Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances
Date: 2005-05-10
Institutions: Council of the European Union
Subjects: European Monitoring Centre for Drugs and Drug Addiction, Europol, drug traffic, exchange of information, psychotropic substance, report

L 127/32

EN

Official Journal of the European Union

20.5.2005

(Acts adopted under Title VI of the Treaty on European Union)

COUNCIL DECISION 2005/387/JHA

of 10 May 2005

on the information exchange, risk-assessment and control of new psychoactive substances

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in
particular Articles 29, 31(1)(e) and 34 (2)(c) thereof,

Council on the mid-term evaluation of the EU Action
Plan on Drugs (2000-2004)
indicated that changes to
the legislation would be introduced in order to enhance
action against synthetic drugs. The mechanism as estab-
lished by the Joint Action should therefore be adapted.

Having regard to the proposal from the Commission,

(4)

New psychoactive substances can be harmful to health.

Having regard to the opinion of the European Parliament (1),

Whereas:

(1)

The particular dangers inherent in the development of
psychoactive substances
require rapid action by the
Member States.

(2) When new psychoactive substances are not brought
within the scope of criminal law in all Member States,
problems may arise in cooperation between the judicial
authorities and law enforcement agencies of Member
States owing to the fact that the offence or offences in
question are not punishable under the laws of both the
requesting and the requested State.

(3)

taking into account

The European Union Action Plan on Drugs 2000-2004
provided for the Commission to organise an appropriate
assessment of
the Joint Action of 16 June 1997
concerning the information exchange, risk assessment
and the control of new synthetic drugs (2)
(herineafter
‘the Joint Action’)
the external
evaluation commissioned by the European Monitoring
Centre on Drugs and Drug Addiction (hereinafter ‘the
EMCDDA’) of the early warning system. The assessment
the Joint Action had fulfilled its expec-
showed that
the assessment
tations. Nevertheless,
made it clear that the Joint Action was in need of rein-
forcement and reorientation.
its main
objective, the clarity of its procedures and definitions,
the transparency of its operation, and the relevance of
its scope had to be redefined. The Communication from
the Commission to the European Parliament and the

the outcome of

In particular,

(5)

(6)

(7)

(8)

substances

The new psychoactive
covered by this
Decision may include medicinal products as defined in
Directive 2001/82/EC of the European Parliament and of
the Council of 6 November 2001 on the Community
Code relating to veterinary medicinal products (3) and
in Directive 2001/83/EC of
the European Parliament
and of
the Council of 6 November 2001 on the
Community Code relating to medicinal products for
human use (4).

The information exchange under
the early warning
system, established under the Joint Action, has proved
to be a valuable asset to the Member States.

Nothing in this Decision should prevent Member States
from exchanging information, within the European Infor-
mation Network on Drugs and Drug Addiction (here-
‘the Reitox network’), on emerging trends in
inafter
new uses of existing psychoactive substances which
may pose a potential risk to public health, as well as
information on possible public health related measures,
in accordance with the mandate and procedures of the
EMCDDA.

No deterioration of either human or veterinary health
care as a result of
this Decision will be permitted.
Substances of established and acknowledged medical
value are therefore excluded from control measures
based on this Decision. Suitable regulatory and public
health related measures should be taken for substances
of established and acknowledged medical value that are
being misused.

(1) Opinion delivered on 13 January 2004 (not yet published in the

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

Official Journal).

(2) OJ L 167, 25.6.1997, p. 1.

(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive

2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(3) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

20.5.2005

EN

Official Journal of the European Union

L 127/33

(9)

(10)

(11)

(12)

(13)

(14)

(15)

the exchange of

In addition to what is provided for under the pharma-
covigilance systems as defined in Directive 2001/82/EC
and in Directive 2001/83/EC,
infor-
mation on abused or misused psychoactive substances
to be reinforced and appropriate cooperation
needs
with the
(hereinafter
European Medicines Agency
‘EMEA’) ensured. The United Nations Commission on
‘CND’) Resolution 46/7
Narcotic Drugs
‘Measures to promote the exchange of information on
new patterns of drug use and on psychoactive substances
consumed’, provides a useful framework for action by the
Member States.

