Explanatory Memorandum to COM(2017)756 - Subjecting the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl)propanamide (4-fluoroisobutyrylfentanyl) to control measures - Main contents
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| dossier | COM(2017)756 - Subjecting the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl)propanamide ... |
|---|---|
| source | COM(2017)756  |
| date | 18-12-2017 |
1. CONTEXT OF THE PROPOSAL
Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of new psychoactive substances 1 provides for a three-step procedure that may lead to the submission of a new psychoactive substance to control measures across the Union.
On 4 July 2017, a joint report of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and Europol drawn up in accordance with Article 5 of Council Decision 2005/387/JHA was issued. On 15 September 2017, following the request made by the Commission and seven Member States and pursuant to Article 6(1) of the above-mentioned Council Decision, the Council requested an assessment of the risks caused by the use, manufacture and trafficking of the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide (4-fluoroisobutyrylfentanyl) the involvement of organised crime and the possible consequences of control measures introduced on this substance.
The risks of 4-fluoroisobutyrylfentanyl were assessed by the Scientific Committee of the EMCDDA, acting in compliance with the provisions of Article 6(2), (3) and i of the Council Decision. The risk assessment report was submitted to the Commission and to the Council on 14 November 2017. The main results of the risk assessment are the following:
·4-fluoroisobutyrylfentanyl is a synthetic opioid and is structurally related to fentanyl, an internationally controlled substance. It is also structurally related to acetylfentanyl, acryloylfentanyl 2 and furanylfentanyl 3 .
·4-fluoroisobutyrylfentanyl has been available in the European Union since at least August 2016 and has been seized in four Member States. 16 deaths have been reported by one Member State where exposure to 4-fluoroisobutyrylfentanyl was confirmed. In at least 13 deaths 4-fluoroisobutyrylfentanyl was the cause of death or is likely to have contributed to the death.
Pursuant to Article 8(1) of Council Decision 2005/387/JHA, within six weeks from the date of receipt of the risk assessment report, the Commission shall present to the Council either an initiative to subject the new psychoactive substances to control measures across the Union, or a report explaining its views on why such an initiative is not deemed necessary. According to the judgment of the Court of Justice of 16 April 2015 in Joined Cases C-317/13 and C-679/13, the European Parliament must be consulted before an act based on Article 8(1) of Council Decision 2005/387/JHA is adopted.
Based on the findings of the risk assessment report, the Commission considers that there are grounds for subjecting this substance to control measures across the Union. According to the risk assessment report, the acute toxicity of 4-fluoroisobutyrylfentanyl is such that it can cause severe harms to the health of individuals.
2. OBJECTIVE OF THE PROPOSAL
The objective of this proposal for a Council Implementing Decision is to call upon the Member States to subject 4-fluoroisobutyrylfentanyl to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol.