COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on new psychoactive substances and for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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, as regards the definition of drug
Date: 2013-09-17
Institutions: European Commission
Subjects: drug traffic, exchange of information, health risk, international convention, market approval, narcotic, penalty, police checks













EUR-Lex - 52013SC0320 - EN











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52013SC0320

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on new psychoactive substances and for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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, as regards the definition of drug /* SWD/2013/0320 final */









 EN 
 || EUROPEAN COMMISSION ||   
Brussels, 17.9.2013 
SWD(2013) 320 final
 
COMMISSION STAFF
WORKING DOCUMENT
EXECUTIVE SUMMARY OF THE
IMPACT ASSESSMENT
Accompanying the
document
Proposal for a 
REGULATION OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL
on new psychoactive substances
and for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
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, as regards the definition of drug

{COM(2013) 619 final}
{COM(2013) 618 final}
{SWD(2013) 319 final}
COMMISSION STAFF WORKING DOCUMENT
EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Accompanying the document
Proposal for a 
REGULATION OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
on new psychoactive substances
and for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
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, as regards the definition of drug

TABLE OF CONTENTS
1........... Introduction.................................................................................................................... 4
2........... Problem definition........................................................................................................... 4
3........... Analysis of subsidiarity.................................................................................................... 6
4........... Policy objectives............................................................................................................. 7
5........... Policy options and assessment......................................................................................... 7
6........... Preferred policy option................................................................................................. 11
7........... Monitoring and evaluation............................................................................................. 11
COMMISSION
STAFF WORKING DOCUMENT
IMPACT ASSESSMENT SUMMARY
Accompanying the documents
Proposal for a 
REGULATION OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
on new psychoactive substances
and for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
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, as regards the definition of drug
1.           Introduction
The Impact Assessment covers measures aimed
at reducing the availability in the internal market of new psychoactive
substances that pose risks to consumers, while preventing the emergence of
obstacles to legitimate trade. 
New psychoactive substances (‘legal highs’) are natural or synthetic substances that act on the
central nervous system and modify mental functions. Many such substances have
or could have other uses ('legitimate uses'), for instance as active
substances for medicines. New psychoactive substances are not subjected
to control measures under the UN Conventions on drugs, unlike psychoactive
substances such as cocaine or amphetamines (‘illicit drugs’).
The rapid emergence and spread of new
psychoactive substances in the internal market is one of the most challenging
developments in EU drugs policy in recent years. Council Decision
2005/387/JHA set up an EU-wide system for exchanging information on such
substances, managed by the European Monitoring Centre for Drugs and Drug
Addiction (EMCDDA) and Europol, for assessing their risks and for submitting
them to control and criminal penalties across the EU. The 2011 Commission
assessment concluded that the Council Decision does not enable an effective
response to the challenge posed by new psychoactive substances. 
2.           Problem
definition
New psychoactive substances, which are used
for various legitimate uses, are increasingly available in the internal market
and are consumed by a growing number of people. The potential risks that
these substances pose have prompted authorities to submit them to various
restrictions, which can hamper legitimate trade and hinder the
development of licit uses. The main causes of the problems are divergent
national approaches to new psychoactive substances and the ineffectiveness of
the EU instrument tackling such substances.
2.1.        The
market for new psychoactive substances
Between 1997 and 2012, Member States
reported 290 new psychoactive substances. A large majority were notified by
several Member States. The pace of notifications has increased drastically in
recent years – from 24 in 2009 to 73 in 2012. The number of substances that
could potentially emerge may run into the thousands. 
2.1.1.     The
market for recreational use of new psychoactive substances
The levels of use of new psychoactive
substances for recreational purposes have increased
in recent years and use is predominant among young people. The 2011
Eurobarometer survey "Youth attitudes on drugs" found that 5% of
young people in the EU reported having used such substances at least once in
their life, with a peak of 16% in Ireland. 
The number of people who have used new
psychoactive substances the last year is estimated to 2.2 million in the
EU. The internet and social networks have facilitated their spread
across the EU - the EMCDDA’s snapshot surveys have recorded a four-fold
increase in the number of online shops selling such substances between 2010 and
2012 (from 170 to 690).
