# EUR-Lex - 52012PC0548 - EN

*|*

# 52012PC0548

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Amending Regulation (EC) No 273/2004 on drug precursors /* COM/2012/0548 final - 2012/0261 (COD) */**

			*

			*

EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

General Context

Many chemicals are used in a wide variety
of important industrial processes (e.g. in the synthesis of plastics,
pharmaceuticals, cosmetics, perfumes, detergents and aromas) and they are traded
for these licit uses on regional and global markets. Some of these chemicals can,
however, be misused for the illicit manufacture of narcotic drugs and
psychotropic substances. The chemicals produced for a licit purpose which can
be misused in the illegal drug production are called drug precursors.

Drug precursors are rarely produced by the
criminals that intend to use them in the illicit manufacture of drugs, as their
production often requires important industrial infrastructure. Therefore,
criminals try to divert these substances from the licit trade.

The trade in drug precursors is not in
itself prohibited because of their important legitimate uses. However, in order
to prevent their diversion to illicit drug production, a specific regulatory
framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic
Drugs and Psychotropic Substances (hereafter referred as UN 1988 Convention).
The European Union is a Party to the Convention and has
implemented its obligations through Regulation (EC) No 273/2004 governing the
monitoring of the intra-EU trade in drug precursors and Regulation (EC)
No 111/2005 governing the external trade. The Union regulatory
framework provides for the monitoring and control of the legitimate trade in
drug precursors. Operators, i.e. manufacturers, distributors, brokers,
importers, exporters and wholesalers of chemicals engaged in the legitimate
trade of drug precursors are required to take measures against theft, check
their customers, detect suspicious transactions and notify the authorities
thereof. This industry-authority partnership is key to the well
functioning of the regulatory framework.

Public authorities monitor that companies dealing with drug precursors properly exercise their
obligations under the legislation by conducting on-site inspections and via
administrative procedures such as granting licences and registrations.

Grounds for and objectives of the
proposal

Traffickers purchase the drug precursors
they need from different regions of the world and exploit weaknesses of control
to their benefit. This proposal aims to address a specific weakness
which has been detected in the European Union, when large quantities of acetic
anhydride ("AA"), the main drug precursor for heroin, were diverted
from the EU-internal trade: in 2008, 75% of the global seizures of AA
happened in the EU. Heroin use has been contributing to public
health problems in Europe since the 1970s. It still accounts for the greatest
share of morbidity and mortality-related drug use in the European Union.

Even though the quantities of AA seized
in the EU have decreased very substantially since 2008, the INCB[1]
continues to mention in its annual reports that the European legislative control
measures are not sufficiently strict to prevent the diversion of the main
heroin precursor from the intra-EU trade.

On 7 January 2010, the European Commission
adopted a Report on the implementation and functioning of the
existing EU legislation on drug precursors[2] which concluded
that the legislation is overall functioning well but also identified some
weaknesses and made recommendations how to address these[3].

This proposal addresses, by amending
Regulation (EC) No 273/2004, the recommendation of the Commission Report to
improve the prevention of the diversion from the EU-internal trade of AA,
the main drug precursor for heroin, by extending the registration
requirement, which so far applies only to operators placing AA on the
market, to also include users of the substance and by enhancing the harmonised
registration provisions to achieve a more robust level playing field preserving
the internal market and avoiding adoption of divergent national measures.

Consistency with other policy and
objectives of the Union

This proposal is fully consistent with the
objectives of the EU Drugs Strategy 2005-2012[4] and the EU
Drugs Action Plan (2009-2012)[5], which set out the
objective to reduce the diversion and trafficking in/via the Union of drug
precursors used for the production of illicit drugs.

As the drug problem is a complex
phenomenon, it requires a multidisciplinary approach of combining demand and
supply reduction[6]. Preventing
the diversion and trafficking of drug precursors aims at reducing the supply
of illicit drugs – the ultimate objective being a high level of protection,
well-being and social cohesion for EU citizens by preventing and reducing drug
use in line with the EU Drug Strategy. The European Commission Services are
currently carrying out an evaluation of the 2005-2012 EU Drugs Strategy; in
preparation of the EU Drug Strategy from 2013[7]. This
evaluation is, however, not questioning the pillar ‘supply reduction’ (which
includes the prevention of diversion of drug precursors) and the Union being a Party
to Article 12 of the 1988 UN Convention is in any case bound to work towards
the objective of preventing the diversion of drug precursors.

A high level of human health protection
is a basic principle of the Treaty, which shall be ensured in the definition
and implementation of all policies and activities of the EU. The control of
drug precursor diversion contributes to the protection of human health,
specifically in the area of drugs-related health damage where the Treaty
invites the Union to complement Member States’ actions on prevention of
drug-use[8].

