Proposal for a COUNCIL DECISION on subjecting 4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25I-NBOMe), 3,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide (AH-7921), 3,4-methylenedioxypyrovalerone (MDPV) and 2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone (methoxetamine) to control measures
Date: 2014-06-16
Institutions: European Commission
Subjects: European Monitoring Centre for Drugs and Drug Addiction, Europol, drug traffic, electronic commerce, health risk, judicial cooperation in criminal matters in the EU, psychotropic substance, toxicology













EUR-Lex - 52014PC0362 - EN











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52014PC0362

Proposal for a COUNCIL DECISION on subjecting 4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (25I-NBOMe), 3,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide (AH-7921), 3,4-methylenedioxypyrovalerone (MDPV) and 2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone (methoxetamine) to control measures /* COM/2014/0362 final - 2014/0183 (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]
provides for a three-step procedure that may lead to the submission of a new
psychoactive substance to control measures across the Union.
On 28 January 2014, 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
substances 25I-NBOMe, AH-7921, MDPV and methoxetamine, the involvement of
organised crime and the possible consequences of control measures introduced on
these substances.
The risks of 25I-NBOMe, AH-7921, MDPV and
methoxetamine 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 23 April 2014.
The main results of the risk assessment are
the following:
·                        
25I-NBOMe is a
derivative of 2C-I, a known synthetic derivative of phenethylamine with
stimulant and hallucinogenic properties, subjected to risk assessment and
control measures in 2003. It has been available on the EU drug market since at
least May 2012 and has been detected in 23 Member States and Norway. There have been four deaths associated with 25I-NBOMe
registered in three Member States. Severe toxicity associated with its use has
been reported in four Member States, which notified 32 non-fatal intoxications.
Information from seizures and collected samples suggest that 25I-NBOMe is being
sold on the illicit market as LSD. 
·                        
AH-7921 is a structurally atypical synthetic
opioid analgesic, which has been available in the EU since at least July 2012
and has been detected in eight Member States and Norway. There have been 15 deaths
associated with AH-7921, all occurred in three Member States within a limited
period, between December 2012 and September 2013. Severe toxicity was reported
by one Member State, where six non-fatal intoxications occurred. AH-7921
appears to be sold by Internet retailers since 2011, advertised as 'research
chemical' or 'legal opioid'.
·                        
MDPV is a ring substituted synthetic derivative
of cathinone, chemically related to pyrovalerone, which are both subject to
control under the 1971 United Nations Convention on Psychotropic Substances. There
have been 108 fatalities registered in eight Member States and Norway between September 2009 and August 2013, where MDPV has been detected in post-mortem
biological samples or implicated in the cause of death. Eight Member States
reported 525 non-fatal intoxications associated with MDPV. MDPV has been
present in the EU drug market since November 2008. Multi-kilogram seizures of
MDPV were reported in 27 Member States, Norway and Turkey. It is mainly sold as
a substance of its own right and it is widely available from Internet suppliers
and retailers, head shops and street level dealers.
·                        
Methoxetamine is an arylcyclohexylamine
substance, chemically similar to ketamine and phencyclidine (PCP). Like
ketamine and PCP, methoxetamine has dissociative properties. Some 20 deaths
associated with methoxetamine were reported by six Member States that detected
the substance in post-mortem samples. Used alone or in combination with other
substances, methoxetamine was also detected in 20 non-fatal intoxications
reported by five Member States. Twenty three Member States, as well as Turkey and Norway reported detections of methoxetamine, since November 2010.  Information suggests
that methoxetamine is sold and used as a substance in its own right, but also
as a ‘legal’ replacement for ketamine by Internet retailers, head shops and
street-level drug dealers.
Pursuant to Article 8(1) of Council
Decision 2005/387/JHA, within six week 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.
Although the scientific evidence concerning
the overall risks of 25I-NBOMe, AH-7921, MDPV and methoxetamine is limited at
this stage, the Commission considers that there are grounds for subjecting these
substances to control measures across the Union. The main reason is that,
according to the information available from the risk assessment reports, the
acute toxicity of 25I-NBOMe, AH-7921, MDPV and methoxetamine 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
stimulant substances.
2.   OBJECTIVE OF THE PROPOSAL
The objective of this proposal for a
Council Decision is to call upon the Member States to subject 25I-NBOMe,
AH-7921, MDPV and methoxetamine 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.
2014/0183 (NLE)
Proposal for a
COUNCIL DECISION
on subjecting 4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine
(25I-NBOMe), 3,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide
(AH-7921), 3,4-methylenedioxypyrovalerone (MDPV) and
2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone (methoxetamine) 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)                   
Risk assessment reports on the new psychoactive
substances 25I-NBOMe, AH-7921, MDPV and methoxetamine were 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 were subsequently submitted to the Commission and
to the Council on 23 April 2014.
