Explanatory Memorandum to COM(2018)253 - Subjecting the new psychoactive substances cyclopropylfentanyl and methoxyacetylfentanyl to control measures

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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 19 December 2017, two joint reports 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 were issued. On 29 January 2018, following the request made by the Commission and eight 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 substances N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]cyclopropanecarboxamide (cyclopropylfentanyl) and 2-methoxy-N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide (methoxyacetylfentanyl), the involvement of organised crime and the possible consequences of control measures introduced on this substance.

The risks of cyclopropylfentanyl and methoxyacetylfentanyl 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 reports were submitted to the Commission and to the Council on 23 March 2018. The main results of the risk assessment are the following:

Cyclopropylfentanyl

·Cyclopropylfentanyl is a synthetic opioid and is structurally related to fentanyl, an internationally controlled substance. Cyclopropylfentanyl is also structurally related to butyrfentanyl, another internationally controlled substance.

·Cyclopropylfentanyl has been available in the European Union since at least June 2017 and has been detected in six Member States. 77 deaths have been reported by two Member States between June and December 2017 where exposure to cyclopropylfentanyl was confirmed. In at least 74 deaths cyclopropylfentanyl was the cause of death or is likely to have contributed to the death.

Methoxyacetylfentanyl

·Methoxyacetylfentanyl is a synthetic opioid and is structurally related to fentanyl, an internationally controlled substance. Methoxyacetylfentanyl is also structurally related to ocfentanil and acetylfentanyl, which are both internationally controlled substances.

·Methoxyacetylfentanyl has been available in the European Union since at least November 2016 and has been detected in eleven Member States between June and December 2017. 13 deaths have been reported by four Member State where exposure to methoxyacetylfentanyl was confirmed. In at least seven deaths methoxyacetylfentanyl 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 reports, 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 reports, the Commission considers that there are grounds for subjecting these substances to control measures across the Union. According to the risk assessment reports, the acute toxicity of cyclopropylfentanyl and methoxyacetylfentanyl are 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 cyclopropylfentanyl and methoxyacetylfentanyl 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.