In the past three years, specialised shops
selling new psychoactive substances have opened up in at least 13 Member
States. Such substances are also sometimes sold in
petrol stations, video rental stores, sex shops or tobacconists. Companies producing these substances are based outside the EU
(China and India) and adapt rapidly to restriction measures by offering
alternative substances. The size of the market for
recreational use of new psychoactive substances is estimated, through analogy with the market for ecstasy, to €0.5
billion per year. 
2.1.2.     The
market for legitimate uses of new psychoactive substances
Many new psychoactive substances that are
used recreationally have or could have various uses in the industry -
examples include GBL (gamma-butyrolactone), 1-4 BDO (1,4-butanediol) and mCPP.
However, comprehensive information is not available across the EU, because the collection
of such data is not foreseen under the existing EU mechanism and Member States'
authorities do not report such uses systematically. 
Since 1997, the EMCDDA has received
information on legitimate uses for around a fifth of the substances notified.
This is a significant proportion and it may be underestimated, considering that
these new substances are often not well known. It is
assumed that the size of the market for legitimate
uses is considerable,
because of the number of psychoactive substances that are present on the
market, that may yet be launched and because of their
potential for 'dual' (recreational use and use in the industry). 
2.2.        Problem
1: Risks posed by the recreational use of new psychoactive substances 
The recreational use of new psychoactive
substances may cause harms to the
health and safety of consumers, and can pose risks to and burdens on society.
The most common harms to health include agitation, delirium,
tachycardia, hypertension, fatal overdose, spread of blood borne infections
(such as HIV or hepatitis C), psychiatric problems, dependence. The risks are higher when several new psychoactive substances
are consumed together, and in combination with illicit drugs or alcohol. Lack
of information on the administration of these substances heightens risks. 
Because they may affect mental health and
social functioning, the frequent use of new psychoactive substances can have a negative
impact on society, adversely affecting family life and communities. The use
of such substances may impair the ability to drive a car, and could lead to
violent behaviour and crime. Organised crime is involved to a limited extent in
this market, mostly in selling such substances alongside illicit drugs.
The cost of health-related harms of
new psychoactive substances is estimated at €211 million per year and that of
enforcing criminal law measures at €117 million to €144 million per year. 
2.3.        Problem
2: Obstacles to legitimate trade in the internal market 
The restriction
measures introduced by public authorities to curb the recreational use of new psychoactive substances can impede
legitimate trade, by making it more difficult for economic operators to get access to such
substances, thus causing loss of business. They can also make research more
difficult, therefore hindering the development of new
uses.
Restrictions vary
from one Member State to another and from substance to substance. Depending on
the type of legislation used, only certain uses are allowed at
national level, and lack of compliance is sanctioned by administrative or
criminal law. This leads to obstacles to trade, fragmentation and an uneven
level playing field, and makes it difficult for companies to operate across
the internal market. 
Restriction measures may have a chain-reaction
impact on economic operators, because these substances are often used in
the production of other substances and goods. Since the
market for new psychoactive substances is likely to grow, and Member States are
likely to introduce further measures to curb their recreational use, the
obstacles to legitimate trade are expected to increase. 
2.4.        Causes
of the problem
The underlying causes of the problem are:
·                        
Divergent national approaches: the differences
between the Member States' laws and uncoordinated national action may have
adverse effects on economic operators in the market for legitimate uses and on
consumers. 
·                        
The EU legislation on new psychoactive
substances is ineffective: the Council Decision is slow and reactive, it provides
insufficient evidence to take appropriate and sustainable decisions on
substances, and it lacks options for restriction measures.
2.5.        Baseline scenario
If the current
framework remains unchanged, the problems are likely to become worse. The market for recreational use
is likely to grow and possibly double by 2020. The health and social costs
associated with a growing availability and use of harmful substances would
increase proportionally. The market for legitimate uses is also expected to
grow, and the adverse effects of divergent national approaches and of ineffective
EU legislation on legitimate trade will continue and possibly intensify.
3.           Analysis
of subsidiarity
Article 114(1) TFEU empowers the European Parliament and the Council to adopt measures
for the approximation of the provisions laid down by law, regulation or
administrative action in Member States which have as their object the
establishment and functioning of the internal market, while Article
114(3) TFEU requires the Commission to aim at ensuring a high level of health,
safety and consumer protection in these proposals. 
