# EUR-Lex - 52013PC0619 - EN

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# 52013PC0619

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on new psychoactive substances /* COM/2013/0619 final - 2013/0305 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

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"[1],
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[2].
In December 2011[3],
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[4].

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[5].
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[6]
and 2013[7]
EMCDDA annual reports, as well as in the EMCCDA-Europol "EU drug markets
report: a strategic analysis"[8],
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[9].

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[10] 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[11] 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.

2.           RESULTS OF CONSULTATIONS WITH THE
INTERESTED PARTIES AND IMPACT ASSESSMENT

2.1.        Consultations with
interested parties

Broad stakeholder and expert consultations
together with a web-based public consultation and an external study have
informed the preparatory work for this proposal. The Commission involved all
Member States in the assessment of the functioning of Council Decision 2005/387/JHA,
through written consultation. In the context of the external study, the
Commission collected and examined the views of a host of national authorities
(responsible for drug legislation, justice and health ministries, health
institutes and law enforcement agencies) and of EU agencies involved in the
implementation of Council Decision 2005/387/JHA. It also collected and examined
the views of international organisations (including the World Health Organisation),
civil society organisations, economic operators in various markets, research
institutes and academic experts.

The survey conducted among Member States in
the context of the assessment report showed that a large number of Member
States view the lack of alternatives to control and criminal penalties in the
current instrument as inadequate and suggest that a wider range of options
should be considered, backed by administrative law. Moreover, all Member States
agreed that swifter action is necessary to address new psychoactive substances (including
temporary measures) and that the current decision-making process is too slow.

During the two experts' meetings organised
by the Commission on 15 December 2011 and 1 March 2012, academic experts and
practitioners stressed that the Council Decision and product safety legislation
are inadequate to tackle the large number of new psychoactive substances emerging
on the market, whose effects and risks are mostly unknown. They pointed out
that new legislation on new psychoactive substances should be calibrated to the
different levels of risks posed by these substances. Certain participants
expressed concern that too rigorous policy responses (such as blanket
restrictions on entire groups of substances or a wide recourse to criminal penalties)
could have adverse effects. Such adverse effects include a displacement of
substances from the licit to the illicit market, a replacement of the
substances withdrawn from the market with other substances, possibly even more
harmful, and rendering such substances inaccessible for research.

Surveys and interviews were conducted with
economic operators which manufacture such substances for various industrial
uses, and with their trade associations, as well as with those who produce or
distribute new psychoactive substances for recreational use. Recreational users
of new psychoactive substances were also interviewed.

The views of young people (15-24 years'
old) were collected through the 2011 Eurobarometer "Youth attitudes on
drugs". Almost half of respondents (47%) thought that only those
substances which are proved to pose risks to health should be restricted, while
34% held that all substances which imitate the effects of controlled drugs
should be restricted.

The Commission run a public consultation on
drugs policy from 28 October 2011 to 3 February 2012. It included a question on
regulatory measures that the EU should develop to contain the spread of new
psychoactive substances. Among the 134 replies, most stressed the need for more
rapid action on new psychoactive substances and warned against imposing
criminal sanctions indiscriminately. The European Economic and Social Committee
has urged[12]
the Commission to explore options that avoid making the personal use of such
substances a criminal offence.

2.2.        Impact Assessment

The Commission conducted an impact
assessment of policy alternatives, taking into account the consultation of
interested parties and the results of external studies. The impact assessment
concluded that the following solution would be preferred:

– 
a more graduated and better targeted set of
restriction measures on new psychoactive substances, which should not hinder the
industrial use of substances.

– 
restriction measures should be introduced
earlier and substances suspected to pose immediate public health risks should
be subjected to temporary restrictions.

– 
restriction measures should be proportionate to
a better determined level of risk of substances, with substances posing
moderate risks subjected to restrictions on the consumer market (covered by
administrative law), while substances posing severe risks should be subjected
to a wider market restriction, as well as being covered by criminal law.

– 
restriction measures should be introduced
through a quicker procedure.

The impact assessment concluded that the
most effective way to keep harmful new psychoactive substances out of the
market is to apply the EU provisions on illicit drug trafficking to new
psychoactive substances that pose severe risks. Applying the same criminal law
provisions to controlled drugs and to equally harmful new psychoactive
substances, posing severe risks, will help deter trafficking in such substances
and the involvement of criminal groups, while streamlining and clarifying the
EU legal framework on drugs.

3.           LEGAL ELEMENTS OF THE PROPOSAL

3.1.        The legal base

The proposal aims at ensuring that trade in
new psychoactive substances having industrial and commercial uses is not
hindered and that the functioning of this market is improved, while the health
and safety of individuals are protected from harmful substances, which cause
concern at the EU level.

The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union (TFEU), which 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 the Member
States which have as their object the establishment and functioning of the
internal market. Article 114(3) TFEU requires the Commission to ensure a high
level of health, safety and consumer protection in its proposals envisaged in paragraph
1 of Article 114 TFEU. This proposal falls within the scope of action to
improve the functioning of the internal market for the following reasons:

– 
it addresses obstacles to trade in new
psychoactive substances having dual uses, while enabling the adoption of
measures to restrict the availability to consumers of substances posing risks.

– 
it addresses the lack of legal certainty for
economic operators by harmonising the response given to substances causing
concern across the EU.

– 
it connects the market for industrial uses of new
psychoactive substances to the wider internal market.

3.2.        Subsidiarity,
proportionality and the respect for fundamental rights

There is a clear need for EU action on new
psychoactive substances. This is because Member States alone cannot reduce the
problems caused by the spread in the internal market of harmful new
psychoactive substances and by the proliferation of divergent national
responses. Uncoordinated national action in this area can produce adverse
knock-on effects, for instance hindrance to the operation of the internal
market as far as licit trade in these substances is concerned or displacement
of harmful substances from one Member State to another.

Consequently, EU-level action is necessary
to ensure that potentially harmful new psychoactive substances, which cause
EU-wide concern, can be identified, assessed and, if they pose risks, withdrawn
from the market rapidly in all Member States.

The proposal is relevant for the following
rights and principles enshrined in the EU Charter of Fundamental Rights: the
right to health care (notably to a high level of human health protection,
Article 35) and to consumer protection (Article 38), the respect of the freedom
to conduct a business (Article 16), the right to property (Article 17), the
right to an effective remedy and to a fair trial (Article 47), the presumption
of innocence and right to defence (Article 48). These rights and freedoms can
be subject to limitations, but only under the limits and requirements set by
Article 52(1) of the EU Charter.

The proposal is proportionate and does not
go beyond what is necessary to achieve the objectives because it only addresses
new psychoactive substances that are a concern at the EU level and because it
sets out a calibrated, graduated approach, under which measures are proportionate
to the actual risks of substances.

Explicit safeguards laid down in the
instrument itself guarantee that any person whose rights are affected by the
implementation of any administrative measures or sanctions pursuant to the
Regulation shall have the right to an effective remedy before a tribunal.

3.3.        Choice of instrument

In order to establish uniform rules, ensure
clarity of concepts and procedures, and provide legal certainty for market
operators, while ensuring that restriction measures are directly applicable in
all Member States, a Regulation is the appropriate instrument.

