Message 001
Communication from the Commission - TRIS/(2024) 0387
Directive (EU) 2015/1535
Notification: 2024/0075/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: 20240387.EN
1. MSG 001 IND 2024 0075 DE EN 13-02-2024 DE NOTIF
2. Germany
3A. Bundesministerium für Wirtschaft und Klimaschutz, Referat EB3
3B. Bundesministerium für Gesundheit, Referat 122, 53107 Bonn
4. 2024/0075/DE - C00C - CHEMICALS
5. Fifth Ordinance amending the Annex to the New Psychoactive Substances Act
6. The Annex to the New Psychoactive Substances Act is adapted to the current state of knowledge by extending the seven substance groups to record further new psychoactive substances. The Annex is being recast.
7.
8. Article 1 of the Regulation contains a recasting of the Annex to the New Psychoactive Substances Act (NpSG) on the basis of the authorisation in § 7 of the NpSG. The Regulation amends the NpSG. The seven groups of substances are thereby updated in order to effectively reduce the hazardous abuse of emerging psychoactive substances.
9. Scientific findings are available on the new psychoactive substances. These findings include pharmacological-clinical data on the mode of action and toxicity as well as data on the extent of misuse and the associated direct or indirect risk to health. In order to limit the spread and dangerous abuse, it is necessary to add further psychoactive substances to the existing seven groups of substances in the NpSG Annex, due to the mode of action, the extent of abuse and the associated health risk. The extension concerns the substance groups of cannabimimetics/synthetic cannabinoids, benzodiazepines and the substance group of the compounds derived from tryptamine.
The consumption and supply of new psychoactive substances [NPS] has spread rapidly in Germany (as in other EU Member States) in the past few years, particularly among young people. Furthermore, consumers are insufficiently or not at all informed about the ingredients of the products offered on the drug market and their health risks, as the unscrupulous manufacturers and distributors usually do not declare the ingredients of their NPS products.
The updating of the groups of substances in the NpSG Annex is urgently needed because of the extent of misuse and the immediate threat to health.
Following consultation with national experts who have endorsed the amendments proposed by the German Federal Government, the NpSG is therefore recast on the basis of the national authorisation provision in § 7 of the NpSG.
10. Reference to the basic texts: The basic texts were submitted as part of an earlier notification:
2023/0091/D
11. Yes
12. In the view of the Federal Government, the significant and incalculable health risks associated with the new substances as well as the extent of misuse make it imperative and urgently necessary to supplement the groups of substances. The availability of these substances has risen sharply within short periods, among other things, due to the ease of availability of corresponding products. The substances have thus far been freely available, mainly in online shops for adults and also for young people. Since most of these substances have not been scientifically described before, findings on the effects of a new substance are often generated for the first time through consumption for intoxication purposes, whereby severe consequences, including deaths, have repeatedly been repeatedly reported. Seizures by law enforcement authorities as well as the increase in need for treatment indicate a high market presence. Due to only minor structural chemical changes, the new substances are no longer subject to the national prohibition rules. The new substances come close to the imputed substances in their effect and are declared as alternative products. At the same time, by not providing further information about the type/quantity of the new psychoactive substances contained in their products, they mislead about their health-related hazards.
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