Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance methyl 2-{[1-(5-fluoropentyl)-1H-indazole-3-carbonyl]amino}-3,3-dimethylbutanoate (5F-MDMB-PINACA) 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) 766 final 2017/0346 (NLE)  Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance methyl 2-{[1-(5-fluoropentyl)-1H-indazole-3-carbonyl]amino}-3,3-dimethylbutanoate (5F-MDMB-PINACA) 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  methyl  2-{[1-(5-
fluoropentyl)-1H-indazole-3-carbonyl]amino}-3,3-dimethylbutanoate  (5F-MDMB-PINACA, 
5F-ADB)  the  involvement  of  organised  crime  and  the  possible  consequences  of  control 
measures introduced on this substance. 

The  risks  of  5F-MDMB-PINACA  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: 

 

 

5F-MDMB-PINACA  is  a  synthetic  cannabinoid.  It  shows  similar  effects  to  THC, 
which  is  responsible  for  the  major  psychoactive  effects  of  cannabis,  but  with 
additional  life-threatening  toxicity.  The  high  potency  of  5F-MDMB-PINACA  and 
the large and variable content of the substance in smoking mixtures constitute a high 
risk of poisoning. 

5F-MDMB-PINACA  has  been  available  in  the  European  Union  since  at  least 
September  2014  and  has  been  detected  in  25  Member  States.  28  deaths  associated 
with 5F-MDMB-PINACA have been reported by two Member States. In at least 20 
deaths 5F-MDMB-PINACA 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  5F-MDMB-PINACA  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 5F-MDMB-PINACA to control measures and criminal penalties as 

1 

OJ L 127, 20.5.2005, p. 32. 

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provided under their legislation by virtue of their obligations under the 1971 United Nations 
Convention on Psychotropic Substances. 

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2017/0346 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance methyl 2-{[1-(5-fluoropentyl)-1H-
indazole-3-carbonyl]amino}-3,3-dimethylbutanoate (5F-MDMB-PINACA) 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  2-{[1-(5-
fluoropentyl)-1H-indazole-3-carbonyl]amino}-3,3-dimethylbutanoate 
(5F-MDMB-
PINACA) 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. 

5F-MDMB-PINACA  is  a  synthetic  cannabinoid.  It  shows  similar  effects  to  THC, 
which  is  responsible  for  the  major  psychoactive  effects  of  cannabis,  but  with 
additional life-threatening toxicity. The high potency of 5F-MDMB-PINACA and the 
large and variable content of the substance in smoking mixtures constitute a high risk 
of poisoning.   

5F-MDMB-PINACA  has  been  available  in  the  Union  since  at  least  September  2014 
and  has  been  detected  in  25  Member  States.  Due  to  the  nature  of  5F-MDMB-
PINACA,  detections  are  likely  to  be  under-reported  since  the  substance  is  not 
routinely screened for. In most cases, the substance was seized as herbal/plant material 
and powder, but it was also seized, though to a lesser extent, as liquid, blotter and in 
other  unspecified  physical  forms.  More  than  1770  seizures  of  herbal  material  have 
been made within the European Union.  

28  deaths  associated  with  5F-MDMB-PINACA  have  been  reported  by  two  Member 
States. In at least 20 deaths 5F-MDMB-PINACA was the cause of death or is likely to 
have contributed to the death. In addition, 35 acute non-fatal intoxications associated 
with 5F-MDMB-PINACA were reported by two Member States. Due to the nature of 
5F-MDMB-PINACA,  both  non-fatal  intoxications  and  deaths  are  likely  to  be  under-
detected and under-reported. 

2 
3 

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

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(5) 

(6) 

(7) 

(8) 

(9) 

There  is  no  specific  information  on  the  involvement  of  organised  crime  in  the 
manufacture, distribution (trafficking) and supply of  5F-MDMB-PINACA within the 
Union.  The  available  data  suggest  5F-MDMB-PINACA  is  produced  by  chemical 
companies in China.  

5F-MDMB-PINACA  is  typically  sold  in  small  and  wholesale  amounts  branded  as 
"legal-high" smoking mixtures and as powder in head shops as well as on the internet 
as  "legal"  replacements  for  cannabis.  It  may  also  be  sold  directly  on  the  illicit  drug 
market. Because these products rarely state the ingredients, most users will be unaware 
that  they  are  using  synthetic  cannabinoids  in  general  and  5F-MDMB-PINACA  in 
particular.  

5F-MDMB-PINACA has no recognised human or veterinary medical use in the Union 
nor, it appears, elsewhere. There are no indications that 5F-MDMB-PINACA may be 
used  for  any  other  purpose  aside  from  as  an  analytical  reference  standard  and  in 
scientific research. 

The risk assessment report reveals  that many of  the questions related to  5F-MDMB-
PINACA 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  provides  sufficient  ground  for  subjecting  5F-MDMB-PINACA  to  control 
measures across the Union. 

5F-MDMB-PINACA  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 submit the substance to 
control measures. 

(10)  Given that 14 Member States control 5F-MDMB-PINACA under national drug control 
legislation  and  four  Member  States  control  5F-MDMB-PINACA  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 
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 5F-MDMB-PINACA 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, 

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HAS ADOPTED THIS DECISION:  

Article 1 

new 

psychoactive 

The 
2-{[1-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino}-3,3-dimethylbutanoate  (5F-MDMB-PINACA)  shall  be  subjected to  control 
measures across the Union. 

substance  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  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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