Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting 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) to control measures
Date: 2018-04-30
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, narcotic

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   EUROPEAN COMMISSION  Brussels, 30.4.2018  COM(2018) 253 final 2018/0118 (NLE)  Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting 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) 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  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, 
the  new  psychoactive  substances  N-phenyl-N-[1-(2-
manufacture  and 
phenylethyl)piperidin-4-yl]cyclopropanecarboxamide  (cyclopropylfentanyl)  and  2-methoxy-
N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide 
the 
involvement  of  organised  crime  and  the  possible  consequences  of  control  measures 
introduced on this substance. 

(methoxyacetylfentanyl), 

trafficking  of 

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 
(4) 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 
deaths 
confirmed. 
methoxyacetylfentanyl was the cause of death or is likely to have contributed to the 
death.   

seven 

least 

In 

at 

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 

1 

OJ L 127, 20.5.2005, p. 32. 

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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 
and 
acute 
methoxyacetylfentanyl are such that it can cause severe harms to the health of individuals. 

cyclopropylfentanyl 

toxicity  of 

assessment 

reports, 

risk 

the 

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. 

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2018/0118 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting 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) 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) 

2 
3 
4 

Risk  assessment  reports  on  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)  were  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) on 21 March 
2018, and were subsequently submitted to the Commission and to the Council on 23 
March 2018. 

Cyclopropylfentanyl  and  methoxyacetylfentanyl  are  synthetic  opioids  and  are 
structurally related to fentanyl, a controlled substance widely used in medicine as an 
adjunct 
for  pain  management. 
to  butyrfentanyl,  another 
Cyclopropylfentanyl 
internationally controlled substance. Methoxyacetylfentanyl is also structurally related 
to ocfentanil4 and acetylfentanyl, which are both internationally controlled substances.  

to  general  anaesthesia  during  surgery  and 

structurally 

is  also 

related 

Cyclopropylfentanyl has been available in the Union since at least June 2017 and has 
been detected in six Member States who reported 140 seizures in total between June 
2017 and January 2018. 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 lesser extent, as liquids and in 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. 

OJ L 127, 20.5.2005, p. 32. 
OJ C …, xx.xx.2018, p. xx. 
Ocfentanil  was  scheduled  in  Schedule  I  of  the  United  Nations  (UN)  Single  Convention  on  Narcotic 
Drugs  of  1961  as  amended  by  the  1972  Protocol  (the  'Convention  on  Narcotic  Drugs')    at  the  61st 
session of the Commission on Narcotic Drugs in March 2018. 

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(4) 

(5) 

(6) 

two  Member  States  where  exposure 

77  deaths  have  been  reported  by 
to 
cyclopropylfentanyl  was  confirmed.  The  deaths  occurred  within  a  short  time  period, 
i.e.  between  June  and  December  2017.  In  most  of  the  cases,  other  drugs  were  also 
detected  with  cyclopropylfentanyl.  In  at  least  74  deaths  cyclopropylfentanyl  was  the 
cause of death or is likely to have contributed to the death. No acute intoxications with 
confirmed  exposure  to  cyclopropylfentanyl  were  reported.  It  is  likely  that  naloxone 
works  as  an  antidote  to  poisoning  caused  by  cyclopropylfentanyl.  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 cyclopropylfentanyl may pose a risk 
to family and friends of the user, law enforcement, emergency personnel, medical and 
forensic  laboratory  personnel,  as  well  as  to  those  in  custodial  settings  and  postal 
services. 

There  is  no  direct  evidence  showing  the  involvement  of  organised  crime  in  the 
manufacture,  distribution  (trafficking)  and  supply  of  cyclopropylfentanyl  within  the 
Union.  However,  given  the  fact  that  it  has  been  detected  in  a  heroin  sample  and  in 
falsified  medicines,  the  involvement  of  organised  crime  cannot  be  excluded.  The 
available  information  suggests  that  cyclopropylfentanyl  is  produced  by  chemical 
companies based in China, but the capability to manufacture fentanils may also exist 
within the Union. 