3.4       Specific
provisions

Article
1: Subject matter and scope – this provision sets
out the purpose and scope of the proposal, and in particular that it establishes
rules for restrictions to the free movement of new psychoactive substances in
the internal market.

Article 2: Definitions – this provision sets out definitions which apply throughout the
instrument.

Article 3: Free movement – this provision lays down the principle of free movement of new
psychoactive substances for industrial and commercial uses, and for research
and development.

Article 4: Prevention of barriers to
free movement – this provision clarifies under what
conditions Member States may introduce restrictions on new psychoactive
substances.

Article 5: Information exchange – this provision establishes the respective roles of Member States,
the EMCDDA and Europol in the process of exchange of information on new psychoactive
substances.

Article 6: Joint report – this provision lays down the contents and the procedures for the
drawing up and the transmission by the EMCDDA and Europol of a joint report on a
new psychoactive substance. The Commission, the European Medicines Agency, the
European Chemicals Agency and the European Food Safety Authority are associated
to the collection of information for a joint report.

Article 7: Risk assessment procedure and
report – this provision empowers the Commission to
request the EMCDDA to assess the risks of a new psychoactive substance on which
a joint report was drawn up. It lays down the procedures for the risk
assessment, which is to be conducted by the Scientific Committee of the EMCDDA,
and for the drawing up and the transmission of a risk assessment report.

Article 8: Exclusion from risk
assessment – this provision details such
circumstances in which no risk assessment is to be conducted on a new
psychoactive substance.

Article 9: Immediate risks to public
health and temporary consumer market restriction – this
provision lays down the criteria on the basis of which the Commission determines
whether a new psychoactive substance poses immediate risks to public health, and
empowers the Commission to prohibit, temporarily, the making available of this
substance on the consumer market, if it poses such immediate risks to public
health.

Article 10: Determination of the level
of health, social and safety risks following the risk assessment – this provision lays down the criteria on the basis of which the
Commission determines the level of health, social and safety risks posed by a
new psychoactive substance.

Article 11: Low risks – this provision sets out that the Commission shall introduce no
restriction measures on new psychoactive substances posing low health, social
and safety risks and provides a definition of low risks.

Article 12: Moderate risks and permanent
consumer market restriction – this provision
empowers the Commission to prohibit the making available on the consumer market
of new psychoactive substances which pose moderate health, social and safety
risks, and provides a definition of moderate risks.

Article 13: Severe risks and permanent
market restriction – this provision empowers the
Commission to prohibit the production, manufacture, making available on the market,
transport, importation or exportation of new psychoactive substances which pose
severe health, social and safety risks, and provides a definition of severe risks.

Article 14: Authorised uses – this provision sets out the exceptions to the market restrictions
introduced under the Regulation.

Article 15: Monitoring – this provision lays down monitoring obligations with regard to
substances on which a joint report has been drawn up.

Article 16: Re-examination of the level
of risks – this provision sets out the procedure
for re-examining the level of risks posed by a new psychoactive substance in
the light of new information and evidence on the substance.

Article 17: Sanctions – this provision establishes the obligation for the Member States
to lay down the rules on administrative sanctions applicable to infringements to
market restriction, and to ensure that they are effective, proportionate and
dissuasive.

Article 18: Remedy – this provision sets out the right to an effective judicial remedy
enshrined in Article 47 of the Charter of Fundamental Rights.

Articles 19: Committee – this provision lays down the standard rules for the exercise of implementing
powers in line with Article 291 TFEU.

Article 20: Research and analysis – this provision describes the ways in which the EU shall support
the development, sharing and dissemination of information and knowledge on new
psychoactive substances, to support the rapid exchange
of information on and risk assessment of new psychoactive substances.

Article 21: Reporting – this provision requests the EMCDDA and Europol to report annually
on the implementation of certain aspects of the Regulation.

Article 22: Evaluation – this provision sets out an obligation for the Commission to regularly
assess the implementation, application and effectiveness of this Regulation and
to report to the European Parliament and Council.

Article 23: Replacement of Decision
2005/387/JHA – this provision sets out that this Regulation
replaces Council Decision 2005/387/JHA.

Article 24: Entry into force – this establishes when the Regulation shall enter into force.

4.           BUDGETARY IMPLICATION

The proposal has no direct impact on the EU
budget and does not create new tasks for the EMCDDA, Europol, the European
Medicines Agencies, the European Chemicals Agency (ECHA) and the European Food
Safety Authority (EFSA). For the purpose of this Regulation, the ECHA and the EFSA
are only required to share the information at their disposal, on a limited
number of substances, and are not requested to produce new information.

2013/0305 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on new psychoactive substances

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article
114 thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national parliaments,

Having regard to the opinion of the
European Economic and Social Committee[13],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       New psychoactive
substances, which may have numerous commercial and industrial uses, as well as
scientific uses, can pose health, social and safety risks when consumed by
humans.

(2)       During the past years,
Member States have notified an increasing number of new psychoactive substances
via the mechanism for rapid exchange of information which was established by
Joint Action 97/396/JHA of 16 June 1997 adopted by the Council on the basis of
Article K.3 of the Treaty on European Union, concerning the information
exchange, risk assessment and the control of new synthetic drugs[14] and was further strengthened
by the Council Decision 2005/387/JHA of 10 May 2005 on the information
exchange, risk-assessment and control of new psychoactive substances[15]. A large majority of these new
psychoactive substances were reported by more than one Member State. Many such new
psychoactive substances were sold to consumers without appropriate labelling
and instructions of use.

(3)       Member States' competent
public authorities introduce various restriction measures on these new
psychoactive substances to address the risks that they pose or may pose when
consumed. As new psychoactive substances are often used in the production of various
goods or of other substances which are used for manufacturing goods, such as
medicines, industrial solvents, cleaning agents, goods in the hi-tech industry,
restricting their access for this use can have an important impact on economic
operators, potentially disrupting their business activities in the internal market.

(4)       The increasing number of
new psychoactive substances available in the internal market, their growing
diversity, the speed with which they emerge on the market, the different risks
that they may pose when consumed by humans and the growing number of
individuals who consume them, challenge the capacity of public authorities to
provide effective responses to protect public health and safety without
hampering the functioning of the internal market.

(5)       Restriction measures vary
significantly in different Member States, meaning that economic operators that
use them in the production of various goods must comply, in the case of the
same new psychoactive substance, with different requirements, such as
pre-export notification, export authorisation, or import and export licences. Consequently,
the differences between the Member States' laws, regulations and administrative
provisions on new psychoactive substances hinder the functioning of the
internal market, by causing obstacles to trade, market fragmentation, lack of
legal clarity and of an even level playing field for economic operators, making
it difficult for companies to operate across the internal market.

(6)       Restriction measures not
only cause barriers to trade in the case of new psychoactive substances that
already have commercial, industrial or scientific uses, but can also impede the
development of such uses, and are likely to cause obstacles to trade for
economic operators that seek to develop such uses, by making access to those new
psychoactive substances more difficult.

(7)       The disparities between
the various restriction measures applied to new psychoactive substances can
also lead to displacement of harmful new psychoactive substances between the
Member States, hampering efforts to restrict their availability to consumers and
undermining consumer protection across the Union.