(hereinafter

HAS DECIDED AS FOLLOWS:

Article 1

Subject matter

This Decision establishes a mechanism for a rapid exchange of
information on new psychoactive substances. It takes note of
information on suspected adverse reactions to be reported
under the pharmacovigilance system as established by Title IX
of Directive 2001/83/EC.

The introduction of deadlines into every phase of the
procedure established by this Decision should guarantee
that the instrument can react swiftly and enhances its
ability to provide a quick-response mechanism.

This Decision also provides for an assessment of the risks asso-
ciated with these new psychoactive substances in order to
permit
the measures applicable in the Member States for
control of narcotic and psychotropic substances to be applied
also to new psychoactive substances.

The Scientific Committee of the EMCDDA has a central
role in the assessment of the risks associated with a new
it will for the purpose of this
psychoactive substance,
Decision be extended to include experts
from the
Commission, Europol and the EMEA, and experts from
scientific fields not represented, or not sufficiently repre-
sented, in the Scientific Committee of the EMCDDA.

The extended Scientific Committee that assesses the risks
should
associated with new psychoactive substances
remain a concise technical body of experts, capable of
assessing effectively all
risks associated with a new
psychoactive substance. Therefore the extended Scientific
Committee should be kept to a manageable size.

Article 2

Scope

This Decision applies to substances not currently listed in any
of the schedules to:

(a)

that may pose a comparable threat

the 1961 United Nations Single Convention on Narcotic
Drugs,
to public
health as the substances listed in Schedule I or II or IV
thereof, and

(b) the 1971 United Nations Convention on Psychotropic
Substances, that may pose a comparable threat to public
health as the substances listed in Schedule I or II or III or
IV thereof.

a

for

substances

information,

an exchange of

bringing notified

Since the objectives of the proposed action, namely to
bring about
risk-
assessment by a scientific committee and an EU-level
procedure
under
control, cannot be sufficiently achieved by the Member
States and can therefore, by reason of the effects of the
envisaged action, be better achieved at European Union
level, the Union may adopt measures, in accordance with
the principle of subsidiarity as set out in Article 5 of the
Treaty.
In accordance with the principle of propor-
tionality as set out in that Article, this Decision does
not go what is beyond what is necessary in order to
achieve those objectives

the Treaty,
In conformity with Article 34(2)(c) of
measures based upon this Decision can be taken by
qualified majority as these measures are necessary to
implement this Decision.

This Decision respects fundamental rights and observes
the principles recognised by Article 6 of the Treaty and
reflected in the Charter of Fundamental Rights of the
European Union,

as distinct

to end-products,

from
This Decision relates
precursors in respect of which Council Regulation (EEC) No
3677/90 of 13 December 1990 laying down measures to be
taken to discourage the diversion of certain substances to the
and psychotropic
illicit manufacture of narcotic
substances (1), and Regulation (EC) No 273/2004 of
the
European Parliament and of the Council of 11 February 2004
on drug precursors (2) provide for a Community regime.

drugs

Article 3

Definitions

For the purpose of this Decision the following definitions shall
apply:

(a)

‘new psychoactive substance’ means a new narcotic drug or
a new psychotropic drug in pure form or in a preparation;

(1) OJ L 357, 20.12.1990, p. 1. Regulation as last amended by
L 180,

(EC) No 1232/2002 (OJ

Commission Regulation
10.7.2002, p. 5).

(2) OJ L 47, 18.2.2004, p. 1.

L 127/34

EN

Official Journal of the European Union

20.5.2005

(b) ‘new narcotic drug’ means a substance in pure form or in a
preparation, that has not been scheduled under the 1961
United Nations Single Convention on Narcotic Drugs, and
that may pose a threat to public health comparable to the
substances listed in Schedule I, II or IV;

Europol and the EMCDDA shall collect the information received
from Member States through a Reporting Form and commu-
nicate this information immediately to each other and to the
Europol National Units and the representatives of the Reitox
network of the Member States, the Commission, and to the
EMEA.

