Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl)propanamide (4-fluoroisobutyrylfentanyl) to control measures
Date: 2017-12-18
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, 18.12.2017  COM(2017) 756 final 2017/0339 (NLE)  Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-yl)propanamide (4-fluoroisobutyrylfentanyl) 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  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 
the 
involvement  of  organised  crime  and  the  possible  consequences  of  control  measures 
introduced on this substance. 

(4-fluoroisobutyrylfentanyl) 

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  (4)  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 
to 
acetylfentanyl, acryloylfentanyl2 and furanylfentanyl3. 

internationally  controlled  substance. 

is  also  structurally 

related 

It 

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. 

1 
2 

3 

OJ L 127, 20.5.2005, p. 32. 
Acryloylfentanyl  has  been  subjected  to  control  measures  by  Council  Implementing  Decision  (EU) 
2017/1774  of  25  September  2017  on  subjecting  N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide 
(acryloylfentanyl) to control measures, OJ L 251, 29.9.2017, p. 21. 
Furanylfentanyl  has  been  subjected  to  control  measures  by  Council  Implementing  Decision  (EU) 
2017/2170  of  15  November  2017  on  subjecting  N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]furan-2-
carboxamide (furanylfentanyl) to control measures, OJ L 306, 22.11.2017, p. 19. 

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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. 

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2017/0339 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-
phenylethyl)piperidin-4-yl)propanamide (4-fluoroisobutyrylfentanyl) 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  substances4,  and  in  particular  Article  8(3) 
thereof, 

Having regard to the proposal from the European Commission, 
Having regard to the opinion of the European Parliament5,  

Whereas: 

(1) 

(2) 

(3) 

A  risk  assessment  report  on  the  new  psychoactive  substance  N-(4-fluorophenyl)-2-
methyl-N-[1-(2-phenylethyl)piperidin-4-yl)propanamide 
(4-fluoroisobutyrylfentanyl) 
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 14 November 2017. 

4-fluoroisobutyrylfentanyl is a synthetic opioid and is structurally related to fentanyl, a 
controlled  substance  widely  used  in  medicine  as  an  adjunct  to  general  anaesthesia 
during  surgery  and  for  pain  management.  It  is  also  structurally  related  to 
acetylfentanyl, acryloylfentanyl6 and furanylfentanyl7. 

4-fluoroisobutyrylfentanyl has been available in the Union since at least August 2016 
and  has  been  seized  in  four  Member  States  who  reported  24  seizures  in  total. 
Detections  in  general  are  likely  to  be  under-reported  since  the  substance  is  not 
routinely screened for. In most cases, the substance was seized as powder, but it was 
also seized, to a smaller extent, in liquid form and as tablets. The detected quantities 
are  relatively  small.  However,  they  should  be  seen  within  the  context  of  the  high 
potency that is typical of the fentanils. 

(4) 

16  deaths  have  been  reported  by  one  Member  State  where  exposure  to  4-
fluoroisobutyrylfentanyl  was confirmed. In  many of the cases,  other  drugs were  also 

4 
5 
6 

7 

OJ L 127, 20.5.2005, p. 32. 
OJ C , , p. . 
Council  Implementing  Decision  (EU)  2017/1774  of  25  September  2017  on  subjecting  N-(1-
phenethylpiperidin-4-yl)-N-phenylacrylamide  (acryloylfentanyl)  to  control  measures,  OJ  L  251, 
29.9.2017, p. 21. 
Council Implementing Decision (EU) 2017/2170 of 15 November 2017 on subjecting N-phenyl-N-[1-
(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide  (furanylfentanyl)  to  control  measures,  OJ  L  306, 
22.11.2017, p. 19. 

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at 

In 

least 

4-fluoroisobutyrylfentanyl. 

detected  with 
4-
fluoroisobutyrylfentanyl was the cause of death or is likely to have contributed to the 
death.  No  acute  intoxications  with  confirmed  exposure  to  4-fluoroisobutyrylfentanyl 
were reported. It is likely that naloxone works as an antidote to poisoning caused by 4-
fluoroisobutyrylfentanyl.  Both  non-fatal  intoxications  and  deaths  are  likely  to  be 
under-detected  and  under-reported  as  they  are  not  routinely  screened  for.  Accidental 
exposure  to  4-fluoroisobutyrylfentanyl  may  pose  a  risk  to  law  enforcement, 
emergency personnel, medical and forensic laboratory personnel, as well as to those in 
custodial settings and postal services.    

deaths 

13 

(5) 

(6) 

(7) 

(8) 

(9) 

There  is  no  information  on  the  involvement  of  organised  crime  in  the  manufacture, 
distribution  (trafficking)  and  supply  of  4-fluoroisobutyrylfentanyl  within  the  Union. 
However, given the fact that it has been detected in heroin samples the involvement of 
organised  crime  cannot  be  excluded.  The  available  information  suggests  that  4-
fluoroisobutyrylfentanyl  is  produced  by  chemical  companies  in  China,  but  the 
capability to manufacture fentanils may also exist within the Union. 

4-fluoroisobutyrylfentanyl appears to be sold online in small and wholesale amounts, 
under the guise of a "research chemical" or as a "legal" replacement to illicit opioids, 
as  powder,  liquid  (e.g.  in  ready-to-use  nasal  spray)  and  blotter.  Information  from 
seizures suggests that 4-fluoroisobutyrylfentanyl may have also been sold on the illicit 
opioid market, where it is sold as heroin or was found in mixtures with other opioids 
such as heroin and furanylfentanyl, or is used to make counterfeits of highly sought-
after analgesics and benzodiazepine. Due to this, users may not be aware that they are 
using a fentanyl. 

4-fluoroisobutyrylfentanyl  has no recognised human or veterinary medical use in the 
Union  nor, 
that  4-
fluoroisobutyrylfentanyl may be used for any other purpose aside from as an analytical 
reference standard and in scientific research. 

elsewhere.  There  are  no 

it  appears, 

indications 

The  risk  assessment  report  reveals  that  many  of  the  questions  related  to  4-
fluoroisobutyrylfentanyl  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, acryloylfentanyl 
4-
sufficient 
provides 
and 
fluoroisobutyrylfentanyl to control measures across the Union. 

furanylfentanyl, 

subjecting 

ground 

for 

4-fluoroisobutyrylfentanyl  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  currently  under  assessment  by  the 
United Nations system and has been reviewed at the 39th meeting of the WHO Expert 
Committee  on  Drug  Dependence  (ECDD)  held  from  6  to  10  November  2017  in 
Geneva. This does not preclude the Union taking a decision to subject the substance to 
control measures. 

(10)  Given  that  seven  Member  States  control  4-fluoroisobutyrylfentanyl  under  national 
drug  control  legislation  and  five  Member  States  control  4-fluoroisobutyrylfentanyl 
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. 

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(11)  Decision 2005/387/JHA confers implementing powers upon the Council 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 
4-
should 
implementing 
fluoroisobutyrylfentanyl to control measures across the Union. 

decision 

adopted 

subject 

order 

be 

in 

to 

(12)  Denmark  is  bound  by  Decision  2005/387/JHA  and  is  therefore  taking  part  in  the 

adoption and application of this Decision. 

(13) 

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

(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 and is not bound by it or 
subject to its application, 

HAS ADOPTED THIS DECISION:  

The new psychoactive substance N-(4-fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-
4-yl)propanamide  (4-fluoroisobutyrylfentanyl)  shall  be  subjected  to  control  measures  across 
the Union. 

Article 1 

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,  in  compliance  with  their  obligations  under  the  1961 
United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol. 

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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