(8)       Such disparities are
expected to increase as Member States continue to pursue divergent approaches
to addressing new psychoactive substances. Therefore, the obstacles to trade
and market fragmentation, and the lack of legal clarity and of a level playing field
are expected to increase, further hindering the functioning of the internal
market.

(9)       Those distortions to the
functioning of the internal market should be eliminated and, to that end, the
rules relating to new psychoactive substances that are of concern at Union
level should be approximated, while, at the same time, ensuring a high level of
health, safety and consumer protection.

(10)     New psychoactive substances
and mixtures should be able to move freely in the Union when intended for
commercial and industrial use, as well as for scientific research and
development. This Regulation should establish rules for introducing restrictions
to this free movement.

(11)     New psychoactive substances
that pose health, social and safety risks across the Union should be addressed
at the Union level. Action on new psychoactive substances under this Regulation
should contribute to a high level of protection of human health and safety, as
enshrined in the Charter of Fundamental Rights of the European Union.

(12)     This Regulation should not
apply to drug precursors because the diversion of those
chemical substances for the purpose of manufacturing narcotic drugs or
psychotropic substances is addressed under Regulation
(EC) No 273/2004 of the European Parliament and of the Council of 11 February
2004 on drug precursors[16]
and Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules
for the monitoring of trade between the Community and third countries in drug
precursors[17].

(13)     Any Union action on new
psychoactive substances should be based on scientific evidence and subject to a
specific procedure. Based on the information notified by Member States, a
report should be drawn up on new psychoactive substances that give rise to
concerns across the Union. The report should indicate whether it is necessary
to carry out a risk assessment. Following the risk assessment, the Commission
should determine whether the new psychoactive substances should be subjected to
any restriction measures. In case of immediate public health concerns, the
Commission should subject them to temporary consumer market restriction before
the conclusion of the risk assessment. In case new information emerges on a new
psychoactive substance, the Commission should re-assess the level of risks that
it poses. Reports on new psychoactive substances should be made publicly
available.

(14)     No risk assessment should
be conducted under this Regulation on a new psychoactive substance if it is
subject to an assessment under international law, or if it is an active
substance in a medicinal product or in a veterinary medicinal product.

(15)     Where
the new psychoactive substance
on which a report is drawn up is an active substance in
a medicinal product or in a veterinary medicinal product, the Commission should
assess with the European Medicines Agency the need for further action.

(16)     The measures taken on new
psychoactive substances at Union level should be proportionate to the health,
social and safety risks that they pose.

(17)     Certain new psychoactive substances
pose immediate public health risks, requiring urgent action. Therefore, their
availability to consumers should be restricted for a limited time, pending
their risk assessment.

(18)     No restriction measures should
be introduced at Union level on new psychoactive substances which pose low
health, social and safety risks.

(19)     Those new psychoactive
substances which pose moderate health, social and safety risks should not be
made available to consumers.

(20)     Those new psychoactive
substances which pose severe health, social and safety risks should not be made
available on the market.

(21)     This Regulation should
provide for exceptions in order to ensure the protection of human and animal
health, to facilitate scientific research and development, and to allow the use
of new psychoactive substances in industry, provided that they cannot be abused
or recovered.

(22)     In order to ensure the efficient
implementation of this Regulation, the Member States should lay down rules on
the sanctions applicable to infringements of restriction measures. Those
sanctions should be effective, proportionate and dissuasive.

(23)     The European Monitoring
Centre for Drugs and Drug Addiction (EMCDDA) established by Regulation
1920/2006/EC of the European Parliament and of the Council of 12 December 2006[18] should have a central role in
the exchange of information on new psychoactive substances and in the
assessment of the health, social and safety risks that they pose.

(24)     The mechanism for rapid
exchange of information on new psychoactive substances has proved to be a
useful channel for sharing information on new psychoactive substances, on new
trends in the use of controlled psychoactive substances and on related public
health warnings. That mechanism should be further strengthened to enable a more
effective response to the rapid emergence and spread of new psychoactive
substances across the Union.

(25)     Information from Member States
is crucial for the effective functioning of the procedures leading to decision
on market restriction of new psychoactive substances. Therefore, Member States should
collect, on a regular basis, data on the use of new psychoactive substances,
related health, safety and social problems and policy responses, in accordance
with the EMCDDA framework for data collection for the key epidemiological
indicators and other relevant data. They should share this data.

(26)     A lack of capacity to identify
and anticipate the emergence and spread of new psychoactive substances and a
lack of evidence about their health, social and safety risks hamper the
provision of an effective response. Therefore, support should be provided,
including at Union level, to facilitate cooperation between the EMCDDA,
research institutes and forensic laboratories with relevant expertise, in order
to increase the capacity to assess and address effectively new psychoactive
substances.

(27)     The procedures for
information exchange, risk assessment and adoption of temporary and permanent
restriction measures on new psychoactive substances established by this
Regulation should enable swift action. Market restriction measures should be
adopted without undue delay, not later than eight weeks from receipt of the joint
report or risk assessment report.

(28)     As long as the Union has
not adopted measures to subject a new psychoactive substance to market
restriction under this Regulation, Member States may adopt technical
regulations on that new psychoactive substance in compliance with the
provisions of 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[19]. In order to preserve the unity of the Union’s internal market and to
prevent the emergence of unjustified barriers to trade, Member States should immediately communicate to the Commission any
draft technical regulation on new psychoactive substances, in accordance with the procedure established by Directive 98/34/EC.

(29)     Prevention, treatment and
harm reduction measures are important for addressing the growing use of new
psychoactive substances and their potential risks. The internet, which is one
of the important distribution channels through which new psychoactive substances
are sold, should be used for disseminating information on the health, social and
safety risks that they pose.

(30)     Medicinal products and
veterinary medicinal products are addressed under 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[20], 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[21] and Regulation (EC) No
726/2004 of the European Parliament and of the Council of 31 March 2004 laying
down Community procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a European Medicines
Agency[22].
Their abuse or misuse should, therefore, not be covered by this Regulation.

(31)     In order to ensure uniform
conditions for the implementation of temporary and permanent market
restrictions, implementing powers should be conferred on the Commission.
Those powers should be
exercised in accordance with Regulation (EU) No 182/2011 of the
European Parliament and of the Council of 16 February 2011 laying down the
rules and general principles concerning mechanisms for control by the Member
States of the Commission's exercise of implementing powers[23].

(32)     The Commission should adopt
immediately applicable implementing acts where, in duly justified cases
relating to a rapid increase in the number of reported fatalities in several
Member States associated with the consumption of the new psychoactive substance
concerned, imperative grounds of urgency so require.

(33)     In the application of this
Regulation, the Commission should consult Member States' experts, relevant
Union agencies, civil society and economic operators.

(34)     Since the objectives of the
proposed action cannot be sufficiently achieved by the Member States, and can
therefore, by reason of the effects of the envisaged action, be better achieved
at the Union level, the Union may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the Treaty on European
Union. In accordance with the principle of proportionality as set out in that
Article, this Regulation does not go beyond what is necessary in order to
achieve those objectives.

(35)     In order to establish
uniform rules and ensure clarity of concepts and procedures, as well as to
provide legal certainty for economic operators, it is appropriate to adopt this
act in the form of a Regulation.

