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HomeReport on the risk assessment of N,N-diethyl-2- 4-(1-methylethoxy)phenylmethyl-5-nitro-1Hbenzimidazole- 1-ethanamine (isotonitazene) in accordance with Article 5c of Regulation (EC) No 1920/2006 (as amended)
Report on the risk assessment of N,N-diethyl-2- 4-(1-methylethoxy)phenylmethyl-5-nitro-1Hbenzimidazole- 1-ethanamine (isotonitazene) in accordance with Article 5c of Regulation (EC) No 1920/2006 (as amended)
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New psychoactive substances can cause serious cross-border threats to health. In Europe, Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast) (as amended) (hereafter the ‘Regulation’) and Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking sets up a three-step legal framework of early warning, risk assessment and control measures that allows the EU to rapidly detect, assess and respond to the public health and social risks caused by new psychoactive substances. The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is responsible for the first two steps in this system, namely operating the EU Early Warning System on new psychoactive substances (EU EWS) in close cooperation with Europol, and conducting risk assessments. The European Commission is responsible for proposing control measures. Thus, the legal framework allows the institutions of the EU and the Member States to act on all new psychoactive substances (NPS) that appear on the European drug market. In accordance with Article 5a of the Regulation, N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5- nitro-1H-benzimidazole-1-ethanamine (commonly known as isotonitazene) was formally notified as an NPS by the EMCDDA on behalf of Belgium on 26 August 2019. The notification was based on the identification of the substance in a collected sample of powder that was a test purchase from a private online vendor and which was received on 1 July 2019 (1). Based on the information reported to the EU EWS, and, in accordance with Article 5a of the Regulation, on 20 February 2020, the EMCDDA assessed the existing information on isotonitazene. The EMCDDA concluded that the assessment gave rise to concerns that isotonitazene may pose health or social risks at EU level, and, consequently, determined that an initial report should be produced in accordance with Article 5b of the Regulation. The initial report was submitted to the Commission and Member States on 3 April 2020. Based on the findings of the initial report, on 17 April 2020, the Commission requested that the EMCDDA carry out a risk assessment on isotonitazene in accordance with Article 5c of the Regulation. This risk assessment report presents the summary findings and the conclusion of the risk assessment carried out by the Scientific Committee of the EMCDDA on isotonitazene. The report is intended for policymakers and decision-makers in the institutions of the EU.
- Published:
- Corporate author(s): European Monitoring Centre for Drugs and Drug Addiction (EU body or agency)
- Themes: Social problems , Public health
- Subject: drug addiction , European Monitoring Centre for Drugs and Drug Addiction , European Parliament , health control , health risk , narcotic , psychotropic substance , regulation (EU) , risk management , scientific report
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| ISSN 1725-4493 | ISBN 978-92-9497-495-2 | DOI 10.2810/107576 | Catalogue number TD-AK-20-001-EN-N |
- Released on EU Publications:
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