In addition, the initiative is also in line
with the principle of the Treaty that the Union shall endeavour to ensure a high
level of security through measures to prevent and combat crime, and through
measures for coordination and cooperation between police and other competent
authorities[9].

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

Consultations of interested parties,
collection and use of expertise

The Commission Services consulted in 2009 and early 2010 all stakeholders on the implementation of
Regulation (EC) No 273/2004 and presented its findings in a Report to the
European Parliament and the Council, which was adopted on 7 January 2010[10].
In May 2010, the Council adopted conclusions on the
Commission’s Report, recognising the importance of continuing active
co-operation among authorities and industry and of improving the implementation
of the European legislation. The Council invited the Commission to set up a work
programme to address the identified weaknesses of the legislation in
co-operation with Member States and to propose legislative amendments before
the end of 2011 after carefully assessing their potential impacts on Member
States authorities and economic operators[11].

The Commission subsequently developed six potential policy options (see the next section for
details) and discussed them with the Member States and industry representatives
in a special meeting of the Drug Precursor Working Group in June 2010.

Member States and industry stakeholders
were further consulted on the six options via a written consultation, carried
out from 23 July to 18 October 2010. Three main target groups were identified:
manufacturers and traders (operators), end-users and competent authorities of
Member States. In addition, an SME-consultation was carried out via the
Enterprise Europe network from 1 October until 24 November 2010 to ensure that
the concerns of a specific target group – end-users of drug precursors most of
which are SMEs – were considered.

Finally, the Commission mandated a study to
an external consultant to evaluate in detail the administrative costs on
companies and authorities that would result from each of the policy options.

Impact assessment

The main problem driver being the
insufficient control by competent authorities over all economic players
involved in the legitimate trade with drug precursors, all policy options
examined seek to improve control via enhanced reporting, notification or
registration obligations imposed on the economic players. The impacts of the
following six policy options have been analysed:

– Option 1 (baseline option): no action: the current EU legislation
will remain unchanged;

– Option 2: strengthened reporting obligations;

– Option 3: strengthened rules and obligations on operators related to
customer declarations from end-users;

– Option 4: require operators to systematically notify new end-users
to the authorities to allow verification;

– Option 5: require registration for end-users and reinforce
requirements regarding registration;

– Option 6: move AA from category 2 to category 1 scheduled substances.

For options 2 to 5, two sub-options were analysed,
i.e. to either limit them specifically to AA or to apply them to all scheduled
substances in category 2.

The overall conclusion of the impact
assessment[12] was that both, option 4
(for only AA) and option 5 (for only AA) would be good choices to address the
identified objectives. Both would have effects on SMEs as end-users dealing
with AA are primarily SMEs, but option 5 would be less burdensome than option 4
in terms of annual costs for enterprises (provided authorities do not pass on
all costs to registrants by imposing fees), an argument which is particular
relevant for SMEs. All in all the strong political support which option 5 has
from most Member States, combined with views expressed on international level
that a more systematic control of (all) AA end-users is lacking in the European
legislation, and the somewhat lower burden on SMEs tip the balance in the end
in favour of option 5.

3.           LEGAL ELEMENTS OF THE PROPOSAL

Legal basis

The legal basis of the proposal is Article
114 of the Treaty on the Functioning of the European Union (TFEU). Article 114
has the objective to establish an internal market while ensuring a high level
of protection of human health and the environment.

Subsidiarity principle

The subsidiarity principle as set out in Article
5(3) of the Treaty on the European Union applies insofar as the proposal does
not fall under the exclusive competence of the Union.

The general objective of Regulation (EC) No
273/2004 is to prevent the diversion of drug precursors from legitimate trade
in accordance with the Union's obligations under Article 12 of the 1988 UN
Convention. It contributes to the world-wide combat against the illicit
production and trafficking of narcotic drugs and psychotropic substances, while
ensuring a proper functioning of the internal market for drug precursors by subjecting
operators to the same, harmonised rules within the EU whilst avoiding
unnecessary obstacles to legitimate trade and administrative burden for
enterprises and competent authorities.

The objective of this proposal, namely to
strengthen control measures on AA in order to prevent it diversion from the EU
internal market while avoiding market distortions, cannot be sufficiently
achieved by the Member States alone and action by the Union will be more
efficiently achieved for the following reasons:

–
Some Member States feel legally prevented from
adopting national control measures going beyond the EU legislation on the basis
of Article 10 of Regulation (EC) No 273/2004, which empowers Member States
to adopt national measures which are necessary to enable its authorities to
perform their control and monitoring duties. They argue that the EU legislation
is subjecting only operators to control measures (no obligations are
imposed on end-users), which should be understood as a deliberate and binding
decision of the EU-legislator that end-users should not be subject to
the control of the drug precursor legislation

–
On the contrary, other Member States are
contemplating or have already based substantive national controls on Article
10, leading in first instance to different approaches of control in different
Member States which might be detrimental to the functioning of the Union Market
and, secondly, isolated actions in individual Member States risks shifting the
problem from one Member State to the next, as traffickers will exploit the
“weakest link” in the Union market. A combination of different national
measures will not be as effective as a harmonised approach at EU-level. This is
also confirmed by the fact that both, Member States and concerned industry
sectors have called on the Commission to act to preserve the internal market
with a level playing field, and not to rely too much on supplementary national
measures.