(36)     This Regulation respects
fundamental rights and observes the principles recognised by the Charter of
Fundamental Rights of the European Union, including the freedom to conduct a
business, the right to property and the right to an effective remedy,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

Subject matter - Scope - Definitions

Article 1

Subject matter and scope

1.           This Regulation
establishes rules for restrictions to the free movement of new psychoactive
substances in the internal market. For that purpose it sets up a mechanism for
information exchange on, risk assessment and submission to market restriction
measures of new psychoactive substances at Union level.

2.           This Regulation shall not
apply to scheduled substances as
defined in Regulation (EC) No 273/2004 and Regulation (EC) No 111/2005.

Article 2

Definitions

For the purpose of this Regulation, the
following definitions apply:

(a) 
‘new psychoactive substance’ means a natural or
synthetic substance that, when consumed by a human, has the capacity to produce
central nervous system stimulation or depression, resulting in hallucinations,
alterations in motor function, thinking, behaviour, perception, awareness or
mood, which is intended for human consumption or is likely to be consumed by
humans even if not intended for them with the purpose of inducing one or more
of the effects mentioned above, which is neither controlled under the 1961
United Nations Single Convention on Narcotic Drugs, as amended by the 1972
Protocol, nor the 1971 United Nations Convention on Psychotropic Substances; it
excludes alcohol, caffeine and tobacco, as well as tobacco products within the
meaning of Council Directive 2001/37/EC of 5 June 2001 on the approximation of
the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco products [24];

(b) 
‘mixture’ means a mixture or solution containing
one or more new psychoactive substances;

(c) 
‘medicinal product’ means a product as defined
in point 2 of Article 1 of Directive 2001/83/EC;

(d) 
‘veterinary medicinal product’ means a product
as defined in point 2 of Article 1 of Directive 2001/82/EC;

(e) 
‘marketing authorisation’ means an authorisation
to place a medicinal product or a veterinary medicinal product on the market, in
accordance with Directive 2001/83/EC, Directive 2001/82/EC or Regulation (EC)
No 726/2004;

(f) 
‘making available on the market’ means any
supply of a new psychoactive substance for distribution, consumption or use on
the Union market in the course of a commercial activity, whether in return for
payment or free of charge;

(g) 
‘consumer’ means any natural person who is
acting for purposes which are outside his/her trade, business or profession;

(h) 
‘commercial and industrial use’ means any
manufacture, processing, formulation, storage, mixing, production and sale to
natural and legal persons other than consumers;

(i) 
‘scientific research and development’ means any scientific
experimentation, analysis or research carried out under strictly controlled
conditions, in accordance with Regulation (EC) No 1907/2006;

(j) 
‘United Nations system’ means the World Health
Organisation, the Commission on Narcotic Drugs and the Economic and Social
Committee acting in accordance with their respective responsibilities as
described in Article 3 of the 1961 United Nations Single Convention on Narcotic
Drugs, as amended by the 1972 Protocol, or in Article 2 of the 1971 United
Nations Convention on Psychotropic Substances.

CHAPTER II

Free movement

Article 3

Free movement

New psychoactive substances and mixtures
shall move freely in the Union for commercial and industrial use, as well as for
scientific research and development purposes.

Article 4

Prevention of barriers to free movement

Insofar as the
Union has not adopted measures to subject a new psychoactive substance to
market restriction under this Regulation, Member States may adopt technical
regulations on such new psychoactive substance in accordance with Directive 98/34/EC.

Member States shall immediately communicate
to the Commission any such draft technical regulation on new psychoactive
substances, in accordance with Directive 98/34/EC.

CHAPTER III

Exchange and collection of information

Article 5

Information exchange

National Focal
Points within the European Information Network on Drugs and Drug Addiction ("Reitox")
and Europol National Units shall provide to the EMCDDA and Europol the
available information on the consumption, possible risks, manufacture,
extraction, importation, trade, distribution, trafficking, commercial and
scientific use of substances that appear to be new psychoactive substances or mixtures.

The EMCDDA and
Europol shall communicate that information immediately to Reitox and the
Europol National Units.

Article 6

Joint report

1.           Where
the EMCDDA and Europol, or the Commission, consider that the information shared
on a new psychoactive substance notified by several Member States gives rise to
concerns across the Union because of the health, social and safety risks that the
new psychoactive substance may pose, the EMCDDA and Europol shall draw up a
joint report on the new psychoactive substance.

2.           The
joint report shall contain the following information:

(a) 
the nature of the risks that the new
psychoactive substance poses when consumed by humans and the scale of the risk
to public health, as referred to in Article 9(1);

(b) 
the chemical and physical identity of the new
psychoactive substance, the methods and, if known, the chemical precursors used
for its manufacture or extraction, and other new psychoactive substances with a
similar chemical structure that have emerged;

(c) 
the commercial and industrial use of the new
psychoactive substance, as well as its use for scientific research and
development purposes;

(d) 
the human and veterinary medical use of the new
psychoactive substance, including as an active substance in a medicinal product
or veterinary medicinal product;

(e) 
the involvement of criminal groups in the
manufacture, distribution or trade in the new psychoactive substance, and any
use of the new psychoactive substance in the manufacture of narcotic drugs or
psychotropic substances;

(f) 
whether the new psychoactive substance is
currently under assessment, or has been under assessment, by the United Nations
system;

(g) 
whether the new psychoactive substance is
subject to any restriction measures in the Member States;

(h) 
any existing prevention and treatment measure in
place to address the consequences of the use of the new psychoactive substance.

3.           The
EMCDDA and Europol shall request the National Focal Points and the Europol
National Units to provide additional information on the new psychoactive
substance. They shall provide that information within four weeks from receipt
of the request.

4.           The
EMCDDA and Europol shall request the European Medicines Agency to provide
information on whether, in the Union or in any Member State, the new psychoactive
substance is:

(a) 
an active substance in a medicinal product or a
veterinary medicinal product that has obtained a marketing authorisation;

(b) 
an active substance in a medicinal product or a
veterinary medicinal product that is the subject of an application for a
marketing authorisation;

(c) 
an active substance in a medicinal product or a
veterinary medicinal product that has obtained a marketing authorisation, but
the marketing authorisation has been suspended by the competent authority;

(d) 
an active substance in an unauthorised medicinal
product in accordance with Article 5 of Directive 2001/83/EC or in a veterinary
medicinal product prepared extemporaneously by a person authorised to do so
under national legislation in accordance with Article 10(c) of Directive
2001/82/EC.

Member States shall provide the European Medicines
Agency with the above information, if so requested by it.

The European Medicines Agency shall provide the
information at its disposal within four weeks from receipt of the request from
the EMCDDA.

5.           The
EMCDDA shall request the European Chemicals Agency and the European Food Safety
Authority to provide the information and data at their disposal on the new
psychoactive substance. The EMCDDA shall respect the conditions on use of the
information, which are communicated to the EMCDDA by the European Chemicals
Agency and the European Food Safety Authority, including conditions on
information and data security and protection of confidential business
information.

The European Chemicals Agency and the European
Food Safety Authority shall provide the information and data at their disposal within
four weeks from receipt of the request.

