Proposal for a COUNCIL DECISION on subjecting the new psychoactive substance methyl 2-[[1-(cyclohexylmethyl)-1H-indole-3-carbonyl]amino]-3,3-dimethylbutanoate (MDMB-CHMICA) to control measures
Date: 2016-08-31
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, toxicology

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   EUROPEAN COMMISSION  Brussels, 31.8.2016  COM(2016) 548 final 2016/0262 (NLE)   Proposal for a COUNCIL DECISION on subjecting the new psychoactive substance methyl 2-[[1-(cyclohexylmethyl)-1H-indole-3-carbonyl]amino]-3,3-dimethylbutanoate (MDMB-CHMICA) 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  15  April  2016,  a  joint  report  of  the  European  Monitoring  Centre  for  Drugs  and  Drug 
Addition  (EMCDDA)  and  Europol  drawn  up  in  accordance  with  Article  5  of  Council 
Decision  2005/387/JHA  was  issued.  On  26  May  2016,  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  MDMB-CHMICA,  the 
involvement  of  organised  crime  and  the  possible  consequences  of  control  measures 
introduced on this substance. 

The risks of MDMB-CHMICA 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  Chair  of  the  Scientific  Committee  submitted  the  risk  assessment  report  to  the 
Commission and to the Council on 28 July 2016. The main results of the risk assessment are 
the following: 

 

 

MDMB-CHMICA  is  classed  as  a  synthetic  cannabinoid  receptor  agonist,  a 
chemically  diverse  group  of  substances  also  referred  to  as  synthetic  cannabinoids. 
The substance has been available on the drug market in the European Union since at 
least August 2014 and has been detected in 23 Member States. 

The  high  potency  of  MDMB-CHMICA  and  the  highly  variable  amounts  of  the 
compound  in  "legal  high"  products  constitute  a  high  risk  of  acute  toxicity.  Eight 
Member  States  have  reported  a  total  of  28  deaths  and  25  acute  intoxications 
associated with MDMB-CHMICA.  

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  judgement  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 MDMB-CHMICA is such that it can cause severe 
harms  to  the  health  of  individuals.  Multiple  reports  have  also  indicated  a  possibility  for 
violence and aggression as a consequence of its use. 

2. 

OBJECTIVE OF THE PROPOSAL  

The  objective  of  this  proposal  for  a  Council  Decision  is  to  call  upon  the  Member  States  to 
subject MDMB-CHMICA to control measures and criminal penalties as provided under their 

1 

OJ L 127, 20.5.2005, p. 32. 

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

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2016/0262 (NLE) 

Proposal for a 

COUNCIL DECISION 

on subjecting the new psychoactive substance methyl 2-[[1-(cyclohexylmethyl)-1H-
indole-3-carbonyl]amino]-3,3-dimethylbutanoate (MDMB-CHMICA) 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 of the European Commission, 
Having regard to the opinion of the European Parliament3,  

Acting in accordance with a special legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

A risk assessment report on the new psychoactive substance MDMB-CHMICA was 
drawn  up  in  compliance  with  Article  6  of  Council  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 28 July 2016. 

receptor 

cannabinoid 

MDMB-CHMICA  is  classed  as  a  synthetic  cannabinoid  receptor  agonist,  a 
chemically  diverse  group  of  substances  also  referred  to  as  synthetic  cannabinoids. 
Synthetic 
to  
agonists 
Δ9-tetrahydrocannabinol  (THC),  the  major  psychoactive  principle  of  cannabis. 
Cannabinoid receptor agonists controlled under the 1971 United Nations Convention 
on  Psychotropic  Substances  are:  the  major  active  principle  of  cannabis,  delta-9-
tetrahydocannabinol  (Δ9-THC)  and  two  synthetic  cannabinoids,  naphtalen-1-yl(1-
pentyl-1H-indol-3-yl)methanone  (JWH-018)  and  1-(5-fluoropentyl)-1H-indol-3-yl]-
(naphthalen-1-yl)-methanone (AM-2201). 

functionally 

similar 

are 

The  high  potency  of  MDMB-CHMICA  and  the  highly  variable  amounts  of  the 
compound in "legal high" products constitute a high risk of acute toxicity. 