Proportionality principle

The proposal does not go beyond what is
necessary in order to achieve the intended objectives, in accordance with the principle
of proportionality, as set out in Article 5(4) of the Treaty on European Union.
By preventing the diversion of drug precursor from the legal trade to illicit
drug production, this proposal is expected to contribute to the fight against
illicit trafficking in narcotic drugs and psychotropic substances, and
consequently to protect citizens from the health damage related to drug
addiction. Furthermore by ensuring that operators and users engaged in the
legal trade of those drug precursors are subject to harmonised rules, it should
ensure a proper functioning of the Union market by avoiding unnecessary
barriers to such legitimate trade and by reducing administrative burdens for
operators and competent authorities.

The proposal only tackles the weaknesses
identified in the evaluation on the functioning and on the implementation of
the Regulations on Drug Precursors, namely by requiring registration not only for
operators placing AA on the market but also for users possessing it for their
own uses or processes (i.e. end-users). The proposal does not extend the envisaged
provisions for AA to other scheduled substances in category 2.

Choice
of the instrument

The chosen
legal instrument is a Regulation as it aims to harmonise the rules applicable
to economic operators (end-users) dealing with AA for their own uses or
processes. It amends the already existing Regulation (EC) No 273/2004.

Main provisions of the proposal

The proposal introduces
the requirement that end-users of AA must obtain a registration as already
exists for operators placing the substance on the market, and strengthens the
rules for registration.

Additionally it
proposes to establish and maintain a European Database on Drug Precursors in
order to modernize the collection of the information provided by Member States
on drug precursor seizures and stopped shipments, in accordance with current
Article 13 of Regulation (EC) No 273/2004, and to maintain a list of EU
licensed or registered operators and users legally trading or using drug
precursors, as well as to enable operators to provide
competent authorities in summary form with information about their transactions
involving scheduled substances in accordance with current Article 8 (2) of
Regulation (EC) No 273/2004.

Finally, the
draft Regulation adapts the provisions of Regulation (EC) No 273/2004 regarding
ex-Comitology to the new rules of the Lisbon Treaty.

4.           BUDGETARY IMPLICATION

The proposal has no impact on the European
Union budget because no additional resources are required to implement the
action proposed. The necessary resources to implement the European database are
already included in the allocations granted during the budget procedure and
within the Internal Market line. Therefore it does not have a budgetary impact
over and above the appropriations already foreseen for the years to come in the
official programming of the Commission.

5.           ADDITIONAL INFORMATION

–
The proposal is subject to a notification to the
WTO in the framework of the TBT Agreement.

–
The proposed act is relevant for the European
Economic Area (EEA).

–
The proposed act contains transitional period
for the coming into force of the new registration obligations for end-users of AA.

–
The proposed act includes a review clause to
assess whether the amended Regulation will have been effective to prevent the
diversion of AA.

2012/0261 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

Amending Regulation (EC) No 273/2004 on
drug precursors

(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],

Having regard to the opinion of the
European Data Protection Supervisor[14],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Pursuant to Article 16 of Regulation (EC) No 273/2004 of the European
Parliament and of the Council of 11 February 2004 on drug precursors[15],
the Commission adopted on 7 January 2010 a report to the Council and the
European Parliament on the implementation and functioning of the existing EU
legislation on drug precursors[16].

(2)       In that report, the
Commission recommended further analysing ways to strengthen the control of the
trade of acetic anhydride (scheduled substance in Category 2) in order to
better prevent the diversion of acetic anhydride for the illicit production of
heroin.

(3)       In its Conclusions
on the functioning and implementation of the EU drug precursor's legislation of
25 May 2010, the Council invited the Commission to propose legislative
amendments after assessing their potential impacts on competent authorities and
economic operators.

(4)       The definition of
scheduled substances should be clarified: the term 'pharmaceutical preparation'
stemming from the United Nations Convention against Illicit Traffic in Narcotic
Drugs and Psychotropic Substances adopted in Vienna on 19 December 1988, (hereinafter
referred to as the "United Nations Convention") should be replaced by
the relevant terminology of the Union legislation, 'medicinal products', and
the term 'other preparations' should be deleted as it duplicates the term 'mixtures'
already used in the definition.