(2)                   
25I-NBOMe, AH-7921, MDPV and methoxetamine have
not been under assessment at the United Nations’ level, but they will be
subject to evaluation in June 2014 by the Expert Committee on Drug Dependence
of the World Health Organization. 
(3)                   
25I-NBOMe, AH-7921, MDPV and methoxetamine have
no established or acknowledged medical use (human or veterinary). Apart from
their use in analytical reference materials, and in scientific research
investigating their chemistry, pharmacology and toxicology as a result of their
emergence on the drug market - and, in the case of 25I-NBOMe, also in the field
of neurochemistry - there is no indication that they are being used for other
purposes.
(4)                   
25I-NBOMe is a potent synthetic derivative of
the 2C-I, a classical serotonergic hallucinogen, which was subject to risk
assessment  and to control measures and criminal penalties at Union level in
2003.
(5)                   
The specific physical effects of 25I-NBOMe are
difficult to determine because there are no published studies assessing its
acute and chronic toxicity, its psychological and behavioural effects, and dependence
potential, and because of the limited information and data available. Clinical
observations of individuals who have used this substance suggest that it has
hallucinogenic effects and has the potential for inducing severe agitation,
confusion, intense auditory and visual hallucinations, aggression, violent accidents
and self-induced trauma.
(6)                   
There have been four deaths associated with
25I-NBOMe registered in three Member States. Severe toxicity associated with its
use has been reported in four Member States, which notified 32 non-fatal
intoxications. If this new psychoactive substance were to become more widely
available and used, the implications for individual and public health could be
significant. There is no available information on the social risks associated
with 25I-NBOMe.
(7)                   
Twenty two Member States and Norway have reported to the EMCDDA and Europol that they detected 25I-NBOMe. No prevalence
data is available on the use of 25I-NBOMe, but the limited information that
exists suggests that it may be consumed in a wide range of settings, such as home,
bars, nightclubs and music festivals.
(8)                   
25I-NBOMe is openly marketed and sold on the
Internet as a 'research chemical' and information from seizures, collected samples,
user websites and Internet retailers suggests that it is being sold as a drug
in its own right and also marketed as a 'legal' replacement for LSD. EMCDDA
identified more than 15 Internet retailers selling this substance, which may be
based within the Union and China.
(9)                   
The risk assessment report reveals that there is
limited scientific evidence available on 25I-NBOMe 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 25I-NBOMe to control measures across the Union. As a result of the health risks that it poses, as documented by its detection in
several reported fatalities, of the fact that users may unknowingly consume it
and of the lack of medical value or use of the substance, 25I-NBOMe should be
subjected to control measures across the Union.
(10)               
Since six Member States control 25I-NBOMe under
national legislation complying with the obligations of the 1971 United Nations
Convention on Psychotropic Substances 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 help protect
from the risks that its availability and use can pose.
(11)               
AH-7921 is a structurally atypical synthetic
opioid analgesic commonly known by Internet suppliers, user websites and media as
'doxylam'. It can be easily confused with 'doxylamine', an antihistaminic
medicine with sedative-hypnotic properties, which could lead to unintentional
overdoses.
(12)               
The specific physical effects of AH-7921 are
difficult to determine because there are no published studies assessing its
acute and chronic toxicity, its psychological and behavioural effects, and dependence
potential, and because of the limited information and data available. Based on
user reports, the effects of AH-7921 appear to resemble those of classical
opioids with the feeling of mild euphoria, itchiness and relaxation; nausea
appears to be a typical adverse effect. In addition to self-experimentation
with AH-7921, as well as ‘recreational use’, some of the users report
self-medicating with this new drug to relieve pain, others to alleviate
withdrawal symptoms due to cessation of the use of other opioids. This may
indicate a potential of AH-7921 to spread among the injecting opioid population.

(13)               
There is no prevalence data on the use of
AH-7921, but the information available suggests that it is not widely used and
that it is used in the home environment. 
(14)               
There have been 15 fatalities registered in
three Member States between December 2012 and September 2013 where AH-7921,
alone or in combination with other substances, was detected in post-mortem
samples. While it is not possible to determine with certainty the role of
AH-7921 in all of fatalities, in some cases it has been specifically noted in
the cause of death. One Member State reported six non-fatal intoxications associated
with AH-7921. If this new psychoactive substance were to become more widely
available and used, the implications for individual and public health could be
significant. There is no available information on the social risks associated
with AH-7921.
(15)               
The risk assessment report reveals that there is
limited scientific evidence available on AH-7921 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 AH-7921 to control measures across the Union. As a result
of the health risks that it poses, as documented by its detection in several
reported fatalities, of the fact that users may unknowingly consume it, and of
the lack of medical value or use of the substance, AH-7921 should be subjected
to control measures across the Union.
(16)               
Since one Member State controls AH-7921 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 help protect
from the risks that its availability and use can pose.
(17)               
MDPV is a ring substituted synthetic derivative
of cathinone chemically related to pyrovalerone, which are both subject to
control under the 1971 United Nations Convention on Psychotropic Substances. 
