Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide (furanylfentanyl) to control measures
Date: 2017-07-05
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, 5.7.2017  COM(2017) 367 final 2017/0152 (NLE)   Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide (furanylfentanyl) 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  23  January  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 28 February 2017, following the request made by the 
Commission  and  9  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  furanylfentanyl,  the 
involvement  of  organised  crime  and  the  possible  consequences  of  control  measures 
introduced on this substance. 

The  risks  of  furanylfentanyl  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 May 2017. The main results of the risk assessment are 
the following: 

 

 

Furanylfentanyl  is  a  synthetic  opioid,  closely  related  to  fentanyl  which  is 
internationally controlled. 

Furanylfentanyl  has  been  available  in  the  European  Union  since  at least  June  2015 
and  has  been  detected 
in  16  Member  States.  23  deaths  associated  with 
furanylfentanyl  have  been  reported  by  5  Member  States.  In  at  least  10  deaths 
furanylfentanyl 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  furanylfentanyl  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  furanylfentanyl  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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2017/0152 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]furan-2-carboxamide (furanylfentanyl) to control measures  

THE COUNCIL OF THE EUROPEAN UNION, 

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

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

Having regard to the proposal of the European Commission, 
Having regard to the opinion of the European Parliament3,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

A  risk  assessment  report  on  the  new  psychoactive  substance  N-phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]furan-2-carboxamide  (furanylfentanyl)  was  drawn  up  in 
compliance  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 May 2017. 

Furanylfentanyl  is  a  synthetic  opioid  and  is  structurally  similar  to  fentanyl,  a 
controlled  substance  widely  used  in  medicine  for  general  anaesthesia  during  surgery 
and for pain management. Furanylfentanyl is also structurally related to acetylfentanyl 
and  acryloylfentanyl,  which  were  both  the  subject  of  an  EMCDDA–Europol  Joint 
Report in December 2015 and December 2016. 

Furanylfentanyl has been available in the Union since at least June 2015 and has been 
detected in 16 Member States. In most cases it was seized in powder form, but also in 
liquid form and as tablets. The detected quantities are relatively small. However, they 
should be taken in the context of the potency of the substance. 

23 deaths associated with furanylfentanyl have been reported by five Member States. 
In  at  least  ten  deaths  furanylfentanyl  was  the  cause  of  death  or  is  likely  to  have 
contributed to the death. In addition, 11 acute non-fatal intoxications associated with 
furanylfentanyl were reported by three Member States. 

There  is  no  information  suggesting  the  involvement  of  organised  crime  in  the 
manufacture, distribution (trafficking) and supply of furanylfentanyl within the Union. 
The  available  data  suggest  that  furanylfentanyl  is  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) 

Furanylfentanyl  is  sold  online  in  small  and  wholesale  amounts  as  a  "research 
chemical",  typically  as  a  powder  and  as  ready-to-use  nasal  sprays.  Information  from 
seizures  suggests  that  furanylfentanyl  may  have  also  been  sold  on  the  illicit  opioid 
market. 

Furanylfentanyl  has  no  recognised  human  or  veterinary  medical  use  in  the  Union. 
There are no indications that furanylfentanyl may be used for any other purpose aside 
from as an analytical reference standard and in scientific research. 

that  many  of 

to 
The  risk  assessment  report  reveals 
furanylfentanyl  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. 
However, the available evidence and information on the health and social risks that the 
substance  poses,  given  also  its  similarities  with  fentanyl,  provides  sufficient  ground 
for subjecting furanylfentanyl to control measures across the Union. 

the  questions  related 

Furanylfentanyl  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. 

(10)  Given  that  ten  Member  States  control  furanylfentanyl  under  national  drug  control 
legislation  and  three  Member  State  control  furanylfentanyl  under  other  legislation, 
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 furanylfentanyl 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 
taking  part  in  the  adoption  and  application  of  this  Decision,  which  implements 
Decision 2005/387/JHA, and is not bound by it or subject to its application, 

HAS ADOPTED THIS DECISION:  

The  new  psychoactive  substance  N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]furan-2-
carboxamide (furanylfentanyl) shall be subjected to control measures across the Union. 

Article 1 

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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 enter into force on the day following that of its publication in the Official 
Journal of the European Union. 

Article 3 

This Decision shall apply in accordance with the Treaties. 

Done at Brussels, 

For the Council 
The President 

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