MDMB-CHMICA has been available on the drugs market in the Union since at least 
August  2014  and  has  been  detected  in  23  Member  States.  It  is  sold  typically  as 
commercial branded "legal high" products in head shops, as well as on the Internet as 
a  "legal"  replacement  for  cannabis.  The  available  information  suggests  that  bulk 
powders of MDMB-CHMICA are produced by chemical companies based in China. 
They are imported into the Union where they are either processed and packaged into 

2 
3 

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

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(5) 

(6) 

(7) 

(8) 

(9) 

commercial smoking mixtures or sold as powder. There is no information indicating 
production of MDMB-CHMICA within the Union. 

MDMB-CHMICA  is  typically  administered  by  smoking  a  herbal  mixture  that  is 
either from a ready-to-use commercial "legal high" product, or, less commonly, that 
is  self-prepared.  In  commercial  products  it  is  usually  not  stated  if  the  product 
contains  MDMB-CHMICA  or  any  other  synthetic  cannabinoid  receptor  agonist. 
Therefore,  many  individuals  exposed  to  MDMB-CHMICA  might  be  unaware  that 
they are using the substance. In addition, these consumers might be unaware of the 
dose  they  are  consuming.  The  manufacturing  process  can  also  lead  to  an  uneven 
distribution  of  the  substance  within  the  plant  material  with  the  result  that  some 
products  contain  regions  where  cannabinoid  is  highly  concentrated,  increasing  the 
risk of acute toxicity and outbreak of mass poisonings.  

The  available  data  suggests  that  MDMB-CHMICA  is  used  by  cannabis  users, 
"psychonauts" and by those who are regularly subjected to drug testing procedures, 
including those in prison.  

While there is no specific information on the possible effects of MDMB-CHIMICA 
on  the  direct  social  environment  or  on  society  as  a  whole,  multiple  reports  have 
indicated  a  possibility  for  violence  and  aggression  as  a  consequence  of  its  use.  In 
addition,  the  detection  of  MDMB-CHMICA  in  cases  of  suspected  driving  under 
influence indicated a potential for wider risk to public safety. 

Eight  Member  States  have  reported  a  total  of  28  deaths  and  25  acute  intoxications 
associated  with  MDMB-CHMICA.  If  MDMB-CHMICA  were  to  become  more 
widely available and used, the implications for individual and public health could be 
significant. 

There is limited information to suggest the potential involvement of organised crime 
in the manufacture, distribution, trafficking and supply of MDMB-CHMICA within 
the Union. 

(10)  MDMB-CHMICA  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. However, it is listed among the substances considered for 
review  at  the  38th  WHO  Expert  Committee  on  Drug  Dependence  (ECDD)  which 
makes recommendations to the United Nations Commission of Narcotic Drugs on the 
control measures that it considers appropriate. 

(11)  MDMB-CHMICA has no established or acknowledged human or veterinary medical 
use.  Apart  from  its  use  in  analytical  reference  materials  and  in  scientific  research 
investigating its chemistry, pharmacology and toxicology as a result of its emergence 
on the drug market, there is no indication that it is being used for other purposes. 

(12) 

(13) 

The risk assessment report reveals that there is limited scientific evidence available 
on  MDMB-CHMICA  and  points  out  that  further  research  would  be  needed. 
However, the available evidence and information on the health and social risks that 
the  substance  poses  provides  sufficient  ground  for  subjecting  MDMB-CHMICA  to 
control measures across the Union. 

Given  that  ten  Member  States  control  MDMB-CHMICA  under  national  legislation 
complying  with  the  obligations  of  the  1971  United  Nations  Convention  on 
Psychotropic Substances and that five Member States use other legislative measures 
to  control  it,  subjecting  this  substance  to  control  measures  across  the  Union  would 
help avoid the emergence of obstacles in cross-border law enforcement and judicial 

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cooperation,  and  would  help  protect  from  the  risks  that  its  availability  and  use  can 
pose. 

(14) 

The  United  Kingdom  is  not  bound  by  Decision  2005/387/JHA  and  is  therefore  not 
taking  part  in  the  adoption  of  this  Decision,  which  implements  Decision 
2005/387/JHA, and is not bound by it or subject to its application 

HAS ADOPTED THIS DECISION:  

Article 1 

new 

psychoactive 

The 
2-[[1-(cyclohexylmethyl)-1H-indole-3-
carbonyl]amino]-3,3-dimethylbutanoate  (MDMB-CHMICA)  shall  be  subjected  to  control 
measures across the Union. 

substance  methyl 

Article 2 

As soon as possible, but no later than by [one year from the date this Decision is published] 
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,  complying  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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