(5)       A definition of the term
'user' should be introduced for companies possessing substances for purposes other
than placing them on the market.

(6)       It should be clarified
that companies using scheduled substances in category 1 for other purposes than
placing them on the market are obliged to obtain a licence.

(7)       More detailed rules on registration
should be introduced to ensure uniform conditions of registration in all Member
States for scheduled substances in category 2 of Annex I. For substances
scheduled in a new subcategory 2A of Annex I, not only operators but also users
should be subject to a registration requirement.

(8)       In order to safeguard the
competitiveness of microenterprises, no fees should be imposed on them for
obtaining a registration or a licence.

(9)       Explicit provisions should
be foreseen to clarify that Member States have the possibility to act with
regard to suspicious transactions involving non-scheduled substances in order
to enable them to react more quickly with regard to new trends in the illicit
production of drugs.

(10)     A European database on drug
precursors should be created to simplify the reporting by Member States with
regard to seizures and stopped shipments, to create a European register of
operators and users holding a license or a registration which will facilitate verification of the legitimacy of commercial
transactions involving scheduled substances, and to enable operators to provide
the competent authorities with information about their legal transactions
involving scheduled substances.

(11)     Regulation (EC) No 273/2004
envisages the processing of data. Such processing of data may also cover
personal data which should be carried out in accordance with Union Law.

(12)     Acetic anhydride, currently
scheduled in category 2 of Annex I, should be included in a new subcategory 2A
of Annex I to allow increased control of its trade. The remaining substances of
category 2 should be listed as subcategory 2B.

(13)     Regulation
(EC) No 273/2004 confers powers
on the Commission in order to implement some of its provisions, to be exercised
in accordance with the procedures laid down in Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission[17]
as amended by Council Decision 2006/512/EC[18].

(14)     As
a consequence of the entry into force of the Lisbon Treaty, those powers need
to be aligned to Articles 290 and 291 of the Treaty on the Functioning of the
European Union.

(15)     In order to achieve
the objectives of Regulation (EC) No 273/2004, the power to adopt acts in
accordance with Article 290 of the Treaty on the Functioning
of the European Union should be
delegated to the Commission to specify the requirements
and conditions for the granting of the licence and registration, for obtaining
and using customer declarations, for the documentation and labelling of mixtures,
for provision of information by the operators on transactions involving
scheduled substances, for listing operators and users having obtained a licence
or registration in the European register and in order to amend the Annexes. It is of particular importance that the Commission carry out
appropriate consultations during its preparatory work, including at expert
level.

(16)     The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and Council.

(17)     In order to ensure uniform
conditions for the implementation of Regulation (EC) No 273/2004,
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[19].

(18)     The examination procedure
should be used for the adoption of the implementing acts in order to set up
details on how customer declarations should be provided in electronic form; to
set up details on how to provide the information about transactions of operators
with scheduled substances to a European database.

(19)     Since the objectives of
this Regulation, namely to strenghen the rules for registration of operators
placing on the internal market or possessing scheduled substances of category 2,
in particular acetic anhydride, in order to prevent its diversion towards the illicit
production of drugs, cannot be sufficiently achieved by Member States because
traffickers gain from national differences in registration and move their
illicit business where drug precursors are easiest to divert and can therefore
be better achieved at the level of the Union, 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.

Regulation (EC) No
273/2004 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 273/2004 is amended as
follows:

(1)
Article 2 is amended as follows:

(a)
point (a) is replaced by the following:

"(a)       'scheduled
substance’ means any substance used for the illicit manufacture of narcotic
drugs or psychotropic substances and listed in Annex I including mixtures and natural
products containing such substances. This excludes natural products and mixtures
which contain scheduled substances and which are compounded in such a way that the
scheduled substances cannot be easily used or extracted by readily applicable
or economically viable means
and medicinal products within the meaning of Article 1(2) of Directive
2001/83/EC of the European Parliament and of the Council[20];"

(b)
the following point (h) is inserted:

"(h)       'user' means any natural or
legal person who possesses a scheduled substance and is engaged in the
processing, formulation, consumption, storage, keeping, treatment, filling into
containers, transfer from one container to another, mixing, transformation or
any other utilisation of scheduled substances."

(2)
Article 3 is amended as follows:

(a)
paragraphs 2 and 3 are replaced by the following:

"2.        Operators and users shall be
required to obtain a licence from the competent authorities before they may
possess or place on the market scheduled substances of category 1 of Annex I.
Special licences may be granted by the competent authorities to pharmacies,
dispensaries of veterinary medicine, certain types of public authorities or
armed forces. Such special licences shall only be valid for the use of scheduled substances of
category 1 of Annex I within the scope of the official duties of the operators
concerned.

