2023/0019/CZ
2023/0436/CZ
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects: No
SPS aspects: No
**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
