CELEX: 52014PC0716
Language: en
Date: 2014-12-01
Title: Proposal for a COUNCIL DECISION on subjecting 4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4'-DMAR) and 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45) to control measures

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		52014PC0716
		
			Proposal for a COUNCIL DECISION on subjecting 4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4'-DMAR) and 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45) to control measures /* COM/2014/0716 final - 2014/0340 (NLE) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.   CONTEXT OF THE PROPOSAL
The Council Decision 2005/387/JHA on the
information exchange, risk-assessment and control of new psychoactive
substances[1]
(hereby "Council Decision") provides for a three-step procedure that
may lead to the submission of a new psychoactive substance to control measures across
the Union.
On 20 June 2014, pursuant to Article 6(1)
of the Council Decision, the Council requested an assessment of the risks posed
by the use, manufacture and trafficking of the new psychoactive substance 4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine
(also known as 4,4'-DMAR or 4,4'-dimethylaminorex), the involvement of
organised crime and the possible consequences of control measures introduced on
this  substance.
The risks of 4,4'-DMAR were assessed by the
Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction
(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 19 September 2014.
The main findings of the risk assessment
are the following:
·                        
The new psychoactive substance 4,4'-DMAR appears
to have psychostimulant properties. 4,4'-DMAR is structurally related to two
substances listed in the 1971 United Nations Convention on Psychotropic
Substances (4-methylaminorex and aminorex).
·                        
4,4'-DMAR has been available on the drug market
in the European Union since at least December 2012 and has been detected in
nine Member States.
·                        
Although the information available suggests that
this substance has not been widely used, there have been 31 deaths associated
with 4,4'-DMAR, registered in three Member States over a period of
approximately one year, and one non-fatal intoxication.
On 25 September 2014, pursuant to Article
6(1) of the Council Decision, the Council decided to request the risk
assessment of 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (also known as MT-45). 

