Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]oxolane-2-carboxamide (tetrahydrofuranylfentanyl; THF-F) 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) 759 final 2017/0342 (NLE)  Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]oxolane-2-carboxamide (tetrahydrofuranylfentanyl; THF-F) 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-phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]oxolane-2-carboxamide  (tetrahydrofuranylfentanyl;  THF-F),  the 
involvement  of  organised  crime  and  the  possible  consequences  of  control  measures 
introduced on this substance. 

The  risks  of  tetrahydrofuranylfentanyl  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: 

 

 

Tetrahydrofuranylfentanyl is a synthetic opioid and is structurally related to fentanyl, 
an 
the  saturated  derivative  of 
furanylfentanyl2.  

internationally  controlled  substance. 

is 

It 

Tetrahydrofuranylfentanyl  has  been  available  in  the  European  Union  since  at  least 
September  2016  and  has  been  seized  in  one  Member  State.  14  deaths  have  been 
reported  by  one  Member  State  where  exposure  to  tetrahydrofuranylfentanyl  was 
confirmed. In at least 12 deaths tetrahydrofuranylfentanyl 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 tetrahydrofuranylfentanyl 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  tetrahydrofuranylfentanyl  to  control  measures  and  criminal 

1 
2 

OJ L 127, 20.5.2005, p. 32. 
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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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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2017/0342 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance N-phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide (tetrahydrofuranylfentanyl; THF-F) 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  substances3,  and  in  particular  Article  8(3) 
thereof, 

Having regard to the proposal from the European Commission, 
Having regard to the opinion of the European Parliament4,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

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A  risk  assessment  report  on  the  new  psychoactive  substance  N-phenyl-N-[1-(2-
(tetrahydrofuranylfentanyl; 
phenylethyl)piperidin-4-yl]oxolane-2-carboxamide 
THF-F) 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. 

Tetrahydrofuranylfentanyl 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  the  saturated  derivative  of 
furanylfentanyl5. 

Tetrahydrofuranylfentanyl  has  been  available  in  the  Union  since  at  least  September 
2016 and has been seized in one Member State who reported 53 seizures taking place 
in 2016 and the first half of 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 liquid, but it was also seized, to a lesser extent, in powder form. The detected 
quantities are relatively small. However, they should be seen within the context of the 
high potency that is typical of the fentanils. 

14  deaths  have  been  reported  by  one  Member  State  where  exposure 
to 
tetrahydrofuranylfentanyl was confirmed. In many of the cases, other drugs were also 
detected  with 
deaths 
tetrahydrofuranylfentanyl was the cause of death or is likely to have contributed to the 
intoxication  associated  with 
death. 

In  addition,  a  single  acute  non-fatal 

tetrahydrofuranylfentanyl. 

twelve 

least 

In 

at 

OJ L 127, 20.5.2005, p. 32. 
OJ C , , p. . 
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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tetrahydrofuranylfentanyl  was  reported  by  the  same  Member  State.  It  is  likely  that 
naloxone works as an antidote to poisoning caused by tetrahydrofuranylfentanyl. Both 
non-fatal  intoxications  and  deaths  are  likely  to  be  under-detected and  under-reported 
as 
to 
screened 
tetrahydrofuranylfentanyl 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.    

for.  Accidental 

routinely 

exposure 

they 

not 

are 

There  is  no  information  on  the  involvement  of  organised  crime  in  the  manufacture, 
distribution  (trafficking)  and  supply  of  tetrahydrofuranylfentanyl  within  the  Union. 
The  available  data  suggest  that  tetrahydrofuranylfentanyl  is  produced  by  chemical 
companies in China, but the capability to manufacture fentanils may also exist within 
the Union. 

Tetrahydrofuranylfentanyl is sold online (on the surface web) in small and wholesale 
amounts, under the guise of a "research chemical" or as "legal" replacement to illicit 
opioids,  typically  as  a  liquid  (e.g.  in  ready-to-use  nasal  sprays)  or  as  powder. 
Information from seizures suggests that tetrahydrofuranylfentanyl may have also been 
sold  on  the  illicit  opioid  market.  Tetrahydrofuranylfentanyl  is  sometimes  sold  as 
heroin  or  mixed  with  heroin  or  is  used  to  make  counterfeits  of  highly  sought-after 
analgesics  and  benzodiazepines.  Due  to  this,  users  may  not  be  aware  that  they  are 
using a fentanyl. 

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

indications 

appears, 

nor, 

are 

no 

it 

that  many  of 

The  risk  assessment  report  reveals 
to 
tetrahydrofuranylfentanyl 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  and 
furanylfentanyl, provides sufficient ground for subjecting tetrahydrofuranylfentanyl to 
control measures across the Union. 

the  questions  related 

Tetrahydrofuranylfentanyl  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  was  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 five Member States  control  tetrahydrofuranylfentanyl  under national drug 
control  legislation  and  five  Member  States  control  tetrahydrofuranylfentanyl  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 tetrahydrofuranylfentanyl 
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:  

The  new  psychoactive  substance  N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]oxolane-2-
carboxamide  (tetrahydrofuranylfentanyl;  THF-F)  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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