1.1.
General context
A growing number of new psychoactive
substances, which imitate the effects of substances controlled under
the UN Conventions on Drugs and are marketed as legal alternatives
to them (‘legal highs’), are emerging and spreading fast in the
internal market. These substances, which act on the central nervous
system, modifying mental functions, also have uses in industry or
research - as active substances for medicines, for instance. A
rising number of individuals, in particular young people, consume
new psychoactive substances, despite the risks that they may pose,
which may be comparable to those posed by UN-controlled drugs.
During the past years, one new
psychoactive substance was reported every week in the EU, and the
rapid pace of notification is expected to continue in the coming
years. These substances are sold freely, unless public authorities
subject them to various restriction measures, underpinned by
administrative or criminal sanctions, because of the risks that they
pose when consumed by humans. Such national restriction measures,
which may differ depending on the Member State and on the substance,
can hamper trade in the internal market and hinder the development
of future industrial or commercial uses.
New psychoactive substances are not subjected to control
measures under the UN Conventions on Drugs, unlike psychoactive
substances such as cocaine or amphetamines, although they could be
considered for UN-level control on the basis of a risk assessment
conducted by the World Health Organisation at the request of at
least one UN Member State.
The [Commission Communication "Towards a
stronger European response to drugs"]
[COM(2011) 689 final].
, adopted in October 2011, identified the spread of
new psychoactive substances as one of the most challenging
developments in drugs policy requiring a firmer EU response. The
Communication set the ground for new EU legislative proposals on new
psychoactive substances, building on the [Council Decision
2005/387/JHA on the information exchange, risk assessment and
control of new psychoactive substances]
OJ L 127, 10.5.2005, p.32.
. In December 2011
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/jha/126879.pdf
, the Council requested the Commission to table a
legislative proposal revising [Council Decision
2005/387/JHA]. A legislative proposal on new psychoactive
substances is foreseen in the Commission's 2013 Work
Programme
[COM(2012) 629 final].
.
This proposal for a Regulation aims at
improving the functioning of the internal market regarding licit
uses of new psychoactive substances, by reducing obstacles to trade,
preventing the emergence of such obstacles and increasing legal
certainty for economic operators, while reducing the availability of
substances that pose risks through swifter, more effective and more
proportionate EU action. It is accompanied by a proposal for a
Directive amending [Council Framework Decision 2004/757/JHA of
25 October 2004 laying down
minimum provisions on the constituent elements of criminal acts
and penalties in the field of illicit drug
trafficking]
OJ L 335, 11.11.2004, p. 8.
. This aims at expanding the scope of application of
the Framework Decision to cover the most harmful new psychoactive
substances, which pose severe risks. This means that substances that pose severe
health, social and safety risks and are, therefore, submitted to
permanent market restriction under this proposed Regulation, are
also covered, through the proposed amended Framework Decision, by
the criminal law provisions applying to controlled drugs.
The case for swifter, more effective and
more proportionate action on new psychoactive substances at EU level
is compelling, considering the rapid changes in this market, which
put national authorities under pressure to act. During the past
years, Member States have notified an increasing number of new
psychoactive substances to the European Monitoring Centre for Drugs
and Drug Addiction (EMCDDA). Between 1997 and 2012 they reported
around 290 substances. The number of notified substances tripled
between 2009 and 2012 (from 24 to 73). Around 80% of these
substances were reported by more than one Member State. The number
of substances that can emerge may run into the thousands because
many variations of existing or new, still unexploited substances,
can be manufactured at relatively low cost. The issue has been
further highlighted in the 2012
EMCDDA, 2012 Annual
report on the state of the drugs problem in Europe;
available at:
http://www.emcdda.europa.eu/publications/annual-report/2012
and 2013
EMCDDA, European Drug
Report 2013; available at:
http://www.emcdda.europa.eu/edr2013.
EMCDDA annual reports, as well as in the
EMCCDA-Europol "EU drug markets report: a strategic
analysis"
Available at:
http://www.emcdda.europa.eu/publications/joint-publications/drug-markets
, published in January 2013.
Consumption of new psychoactive
substances appears to be increasing in Europe and use is predominant
among young people. According to the 2011 Eurobarometer ‘Youth
attitudes on drugs’, 5% of young people in the EU have used such
substances at least once in their life, with a peak of 16% in
Ireland, and close to 10% in Poland, Latvia and the UK. According to
the results of snapshot surveys conducted by the EMCDDA, the number
of online shops selling new psychoactive substances increased
four-fold between 2010 and 2012, to 690.