The risks of MT-45 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 6 October 2014.
The main findings of the risk assessment
are the following:
·                        
The new psychoactive substance MT-45 is a
synthetic opioid, with a unique structure, which had been investigated for its analgesic
properties in the 1970s.
·                        
MT-45 has been available on the drug market in
the European Union since October 2013 and has been detected in three Member
States.
·                        
A total of 28 deaths associated with MT-45 have
been reported in one Member State, within a period of nine months, as well as
18 non-fatal intoxications.
Pursuant to Article 8(1) of Council
Decision, 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 initiative is not deemed necessary.
Although the scientific evidence concerning
the overall risks posed by the two substances is limited at this stage, the
Commission considers that there are grounds for subjecting 4,4'-DMAR and MT-45 to
control measures across the Union. The main reason is that, according to the
information available from the risk assessment reports, the toxicity of these
substances is such that it can cause severe harms to the health of individuals.
Moreover, the risks are heightened by the fact that these substances have been
reported, in some cases, to be consumed unknowingly by certain users together with
or instead of other psychoactive substances.
2.   OBJECTIVE OF THE PROPOSAL
The objective of this proposal for a
Council Decision is to call upon the Member States to subject 4,4'-DMAR and
MT-45 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.
2014/0340 (NLE)
Proposal for a
COUNCIL DECISION
on subjecting
4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4'-DMAR) and
1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45) 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 the information exchange, risk-assessment and
control of new psychoactive substances[2],
and in particular Article 8(3) thereof, 
Having regard to the initiative of the
European Commission,
Whereas:
(1)       A risk assessment report
on the new psychoactive substance 4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine
(4,4'-DMAR) 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 19 September 2014.
(2)       4,4'-DMAR is a synthetic
substituted oxazoline derivative. It is a derivative of aminorex and
4-methylaminorex (4-MAR), two synthetic stimulants controlled under the 1971
United Nations Convention on Psychotropic Substances.
(3)       4,4'-DMAR has been
available on the Union's drugs market since at least December 2012 and was notified
to the Early Warning System in December 2012. Nine Member States reported
detections in seizures, mainly under the form of white or coloured powders and
tablets, as well as biological and collected samples. 
(4)       4,4'-DMAR emerged on the
new psychoactive substances market
as a 'research chemical' sold by internet retailers, and it is now available on
the street market. 4,4'-DMAR is being sold and consumed as a substance in its
own, but it has also been mis-sold on the illicit market as ecstasy and
amphetamines.
(5)       There have been 31 deaths
associated with this substance registered in three Member States, between June
2013 and June 2014. In most cases, 4,4'-DMAR was either the cause of death or
is likely to have contributed to death together with other substances. One Member State reported a case of non-fatal intoxication.
(6)       There are no studies on the
toxicity of 4,4'-DMAR.
(7)       There is no prevalence
data on the use of 4,4'-DMAR, but the information available suggests that it
has not been widely used. Information from death cases also suggests that users unknowingly consumed 4,4'-DMAR when
seeking other stimulants. 
(8)       There is limited
involvement of organised crime in the manufacture, distribution, trafficking
and supply of 4,4'-DMAR within the Union. The chemical precursors and the
synthetic routes used to manufacture 4,4'-DMAR are unknown. 
(9)       4,4'-DMAR is not listed
for control in the 1961 United Nations Single Convention on Narcotic Drugs or
in the 1971 United Nations Convention on Psychotropic Substances; it is currently
not under assessment and has not been under assessment by the United Nations’ system
and no such assessment is planned.
(10)     4,4'-DMAR has no established
or acknowledged medical human or veterinary use in the Union. Apart from its use
in analytical reference materials, and in scientific research investigating its
chemistry, pharmacology and toxicology, there is no indication that it is being
used for other purposes.
(11)     The risk assessment report
reveals that there is limited scientific evidence available on 4,4'-DMAR and
points out that further research would be needed to determine the health and
social risks that it poses. However, the available evidence and information
provides sufficient ground for subjecting 4,4'-DMAR to control measures across
the Union. As a result of the risks to health that the consumption of 4,4'-DMAR
poses, as documented by its detection in several fatalities, of the fact that
users may unknowingly consume it and of the lack of medical value of this
substance, 4,4'-DMAR should be subjected to control measures.
(12)     Since three Member States
control 4,4'-DMAR under national legislation complying with the obligations of
the 1971 United Nations Convention on Psychotropic Substances and 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 cooperation, and would
protect from the risks that its availability and use can pose.
(13)     A risk assessment report on
the new psychoactive substance 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45)
was drawn up in compliance with Article 6(2), (3) and (4) of Decision
2005/387/JHA by a special session of the extended Scientific Committee of the EMCDDA,
and was subsequently submitted to the Commission and to the Council on 6
October 2014.
(14)     MT-45 is an N,N’-disubstituted
piperazine, having a cyclohexane ring attached to one of the nitrogen atoms of
the piperazine ring and a 1,2-diphenylethyl moiety attached to the other
nitrogen atom. MT-45 is one of a series of 1-(1,2-diphenyl­ethyl) piperazine
analgesics invented in the early 1970s. 
(15)     MT-45 has been present on
the drug market in the Union since October 2013 where it is sold as a 'research
chemical', mostly on the Internet. EMCDDA identified 12 sites of internet
suppliers and retailers that offered MT-45 for sale, including some apparently
based in the Union.
(16)     A total of 28 fatalities
occurring between November 2013 and July 2014 were reported by one Member State. In most cases, the presence of MT-45 in biological samples was analytically
confirmed. Some 18 non-fatal intoxications were also reported by the same Member State and the clinical features were similar to opioid intoxication, responding in
some cases to the opioid receptor antagonist naloxone.
(17)     There are several studies
in animals indicating that the acute toxicity of MT-45 is several-fold higher
than that of morphine. 
(18)     Available information
suggests that MT-45 has not been widely used. The substance appears to be
mostly used in the home environment either by users willing to try any new
substance or by opioid dependent users with no access to heroin or any other
opioid. Users may combine MT-45 with other psychoactive substances. There is no
information on the social risks that may be related to MT-45.
(19)     There is no evidence of involvement
of organised crime in the manufacture, distribution, trafficking and supply.
The chemical precursors and the synthetic routes used to manufacture the MT-45
detected in Member States are unknown. 
(20)     MT-45 is not listed for
control in the 1961 United Nations Single Convention on Narcotic Drugs or in
the 1971 United Nations Convention on Psychotropic Substances; it is currently
not under assessment and has not been under assessment by the United Nations’
system, and no such assessment is planned.
(21)     MT-45 has no established or
acknowledged human or veterinary medical use in the Union. Apart from its use
in analytical reference materials, and in scientific research investigating its
chemistry, pharmacology and toxicology, there is no indication that it is being
used for other purposes.
(22)     The risk assessment report
reveals that there is limited scientific evidence available on MT-45 and points
out that further research would be needed to determine the health and social
risks that it poses. However, the available evidence and information provides
sufficient ground for subjecting MT-45 to control measures across the Union. As a result of the health risks that it poses, as documented by its detection in
several fatalities, and of the lack of medical value of this substance, MT-45
should be subjected to control measures.
(23)     Since one Member States
controls MT-45 under national legislation complying with the obligations of the
United Nations Drug Conventions and seven 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 cooperation, and would protect from the risks that its
availability and use can pose,
HAS ADOPTED THIS DECISION: 
Article 1
The following new psychoactive substances shall
be subjected to control measures across the Union:
(a)         
4-methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine
(4,4'-DMAR);
(b)         
1-cyclohexyl-4-(1,2-diphenylethyl)piperazine
(MT-45).
Article 2
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 substances 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.
Article 3
This Decision shall enter into force on the
twentieth day following that of its publication in the Official Journal of
the European Union
Done at Brussels,
                                                                       For
the Council
                                                                       The
President
[1]               OJ
L 127, 20.5.2005, p. 32.
[2]               OJ
L 127, 20.5.2005, p. 32.