3.          Any operator holding a licence
referred to in paragraph 2 shall supply scheduled substances of category 1 of Annex I only to operators or users who hold
such a licence and have signed a customer declaration as provided for in
Article 4(1)."

(b)
paragraph 5 is replaced by the following:

"5.        Without prejudice to paragraph
9, the competent authorities may either limit the validity of the licence to a
period not exceeding three years or may oblige the operators to demonstrate at
intervals not exceeding three years that the conditions under which the licence
was granted are still fulfilled. The licence shall mention the operation or
operations for which it is valid, as well as the substances concerned. Special
licences within the meaning of paragraph 2 shall be granted in principle for an
unlimited duration but may be suspended or revoked by the competent authorities
under the conditions of paragraph 4, third sentence."

(c)
paragraph 6 is replaced by the following:

"6.        From [18 months after the date
of publication] operators shall be required to obtain a registration from the
competent authorities before placing on the market scheduled substances of
category 2 of Annex I. Furthermore, users shall be required to obtain a
registration from the competent authorities before possessing scheduled
substances of subcategory 2A of Annex I. Special registrations may be granted
by competent authorities to pharmacies, dispensaries of veterinary medicine,
certain types of public authorities or the armed forces. Such registrations
shall be considered valid only for the use of scheduled substances of category
2 of Annex I within the scope of the official duties of the operators or users concerned."

(d)
the following paragraphs 6a and 6b are inserted:

"6a.       Any operator holding a
registration referred to in paragraph 6 shall supply scheduled substances of subcategory
2A of Annex I only to other
operators or users who hold such a registration and have signed a customer
declaration as provided for in Article 4(1).

6b.        When considering whether to grant a
registration, the competent authorities shall take into account in particular
the competence and integrity of the applicant the registration is to be refused
if there are reasonable grounds for doubting the suitability and reliability of
the applicant or of the officer responsible for the trade in scheduled
substances. The registration may be suspended or revoked by the competent
authorities whenever there are reasonable grounds for believing that the holder
is no longer a fit and proper person to hold a registration, or that the
conditions under which the registration was granted are no longer fulfilled."

(e)
in paragraph 7, the following sentence is added:

"An operator or user who is a microenterprise
within the meaning of Article 2(3) of the Annex to the Commission
Recommendation of 6 May 2003 concerning the definition of micro, small and
medium-sized companies[21] shall not be required to
pay any such fees."

(f)
the following paragraphs 8 and 9 are added:

"8.        The competent authorities shall
enter operators and users having obtained a licence referred to in paragraph 2
or a registration referred to in paragraph 6 in a European Database on drug
precursors to be developed by the Commission as provided for in Article 13a.

9.          The Commission shall be empowered
to adopt delegated acts in accordance with Article 15a concerning:

(a)
the requirements and conditions for the granting
of the licence referred to in paragraph 2;

(b)
the requirements and conditions for the granting
of the registration referred to in paragraph 6.

(c)
the requirements and conditions for listing
operators and users having obtained a licence or registration in a European
Database on drug precursors referred to in paragraph 8."

(3)
Article 4 is amended as follows:

(a)
paragraph 1 is replaced by the following:

"1.        Without prejudice to paragraph
4, Articles 6 and 14, any operator established within the Community who
supplies a customer with a scheduled substance of categories 1 or 2 of Annex I
shall obtain a declaration from the customer which shows the specific use or
uses of the scheduled substances. A separate declaration shall be required for
each scheduled substance. This declaration shall conform to the model set out
in point 1 of Annex III. In the case of legal persons, the declaration shall be
made on headed notepaper."

(b)
the following paragraph 4 is added:

"4.        The Commission shall be
empowered to adopt delegated acts in accordance with Article 15a concerning the
requirements and conditions for obtaining and using customer
declarations."

(4)
In Article 5, the following paragraph 7 is added:

"7.      The Commission shall be empowered
to adopt delegated acts in accordance with Article 15a concerning the
requirements and conditions for the documentation of mixtures containing
substances listed in Annex I."

(5)
In Article 7, the following second paragraph is added:

"The Commission shall be empowered to
adopt delegated acts in accordance with Article 15a concerning the requirements
and conditions for the labelling of mixtures containing substances listed in
Annex I."

(6)
Article 8 is replaced by the following:

"1       Operators shall notify the
competent authorities immediately of any circumstances, such as unusual orders
or transactions involving scheduled substances to be placed on the market,
which suggest that such substances might be diverted for the illicit
manufacture of narcotic drugs or psychotropic substances. To this end, operators
shall provide any available information allowing the competent authorities to
verify the legitimacy of the relevant order or transaction.

2.       Operators shall provide the competent
authorities in summary form with relevant information about their transactions
involving scheduled substances.