The EU has the obligation to ensure a high
level of human health protection in the definition and implementation of all EU
policies (Article 168(1) TFEU) and to protect the health, safety and
economic interests of consumers (Article 169(1) TFEU). To tackle those
substances that pose severe risks, the EU is empowered to bring them within the
scope of criminal law provisions on illicit drug trafficking (Article 83(1)
TFEU).
The EU is better placed than the Member
States to take action to restrict the availability
in the internal market of harmful new psychoactive substances for recreational
use, and to ensure that divergent national approaches do not hinder legitimate
trade. EU-level action is necessary to allow harmful new psychoactive
substances to be identified and withdrawn from the market quickly in all Member
States and to reduce and prevent the emergence of obstacles to legitimate trade
resulting from Member State action.
4.           Policy
objectives
The main policy objectives of the EU
action on new psychoactive substances are: 
·                        
To reduce obstacles to legitimate trade
in new psychoactive substances and prevent the emergence of such obstacles.
·                        
To protect the health and safety of consumers
from the risks posed by harmful new psychoactive substances.
The specific objectives are:
·                        
To address substances that pose health, social
and safety risks, and that raise immediate public health concerns.
·                        
To improve the capacity to rapidly identify and
assess new psychoactive substances, and to address them depending on their
risks.
·                        
To facilitate legitimate trade in such
substances within the internal market.
·                        
To improve consistency between national
responses to harmful new psychoactive substances which raise cross-border
concerns and to reduce the risk of their displacement between the Member
States.
5.           Policy
options and assessment
The policy options have been grouped in four
clusters, including the "status quo". The following options have
been discarded: regulation of specialised shops and of online shops; introduction
of an EU-level authorisation system for new psychoactive substances;
introduction of a blanket ban; discontinuation of EU action.
5.1.        Overview
of the policy options
Cluster 1: improving knowledge and
analysis on new psychoactive substances
This cluster presents options for
strengthening EU-level research and analytical capacities on new psychoactive
substances, to enable the EU to provide a more effective response. 
(1)                   
Status quo
EMCDDA and Europol only collate and analyse
information on composition or expected effects of substances as submitted by
the Member States.
(2)                   
Facilitating structural cooperation between the EMCDDA, research institutes and
forensic laboratories 
The EU provides financial support for
structural cooperation between the EMCDDA, research institutions, including the
Joint Research Centre (JRC) and forensic laboratories across the EU, to support
the information needs on specific substances, and to help produce and disseminate
analysis about new psychoactive substances.
(3)                   
Establishment of an EU-level research
infrastructure 
A research infrastructure is established in
an existing EU research facility (JRC) or agency (EMCDDA). It would have the
same tasks as those mentioned under option (2). 
Cluster
2: addressing new psychoactive substances individually or in a group
This cluster presents options for
addressing new psychoactive substances, by assessing their risks (and adopting
measures) either on individual substances or on groups of substances. 
(1)                   
Individual approach (status quo)
Each substance is monitored and assessed
individually and a decision on whether or not to introduce restriction measures
is taken on the basis of the specific risks that it poses. 
(2)                   
Approach by group of substances
Entire groups of similar substances are
monitored, assessed and submitted to restriction measures. The group is defined
on the basis of similar chemical structure (generic approach) or
pharmacological effect (analogue approach). 
(3)                   
Individual approach supported by
information on an 'intelligently clustered' group of substances
Each substance is monitored, assessed and
submitted to restriction measures individually (as under option (1)), but
information is collected on other substances from the same group. Therefore,
the emergence of certain substances can be anticipated, but a risk assessment
will be conducted on each individual substance.
Cluster
3: temporary measures
This cluster presents options for
restricting temporarily the availability on the consumer market of new
psychoactive substances suspected to pose immediate risks to public health, evidenced
by reported fatalities and severe health consequences associated with their
consumption, as well as the prevalence of use of the substances in several
Member States. The restrictions are in place pending the risk assessment of
substances and do not apply to their commercial and scientific use, or
to products containing the substance that have been authorised under other EU
legislation.
(1)                   
No temporary measures (status quo)
Under the Council Decision, there is no
possibility to introduce temporary measures across the EU. A decision on
whether to restrict or not the availability of a substance is taken only after
the risk assessment is completed and this decision is permanent. 
(2)                   
EU recommendation to introduce
temporary measures
The Commission issues a recommendation to
the Member States to introduce temporary measures to immediately withdraw a
substance from the market and prohibit its distribution, sale, display or
offering to consumers (industrial and scientific use would fall outside the
scope of the restriction). Member States that implement the recommendation take
the appropriate measures to ensure that the substance is withdrawn from the
market.