(18)               
Information on the chronic and acute toxicity
associated with MDPV, as well as on psychological and behavioural effects, and
on dependence potential, is not collected uniformly across the Union. Information from published studies, confirmed by clinical cases, suggests that the
psychopharmacological profile observed for MDPV is similar to that for cocaine
and methamphetamine, albeit more potent and longer lasting. Furthermore, MDPV
was found to be ten-time more potent in its ability to induce locomotor
activation, tachycardia and hypertension. 
(19)               
Users' websites indicate that its acute toxicity
can provoke adverse effects on humans, similar to those associated with other
stimulants. These include paranoid psychosis, tachycardia, hypertension, diaphoresis,
breathing problems, severe agitation, auditory and visual hallucinations, profound
anxiety, hyperthermia, violent outbursts and multiple organ dysfunctions. 
(20)               
There have been 108 fatalities registered in
eight Member States and Norway between September 2009 and August 2013, where MDPV
has been detected in post-mortem biological samples or implicated in the cause
of death. A total of 525 non-fatal intoxications associated with MDPV have been
reported by eight Member States. If this new psychoactive substance were to
become more widely available and used, the implications for individual and
public health could be significant. 
(21)               
The detection of MDPV has also been reported in
biological samples related to fatal and non-fatal road traffic accidents, or driving
under the influence of drugs, in four Member States since 2009. 
(22)               
MDPV has been present in the Union drug market
since November 2008 and 27 Member States, Norway and Turkey reported multi-kilogram
seizures of the substance. MDPV is being sold as a substance of its own right but
it has also been detected in combination with other substances. It is widely
available from Internet suppliers and retailers, head shops and street-level
dealers. There are some indications that suggest a degree of organisation in
the tableting and distribution of this substance in the Union.
(23)               
The risk assessment report reveals that further
research would be needed to determine the health and social risks posed by MDPV.
However, the available evidence and information provides sufficient ground for
subjecting MDPV to control measures across the Union. As a result of the health
risks that it poses, as documented by its detection in several reported
fatalities, of the fact that users may unknowingly consume it, and of the lack
of medical value or use of the substance, MDPV should be subjected to control
measures across the Union.
(24)               
Since 21 Member States control MDPV under
national legislation complying with the obligations of the 1971 United Nations
Convention on Psychotropic Substances and four 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.
(25)               
Methoxetamine is an arylcyclohexylamine
substance which is chemically similar to ketamine and the internationally
control substance phencyclidine (PCP). Like ketamine and PCP, it has
dissociative properties. 
(26)               
There are no studies assessing the chronic and
acute toxicity associated with methoxetamine, as well as its psychological and
behavioural effects, and dependence potential. Self-reported experiences from
user websites suggest adverse effects similar to ketamine intoxication. These include
nausea and severe vomiting, difficulty in breathing, seizures, disorientation,
anxiety, catatonia, aggression, hallucination, paranoia and psychosis. In
addition, acute methoxetamine intoxications may include stimulants effects
(agitation, tachycardia and hypertension) and cerebral features, which are not
expectable with acute ketamine intoxication. 
(27)               
Twenty deaths associated with methoxetamine were
reported by six Member States that detected the substance in post-mortem
samples. Used alone or in combination with other substances, methoxetamine was
detected in 20 non-fatal intoxications reported by five Member States. If this
new psychoactive substance were to become more widely available and used, the
implications for individual and public health could be significant. 
(28)               
Twenty three Member States, Turkey and Norway have reported that they detected methoxetamine, since November 2010.  Information
suggests that it is sold and used as a substance in its own right, but it is also
sold as a ‘legal’ replacement for ketamine by Internet retailers, head shops
and street-level drug dealers. 
(29)               
Multi-kilograms quantities in powder were seized
within the Union, but there is no information on the possible involvement of
organised crime. The manufacture of methoxetamine does not require
sophisticated equipment. 
(30)               
Data prevalence is limited to
non-representatives studies in two Member States. These suggest that the
prevalence of the use of methoxetamine is lower than that of ketamine. The
available information suggests that it may be consumed in a wide range of
settings, including home, bars, nightclubs and music festivals.
(31)               
The risk assessment report reveals that further
research would be needed to determine the health and social risks posed by methoxetamine.
However, the available evidence and information provides sufficient ground for
subjecting methoxetamine to control measures across the Union. As a result of
the health risks that it poses, as documented by its detection in several
reported fatalities, of the fact that users may unknowingly consume it, and of
the lack of medical value or use, methoxetamine should be subjected to control
measures across the Union.
(32)               
Since nine Member States control methoxetamine
under national legislation complying with the obligations of the 1971 United
Nations Convention on Psychotropic Substances and nine 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-iodo-2,5-dimethoxy-N-(2-methoxybenzyl) phenethylamine(25I-NBOMe);
(b)         
3,4-dichloro-N-[[1-dimethylamino) cyclohexyl]methyl]
benzamide (AH-7921);
(c)         
3,4-methylenedioxypyrovalerone (MDPV); 
(d)        
2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone
(methoxetamine).
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.