The consumption of new psychoactive
substances can cause harms to individuals' health and safety,
resulting in deaths, injury or disease, and can pose risks to and
burdens on society, as it may lead to violent behaviour and crime.
These risks are amplified by the fact that many such substances are
sold to consumers without appropriate labelling and instructions of
use. In some cases they are sold on the black market alongside, or
instead of, controlled drugs.
The rapid emergence and spread of these
substances, and the potential risks that they pose, have led
national authorities to subject them to various restriction
measures. Hundreds such substances or mixtures of substances have
been subjected to different restriction measures in the Member
States in the past years. Such national measures disrupt trade in
licit uses of these substances. Around a fifth of the substances
notified by the Member States have other uses (but information on
such uses is not collected systematically across the EU).
National restriction measures, which
can vary depending on the Member State and on the substance, lead to
obstacles to trade in licit uses, fragmentation, an uneven level
playing field and legal uncertainties for economic operators, and
make it difficult for companies to operate across the internal
market. They make research more cumbersome, hampering the
development of new uses for these substances. They have a
chain-reaction impact on operators in different markets, because
such substances are used in the production of other substances or
mixtures, which in turn are used for manufacturing various goods. As
the market for new psychoactive substances is likely to grow, so
will these obstacles to licit trade.
In order to facilitate the functioning
of the internal market while protecting consumers from harmful new
psychoactive substances, EU-level action shall ensure the free
movement of new psychoactive substances for commercial and
industrial use, and for scientific research and development, and
provide for a graduated set of restriction measures for substances
posing risks, proportionate to their level of risk.
This proposal, therefore, sets up a
robust system for exchanging rapidly information on new psychoactive
substances emerging on the market, including on their commercial and
industrial uses, for assessing the risks of substances that cause
EU-wide concern and for withdrawing from the market those substances
that pose risks.
The substances suspected to pose
immediate public health risk will be withdrawn from the consumer
market temporarily, pending their risk assessment. Once the risk
assessment is completed, measures will be taken proportionate to the
risks of substances. While no restrictions will be introduced at the
EU level on substances posing low health, social and safety risks,
substances posing moderate risks will be subjected to consumer
market restriction, which means that they cannot be sold to
consumers (except for uses specifically authorised, for instance by
medicines legislation) but their trade is allowed for commercial and
industrial purposes as well as for scientific research and
development.
New psychoactive substances posing
severe risks will be subjected to permanent market restriction,
covering both the consumer and commercial markets, and their use
will only be possible for specifically authorised industrial and
commercial purposes, as well as for scientific research and
development. In addition, as explained above, these substances will
be subjected to EU criminal law provisions under the accompanying
proposal for a Directive amending the Framework Decision on illicit
drug trafficking.
In relation to new psychoactive
substances on which the EU has not acted, Member States may
introduce national technical regulations, in full compliance with
the EU provisions preventing the emergence of unjustified barriers
to trade
[Directive 98/34/EC of the European Parliament and of the
Council of 22 June 1998
laying down a procedure for the provision of information
in the field of technical standards and regulations and
of rules on Information Society Services], OJ L
204, 21.7.1998, p. 37.
.
1.2.
Legal context
Soon after a borderless internal market
was created, and following the emergence and rapid spread of
synthetic drugs, such as amphetamines and ecstasy, it became clear
that the effectiveness of national actions is limited and that EU
action was necessary to contain the spread of harmful substances.
The [EU Joint Action 97/396/JHA concerning the information
exchange, risk assessment and the control of new synthetic
drugs]
OJ L 167, 25.6.1997, p.1.
was adopted in 1997 to address this problem.
[Council Decision
2005/387/JHA], which repealed [Joint Action
97/396/JHA], established an EU-wide system for tackling new
psychoactive substances (synthetic and natural) that raise concern
at EU level. It lays down rules on the exchange of information on
these substances between Member States, coordinated by the EMCDDA
and Europol, on the assessment of their risks and the submission to
control and criminal penalties across the EU of those substances
that pose risks.
The Commission's assessment
report
[COM(2011) 430 final] and [SEC(2011) 912
final].
of July 2011, concluded that, while [Council
Decision 2005/387/JHA] is a useful instrument, it is
inadequate, considering the scale and complexity of the problem, and
it, therefore, requires revision. This is because it involves a
lengthy process, it is reactive and it lacks options to the
submission to control and criminal penalties.
This Regulation replaces [Council
Decision 2005/387/JHA].