(c)

‘new psychotropic drug’ means a substance in pure form or
in a preparation that has not been scheduled under the
1971 United Nations Convention
Psychotropic
Substances, and that may pose a threat to public health
comparable to the substances listed in Schedule I,
III
or IV;

on

II,

granted by

for human use) or Title

(d) ‘marketing authorisation’ means a permission to place a
medicinal product on the market,
the
competent authority of a Member State, as required by
Title III of Directive 2001/83/EC (in the case of medicinal
products
III of Directive
2001/82/EC (in the case of veterinary medicinal products)
or a marketing authorisation granted by the European
(EC)
Commission
No 726/2004 of
the
Council of 31 March 2004 laying down Community
procedures
authorisation and supervision of
medicinal products for human and veterinary use and estab-
lishing a European Medicines Agency (1);

of
the European Parliament and of

under Article

Regulation

the

for

3

(e)

‘United Nations system’ means the World Health Organi-
sation (WHO), the Commission on Narcotic Drugs (CND)
the Economic and Social Committee acting in
and/or
accordance with
as
respective
described in Article 3 of the 1961 United Nations Single
Convention on Narcotic Drugs or in Article 2 of the 1971
United Nations Convention on Psychotropic Substances;

responsibilities

their

2.
Should Europol and the EMCDDA consider that the infor-
mation provided by a Member State on a new psychoactive
substance does not merit the communication of information
as described in paragraph 1, they shall
inform the notifying
Member State immediately thereof. Europol and the EMCDDA
shall justify their decision to the Council within six weeks.

Article 5

Joint Report

1. Where Europol and the EMCDDA, or the Council, acting
by a majority of its members, consider that the information
provided by the Member State on a new psychoactive
substance merits the collection of
this
information shall be collated and presented by Europol and
the EMCDDA in the form of a Joint Report (hereinafter the
‘Joint Report’). The Joint Report shall be submitted to the
Council, the EMEA and the Commission.

further information,

2.

The Joint Report shall contain:

(a) a chemical and physical description,

including the name
under which the new psychoactive substance is known,
the scientific name (International
if available,
including,
Non-proprietary Name);

(f)

‘preparation’ means
psychoactive substance;

a mixture

containing

a

new

(b) information on the frequency, circumstances and/or quan-
tities in which a new psychoactive substance is encountered,
and information on the means and methods of manufacture
of the new psychoactive substance;

(g)

‘Reporting Form’ means a structured form for notification of
a new psychoactive substance and/or of a preparation
containing a new psychoactive substance agreed between
the EMCDDA/Europol and their respective networks in the
Member States’ Reitox and the Europol National Units.

(c)

information on the involvement of organised crime in the
manufacture or
the new psychoactive
substance;

trafficking of

Article 4

(d) a first

indication of

psychoactive substance,
risks, and the characteristics of users;

the risks associated with the new
including the health and social

Exchange of information

1.
Each Member State shall ensure that its Europol National
Unit and its representative in the Reitox network provide infor-
mation on the manufacture, traffic and use, including supple-
information on possible medical use, of new
mentary
psychoactive substances and of preparations containing new
psychoactive substances, to Europol and the EMCDDA, taking
into account the respective mandates of these two bodies.

(e)

information on whether or not
the new substance is
currently under assessment, or has been under assessment,
by the UN system;

(1) OJ L 136, 30.4.2004, p. 1.

(f)

the date of notification on the Reporting Form of the new
psychoactive substance to the EMCDDA or to Europol;

20.5.2005

EN

Official Journal of the European Union

L 127/35

(g)

information on whether or not
substance
national level in a Member State;

already subject

is

the new psychoactive
at

to control measures

(h) as far as possible, information will be made available on:

(i)

the chemical precursors that are known to have been
used for the manufacture of the substance,

(ii)

the mode and scope of the established or expected use
of the new substance,

(iii) any other use of the new psychoactive substance and
the extent of such use, the risks associated with this use
of the new psychoactive substance, including the health
and social risks.