6.           The
EMCDDA and Europol shall submit the joint report to the Commission within eight
weeks from the request for additional information referred to in paragraph 3.

When the EMCDDA and Europol collect information
on mixtures or on several new psychoactive substances with similar chemical
structure, they shall submit individual
joint reports to the Commission within ten weeks from the request for additional information referred to in paragraph 3.

CHAPTER IV

Risk assessment

Article 7

Risk assessment procedure and report

1.           Within four weeks from the
receipt of the joint report referred to in Article 6, the Commission may
request the EMCDDA to assess the potential risks posed by the new psychoactive
substance and to draw up a risk assessment report. The risk assessment shall be
conducted by the Scientific Committee of the EMCDDA.

2.           The
risk assessment report shall include
an analysis of the criteria and of the information referred to in Article 10(2)
to enable the Commission to determine the level of health, social and safety risks
that the new psychoactive substance poses.

3.           The
Scientific Committee of the EMCDDA shall assess the risks during a special
meeting. The Committee may be extended by not more than five experts, representing
the scientific fields relevant for ensuring a balanced assessment of the risks
of the new psychoactive substance. The Director of the EMCDDA shall designate
them from a list of experts. The Management Board of the EMCDDA shall approve
the list of experts every three years. The Commission, the EMCDDA, Europol and
the European Medicines Agency shall each have the right to nominate two observers.

4.           The
Scientific Committee of the EMCDDA shall carry out the risk assessment on the
basis of information on the
risks of the substance and on its uses, including commercial and industrial
uses, provided by the Member States, the Commission, the EMCDDA, Europol, the European
Medicines Agency, the European Chemicals Agency, the European Food Safety
Authority and on the basis of any other relevant scientific evidence. It shall
take into consideration all opinions held by its members. The EMCDDA shall support
the risk assessment and shall identify information needs, including targeted
studies or tests.

5.           The
EMCDDA shall submit the risk assessment report to the Commission within twelve
weeks from the date when it received the request from the Commission.

6.           Upon
request of the EMCDDA, the Commission may extend the period to complete the risk
assessment by no more than twelve weeks to allow for additional research and
data collection to take place. The EMCDDA shall submit such a request to the
Commission within six weeks from the launch of the risk assessment. If within
two weeks of such request being made the Commission has not objected to such
request, the risk assessment shall be so extended.

Article 8

Exclusion from risk assessment

1.           No risk assessment shall
be carried out where the new psychoactive substance is at an advanced stage of
assessment within the United Nations system, namely once the World Health
Organisation expert committee on drug dependence has published its critical
review together with a written recommendation, except where there is
significant information that is new or of particular relevance for the Union
and that has not been taken into account by the United Nations system.

2.           No risk assessment shall
be carried out where the new psychoactive substance has been assessed within
the United Nations system, but it has been decided not to schedule it under the
1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or
the 1971 Convention on Psychotropic Substances, except where there is
significant information that is new or of particular relevance for the Union.

3.           No risk assessment shall
be carried out where the new psychoactive substance is:

(a) 
an active substance in a medicinal product or a
veterinary medicinal product that has obtained a marketing authorisation;

(b) 
an active substance in a medicinal product or a
veterinary medicinal product that is the subject of an application for a
marketing authorisation;

(c) 
an active substance in a medicinal product or a
veterinary medicinal product that has obtained a marketing authorisation, but
the marketing authorisation has been suspended by the competent authority.

CHAPTER V

Market restrictions

Article 9

Immediate risks to public health and temporary
consumer market restriction

1.           Where it requests a risk
assessment of a new psychoactive substance pursuant to Article 7(1), the Commission
shall, by means of a Decision, prohibit the making available on the market to
consumers of the new psychoactive substance if, based on existing information,
it poses immediate risks to public health, evidenced by:

(a) 
reported fatalities and severe health
consequences associated with the consumption of the new psychoactive substance
in several Member States, related to the serious acute toxicity of the new
psychoactive substance;

(b) 
the prevalence and patterns of use of the new
psychoactive substance in the general population and in specific groups, in
particular frequency, quantities and modality of use, its availability to
consumers and the potential for diffusion, which indicate that the scale of the
risk is considerable.

2.           The Commission shall adopt
the Decision referred to in paragraph 1 by means of implementing acts. Those implementing
acts shall be adopted in accordance with the examination procedure referred to
in Article 19(2).

On duly justified imperative grounds of urgency
relating to a rapid increase in the number of reported fatalities in several
Member States associated with the consumption of the new psychoactive substance
concerned, the Commission shall adopt immediately applicable implementing acts
in accordance with the procedure laid down in Article 19(3).

3.           The market restriction contained
in the Decision referred to in paragraph 1 shall not exceed a period of twelve
months.

Article 10

Determination of the level of health, social and
safety risks following the risk assessment

1.           The Commission shall
determine the level of the health, social and safety risks posed by the new
psychoactive substance on which a risk assessment report was drafted. It shall
do so on the basis of all available evidence, in particular the risk assessment
report.

2.           The Commission shall take
the following criteria into account when determining the level of risk of a new
psychoactive substance:

(a) 
the harm to health caused by the consumption of
the new psychoactive substance associated with its acute and chronic toxicity, abuse
liability and dependence-producing potential, in particular injury, disease,
and physical and mental impairment;

(b) 
the social harm caused to individuals and to
society, in particular its impact on social functioning, public order and
criminal activities, organised crime activity associated with the new
psychoactive substance, illicit profits generated by the production, trade and
distribution of the new psychoactive substance, and associated economic costs
of the social harm;

(c) 
the risks to safety, in particular the spread of
diseases, including transmission of blood borne viruses, the consequences of
physical and mental impairment on the ability to drive, the impact of the
manufacture, transport and disposal of the new psychoactive substance and
associated waste materials on the environment.

The Commission shall also take into account the
prevalence and patterns of use of the new psychoactive substance
in the general population and in specific groups, its availability to
consumers, its potential for diffusion, the number of Member States where it
poses health, social and safety risks, the extent of its commercial and
industrial use, and its use for scientific research and development purposes.

Article 11

Low risks

The Commission shall not adopt restriction
measures on a new psychoactive substance if, based on existing evidence, it
poses, overall, low health, social and safety risks, in particular:

(a) 
the harm to health caused by the consumption of
the new psychoactive substance associated with its acute and chronic toxicity,
abuse liability and dependence-producing potential, is limited, as it provokes
minor injury and disease, and minor physical or mental impairment;

(b) 
the social harm caused to individuals and to
society is limited, in particular regarding its impact on social functioning
and public order, criminal activities associated with the new psychoactive substance
is low, illicit profits generated by the production, trade and distribution of
the new psychoactive substance and associated economic costs are non-existent
or negligible;

(c) 
the risks to safety are limited, in particular
low risk of spread of diseases, including transmission of blood borne viruses, non-existent
or low consequences of physical and mental impairment on the ability to drive, and
the impact of the manufacture, transport and disposal of the new psychoactive substance
and associated waste materials on the environment is low.

