# EUR-Lex - 52013PC0436 - EN

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# 52013PC0436

**Proposal for a COUNCIL DECISION on subjecting 5-(2-aminopropyl)indole to control measures /* COM/2013/0436 final - 2013/0207 (NLE) */**

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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 22 January 2013, pursuant to Article 6(1)
of the above-mentioned Council Decision, the Council requested[2] an assessment of the risks caused
by the use, manufacture and trafficking of the new psychoactive substance 5-(2-aminopropyl)indole,
the involvement of organised crime and the possible consequences of control
measures introduced on this substance.

The risks of 5-(2-aminopropyl)indole 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 16 April 2013.

The main results of the risk assessment are
the following:

(1)
5-(2-aminopropyl)indole is a synthetic
derivative of indole substituted at the phenyl side of the indole ring system.
It appears to be a stimulant substance that may also have hallucinogenic
effects. Despite the structural similarities with better known compounds such
as α-Methyltryptamine (AMT), 5-(2-aminopropyl)benzofuran (5-APB) and the
internationally controlled drug 3,4-methylenedioxyamphetamine (MDA), the
effects of 5-(2-aminopropyl)indole cannot be compared with the ones of these
substances due to potential differences in mechanisms of action.

(2)
The acute toxicity of 5-(2-aminopropyl)indole
appears to provoke adverse effects in humans such as tachycardia and
hyperthermia, and may also cause mydriasis, agitation and tremor. In addition,
5-(2-aminopropyl)indole may interact with other substances, including medical
products and stimulants that act on the monoaminergic system.

(3)
Since 2012, seven Member States, as well as Croatia and Norway, have detected 5-(2-aminopropyl)indole and reported information about it to the
EMCDDA and Europol. Between April and August 2012, four Member States reported 24
fatalities where 5-(2-aminopropyl)indole alone or in combination with other
substances has been detected post-mortem, and three Member States have reported
21 non-fatal intoxications associated with this new psychoactive substance. If
this new psychoactive substance were to become more widely available and used,
the implications for individual and public health could be significant.

(4)
5-(2-aminopropyl)indole has no known,
established or acknowledged medical value or use and, apart from its use as an
analytical reference standard and in scientific research, there is no
indication that it is being used for other purposes.

Pursuant to Article 8 (1) of the Council
Decision, 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 substance 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 5-(2-aminopropyl)indole is limited at this stage, the
Commission considers that there are grounds for subjecting the substance to
control measures across the Union. The main reason is that, according to the
information available from the risk assessment report, the acute toxicity of
5-(2-aminopropyl)indole is such that it can cause severe harms to the health of
individuals. Moreover, the risks are heightened by the fact that
5-(2-aminopropyl)indole has been reported to be consumed unknowingly by some
users together with or instead of other stimulant substances.

The objective of this proposal for a
Council Decision is to call upon the Member States to subject 5-(2-aminopropyl)indole
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.

2013/0207 (NLE)

Proposal for a

COUNCIL DECISION

on subjecting 5-(2-aminopropyl)indole 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[3],
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 5-(2-aminopropyl)indole 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, and was subsequently submitted to the Commission and to the
Council on 16 April 2013.

(2)       5-(2-aminopropyl)indole is
a synthetic derivative of indole substituted at the phenyl side of the indole
ring system. It appears to be a stimulant substance that may also have
hallucinogenic effects. 5-(2-aminopropyl)indole has been found mostly as a
powder but also in tablets and capsules, and is commercially available on the
internet and from 'head shops', marketed as 'research chemical'. It has also
been detected in samples of a product sold as a 'legal high', called 'Benzo
Fury', and in tablets resembling ecstasy.

(3)       The existing information
and data suggests that the acute toxicity of 5-(2-aminopropyl)indole can
provoke adverse effects in humans, such as tachycardia and hyperthermia, and
may also cause mydriasis, agitation and tremor. 5-(2-aminopropyl)indole may
interact with other substances, including medical products and stimulants that
act on the monoaminergic system. The specific physical effects of
5-(2-aminopropyl)indole in humans 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.

(4)       There have been a total of
24 fatalities registered in four Member States between April and August 2012,
where 5-(2-aminopropyl)indole alone, or in combination with other substances,
has been detected in post-mortem samples. While it is not possible to determine
with certainty the role of 5-(2-aminopropyl)indole in all of the fatalities, in
some cases it has been specifically noted in the cause of death. 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
information available on the social risks posed by 5-(2-aminopropyl)indole.

(5)       Nine European countries
have reported to the European Monitoring Centre for Drugs and Drug Addiction
and Europol that they detected 5-(2-aminopropyl)indole. No prevalence data is
available on the use of 5-(2-aminopropyl)indole, but the limited information that
exists suggests that it may be consumed in similar environments as other
stimulants, such as home, bars, nightclubs, music festivals.

(6)       There is no information
that suggests that 5-(2-aminopropyl)indole is manufactured in the Union, and there is no evidence suggesting the involvement of organised crime in the
manufacture, distribution or supply of this new psychoactive substance.

(7)       5-(2-aminopropyl)indole
has no known, established or acknowledged medical value or use, and there is no
marketing authorisation covering this new psychoactive substance in the Union. Apart from its use as an analytical reference standard and in scientific research,
there is no indication that it is being used for other purposes.

(8)       5-(2-aminopropyl)indole
has not been under assessment and is currently not under assessment by the
United Nations system. Two Member States control this new psychoactive
substance under national legislation complying with the obligations of the 1971
United Nations Convention on Psychotropic Substances. Five European countries apply
legislation on new psychoactive substances, dangerous goods or medicines to
control 5-(2-aminopropyl)indole.

(9)       The risk assessment report
reveals that there is limited scientific evidence available on 5-(2-aminopropyl)indole
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 5-(2-aminopropyl)indole 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,
5-(2-aminopropyl)indole should be subjected to control measures across the
Union.

(10)     Since six Member States
already control 5-(2-aminopropyl)indole via legislative provisions of different
nature, 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 protect users from the risks that its consumption can
pose,

HAS ADOPTED THIS DECISION:

Article 1

The new psychoactive substance,
5-(2-aminopropyl)indole, is hereby subjected to control measures across the Union.

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 5-(2-aminopropyl)indole 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]               Council Document 5284/13.

[3]               OJ L 127, 20.5.2005, p. 32.