Council implementation decision to control acryloylfentanyl

Acryloylfentanyl to be placed under control across the EU

This week, the EU has reacted to serious concerns over the use of the synthetic opioid acryloylfentanyl by deciding to subject it to ‘control measures’ throughout the Union (1). The implementing decision of the Council of the EU (2) was adopted in the final stage of the three-step legal procedure designed to respond to potentially threatening new psychoactive substances (NPS) available on the market (3)(4). The substance in question has been raising health concerns in Europe after harmful effects related to its use were reported by the Member States through the EU Early Warning System (EWS), which is implemented by the EMCDDA and Europol.

The decision is based on the findings of a formal risk assessment of the drug, conducted by the extended EMCDDA Scientific Committee on 22 February 2017, with participation of additional experts from the EU Member States, European Commission, Europol and the European Medicines Agency. The risk assessment report assessed the health and social risks of the drug, as well as international trafficking and the involvement of organised crime (5). It concluded that the high potency of the substance constitutes a serious risk of acute toxicity through respiratory depression.

Acryloylfentanyl is structurally related to fentanyl, which is a controlled substance widely used in medicine as an adjunct to general anaesthesia during surgery and for pain management. Clinical experience suggests that naloxone works as an antidote to poisoning caused by acryloylfentanyl.

Available in the EU since at least April 2016, acryloylfentanyl is sold as a ‘research chemical’, and has been seized in tablet, capsule and liquid form, including ready-to-use nasal sprays. At the time of the risk assessment (February 2017), it had been detected in six EU Member States, with 47 deaths associated with the substance reported by three EU countries.

Today, the decision on subjecting this substance to control measures has been published in the Official Journal of the European Union. Member States will have one year to introduce the controls into national legislation.


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