Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (CUMYL-4CN-BINACA) 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) 764 final 2017/0344 (NLE)  Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (CUMYL-4CN-BINACA) 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  1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-carboxamide  (CUMYL-4CN-BINACA),  the  involvement 
of  organised  crime  and  the  possible  consequences  of  control  measures  introduced  on  this 
substance. 

The  risks  of  CUMYL-4CN-BINACA  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: 

 

 

CUMYL-4CN-BINACA 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 CUMYL-4CN-BINACA and 
the large and variable content of the substance in smoking mixtures constitute a high 
risk of poisoning. 

CUMYL-4CN-BINACA  has  been  available  in  the  European  Union  since  at  least 
October  2015  and  has  been  detected  in  eleven  Member  States.  Eleven  deaths 
associated with CUMYL-4CN-BINACA have been reported by two Member States. 
In at least five deaths CUMYL-4CN-BINACA 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 CUMYL-4CN-BINACA 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 CUMYL-4CN-BINACA to control measures and criminal penalties 

1 

OJ L 127, 20.5.2005, p. 32. 

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

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2017/0344 (NLE) 

Proposal for a 

COUNCIL IMPLEMENTING DECISION 

on subjecting the new psychoactive substance 1-(4-cyanobutyl)-N-(2-phenylpropan-2-
yl)-1H-indazole-3-carboxamide (CUMYL-4CN-BINACA) 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  1-(4-cyanobutyl)-N-(2-
(CUMYL-4CN-BINACA)  was 
phenylpropan-2-yl)-1H-indazole-3-carboxamide 
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. 

CUMYL-4CN-BINACA 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 CUMYL-4CN-BINACA and 
the large and variable content of the substance in smoking mixtures constitute a high 
risk of poisoning.   

CUMYL-4CN-BINACA has been available in the Union since at least October 2015 
and has been detected in eleven Member States. Due to the nature of  CUMYL-4CN-
BINACA,  detections  are  likely  to  be  under-reported  since  the  substance  is  not 
routinely  screened  for.  In  most  cases,  the  substance  was  seized  as  powder  or  herbal 
material, but it was also seized, though to a lesser extent, in other physical forms (e.g. 
as blotter). More than 270 seizures have been made within the Union.  

Eleven  deaths  associated  with  CUMYL-4CN-BINACA  have  been  reported  by  two 
Member States. In at least five deaths CUMYL-4CN-BINACA was the cause of death 
or  is  likely  to  have  contributed  to  the  death.  In  addition,  five  acute  non-fatal 
intoxications associated with CUMYL-4CN-BINACA were reported by two Member 
States. Due to the nature of CUMYL-4CN-BINACA, 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  CUMYL-4CN-BINACA  within 
the  Union.  The  available  data  suggest  that  CUMYL-4CN-BINACA  is  produced  by 
chemical companies in China. 

CUMYL-4CN-BINACA 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  CUMYL-4CN-BINACA in 
particular.  

CUMYL-4CN-BINACA  has  no  recognised  human  or  veterinary  medical  use  in  the 
Union  nor,  it  appears,  elsewhere.  There  are  no  indications  that  CUMYL-4CN-
BINACA  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  CUMYL-
4CN-BINACA 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 CUMYL-4CN-BINACA to 
control measures across the Union. 

CUMYL-4CN-BINACA 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  not  currently  under  assessment  by  the 
United Nations system. 

(10)  Given  that  nine  Member  States  control  CUMYL-4CN-BINACA  under  national  drug 
control  legislation  and  five  Member  States  control  CUMYL-4CN-BINACA  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 CUMYL-4CN-BINACA 
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 

The  new  psychoactive  substance  1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-
carboxamide  (CUMYL-4CN-BINACA)  shall  be  subjected  to  control  measures  across  the 
Union. 

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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