(3)                   
EU decision to introduce temporary
measures
Same as (2), but the measures are binding
on the Member States. The decision to introduce them is taken by the Commission
through an implementing act. Infringement of these measures would entail
administrative sanctions, determined at national level. 
Cluster
4: final decision on a new psychoactive substance
This cluster presents options for
addressing the substance once a risk assessment is completed. The Commission
identifies the level of health, social and safety risk that a substance poses -
low, moderate or severe - and determines if and what type of restrictive
measure should be introduced. It will take the following criteria into
account: harms to health caused by the consumption of the substance (injury,
disease, and physical and mental impairment); social harms to individuals and
society (e.g. on social functioning, organised crime activities, illicit
profits); risks to safety (spread of diseases, impact on road safety). 
(1)                   
EU decision to submit substances to
restriction measures backed by criminal sanctions or no action (status quo)
On the basis of the results of the risk
assessment, the Commission tables a legislative proposal to the Council
requiring Member States to submit the substance to criminal law control
measures (national laws applicable to illicit drugs apply to the new
psychoactive substance) or justifies why this is not necessary. Since national
laws on illicit drugs have to comply with Framework Decision 2004/757/JHA on
drug trafficking, the provisions of the Framework Decision apply to the new
psychoactive substance subjected to control. Only the exceptions for legitimate
uses of the substance foreseen by the UN Conventions on drugs are allowed.
(2)                   
Status quo plus EU recommendation
to submit substances to consumer market restriction measures backed by
administrative sanctions
The Commission has three alternatives for
action: if a substance poses low risks, no restriction is introduced; if it
poses moderate risks, the Commission recommends to the Member States to
withdraw the substance from the market and prohibit its distribution, sale, display
or offering to consumers (commercial and industrial use, as well as scientific
use, are not be restricted); if it poses severe risks, criminal law provisions
apply as in the status quo.
(3)                   
Status quo plus EU decision to
submit substances to consumer market restriction measures backed by
administrative sanctions
Same as (2), but if a substance poses
moderate risks the Commission adopts a decision to submit it to restriction on
the consumer market, instead of a recommendation, which will be binding and
will be introduced through an implementing act.
5.2.        Assessment
of policy options
Cluster
1: improving knowledge of new psychoactive substances
The status quo does not help achieve the
policy objectives. It has low positive impacts on public health and safety, and
low acceptability by stakeholders. It does not entail any additional costs to
the EU or the Member States.
Structural cooperation between the EMCDDA,
research institutes and forensic laboratories has a high positive impact. It
makes EU action more effective by generating evidence on the harms of new
psychoactive substances. It requires EU budget funding of around €3.7 million
in 2014-2020. It enjoys high stakeholder acceptability.
An EU research infrastructure has the same
impacts but is disproportionate because it costs €5.1 million to set up and
€1.4 million per year to run. It meets low stakeholder acceptability.
Cluster
2: addressing new psychoactive substances individually or in a group
The individual approach (status quo) has
medium positive impact on policy objectives. It does not improve the
effectiveness of EU action, since it does not enhance the EU capacity to
anticipate market developments, but it has positive impacts on health and
safety by providing robust evidence on the risks of each substance. It has a positive
impact on operators in the market for legitimate uses because only harmful
substances are restricted. It enjoys good acceptability by stakeholders.
The approach by groups of substances has
medium positive impact on policy objectives because it helps anticipate market
developments and has positive impacts on health and safety, but it has a negative
impact on fundamental rights and on operators in the market for legitimate
uses, as restriction measures can be introduced on substances despite lack of
evidence about their harms. It entails low costs for the EU and the Member States and enjoys good stakeholder acceptability.
The individual approach supported by
information on an 'intelligently clustered' group of substances has a high
positive impact on achieving policy objectives because it combines the advantages
of both approaches presented above. It has high impacts on health and safety
and brings no additional costs to the EU and the Member States. It has positive
impacts on operators in the market for legitimate uses and enjoys high
stakeholder acceptability.
Cluster
3: temporary measures
The lack of temporary measures (status quo)
has high negative impacts on the achievement of policy objectives, since
substances that are likely to cause harm continue being available on the
market. It has low stakeholder acceptability.