Article 12

Moderate risks and permanent consumer market restriction

1.           The Commission shall, by
means of a Decision, without undue delay, prohibit the making available on the
market to consumers of the new psychoactive substance if, based on existing evidence,
it poses, overall, moderate health, social and safety risks, in particular:

(a) 
the harm to health caused by the consumption of
the new psychoactive substance associated with its acute and chronic toxicity,
abuse liability and dependence-producing potential, is moderate, as it generally
provokes non-lethal injury and disease, and moderate physical or mental
impairment;

(b) 
the social harm caused to individuals and to
society is moderate, in particular regarding its impact on social functioning
and public order, producing public nuisance; criminal activities and organised
crime activity associated with the substance are sporadic, illicit profits and
economic costs are moderate;

(c) 
the risks to safety are moderate, in particular sporadic
spread of diseases, including transmission of blood borne viruses, moderate consequences
of physical and mental impairment on the ability to drive, and the manufacture,
transport and disposal of the new psychoactive substance and associated waste
materials results in environmental nuisance.

2.           The Commission shall adopt
the Decision referred to in paragraph 1 by means of implementing acts. Those implementing
acts shall be adopted in accordance with the examination procedure referred to
in Article 19(2).

Article 13

Severe risks and permanent market restriction

1.           The Commission shall, by
means of a Decision, without undue delay, prohibit the production, manufacture,
making available on the market including importation to the Union, transport, and
exportation from the Union of the new psychoactive substance if, based on existing
evidence, it poses, overall, severe health, social and safety risks, in
particular:

(a) 
the harm to health caused by the consumption of
the new psychoactive substance associated with its acute and chronic toxicity,
abuse liability and dependence-producing potential, is life threatening, as it generally
provokes death or lethal injury, severe disease, and severe physical or mental
impairment;

(b) 
the social harm caused to individuals and to
society is severe, in particular regarding its impact on social functioning and
public order, resulting in public order disruption, violent and anti-social
behaviour causing damage to the user, to others and to property; criminal
activities and organised crime activity associated with the new psychoactive substance
are systematic, illicit profits, and economic costs are high;

(c) 
the risks to safety are severe, in particular significant
spread of diseases, including transmission of blood borne viruses, severe consequences
of physical and mental impairment on the ability to drive, and the manufacture,
transport and disposal of the new psychoactive substance and associated waste
materials result in environmental harm.

2.           The Commission shall adopt
the Decision referred to in paragraph 1 by means of implementing acts. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 19(2).

Article 14

Authorised uses

1.           The Decisions referred to in
Article 9(1) and Article 12(1) shall not impede the free movement in the Union
and the making available on the market to consumers of new psychoactive substances
that are active substances in medicinal products or veterinary medicinal
products that have obtained a marketing authorisation.

2.           The Decisions referred to in
Article 13(1) shall not impede the free movement in the Union and the production,
manufacture, making available on the market including importation to the Union,
transport, and exportation from the Union of new psychoactive substances:

(a) 
for scientific research and development purposes;

(b) 
for uses authorised under Union legislation;

(c) 
that are active substances in medicinal products
or veterinary medicinal products that have obtained a marketing authorisation;

(d) 
for use in the manufacture of substances and
products provided that the new psychoactive substances are transformed in such
a condition that they cannot be abused or recovered.

3.           The Decisions referred to in
Article 13(1) may set requirements and conditions for the production,
manufacture, making available on the market including importation to the Union,
transport, and exportation from the Union of new psychoactive substances posing
severe health, social and safety risks for the uses listed in paragraph 2.

CHAPTER VI

Monitoring and re-examination

Article 15

Monitoring

The EMCDDA and Europol, with the support of
Reitox, shall monitor all new psychoactive substances on which a joint report
has been drawn up.

Article 16

Re-examination
of level of risks

Where new information and evidence is
available on the risks posed by a new psychoactive substance the health, social
and safety risks of which have already been determined in accordance with Article
10, the Commission shall request the EMCDDA to update the risk assessment
report drafted on the new psychoactive substance and shall re-examine the level
of risks that the new psychoactive substance poses.

CHAPTER VII

Sanctions and remedy

Article 17

Sanctions

Member States shall lay down the rules on sanctions
applicable to infringements of the Decisions referred to in Article 9(1), Article
12(1) and Article 13(1) and shall take all necessary measures to ensure that
they are implemented. The sanctions provided for shall be effective,
proportionate and dissuasive. Member States shall notify those rules on
sanctions and any subsequent amendment affecting those provisions to the
Commission without delay.

Article 18

Remedy

Any person whose rights are affected by the
implementation of a sanction taken by a Member State in accordance with Article
17 shall have the right to an effective remedy before a tribunal in that Member
State.

CHAPTER VIII

PROCEDURES

Article
19

Committee

1.           The Commission shall be
assisted by a committee. That committee shall be a committee within the
meaning of Regulation (EU) No 182/2011.

2.           Where reference is made to
this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3.           Where reference is made to
this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with
Article 5 thereof, shall apply.

CHAPTER IX

Final Provisions

Article 20

Research and analysis

The Commission
and the Member States shall support the development, sharing and dissemination
of information and knowledge on new psychoactive substances. They shall do so
by facilitating cooperation between the EMCDDA, other Union agencies, and scientific
and research centres.

Article 21

Reporting

The EMCDDA and Europol shall report
annually on the implementation of this Regulation.

Article 22

Evaluation

By [five years after the entry into
force of this Regulation] at the latest and every five years thereafter,
the Commission shall assess the implementation, application and effectiveness
of this Regulation and publish a report.

Article 23

Replacement of Decision 2005/387/JHA

Decision 2005/387/JHA
is hereby repealed and replaced, without prejudice to the obligations of the
Member States relating to the time limit for transposition of that Decision
into national law. References to Decision 2005/387/JHA shall be construed as
reference to this Regulation.

Article 24

Entry into force

This Regulation shall enter into force on
the [twentieth] day following that of its publication in the Official
Journal of the European Union.

This Regulation shall be binding
in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Regulation of the European Parliament and of
the Council on new psychoactive substances

1.2.        Policy area(s) concerned
in the ABM/ABB structure[25]

Title 33: Justice

1.3.        Nature of the
proposal/initiative

ý The proposal/initiative relates to a new action

 ̈ The proposal/initiative relates to a new action
following a pilot project/preparatory action[26]

 ̈ The proposal/initiative relates to the extension of
an existing action

 ̈ The proposal/initiative relates to an action
redirected towards a new action

1.4.        Objective(s)

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

Building a safe and secure Europe: to improve
the capacity to detect, assess and respond rapidly and effectively to the
emergence of new psychoactive substances

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

Specific objective No:

Prevent and reduce drug use, drug dependence and drug-related harm

ABM/ABB activity(ies) concerned

1.4.3.     Expected result(s) and
impact

To reduce the availability in the EU internal
market of new psychoactive substances that pose health, social and safety
risks, and to prevent the emergence of obstacles to legitimate trade and
increase legal certainty for economic operators.

1.4.4.     Indicators of results and
impact

· 
Number of new psychoactive substances notified,
of Member States that notified it.

· 
Known commercial and industrial uses of new
psychoactive substances.

· 
Characteristics and availability (including on
the internet) of the substances.

· 
Number of joint reports and risk assessments
conducted.

· 
Number and type of restriction measures on new psychoactive
substances at the EU and national level.

