Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryloylfentanyl) to control measures
Date: 2017-04-06
Institutions: Directorate-General for Migration and Home Affairs, European Commission
Subjects: EU control, drug addiction, drug traffic, health control, health risk, judicial cooperation in criminal matters in the EU, toxicology, tranquiliser

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   EUROPEAN COMMISSION  Brussels, 6.4.2017  COM(2017) 161 final 2017/0073 (NLE)   Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryloylfentanyl) to control measures  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Council Decision 2005/387/JHA on the information exchange, risk-assessment and control of 
new  psychoactive  substances1  provides  for  a  three-step  procedure  that  may  lead  to  the 
submission of a new psychoactive substance to control measures across the Union. 

On 17 November 2016, a joint report of the European Monitoring Centre for Drugs and Drug 
Addition  (EMCDDA)  and  Europol  drawn  up  in  accordance  with  Article  5  of  Council 
Decision 2005/387/JHA was issued. On 23 January 2017, following the request made by the 
Commission  and  11  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  acryloylfentanyl,  the 
involvement  of  organised  crime  and  the  possible  consequences  of  control  measures 
introduced on this substance. 

The  risks  of  acryloylfentanyl  were  assessed  by  the  Scientific  Committee  of  the  EMCDDA, 
acting in compliance with the provisions of Article 6(2), (3) and (4) of the Council Decision. 
The  Chair  of  the  Scientific  Committee  submitted  the  risk  assessment  report  to  the 
Commission and to the Council on 24 February 2017. The main results of the risk assessment 
are the following: 

– 

– 

Acryloylfentanyl  is  a  synthetic  opioid.  It  is  structurally  similar  to  fentanyl,  a 
controlled substance. The substance has been available in the European Union since 
at least April 2016 and has been detected in 6 Member States.  

47 deaths associated with acryloylfentanyl have been reported by 3 Member States In 
at  least  40  deaths  acryloylfentanyl  was  the  cause  of  death  or  is  likely  to  have 
contributed  to  death.  In  addition,  more  than  20  acute  intoxications  suspected  to  be 
due to acryloylfentanyl have been reported 

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 acryloylfentanyl 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  acryloylfentanyl  to  control  measures  and  criminal  penalties  as 
provided under their legislation by virtue of their obligations under the 1971 United Nations 
Convention on Psychotropic Substances. 

1 

OJ L 127, 20.5.2005, p. 32. 

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2017/0073 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance N-(1-phenethylpiperidin-4-yl)-N-
phenylacrylamide (acryloylfentanyl) to control measures 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union,  

Having regard to Having regard to Council Decision 2005/387/JHA of 10 May 2005 on the 
information  exchange,  risk-assessment  and  control  of  new  psychoactive  substances2,  and  in 
particular Article 8(3)  thereof, 
Having regard to the opinion of the European Parliament3 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

A risk assessment report on the new psychoactive substance N-(1-phenethylpiperidin-
4-yl)-N-phenylacrylamide (acryloylfentanyl) was drawn up in accordance with Article 
6 of Decision 2005/387/JHA by a special session of the extended Scientific Committee 
of  the  European  Monitoring  Centre  for  Drugs  and  Drug  Addiction  (EMCDDA),  and 
was  subsequently  submitted  to  the  Commission  and  to  the  Council  on  24  February 
2017. 

Acryloylfentanyl is a synthetic opioid. It is structurally similar to fentanyl, a controlled 
substance widely used in medicine as an adjunct to general anaesthesia during surgery 
and for pain management. The available data suggest that acryloylfentanyl is a potent 
and long-lasting antinociceptive agent acting on the opioid system. 

Acryloylfentanyl has been available in the European Union since at least April 2016 
and has been detected in 6 Member States. In most cases it has been seized as a liquid, 
but other forms such as tablets, powders and a capsule have also been detected. The 
detected  quantities  are  relatively  small.  However,  they  should  be  considered  in  the 
context of the high potency of the substance. 

47 deaths associated with acryloylfentanyl have been reported by 3 Member States. In 
at  least  40  deaths  acryloylfentanyl  was  the  cause  of  death  or  is  likely  to  have 
contributed to death. In addition, more than 20 acute intoxications suspected to be due 
to acryloylfentanyl have been reported. 

There  is  no  information  to  suggest  the  involvement  of  organised  crime  in  the 
manufacture, distribution, trafficking and supply of acryloylfentanyl within the Union. 
The available data suggest that most of the acryloylfentanyl on the market in Europe 
has been produced by chemical companies based in China. 

2 
3 

OJ L 127, 20.5.2005, p. 32. 
OJ C , , p. . 

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(6) 

(7) 

(8) 

(9) 

Acryloylfentanyl is sold as "research chemical", typically as powder and as ready-to-
use nasal sprays, in small and wholesale amounts. Limited information from seizures 
suggests that acryloylfentanyl may have also been sold on the illicit opioid market. 

Acryloylfentanyl  is  not  listed  for  control  under  the  1961  United  Nations  Single 
Convention  on  Narcotic  Drugs  or  under  the  1971  United  Nations  Convention  on 
Psychotropic  Substances.  The  substance  is  not  currently  under  assessment  by  the 
United Nations system. 

Acryloylfentanyl  has  no  established  or  acknowledged  human  or  veterinary  medical 
use.  Apart  from  its  use  in  analytical  reference  materials  and  in  scientific  research 
investigating its chemistry, pharmacology and toxicology as a result of its emergence 
on the drug market, there is no indication that it is being used for other purposes. 

The risk assessment report reveals that there is limited scientific evidence available on 
acryloylfentanyl  and  points  out  that  further  research  would  be  needed.  However,  the 
available  evidence  and  information  on  the  health  and  social  risks  that  the  substance 
poses  provides  sufficient  ground  for  subjecting  acryloylfentanyl  to  control  measures 
across the Union. 

(10)  Given that only 9 Member States control acryloylfentanyl under national drug control 
legislation and 2 Member State use other legislative measures to control it, subjecting 
this substance to control measures across the Union 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)  Decision 2005/387/JHA confers upon the Council implementing powers 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  subjecting 
those  substances  to  control  measures  across  the  Union.  As  the  conditions  and 
procedure for triggering the exercise of such implementing powers have been met, an 
implementing  decision  should  be  adopted  in  order  to  subject  acryloylfentanyl  to 
control measures across the Union. 

(12)  Denmark  is  bound  by  Decision  2005/387/JHA  and  is  therefore  taking  part  in  the 
adoption and application of this Decision, which implements Decision 2005/387/JHA. 

(13) 

Ireland  is  bound  by  Decision  2005/387/JHA  and  is  therefore  taking  part  in  the 
adoption and application of this Decision, which implements Decision 2005/387/JHA. 

(14)  The  United  Kingdom  is  not  bound  by  Decision  2005/387/JHA  and  is  therefore  not 
implements  Decision 

taking  part 
2005/387/JHA, and is not bound by it or subject to its application, 

this  Decision,  which 

the  adoption  of 

in 

HAS ADOPTED THIS DECISION:  

Article 1 

The  new  psychoactive 
(acryloylfentanyl) shall be subjected to control measures across the Union. 

substance  N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide 

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Article 2 

By [one year from the date this Decision is published] at the latest Member States shall take 
the  necessary  measures,  in  accordance  with  their  national  law,  to  subject  the  new 
psychoactive substance referred to in Article 1 to control measures and criminal penalties, as 
provided for under their legislation, complying with their obligations under the 1971 United 
Nations Convention on Psychotropic Substances. 

This Decision shall apply in accordance with the Treaties. 

Done at Brussels, 

For the Council 
The President 

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