3.
The EMEA shall submit to Europol and the EMCDDA the
following information on whether in the European Union or in
any Member State:

(a)

the new psychoactive substance has obtained a marketing
authorisation;

(b) the new psychoactive substance is the subject of an appli-

cation for a marketing authorisation;

(c) a marketing authorisation that had been granted in respect
of the new psychoactive substance has been suspended.

Where this information relates to marketing authorisations
granted by Member States, these Member States shall provide
the EMEA with this information if so requested by it.

4. Member States shall provide the details referred to under
paragraph 2 within six weeks from the date of notification on
the Reporting Form as set out in Article 4(1).

5.
The Joint Report shall be submitted no more than four
weeks after the date of receipt of the information from Member
States and the EMEA. The Report shall be submitted by Europol
or the EMCDDA, as appropriate, in accordance with Article 5(1)
and (2).

Article 6

Risk assessment

The Council, taking into account the advice of Europol
1.
and the EMCDDA, and acting by a majority of its members,
may request that the risks, including the health and social risks,
caused by the use of, the manufacture of, and traffic in, a new
psychoactive substance, the involvement of organised crime and
possible consequences of control measures, be assessed in

its members or

least a quarter of

accordance with the procedure set out in paragraphs 2 to 4,
provided that at
the
Commission have informed the Council
in writing that they
are in favour of such an assessment. The Member States or
inform the Council thereof as soon as
the Commission shall
possible, but in any case within four weeks of receipt of the
Joint Report. The General Secretariat of the Council shall notify
this information to the EMCDDA without delay.

2.
In order to carry out the assessment, the EMCDDA shall
convene a special meeting under the auspices of its Scientific
Committee. In addition, for the purpose of this meeting the
five
Scientific Committee may be extended by a further
the
to be designated by the Director of
experts at most,
the
EMCDDA, acting on the advice of
the Chairperson of
Scientific Committee,
experts
proposed by Member States and approved every three years
by the Management Board of the EMCDDA. Such experts will
be from scientific fields that are not represented, or not suffi-
in the Scientific Committee, but whose
ciently represented,
the balanced and adequate
contribution is necessary for
assessment of the possible risks,
including health and social
risks. Furthermore, the Commission, Europol and the EMEA
shall each be invited to send a maximum of two experts.

chosen from a panel of

The risk assessment shall be carried out on the basis of
3.
information to be provided to the scientific Committee by the
Member States, the EMCDDA, Europol, the EMEA, taking into
account all factors which, according to the 1961 United Nations
Single Convention on Narcotic Drugs or the 1971 United
Substances, would
Nations Convention on Psychotropic
warrant the placing of a substance under international control.

On completion of the risk assessment, a report (here-
4.
inafter the ‘Risk Assessment Report’) shall be drawn up by
the Scientific Committee. The Risk Assessment Report shall
consist of an analysis of the scientific and law enforcement
information available, and shall reflect all opinions held by
the members of the Committee. The Risk Assessment Report
shall be submitted to the Commission and Council by the
chairperson of the Committee, on its behalf, within a period
of twelve weeks from the date of the notification by the General
to the EMCDDA referred to in
Secretariat of
paragraph 1.

the Council

The Risk Assessment Report shall include:

(a)

and chemical description of

the physical
the new
psychoactive substance and its mechanisms of action,
including its medical value;

(b) the health risks associated with the new psychoactive

substance;

(c)

the social
substance;

risks associated with the new psychoactive

L 127/36

EN

Official Journal of the European Union

20.5.2005

(d)

information on the level of involvement of organised crime
and information on seizures and/or detections by the autho-
rities, and the manufacture of
the new psychoactive
substance;

(e)

information on any assessment of the new psychoactive
substance in the United Nations system;

(f) where appropriate, a description of the control measures
that are applicable to the new psychoactive substance in
the Member States;

listed

under

Where the new psychoactive substance falls into one of the
categories
the
the
Commission, on the basis of data collected by EMCDDA
and Europol, shall assess with the EMEA the need for
in close cooperation with the EMCDDA
further action,
and in accordance with the mandate and procedures of
the EMEA.

subparagraph,

first

The Commission shall
outcome.

report

to the Council on the

Article 8

(g) options for control and the possible consequences of the

control measures, and

Procedure for bringing specific new psychoactive
substances under control

(h) the chemical precursors that are used for the manufacture of

the substance.