An EU recommendation to introduce
temporary measures has a medium positive impact on policy objectives, because
harmful substances are quickly taken off the consumer market. However, the risk
of displacement remains, since not all Member States are likely to implement
the recommendation. It entails limited costs to EU and Member State budgets (linked to implementation). Operators in the market for legitimate uses will see
their activities facilitated by a common approach to certain substances across
the EU. The negative impacts on the business and certain fundamental rights of
operators for recreational use are justified. It is proportionate and enjoys
good stakeholder acceptability.
The impacts of an EU decision to
introduce temporary measures are similar but intensified because all Member
States implement it. It is more costly than a recommendation, but more
efficient in reducing the risk of displacement and on achieving positive
impacts on public health. The activities of operators in the market for
legitimate uses will be facilitated by a common approach on certain substances
across the EU. It is proportionate and enjoys high stakeholder acceptability.
Cluster
4: final decision on a new psychoactive substance
The status quo has low positive impacts on
achieving policy objectives because, although it helps improve the consistency
of national action, it does not allow tackling substances posing medium risks
in a proportionate way. It has negative but justified impacts on fundamental
rights. It raises proportionality concerns and acceptability by stakeholders is
low.
Adding to the status quo the possibility to
adopt EU recommendations on consumer market restrictions has medium
positive impacts on achieving the policy objectives, as it enables a response
that is more proportionate to the harms of substances. However, the risk of
displacement remains. It has medium positive impacts on the protection of
health and safety, and low impact on EU and national budgets (linked to
enforcement). It also has positive impacts on operators in the market for
legitimate uses, because their activity would not be affected by the
restriction measures (medium risks) and certain uses would be authorised even
in the case of severe-risks substances. The negative impacts on fundamental
rights and on the business of operators in the market for recreational uses are
justified. It is proportionate to the risks that substances pose and enjoys
stakeholder acceptability.
Adding to the status quo the possibility to
adopt EU decisions introducing consumer market restriction measures has
similar impacts, but these are intensified because the decision is binding on
the Member States. It is more costly than the previous option, but also more
efficient in reducing the risk of displacement and the negative impacts of
harmful substances on health and safety. It is proportionate and enjoys high
stakeholder acceptability.
6.           Preferred
policy option
A comparative assessment of the impacts
indicates that the following combination of legislative and non-legislative
options would be the most effective in achieving the objectives:
(1)                   
Facilitating structural
cooperation between the EMCDDA, research institutes
and forensic laboratories. 
(2)                   
Individual approach supported by information
on an 'intelligently clustered' group of
substances.
(3)                   
EU decision to introduce temporary measures.
(4)                   
Status quo plus EU decision to submit
substances to market restriction measures backed by administrative sanctions.
The preferred option has high positive
impacts on public health and safety. It enables swifter EU action, because
temporary measures allow substances raising immediate concerns to be withdrawn
from the consumer market earlier and it shortens the time needed for adopting
restriction measures (through implementing acts), which are directly
applicable. 
The preferred option markedly improves
the EU's capacity to anticipate developments and provide adequate responses
to new psychoactive substances. It has positive impacts on operators in the
market for legitimate uses. Although it has negative economic and fundamental
rights impacts on operators in the market for recreational use, these are
justified by the need to address the risks posed by substances, and
counterbalanced by the positive impacts on economic operators in the market for
legitimate uses. 
The preferred policy option strikes the
right balance between the need to protect individuals and society from the
risks posed by the recreational use of new psychoactive substances and the necessity
to reduce obstacles to legitimate trade and prevent the emergence of such
obstacles. It also helps better connect the market for legitimate uses of
new psychoactive substances with the internal market. By providing for a
more graduated and better calibrated set of options, proportionate to the
levels of risks, it reduces the negative impacts of restriction measures on
economic operators and consumers. The positive impacts of this policy option
outweigh the costs to the EU and Member State budgets.
This option respects the principle of subsidiarity
because it only addresses those substances that raise problems across the EU
and leaves to the Member States the responsibility to tackle those that are a local
problem. It also respects the principle of proportionality because it does not
go beyond what is necessary to achieve the objectives, by providing measures
tailored to the level of risk of substances.
7.           Monitoring
and evaluation
The EMCDDA and Europol will report annually
on the implementation of the instrument. The Commission will evaluate regularly
its implementation, functioning, effectiveness, efficiency and added value. It
will initiate an evaluation of the instrument every five years and submit the result
to the European Parliament and the Council, proposing amendments if necessary.