· 
Number of health alerts issued on new
psychoactive substances and follow-up given by responsible authorities.

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

· 
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.

· 
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.

1.5.2.     Added value of EU
involvement

EU action on new psychoactive substances would
boost the exchange of information among the Member States, with the clear added
value of alerting Member States to potentially harmful substances that have
emerged in other Member States, to help them anticipate a potential public
health threat. The assessment of risks of substances at the EU level has the
added value of pooling scientific resources and analytical capacities from
across the EU, to provide the best evidence available on a substance and help
develop effective responses to it. EU-level decisions on restricting the
availability of harmful substances would increase legal certainty and reduce
obstacles for economic operators in the market for legitimate uses, while
improving consumer protection across the EU.

1.5.3.     Lessons learned from
similar experiences in the past

The 2011 Commission's assessment report[27] on the implementing of the
current Council Decision 2005/387/JHA on the information exchange, risk-assessment
and control of new psychoactive substances, based on an extensive consultation
of Member State stakeholders, concluded that the Council Decision is a useful
instrument for tackling new substances at the EU level, but that it has several
major shortcomings, including:

(1)     It is slow and reactive, and it is
therefore not able to address effectively the increase in the number of new
psychoactive substances.

(2)     Insufficient evidence is available to
take appropriate and sustainable decisions under this instrument.

(3)     It lacks options for restriction
measures.

1.5.4.     Compatibility and possible
synergy with other appropriate instruments

Action in the field of new psychoactive
substances is in compliance with the existing rules on the functioning of the
internal market, as well as with EU strategic policy documents, including the
EU Drugs Strategy 2013-2020, the Stockholm Programme and the Commission
Communication "Towards a stronger European response to drugs". EU action
in the field of new psychoactive substances is also fully consistent with
action at the United Nations' level.

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited
duration

– 
 ̈  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

– 
 ̈  Financial impact from YYYY to YYYY

ý Proposal/initiative of unlimited
duration

– 
Implementation with a start-up period from YYYY
to YYYY,

– 
followed by full-scale operation.

1.7.        Management mode(s) planned[28]

From the 2014 budget

ý Direct management by the Commission

– 
ý by its departments, including by its staff in the Union
delegations;

– 
 ̈  by the executive agencies;

 ̈ Shared management with the Member States

 ̈ Indirect management by delegating implementation tasks to:

– 
 ̈ third countries or the bodies they have designated;

– 
 ̈ international organisations and their agencies (to be specified);

– 
 ̈the EIB and the European Investment Fund;

– 
 ̈ bodies referred to in Articles 208 and 209 of the Financial
Regulation;

– 
 ̈ public law bodies;

– 
 ̈ bodies governed by private law with a public service mission to the
extent that they provide adequate financial guarantees;

– 
 ̈ bodies governed by the private law of a Member State that are
entrusted with the implementation of a public-private partnership and that
provide adequate financial guarantees;

– 
 ̈ persons entrusted with the implementation of specific actions in
the CFSP pursuant to Title V of the TEU, and identified in the relevant basic
act.

– If more than one management mode is
indicated, please provide details in the "Comments" section.

Comments:

The only minor costs expected for the EU
budget relate to the evaluation of the legislative instrument and meetings of
the committee of Member States.

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

The Commission will evaluate the
implementation, functioning, effectiveness, efficiency, utility and added value
of the future mechanism on new psychoactive substances every five years,
publish the results and propose amendments, if necessary.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

None identified.

2.2.2.     Information concerning the
internal control system set up

Standard Commission control/infringement
procedures concerning the application of the future Regulation and Directive.

2.2.3.     Estimate of the costs and
benefits of the controls and assessment of the expected level of risk of error

Not relevant as no specific risk identified.

2.3.        Measures to prevent fraud
and irregularities

In order to combat fraud, corruption and other
unlawful activities, the provisions of Regulation (EC) No 1073/1999 apply.

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing expenditure budget lines

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [...]Heading..........................................................] || Diff./non-diff. ([29]) || from EFTA countries[30] || from candidate countries[31] || from third countries || within the meaning of Article 21(2)(b) of the Financial Regulation

3 || [33 03 03] || Diff. || NO || NO || NO || NO

· New budget lines requested

In order of multiannual financial framework
headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [...]Heading..........................................................] || Diff./non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 21(2)(b) of the Financial Regulation

|| [...][XX.YY.YY.YY] || || YES/NO || YES/NO || YES/NO || YES/NO

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to three decimal places)

Heading of multiannual financial framework || Number || [Heading 3: Security and Citizenship]

DG JUST || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Yean 2020 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

Ÿ Operational appropriations || || || || || || || || || || ||

33 03 03 || Commitments || (1) || || || || || || 0,150 || || || || || 0,150

Payments || (2) || || || || || || 0,150 || || || || || 0,150

Number of budget line || Commitments || (1a) || || || || || || || || || || ||

Payments || (2a) || || || || || || || || || || ||

Appropriations of an administrative nature financed from the envelope of specific programmes[32] || || || || || || || || || || ||

Number of budget line || || (3) || || || || || || || || || || ||

TOTAL appropriations for DG JUST || Commitments || =1+1a +3 || || || || || || 0,150 || || || || || 0,150

Payments || =2+2a +3 || || || || || || 0,150 || || || || || 0,150

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || || || 0,150 || || || || || 0,150

Payments || (5) || || || || || || 0,150 || || || || || 0,150

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || || || || ||

TOTAL appropriations for HEADING 3 of the multiannual financial framework || Commitments || =4+ 6 || || || || || || 0,150 || || || || || 0,150

Payments || =5+ 6 || || || || || || 0,150 || || || || || 0,150

If more than one heading is affected by the proposal /
initiative: N/A

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || || || || ||

Payments || (5) || || || || || || || ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 || || || || || || || ||

Payments || =5+ 6 || || || || || || || ||

Heading of multiannual financial framework || 5 || "Administrative expenditure"

EUR million (to three decimal places)

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

DG JUST ||

Ÿ Human resources || 0,013 || 0,013 || 0,013 || 0,013 || 0,013 || 0,065 || 0,013 || 0,143

Ÿ Other administrative expenditure || 0,025 || 0,025 || 0,025 || 0,025 || 0,025 || 0,025 || 0,025 || 0,175

TOTAL DG JUST || Appropriations || || || || || || || ||

TOTAL appropriations for HEADING 5 of the multiannual financial framework || Total commitments = Total payments || 0,038 || 0,038 || 0,038 || 0,038 || 0,038 || 0,09 || 0,038 || 0,318

EUR million (to three decimal places)

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 0,038 || 0,038 || 0,038 || 0,038 || 0,038 || 0,240 || 0,038 || 0,468

Payments || 0,038 || 0,038 || 0,038 || 0,038 || 0,038 || 0,240 || 0,038 || 0,468

3.2.2.     Estimated impact on
operational appropriations

– 
 ̈  The proposal/initiative does not require the use of operational
appropriations

– 
ý  The proposal/initiative requires the use of operational
appropriations, as explained below:

Commitment appropriations in EUR million (to three
decimal places)

Indicate objectives and outputs ò || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

OUTPUTS

Type[33] || Average cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || No total || Total cost

