Proposal for a COUNCIL DECISION on submitting 4-methylamphetamine to control measures
Date: 2013-01-31
Institutions: European Commission
Subjects: criminal court, drug traffic, new product, police checks, psychotropic substance

EUROPEAN 
COMMISSION 

Brussels, 31.1.2013  
COM(2013) 39 final 

2013/0021 (NLE) 

Proposal for a 

COUNCIL DECISION 

on submitting 4-methylamphetamine to control measures 

EN 

   EN 

 
 
 
  
 
EXPLANATORY MEMORANDUM 
The  Council  Decision  2005/387/JHA1  on  the  information  exchange,  risk-assessment  and 
control of new psychoactive substances provides for a three-step procedure that may lead to 
submission of a new psychoactive substance to control measures in the Union. 

On 24 September 2012 and pursuant to Article 6 of the above-mentioned Council Decision, 
the  Council  formally  requested  a  risk  assessment  on  the  psychoactive  substance  4-
methylamphetamine, to be carried out by the extended Scientific Committee of the European 
Monitoring Centre for Drugs and Drug Addiction (EMCDDA).  

The main results of the risk assessment are the following: 

(1) 

(2) 

(3) 

4-methylamphetamine  is  a  synthetic  ring-methylated  derivative  of  the  controlled 
substance amphetamine which provokes physical effects that can be compared to those 
produced by other stimulant substances such as amphetamine.  

Acute health problems and adverse effects related to the use of 4-methylamphetamine 
can  occur  and  have  been  documented.  The  patterns  of  use  appear  to  follow  those 
associated with amphetamine.  

Between 2010 and 2012, 21 fatalities in four Member States have been reported where 
4-methylamphetamine  alone  or  in  combination  with  other  substances  has  been 
detected  in  post-mortem  samples.  In  some  cases  4-methylamphetamine  was  the 
predominant drug detected. 

(4) 

4-methylamphetamine  has  no  known,  established  or  acknowledged  medical  value  or 
use. However, it is used as an analytical reference standard and in scientific research. 

Pursuant to Article 8(1) of the Council Decision, within six weeks from the date on which it 
receives the Risk Assessment Report, the Commission shall either present to the Council an 
initiative  to  have  the  new  psychoactive  substance  subjected  to  control  measures,  or  shall 
present a report justifying why it deems it not necessary to present such an initiative.  

Although  the  scientific  evidence  concerning  the  overall  risks  and  patterns  of  use  of  4-
methylamphetamine is still limited at this stage, there are grounds for subjecting the substance 
to control across the Union. The main reason is that, according to the available information 
from the Risk Assessment Report, the substance poses risks to health, as highlighted above. 
These  risks  are  heightened  by  the  fact  that  4-methylamphetamine  is  often  sold  as 
amphetamine  or  in  combination  with  amphetamine  or  other  substances,  and  that  most  users 
are unaware that they are consuming this specific substance.  

Furthermore,  taking  into  account  that  organised  crime  appears  to  be  involved  in  the 
manufacture, trafficking and supply of 4-methylamphetamine and given the similarity of this 
substance  with  amphetamine,  the  possibility  that  4-methylamphetamine  develops  as  an 
alternative to amphetamine further justifies subjecting the substance to control measures.  

The objective of this proposal for a Council Decision is to call upon Member States to submit 
4-methylamphetamine  to  control  measures  and  criminal  penalties  as  provided  under  their 
legislation  by  virtue  of  their  obligations  under  the  1971  United  Nations  Convention  on 
Psychotropic Substances.  

1 

OJ L 127, 20.5.2005, p. 32. 

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2013/0021 (NLE) 

Proposal for a 

COUNCIL DECISION 

on submitting 4-methylamphetamine to control measures 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union,  

Having regard to the Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, 
risk-assessment and control of new psychoactive substances2, and in particular Article 8 (3) thereof,  

Having regard to the initiative of the Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

A Risk Assessment Report on 4-methylamphetamine was drawn up on the basis of 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,  and  was  subsequently  received 
by the Commission on 29 November 2012.  

4-methylamphetamine  is  a  synthetic  ring-methylated  derivative  of  amphetamine  which  has 
predominantly been seized in powder and paste form in samples containing amphetamine and 
caffeine, but which has also appeared in tablet and liquid form.  It has emerged on the illicit 
amphetamine market where it is sold and used as amphetamine. There has been one report of 
the substance being detected in a commercial product sold on the internet. The main chemical 
precursor  for  the  synthesis  of  4-methylamphetamine  is  4-methylbenzyl  methyl  ketone  (4-
methyl-BMK),  which  appears  to  be  commercially  available  on  the  internet  and  is  not 
controlled under the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs 
and Psychotropic Substances. 

