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HomeReport on the risk assessment of a new psychoactive substance: methyl 2-{1-(4-fluorobutyl)-1H-indole-3-carbonylamino}-3,3-dimethylbutanoate (4F-MDMB-BICA) in accordance with Article 5c of Regulation (EC) No 1920/2006 (as amended)
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This publication presents the data and findings of the risk assessment on 4F-MDMB-BICA (methyl 2-{[1-(4-fluorobutyl)-1H-indole-3-carbonyl]amino}-3,3-dimethylbutanoate), carried out by the extended Scientific Committee of the EMCDDA on 7 December 2020. The Risk Assessment Report, which was submitted to the European Commission on 9 December 2020, examines the health and social risks of the drug, information on international trafficking and the involvement of organised crime, as well as a consideration of the potential implications of subjecting the drug to control measures. On the basis of the Risk Assessment Report, the Commission adopted delegated act in order to add 4F-MDMB-BICA in to the definition of a drug in the Annex of the Council Framework Decision 2004/757/JHA (as amended by Directive (EU) 2017/2103). This decision was adopted in the final stage of the three-step process — early warning, risk assessment and control of new psychoactive substances — established by Regulation (EC) 1920/2006 (as amended) and Council Framework Decision 2004/757/JHA (as amended). Regulation (EC) 1920/2006 (as amended) and Council Framework Decision 2004/757/JHA (as amended) allow the EU institutions and Member States to act on all new and potentially threatening narcotic and psychotropic drugs which appear on the European drug scene, with the EMCDDA and Europol, in collaboration with their respective networks playing a central role in the early detection of such substances as well as the harms caused by their use — information that underpins risk assessment, and, ultimately, decision-making. In this respect we would like to acknowledge the essential role played by the respective networks in the Member States — the Reitox national focal points — in collecting and providing national data. We would also like to acknowledge the role of Europol and Europol National Units, the European Medicines Agency (EMA) and the national competent authorities responsible for medicinal products, the European Chemicals Agency (ECHA), the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) that provided valuable input to the report, thus guaranteeing its truly multidisciplinary nature. Finally, we would like to thank all the participants in the risk assessment process for the high quality of work carried out. This procedure occurred under challenging circumstances, amidst the coronavirus (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The resulting report is a valuable contribution at European level, and provides clear support to political decision-making.
- Published:
- Corporate author(s): European Monitoring Centre for Drugs and Drug Addiction (EU body or agency)
- Themes: Public health , Social problems
- 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 978-92-9497-701-4 | DOI 10.2810/398973 | Catalogue number TD-AK-22-001-EN-N |
- Released on EU Publications:
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