3.       The Commission shall be empowered to
adopt delegated acts in accordance with Article 15a concerning the requirements
and conditions for operators to provide information as referred to in paragraph
2."

(7)
In Article 9, paragraph 1 is replaced by the
following:

“In order to facilitate cooperation between the
competent authorities, the operators, and the chemical industry, in particular
as regards non-scheduled substances, the Commission shall draw up and update
guidelines to assist the chemical industry.”

(8)
In Article 10, paragraph 2 is replaced by the
following:

"2.      Each Member State may adopt the
measures necessary to enable its competent authorities to control and monitor
suspicious transactions with non-scheduled substances, in particular:

(a)
to obtain information on any orders for non-scheduled
substances or operations involving non-scheduled substances;

(b)
to enter operators' business premises in order
to obtain evidence of suspicious transactions with non-scheduled substances.

3.       The competent authorities shall
respect confidential business information."

(9)
The following Article 13a is inserted:

"Article
13a

Database

The Commission shall develop a European
Database on drug precursors with the following functions:

(a)
facilitating the communication of information
pursuant to Article 13(1), its synthesis and analysis on the level of the Union,
and the reporting to the International Narcotics Control Board pursuant to
Article 13(2);

(b)
creating a European register of operators and users,
which have been granted a licence pursuant to Article 3(2) or registration pursuant
to Article 3(6);

(c)
enabling operators to provide the competent
authorities with information about their transactions according to Article 8(2)
in electronic form, as specified in implementing measures adopted pursuant to
Article 14."

(10)
The following Article 13b is inserted:

“Article
13b

Data
protection

1.       The processing of personal data by the
competent authorities in the Member States shall be carried out in accordance
with Directive 95/46/EC[22] and under the
supervision of the public independent authority of the Member State referred to
in Article 28 of this Directive.

2.       The processing of personal data by the
Commission, including for the purpose of the European Database provided for in
Article 13a, shall be carried out in accordance with Regulation (EC) No 45/2001
of the European Parliament and of the Council[23] and under the
supervision of the European Data Protection Supervisor."

(11)
Articles 14 and 15 are replaced by the
following:

“Article
14

Implementing
Acts

1.       The Commission may adopt the following
implementing acts:

(a)
rules on how to provide customer declarations
referred to in Article 4 in electronic form, where appropriate;

(b)
rules on how to provide the information referred
to in Article 8(2) in electronic form to a European database, where appropriate.

2.       The acts referred to in paragraph 1 of
this Article shall be adopted in accordance with the examination procedure
referred to in Article 14a(2).

Article
14a

Committee
Procedure

1.       The Commission shall be assisted by
the Drug Precursors Committee established by Article 30 of Council Regulation
(EC) No 111/2005[24]. That committee shall be a committee within the meaning of Regulation
(EU) No 182/2011.

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

Article
15

Adaptation
of Annexes

The Commission shall be empowered to adopt
delegated acts in accordance with Article 15a in order to adapt Annexes I,
II and III to new trends in diversion of drug precurors and to follow an amendment to the tables in the Annex to the United Nations
Convention.

Article
15a

Exercise
of delegation

1.       The power to adopt delegated acts is
conferred on the Commission subject to the conditions laid down in this
Article.

2.       The delegation of power referred to in
Article 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 15 shall be conferred for an
indeterminate period of time from [date of entry into force of this amending Regulation].

3.       The delegation of powers referred to
in Article 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 15 may be revoked at any
time by the European Parliament or by the Council. A decision of revocation
shall put an end to the delegation of power spedified in that decision. It
shall take effect the day following the publication of the decision in the
Official Journal of the European Union or at a later date specified therein. It
shall not affect the validity of any delegated acts already in force.

4.       As soon as it adopts a delegated act,
the Commission shall notify it simultaneously to the European Parliament and
the Council.

5.       A delegated act adopted pursuant to
Article 3(9), 4(4), 5(7), 7, 8(2), 13a(2), 15 shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of 2 months of notification of that act to the European Parliamant
and the Council or if, before the expiry of that period, the European
Parliament and the Council have both informed the Commission that they will not
object. That period shall be extended by 2 months at the initiative of the
European Parliament or the Council.”

(12)
Article 16 is replaced by the following:

"Article
16

Information
about measures adopted by Member States

1.       Member States shall inform the
Commission of the measures it adopts pursuant to this Regulation, and in
particular of the measures adopted pursuant to Articles 10 and 12. They shall
also notify any subsequent amendments thereof.

2.       The Commission shall communicate that
information to the other Member States.

3.       The Commission shall evaluate the
implementation and functioning of this Regulation by [78 months after of the
date of entry into force of this amending Regulation]."