Article 7

Circumstances where no risk assessment is carried out

No risk assessment shall be carried out in the absence of a
1.
Europol/EMCDDA Joint Report. Nor shall a risk assessment be
carried out where the new psychoactive substance concerned is
at an advanced stage of assessment within the United Nations
system, namely once the WHO expert committee on drug
dependence has published its critical review together with a
significant
written recommendation, except where there is
new information that
this
Decision.

in the framework of

is relevant

2. Where the new psychoactive substance has been assessed
within the United Nations system, but it has been decided not
to schedule the new psychoactive substance under the 1961
Single Convention on Narcotic Drugs or the 1971 Convention
on Psychotropic Substances, a risk assessment shall be carried
out only if there is significant new information that is relevant
in the framework of this Decision.

3.
No risk assessment
psychoactive substance if:

shall be carried out on a new

(a)

the new psychoactive substance is used to manufacture a
medicinal product which has been granted a marketing
authorisation; or,

(b) the new psychoactive substance is used to manufacture a
medicinal product for which an application has been made
for a marketing authorisation or,

1. Within six weeks from the date on which it received the
Risk Assessment Report, the Commission shall present to the
Council an initiative to have the new psychoactive substance
subjected to control measures. If the Commission deems it is
not necessary to present an initiative on submitting the new
psychoactive substance to control measures, within six weeks
from the date on which it received the Risk Assessment Report,
the Commission shall present a report to the Council explaining
its views.

2.
Should the Commission deem it not necessary to present
an initiative on submitting the new psychoactive substance to
control measures, such an initiative may be presented to the
Council by one or more Member States, preferably not later
than six weeks from the date on which the Commission
presented its report to the Council.

3.
The Council shall decide, by qualified majority and acting
on an initiative presented pursuant to paragraph 1 or 2, on the
basis of Article 34(2) (c) of the Treaty, whether to submit the
new psychoactive substance to control measures.

Article 9

Control measures taken by Member States

If

1.
the Council decides to submit a new psychoactive
substance to control measures, Member States shall endeavour
to take, as soon as possible, but no later than one year from the
date of that decision, the necessary measures in accordance with
their national law to submit:

(a)

the new psychotropic drug 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;

(c)

the new psychoactive substance is used to manufacture a
medicinal product for which a marketing authorisation has
been suspended by a competent authority.

(b) the new narcotic drug to control measures and criminal
penalties as provided under their legislation by virtue of
their obligations under the 1961 United Nations Single
Convention on Narcotic Drugs.

20.5.2005

EN

Official Journal of the European Union

L 127/37

2. Member States shall report the measures taken to both the
Council and the Commission as soon as possible after the
relevant decision has been taken. Thereafter this information
shall be communicated to the EMCDDA, Europol, the EMEA,
and the European Parliament.

3.
Nothing in this Decision shall prevent a Member State
from maintaining or introducing on its territory any national
control measure it deems appropriate once a new psychoactive
substance has been identified by a Member State.

Article 10

Annual report

shall

this Decision. The report will

The EMCDDA and Europol
report annually to the
European Parliament, the Council and the Commission on the
implementation of
take into
account all aspects required for an assessment of the efficacy
and achievements of the system created by this Decision. The
Report shall, in particular, include experience relating to coor-
dination between the system set out in this Decision and the
pharmacovigilance system.

means of this Decision and the pharmacovigilance systems as
defined and established under Title VII of Directive 2001/82/EC
and Title IX of Directive 2001/83/EC.

Article 12

Repeal

The Joint Action on New Synthetic Drugs of 16 June 1997 is
hereby repealed. Decisions taken by the Council based on
Article 5 of that Joint Action shall continue to be legally valid.

Article 13

Publication and taking effect

This Decision shall take effect on the day following that of its
publication in the Official Journal of the European Union.

Article 11

Pharmacovigilance system

Member States and the EMEA shall ensure an appropriate
exchange of information between the mechanism set up by

Done at Brussels, 10 May 2005.

For the Council
The President

J. KRECKÉ