Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance methyl 1-(2-phenylethyl)-4-[phenyl(propanoyl)amino]piperidine-4-carboxylate (carfentanil) 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) 765 final 2017/0345 (NLE)  Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance methyl 1-(2-phenylethyl)-4-[phenyl(propanoyl)amino]piperidine-4-carboxylate (carfentanil) 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  27  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 13 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  methyl  1-(2-phenylethyl)-4-
[phenyl(propanoyl)amino]piperidine-4-carboxylate 
of 
organised  crime  and  the  possible  consequences  of  control  measures  introduced  on  this 
substance. 

(carfentanil), 

involvement 

the 

The risks of carfentanil 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: 

 

 

Carfentanil is a synthetic opioid and is closely related to fentanyl, an internationally 
controlled substance. Carfentanil is one of the most potent narcotic opioid analgesics. 

Carfentanil was formally notified to the EMCDDA in February 2013. 60 deaths with 
confirmed exposure to carfentanil have been reported by seven Member States. In at 
least six deaths carfentanil 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 carfentanil 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 carfentanil 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. 

1 

OJ L 127, 20.5.2005, p. 32. 

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2017/0345 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance methyl 1-(2-phenylethyl)-4-
[phenyl(propanoyl)amino]piperidine-4-carboxylate (carfentanil) 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 from the European Commission, 
Having regard to the opinion of the European Parliament3,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

A risk assessment report on the new psychoactive substance methyl 1-(2-phenylethyl)-
4-[phenyl(propanoyl)amino]piperidine-4-carboxylate  (carfentanil)  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. 

Carfentanil  is  a  synthetic  opioid  and  is  closely  related  to  fentanyl,  a  controlled 
substance widely used in medicine as an adjunct to general anaesthesia during surgery 
and  for  pain  management.  Carfentanil  is  one  of  the  most  potent  narcotic  opioid 
analgesics. 

Carfentanil was formally notified to the EMCDDA in February 2013 based on a first 
detection  in  December  2012.  In  the  past  two  years  there  has  been  an  increase  in  the 
availability  of  the  substance  as  well  as  seizures  by  law  enforcement.  Detections  in 
general  are  likely  to  be  under-reported  since  the  substance  is  not  routinely  screened 
for. More than 800 seizures were reported by seven Member States, more than a fourth 
of it in the first half of 2017. Typically, carfentanil was seized as a powder. In some 
cases it has also been seized as a liquid.  The detected quantities are relatively small. 
However, they should be seen within the context of the high potency that is typical of 
the fentanils. 

60 deaths with confirmed exposure to carfentanil, occurring between November 2016 
and  June  2017,  have  been  reported  by  seven  Member  States.  Many  of  the  deaths 
involved  high-risk  drug  users,  including  heroin  injectors.  Other  drugs,  including 
morphine and other fentanils, were also detected in many of the cases.  In at least six 
deaths carfentanil was the cause of death or is likely to have contributed to the death; 
in  many  of  the  remaining  cases  the  investigation  into  death  is  ongoing.  In  addition, 

2 
3 

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

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three  acute  non-fatal  intoxications  associated  with  carfentanil  were  reported  by  two 
Member States. It is likely that naloxone works as an antidote to poisoning caused by 
carfentanil. 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 
carfentanil  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. 

There  is  limited  information  on  the  involvement  of  organised  crime  or  established 
criminal groups in the manufacture, distribution (trafficking) and supply of carfentanil. 
In this respect, one Member State reported that almost all trafficking and distribution 
of  fentanils,  including  carfentanil,  are  linked  with  organised  crime  groups  in  that 
Member  State.  The  available  data  suggest  that  carfentanil  is  produced  by  chemical 
companies  in  China/Hong  Kong.  Data  also  demonstrate  that  the  capability  to 
manufacture fentanils may also exist within the Union. 

Carfentanil  is  sold  online,  both  on  the  surface  web  and  on  the  darknet,  in  small  and 
wholesale  amounts  as  a  drug  in  its  own  right,  but  also  as  "research  chemical", 
"pharmaceutical intermediate" and/or "legal" replacement to illicit opioids, typically as 
a powder. Information from reported seizures and deaths show that carfentanil is being 
mixed with  heroin,  fentanyl and other fentanils, sold  on the illicit opioid  market and 
injected by opioid users, including heroin injectors. It is highly unlikely that users are 
aware that they are using carfentanil. 

Carfentanil  is  authorised  as  a  veterinary  medicine  in  the  United  States  for  the 
immobilisation of large animals. It is possible that the substance may have limited use 
in  veterinary  medicine  in  the  Union  based  on  a  medicinal  product  that  is  prepared 
extemporaneously  in  accordance  with  national  legislation.  A  radiolabelled  form  of 
carfentanil  is  widely  used  in  scientific  research.  Carfentanil  is  also  used  as  an 
analytical reference standard and in scientific research. 

The risk assessment report reveals that many of the questions related to carfentanil 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 carfentanil 
to control measures across the Union. 

Carfentanil 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. 

(5) 

(6) 

(7) 

(8) 

(9) 

(10)  Given  that  twelve  Member  States  control  carfentanil  under  national  drug  control 
legislation  and  four  Member  States  control  carfentanil  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 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 

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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  carfentanil  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.  

(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:  

Article 1 

new 

The 
1-(2-phenylethyl)-4-
substance 
[phenyl(propanoyl)amino]piperidine-4-carboxylate  (carfentanil)  shall  be  subjected  to  control 
measures across the Union. 

psychoactive 

methyl 

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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