(13)
Annex I is amended as follows:

(a)
the title of Annex I is replaced by the
following:

"List of scheduled substances";

(b)
the text set out for Category 2 is replaced by
the text set out in the Annex to this Regulation;

(14)
In Annex III, the term "authorisation/"
shall be deleted.

Article 2

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

ANNEX

"CATEGORY
2

SUBCATEGORY
2A

Substance || CN designation (if different) || CN code(1) || CAS No(2)

Acetic anhydride || || 2915 24 00 || 108-24-7

The salts of the substances listed in this category,
whenever the existence of such salts is possible.

___________________________________________________________________________

(1) OJ L290, 28.10.2002, p.1.

(2) The CAS No is the 'chemical abstracts service registry
number', which is a unique numeric identifier specific to each substance and
its structure. The CAS No is specific to each isomer and to each salt of each
isomer. It must be understood that the CAS Nos for the salts of the substances
listed above will be different to those given.

___________________________________________________________________________

SUBCATEGORY
2B

Substance || CN designation (if different) || CN code(1) || CAS No(2)

Phenylacetic acid || || 2916 34 00 || 103-82-2

Anthranilic acid || || 2922 43 00 || 118-92-3

Piperidine || || 2933 32 00 || 110-89-4

Potassium permanganate || || 2841 61 00 || 7722-64-7

The salts of the substances listed in this category,
whenever the existence of such salts is possible.

___________________________________________________________________________

(1) OJ L290, 28.10.2002, p.1.

(2) The CAS No is the 'chemical abstracts service registry
number', which is a unique numeric identifier specific to each substance and
its structure. The CAS No is specific to each isomer and to each salt of each
isomer. It must be understood that the CAS Nos for the salts of the substances
listed above will be different to those given.

___________________________________________________________________________

LEGISLATIVE FINANCIAL STATEMENT
FOR PROPOSALS

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

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

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

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

3.2.    Estimated
impact on expenditure

3.2.1. Summary of estimated impact on expenditure

3.2.2. Estimated
impact on operational appropriations

3.2.3. Estimated
impact on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
participation in financing

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Proposal for a Regulation of the European Parliament and of the
Council amending Regulation (EC) No 273/2004 on Drug Precursors

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

Title 2: Enterprise and Industry

Chapter 02.03: Internal market for goods and sectoral policies

1.3.        Nature of the
proposal/initiative

 ̈ The
proposal/initiative relates to a new action

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

X 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.        Objectives

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

1a. Competitiveness for growth and employment

Following the continuous review of existing internal market acquis
and its implementation, the new legislative proposal aims at improving
efficiency of exiting legislation on drug Precursors.

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

Specific objective No.

The development of a European Database aims at facilitating exchange
of information between the Member States Competent Authorities and the
Commission, and the economic operators and the Member States Competent
Authorities.

ABM/ABB activity(ies) concerned

Title 2 – Chapter 02.03 Internal market for goods and sectoral
policies

1.4.3.     Expected result(s) and
impact

Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.

The proposal, amending Regulation (EC) No 273/2004 aims mainly at
improving the prevention of the diversion from the EU-internal trade of acetic
anhydride, the main drug precursor for heroin, by extending the
registration requirement, which so far applies only to operators placing acetic
anhydride on the market, to also include users of the substance and by
enhancing the harmonised registration provisions to achieve a more robust level
playing field preserving the internal market and avoiding adoption of divergent
national measures.

Additionally, it proposes to establish and maintain a European
Database on Drug Precursors in order to modernize the annual collection of the
information provided by Member States on seizures and stopped shipments of drug
precursors, in accordance with Article 13 of Regulation (EC) No 273/2004, as
well as to maintain a list of EU licensed or registered operators and users
legally trading or using drug precursors;

The EU Database on Dugs precursors aims at providing a modern tool
for strengthening the control of legitimate trade in drug precursors:

- to Member States' Competent Authorities
to comply with their reporting obligations to
 the Commission in accordance with Article 13 of Regulation (EC) No 273/2004 and
 Article 29 of Commission Regulation (EC) No1277/2005;

- to Member States' Competent
Authorities and to EU industry operators to facilitate
 checking the legitimacy of potential clients and to reduce the burdens for
operators
 related to the yearly reporting of their transactions involving drug
precursors in accordance with Articles 4 and 8.2 of Regulation (EC) No 273/2004
and with Articles17
 and 19 of Council Regulation (EC) No 111/2005,

- to the Commission to facilitate
completion of its obligations towards the International
 Narcotics Control Board under Article 13 (1) of Regulation (EC) No 273/2004
and
 Article 32 (1) of Regulation No 111/2005 as well as towards Member States
under
 Article 29 of Commission Regulation ( EC) No 1277/2005.

Finally, the proposal adapts the provisions of Regulation (EC) No
273/2004 regarding ex-Comitology to the new rules of the Lisbon Treaty.