SPECIFIC OBJECTIVE No 1 Prevent and reduce drug use, drug dependence and drug-related harm || || || || || || || || || || || || || || || ||

- Output || Evaluation || 0,1580 || || || || || || || || || || || 1 || 0,150 || || || 1 || 0,150

- Output || || || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

Subtotal for specific objective No 1 || || || || || || || || || || || 1 || 0,150 || || || 1 || 0,150

SPECIFIC OBJECTIVE NO 2 ... || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

Subtotal for specific objective No 2 || || || || || || || || || || || || || || || ||

TOTAL COST || || || || || || || || || || || 1 || 0,150 || || || 1 || 0,150

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

– 
 ̈  The proposal/initiative does not require the use of appropriations
of an administrative nature

– 
ý  The proposal/initiative requires the use of appropriations of an
administrative nature, as explained below:

EUR million (to three
decimal places)

|| Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || 0,013 || 0,013 || 0,013 || 0,013 || 0,013 || 0,065 || 0,013 || 0,143

Other administrative expenditure || 0,025 || 0,025 || 0,025 || 0,025 || 0,025 || 0,025 || 0,025 || 0,175

Subtotal HEADING 5 of the multiannual financial framework || 0,038 || 0,038 || 0,038 || 0,038 || 0,038 || 0,090 || 0,038 || 0,318

Outside HEADING 5[34] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || || || || || || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || || || || || || || ||

TOTAL || 0,038 || 0,038 || 0,038 || 0,038 || 0,038 || 0,090 || 0,038 || 0,318

The human resources
appropriations required will be met by appropriations from the DG that are
already assigned to management of the action and/or have been redeployed within
the DG, together if necessary with any additional allocation which may be
granted to the managing DG under the annual allocation procedure and in the light
of budgetary constraints.

3.2.3.2.  Estimated
requirements of human resources

– 
 ̈  The proposal/initiative does not require the use of human
resources.

– 
ý  The proposal/initiative requires the use of human resources, as
explained below:

Estimate to be expressed in full time
equivalent units

|| Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

Ÿ Establishment plan posts (officials and temporary staff)

33 01 01 01 (Headquarters and Commission’s Representation Offices) || 0,1 || 0,1 || 0,1 || 0,1 || 0,1 || 0,5 || 0,1 || 1,1

XX 01 01 02 (Delegations) || || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || || ||

10 01 05 01 (Direct research) || || || || || || || ||

Ÿ External staff (in Full Time Equivalent unit: FTE)[35] ||

XX 01 02 01 (CA, SNE, INT from the "global envelope") || || || || || || || ||

XX 01 02 02 (CA, LA, SNE, INT and JED in the delegations) || || || || || || || ||

XX 01 04 yy[36] || - at Headquarters || || || || || || || ||

- Delegations || || || || || || || ||

XX 01 05 02 (CA, SNE, INT - Indirect research) || || || || || || || ||

10 01 05 02 (CA, INT, SNE - Direct research) || || || || || || || ||

Other budget lines (specify) || || || || || || || ||

TOTAL || 0,1 || 0,1 || 0,1 || 0,1 || 0,1 || 0,5 || 0,1 || 1,1

33 is the policy
area or budget title concerned.

The human resources
required will be met by staff from the DG who are already assigned to
management of the action and/or have been redeployed within the DG, together if
necessary with any additional allocation which may be granted to the managing
DG under the annual allocation procedure and in the light of budgetary
constraints.

Description of
tasks to be carried out:

Officials and temporary staff || Preparation of one committee meeting of Member States per year. Coordination of an external study for the evaluation of the instrument every five years.

External staff ||

3.2.4.     Compatibility with the
current multiannual financial framework

– 
ý  Proposal/initiative is compatible with the current multiannual
financial framework.

– 
 ̈  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts.

– 
 ̈  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[37].

Explain what is required, specifying the
headings and budget lines concerned and the corresponding amounts.

3.2.5.     Third-party contributions

– 
The proposal/initiative does not provide for
co-financing by third parties.

– 
The proposal/initiative provides for the
co-financing estimated below:

Appropriations in EUR million (to 3 decimal places)

|| Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || Total

Specify the co-financing body || || || || || || || ||

TOTAL appropriations cofinanced || || || || || || || ||

3.3.        Estimated impact on
revenue

– 
ý  Proposal/initiative has no financial impact on revenue.

– 
 ̈  Proposal/initiative has the following financial impact:

-  ̈       on own resources

-  ̈       on miscellaneous revenue

EUR million (to three decimal places)

Budget revenue line: || Appropriations available for the current financial year || Impact of the proposal/initiative[38]

Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6)

Article ............. || || || || || || || ||

For miscellaneous
‘assigned’ revenue, specify the budget expenditure line(s) affected.

Specify the method for
calculating the impact on revenue.

[1]               COM(2011) 689 final.

[2]               OJ L 127, 10.5.2005, p.32.

[3]               http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/jha/126879.pdf

[4]               COM(2012) 629 final.

[5]               OJ L 335, 11.11.2004, p. 8.

[6]               EMCDDA, 2012 Annual report on the state of the
drugs problem in Europe; available at: http://www.emcdda.europa.eu/publications/annual-report/2012

[7]               EMCDDA, European Drug Report 2013; available
at: http://www.emcdda.europa.eu/edr2013.

[8]               Available at:
http://www.emcdda.europa.eu/publications/joint-publications/drug-markets

[9]               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.

[10]             OJ L 167, 25.6.1997, p.1.

[11]             COM(2011) 430 final and SEC(2011) 912 final.

[12]             OJ C 229, 31.7.2012, p. 85.

[13]             OJ C [...], [...], p. [...].

[14]             OJ L 167, 25.6.1997, p. 1.

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

[16]             OJ L 47, 18.2.2004, p. 1.

[17]             OJ L 22, 26.1.2005, p. 1.

[18]             OJ L 376, 27.12.2006, p. 1.

[19]             OJ L 204, 21.7.1998. p. 37.

[20]             OJ L 311, 28.11.2001, p. 67.

[21]             OJ L 311, 28.11.2001, p. 1.

[22]             OJ L 136, 30.4.2004, p. 1.

[23]             OJ L 55, 28.02.2011, p.13.

[24]             OJ L 194, 18.7.2001, p. 26.

[25]             ABM: activity-based management – ABB: activity-based
budgeting.

[26]             As referred to in Article 54(2)(a) or (b) of the
Financial Regulation.

[27]             COM(2011) 430 final and SEC(2011) 912.

[28]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[29]             Diff. = Differentiated appropriations / Non-Diff. =
Non-differentiated appropriations.

[30]             EFTA: European Free Trade Association.

[31]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[32]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[33]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[34]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[35]             CA= Contract Staff; LA = Local Staff; SNE= Seconded
National Expert; INT = agency staff; JED= Junior Experts in Delegations).

[36]             Sub-ceiling for external staff covered by operational
appropriations (former "BA" lines).

[37]             See points 19 and 24 of the Interinstitutional
Agreement (for the period 2007-2013).

[38]             As regards traditional own resources (customs duties,
sugar levies), the amounts indicated must be net amounts, i.e. gross amounts
after deduction of 25% for collection costs.