Message 001
Communication from the Commission - TRIS/(2024) 2787
Directive (EU) 2015/1535
Notification: 2024/0569/DE
Notification of a draft text from a Member State
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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: 20242787.EN
1. MSG 001 IND 2024 0569 DE EN 11-10-2024 DE NOTIF
2. Germany
3A. Bundesministerium für Wirtschaft und Klimaschutz, Referat EB3
3B. Bundesministerium für Gesundheit, Referat 122
4. 2024/0569/DE - C00C - CHEMICALS
5. Twenty-fourth Ordinance amending the Annexes to the Narcotic Drugs Act
6. The Federal Republic of Germany intends to place four new psychoactive substances under the Narcotic Drugs Act (Betäubungsmittelgesetz, BtMG). Butonitazene, dipentylone, 2-fluorodeschloroketamine and bromazolam are to be included in Annex II to the BtMG.
7.
8. The emergence and spread of ever new chemical variants of psychoactive substances pose a threat to public health. The purpose of the draft Ordinance is to transpose into national law the decisions made at the 67th session of the United Nations Commission on Narcotic Drugs held on 19 March 2024.
At the 67th session of the United Nations Commission on Narcotic Drugs, it was decided to include butonitazene in Schedule I of the 1961 Single Convention on Narcotic Drugs. In addition, 3-CMC, dipentylone and 2-fluorodeschloroketamine were included in Schedule II of the 1971 Convention on Psychotropic Substances, and bromazolam was included in Schedule IV of the Convention on Psychotropic Substances.
On the basis of § 1(4) of the BtMG, the aim of this Ordinance is to include four of these new psychoactive substances (NPS), which do not yet fall under the BtMG, in Annex II to the BtMG. 3-CMC already falls under the BtMG and therefore does not need to be considered in this Ordinance.
The effects of the four substances being added are similar to those of other substances listed in the annexes to the 1961 United Nations Single Convention and the 1971 United Nations Convention on Psychotropic Substances. Consumption of these four NPSes may result in severe intoxication, including hospitalisation. Cases of fatal intoxication have been recorded in connection with the intake of bromazolam, butonitazene and 2-fluorodeschloroketamine.
The consumption and supply of NPSs has recently spread significantly in Germany – especially among young people. Furthermore, consumers lack adequate information or even any information at all on the ingredients of the products offered and the health risks they pose, as manufacturers and distributors typically do not declare the ingredients. Placing the four substances under the Narcotic Drugs Act is therefore urgently needed because of the immediate danger to health.
9. Inclusion of the aforementioned NPSs is urgently needed because the consumption of these substances, particularly owing to the ease with which corresponding products can be obtained, over the internet for example, has risen very sharply in a short period of time.
Bromazolam, a benzodiazepine, has no known therapeutic benefit and is not authorised as a medicinal product. There is sufficient evidence to indicate that bromazolam is or is probably being misused and that the substance could pose a public health and social problem. Member States have reported acute poisoning following exposure to bromazolam. A total of 15 deaths have been reported following confirmed exposure to bromazolam.
Butonitazene, a synthetic opioid, is chemically/structurally and pharmacologically similar to substances in Schedule I of the 1961 Single Convention on Narcotic Drugs, such as etonitazene and isotonitazene, has no therapeutic benefit and is not authorised as a medicinal product. There is sufficient evidence to indicate that butonitazene is or is probably being misused and that the substance could pose a public health and social problem. The synthetic opioid is associated with serious adverse consequences, including one death.
Dipentylone, a synthetic stimulant of the cathinone family, has a similar chemical structure and pharmacological effect to other synthetic cathinones in Schedule II of the Convention on Psychotropic Substances. Dipentylone has not yet been reviewed by the ECDD. Dipentylone has no known therapeutic benefit and is not authorised. There is sufficient evidence to indicate that dipentylone is or is probably being misused and that the substance could pose a public health and social problem, therefore justifying international controls. There are no reports on any authorisation for medical use.
2-fluorodeschloroketamine (2-FDCK) is an arylcyclohexylamine. 2-FDCK has no known therapeutic benefit and is not authorised. There is sufficient evidence to indicate that 2-FDCK is or is probably being misused and that the substance could pose a public health and social problem. 2-FDCK is currently being closely monitored by the EUDA. Two deaths have been reported following confirmed exposure to 2-FDCK. In addition, a total of eleven cases of acute poisoning have been reported following confirmed exposure and another acute poisoning following suspected exposure to 2-FDCK.
10. Reference to the basic texts: The basic texts were submitted as part of an earlier notification:
2023/0199/D
11. Yes
12. In the view of the Federal Government, the extension of the Narcotic Drugs Act is urgent so as to protect the health of the population and individuals and to protect against the dangers arising from these substances, and so as to combat the further spread of the other psychoactive substances covered by the Ordinance. The availability of these substances has increased sharply in a short period of time owing, among other things, to the ease with which corresponding products can be obtained.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