Cyclopropylfentanyl appears to be sold online in small and wholesale amounts, under 
the guise of a "research chemical" or as "legal" replacement to illicit opioids, mainly 
as a powder or as a solution in ready-to-use nasal sprays. In addition, information from 
seizures  shows  that  cyclopropylfentanyl  has  also  been  used  to  make  falsified  (fake) 
tablets of popular benzodiazepine and analgesic medicines. Information from seizures 
suggests that cyclopropylfentanyl may have also been sold on the illicit opioid market 
as methoxyacetylfentanyl, as heroin and in mixtures with other opioids such as heroin. 
Due to this, users may not be aware that they are using a fentanil. 

(7)  Methoxyacetylfentanyl has been available in the Union since at least November 2016 
and  has  been  detected  in  eleven  Member  States  who  reported  44  seizures  in  total 
between  June  and  December  2017.  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 or liquid, but it was also seized, to a lesser extent, 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. 

(8) 

13  deaths  have  been  reported  by  four  Member  States  where  exposure 
to 
methoxyacetylfentanyl  was  confirmed.  In  all  cases,  other  drugs  were  also  detected 
with  methoxyacetylfentanyl.  In  at  least  seven  deaths  methoxyacetylfentanyl  was  the 
cause  of  death  or  is  likely  to  have  contributed  to  the  death.  Two  acute  intoxications 
with  confirmed  exposure  to  methoxyacetylfentanyl  were  reported.  It  is  likely  that 
naloxone  works  as  an  antidote  to  poisoning  caused  by  methoxyacetylfentanyl.  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 methoxyacetylfentanyl 
may pose a risk to family and friends of users, law enforcement, emergency personnel, 
medical and forensic laboratory personnel, as well as to those in custodial settings and 
postal services.    

(9) 

There  is  no  information  to  suggest  the  involvement  of  organised  crime  in  the 
manufacture, distribution (trafficking) and supply of methoxyacetylfentanyl within the 
Union. The available information suggests that methoxyacetylfentanyl is produced by 

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chemical  companies  in  China,  but  the  capability  to  manufacture  fentanils  may  also 
exist within the Union. 

(10)  Methoxyacetylfentanyl  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  or  as  a  solution  in  ready-to-use  nasal  sprays.  Information  from  seizures 
suggests  that  methoxyacetylfentanyl  may  have  also  been  sold  on  the  illicit  opioid 
market,  where  it  is  sold  as  or  is  used  to  make  counterfeits  of  opioid  analgesics  and 
benzodiazepine. Due to this, users may not be aware that they are using a fentanil. 

(11)  Cyclopropylfentanyl  and  methoxyacetylfentanyl  have  no  recognised  human  or 
veterinary  medical  use  in  the  Union  nor,  it  appears,  elsewhere.  There  are  no 
indications  that  the  substances  may  be  used  for  any  other  purpose  aside  from  as  an 
analytical reference standard and in scientific research. 

(12)  The  risk  assessment  reports  reveal 

that  many  of 

to 
cyclopropylfentanyl and methoxyacetylfentanyl 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 substances pose, given also their similarities with 
fentanyl,  provides  sufficient  ground 
for  subjecting  cyclopropylfentanyl  and 
methoxyacetylfentanyl to control measures across the Union. 

the  questions  related 

(13)  Cyclopropylfentanyl  and  methoxyacetylfentanyl  are  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  substances  are  not  currently 
under assessment by the United Nations system. 

(14)  Given that eight Member States control cyclopropylfentanyl and nine Member States 
control  methoxyacetylfentanyl  under  national  drug  control  legislation  and  five 
Member  States  control  cyclopropylfentanyl  and  methoxyacetylfentanyl,  respectively, 
under  other  legislation,  subjecting  these  substances  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 their availability 
and use can pose. 

(15)  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 
implementing decision should be adopted in order to subject cyclopropylfentanyl and 
methoxyacetylfentanyl to control measures across the Union. 

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

adoption and application of this Decision. 

(17) 

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

(18)  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, 

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HAS ADOPTED THIS DECISION:  

Article 1 

new 

psychoactive 

N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
The 
2-methoxy-N-phenyl-N-[1-(2-
yl]cyclopropanecarboxamide 
phenylethyl)piperidin-4-yl]acetamide  (methoxyacetylfentanyl)  shall  be  subjected  to  control 
measures across the Union. 

(cyclopropylfentanyl) 

substances 

and 

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 substances 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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