4-methylamphetamine's specific physical effects have been rarely reported by users as they are 
typically  unaware  that  they  have  taken  the  substance.  However,  the  few  reports  that  are 
available  suggest  that  it  has  stimulant-type  effects.  Limited  available  data  related  to  humans 
suggest that the adverse effects of 4-methylamphetamine include hyperthermia, hypertension, 
anorexia,  nausea,  perspiration,  gastric  distress,  coughing,  vomiting,  headache,  palpitations, 
insomnia,  paranoia,  anxiety  and  depression.  Current  data  is  not  sufficient  to  determine  the 
relative dependence-producing potential of this substance. 

The acute toxicity of 4-methylamphetamine is similar to that of other stimulants, according to 
the  limited  data  sources  available.  Certain  evidence  suggests  that  in  combination  with  other 
substances,  including  amphetamine  and  caffeine,  there  may  be  a  higher  risk  of  overall 
enhanced toxicity.  

There  have  been  a  total  of  21  fatalities  registered  in  four  Member  States  where  4-
methylamphetamine  alone  or  in  combination  with  one  or  more  substances,  especially 
amphetamine, has been detected in post-mortem samples. While it is not possible to determine 

2 

OJ L 127, 20.5.2005, p. 32. 

EN 

3 

   EN 

                                                 
with  certainty  the  role  of  4-methylamphetamine  in  these  fatalities  from  the  available 
information,  in  some  cases  the  substance  was  the  predominant  drug  detected,  with  levels 
comparable  to  those  found  in  certain  cases  of  death  caused  by  the  consumption  of 
amphetamine.  

4-methylamphetamine  has  been  detected  in  15 Member  States,  while  one  Member  State  has 
reported  the  manufacture  of  the  substance  on  its  territory.  Prevalence  specific  to  4-
methylamphetamine  is  difficult  to  estimate.  There  is  no  information  on  specific  demand  for 
the substance from user groups. It is not commercially marketed through internet shops. 

The available information suggests that it is produced and distributed by the same organised 
crime  groups  that  are  involved  in  the  manufacture  and  trafficking  of  the  controlled  drug 
amphetamine.  

4-methylamphetamine has no known, established or acknowledged medical value or use in the 
Union and there is no marketing authorisation for the substance in the Union. Apart from its 
use as an analytical reference standard and in scientific research, there are no indications that it 
may be used for any other legitimate purpose. 

4-methylamphetamine is currently not under assessment and has not been under assessment by 
the  United  Nations  system.  Eight  Member  States  control  the  substance  under  drug  control 
legislation  by  virtue  of  their  obligations  under  the  1971  United  Nations  Convention  on 
Psychotropic  Substances.  Two  other  Member  States  apply  the  generic  definition  in  their 
national  legislation  to  the  product  while  one  Member  State  controls  it  under  its  medicines 
legislation.  

Although the Risk Assessment Report reveals that limited scientific evidence is available on 
the  characteristics  and  risks  of  4-methylamphetamine  and  points  out  that  further  studies  are 
required  on  the  overall  health  and  social  risks  associated  with  the  substance,  the  available 
evidence provides sufficient grounds for subjecting the substance to control measures across 
the Union. This is because of the health risks that the substance poses, as documented in its 
detection  in  several  cases  of  fatalities,  especially  when  used  in  combination  with  other 
substances,  because  of  its  strong  resemblance  in  terms  of  appearance  and  effects  with 
amphetamine and the fact that users may unknowingly consume this substance. These risks as 
well as the limited medical value or use of 4-methylamphetamine, justify a decision to subject 
it to control measures across the Union.  

Since  ten  Member  States  already  control  4-methylamphetamine,  placing  it  under  control 
across  the  Union  may  help  avoid  problems  in  cross-border  law  enforcement  and  judicial 
cooperation.  

Union-wide  control  measures  may  help  prevent  4-methylamphetamine  developing  as  an 
alternative to amphetamine in the illicit drug markets,  

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

HAS ADOPTED THIS DECISION:  

The new psychoactive substance 4-methylamphetamine is hereby submitted to control measures. 

Article 1 

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Article 2 

Member States shall take the necessary measures, in accordance with their national law, and not later 
than  one  year  from  the  date  this  decision  is  published,  to  submit  4-methylamphetamine  to  control 
measures  and  criminal  penalties  as  provided  for  under  their  legislation  by  virtue  of  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. 

Done at Brussels,  

Article 3 

For the Council 
The President 

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