(1)

A risk assessment report on the new psychoactive substance N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1-ethanamine (isotonitazene) was drawn up in compliance with Article 5c of Regulation (EC) No 1920/2006 of the European Parliament and of the Council (2) by the Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA; the Centre), extended following the procedure laid down in Article 5c(4) of the same Regulation, on 26 May 2020. The Centre submitted the risk assessment report to the Commission and to the Member States on 29 May 2020.

(2)

Isotonitazene is a synthetic opioid analgesic and is closely related to etonitazene and clonitazene, both of which are under international control under the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol.

(3)

Isotonitazene has been available in the Union since at least April 2019 and has been detected in five Member States as well as in the United Kingdom. 24 seizures in total were reported by four Member States; in addition, one Member State reported a collected sample and the United Kingdom reported post-mortem biological samples. Isotonitazene in general is likely to be under-detected since the substance is not routinely screened for due to its novelty on the market. In most cases, the substance was seized as powder, but it was also identified in liquid form. The detected quantities are relatively small. However, they should be seen within the context of the high potency of isotonitazene.

(4)

Two deaths have been reported so far by Germany and the United Kingdom where isotonitazene was involved. The deaths occurred in 2019. No detailed information is available for the death case in Germany. In the case reported by the United Kingdom, several other substances were identified in the postmortem biological samples (3). No acute intoxications with confirmed exposure to isotonitazene were reported so far. It is likely that naloxone works as an antidote to poisoning caused by isotonitazene as for other synthetic opioids. Both intoxications and deaths are likely to be under-detected and under-reported as they are not routinely screened for and as the substance appeared very recently on the Union market.

(5)

There is no direct evidence showing the involvement of organised crime in the manufacture, distribution (trafficking) and supply of isotonitazene within the Union. The available information suggests that isotonitazene is produced by chemical companies based outside the Union.

(6)

Isotonitazene appears to be sold online in small and wholesale amounts, mainly as a powder; it is also sold as ready to-use nasal sprays. Information from seizures suggests that isotonitazene may have also been sold on the illicit opioid market. Due to this, users may not be aware that they are using isotonitazene.

(7)

Isotonitazene has no recognised human or veterinary medical use in the Union nor, it appears, elsewhere. There are no indications that the substance may be used for any other purpose aside from as an analytical reference standard and in scientific research.

(8)

The risk assessment report reveals that many of the questions related to isotonitazene that are posed by the lack of data on the risks to individual health, risks to public health and social risks could be answered through further research. There is no specific information on the social risks posed by isotonitazene. However, the available evidence and information on the health risks that the substance poses, given also that the substance is relatively unknown, provides sufficient ground for including isotonitazene in the definition of ‘drug’.

(9)

Isotonitazene is not listed for control under the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or under the 1971 United Nations Convention on Psychotropic Substances. Isotonitazene is not currently under assessment by the United Nations system.

(10)

Given that four Member States control isotonitazene under national drug control legislation and one Member State as well as the United Kingdom and Norway control isotonitazene under other legislation, including this substance in the definition of ‘drug’ and thereby covering it by provisions on the criminal offences and sanctions as defined in Framework Decision 2004/757 would help avoid the emergence of obstacles in cross-border law enforcement and judicial cooperation, and would help protect from the risks that its availability and use can pose.

(11)

Article 1a of Framework Decision 2004/757/JHA confers the power to adopt delegated acts upon the Commission with a view to giving a quick and expertise-based response at Union level to the emergence of new psychoactive substances detected and reported by the Member States, by amending the Annex to that Framework Decision to include those substances in the definition of ‘drug’.

(12)

The available information would suggest that the consumption of isotonitazene causes harm to health associated with its acute toxicity and abuse liability or dependence producing potential. This harm to health is considered life-threatening. In addition, there is a potential for severe physical and mental impairment and a significant spread of diseases, including the transmission of blood-borne viruses. These effects, including dependence, are comparable to other opioid analgesics that are under international control.

(13)

As the conditions and procedure for triggering the exercise of the powers to adopt a delegated act have been met, a delegated directive should be adopted in order to include isotonitazene in the Annex to Framework Decision 2004/757/JHA and, as a consequence thereof, subject that substance to the Union criminal law provisions on illicit drug trafficking.

(14)

Ireland is bound by Framework Decision 2004/757/JHA, as amended by Directive (EU) 2017/2103 of the European Parliament and of the Council (4), and is therefore taking part in the adoption and application of this Decision.

(15)

Denmark is bound by Framework Decision 2004/757/JHA as applicable until 21 November 2018, but is not bound by Directive (EU) 2017/2103. It is therefore not taking part in the adoption and application of this Directive and is not bound by it or subject to its application.

(16)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (5), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(17)

Framework Decision 2004/757/JHA should therefore be amended accordingly,

‘17.

N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1-ethanamine (isotonitazene). (*1)