Report on the risk assessment of N,N-diethyl-2- [[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1Hbenzimidazole- 1-ethanamine (isotonitazene) in accordance with Article 5c of Regulation (EC) No 1920/2006 (as amended)

This publication presents the data and findings of the risk assessment on N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1- ethanamine (isotonitazene), carried out by the extended Scientific Committee of the EMCDDA on 26 May 2020. On the basis of the Risk Assessment Report, on 2 September 2020, the Commission decided that isotonitazene should be included in the definition of ‘drug’, in the Annex to Framework Decision 2004/757/JHA. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Commission Delegated Directive (EU) 2020/1687 by 3 June 2021.