1.4.4.     Indicators of results and
impact

Specify the
indicators for monitoring implementation of the proposal/initiative.

The proposed Regulation aims to improve the prevention of the
diversion of drug precursors – in particular acetic anhydride - by traffickers
from the legitimate trade towards production of illicit drugs. Annual trends in
EU diversion of drug precursors will continue to be collected and reported, to
the general public, the Member States and the International Narcotics Control
Board. The objective is to achieve a decreasing trend in seizures and stopped
shipments.

1.5.        Grounds for the
proposal/initiative

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

The main aim of the proposal to amend Regulation (EC) No 273/2004 is
to address the weaknesses identified in the functioning of that Regulation in
preventing the diversion of certain drug precursors (in particular acetic
anhydride) from the legitimate trade to production of illicit drugs, through
control and monitoring of this legitimate trade.

The EU Drug Precursors' Database should facilitate the monitoring
and control activities by Member States, as well as the reporting tasks for
Member States and operators.

1.5.2.     Added value of EU
involvement

The objective of this proposal, namely to strengthen control
measures on acetic anhydride in order to prevent it diversion from the EU
internal market while avoiding market distortions, cannot be sufficiently
achieved by the Member States alone and action by the Union will be more
efficient for the following reasons:

1. Some Member States feel legally prevented from adopting national
control measures going beyond the EU legislation on the basis of Article 10 of
Regulation (EC) No 273/2004, which empowers Member States to adopt
national measures which are necessary to enable its authorities to perform
their control and monitoring duties. They argue that the EU legislation is
subjecting only operators to control measures (no obligations are
imposed on end-users), which should be understood as a deliberate and binding
decision of the EU-legislator that end-users should not be subject to
the control of the drug precursor legislation.

2. On the contrary, other Member States are contemplating or have
already based substantive national controls on Article 10, leading in first
instance to different approaches of control in different Member States which
might be detrimental to the functioning of the Union Market and, secondly,
isolated actions in individual Member States risks shifting the problem from
one Member State to the next, as traffickers will exploit the “weakest link” in
the Union market. A combination of different national measures will not be as
effective as a harmonised approach at EU-level. This is also confirmed by the fact
that both, Member States and concerned industry sectors have called on the
Commission to act to preserve the internal market with a level playing field,
and not to rely too much on supplementary national measures.

1.5.3.     Lessons learned from
similar experiences in the past

The Commission has conducted a thorough analysis of the functioning
of the existing Regulation (EC) No 273/2004 and on 7 January 2010, the European
Commission adopted a Report on the implementation and functioning
of the existing EU legislation on drug precursors[27].
While the Commission’s evaluation concluded that the legislation is overall
functioning well[28], it identified some
weaknesses and made recommendations how to address these, including in
particular a modification of some requirements for category 2 substances –
either specifically for acetic anhydride or for all category 2 substances – in
order to discourage diversion from the EU internal market.

This proposal aims to address this recommendation of the Commission
Report by amending Regulation (EC) No 273/2004, mainly to improve the
prevention of the diversion from the EU-internal trade of acetic anhydride,
the main drug precursor for heroin, by extending the registration
requirement, which so far applies only to operators placing acetic anhydride on
the market, to also include users of the substance and by enhancing the
harmonised registration provisions to achieve a more robust level playing field
preserving the internal market and avoiding adoption of divergent national
measures.

1.5.4.     Coherence and possible
synergy with other relevant instruments

This proposal is fully consistent with the objectives of the EU
drugs strategy 2005-2012 and the EU drugs Action Plan (2009-2012), setting out
the objective to reduce the diversion and trafficking in/via the Union of Drug
Precursors used in the production of illicit drugs, ultimately aiming at
reducing the supply of illicit drugs to EU citizens while ensuring a high level
of human health protection and a high level of security.

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

x Proposal/initiative of unlimited duration

–
Implementation with a start-up period from
January 2014 to December 2014,

–
followed by full-scale operation from 01 January
2015 (Estimated).

1.7.        Management mode(s)
envisaged[29]

x Centralised direct management by the Commission

 ̈ Centralised indirect management with the delegation of implementation tasks to:

–
 ̈  executive agencies

–
 ̈  bodies set up by the Communities[30]

–
 ̈  national public-sector bodies/bodies with public-service mission

–
 ̈  persons entrusted with the implementation of specific actions
pursuant to Title V of the Treaty on European Union and identified in the
relevant basic act within the meaning of Article 49 of the Financial Regulation

 ̈ Shared management with the Member States

 ̈ Decentralised management with third countries

 ̈ Joint management with international organisations (to be specified)

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

Comments

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

(1) Members States will yearly communicate to the Commission
the information on the cases where the delivery of drug precursors was
suspended or seized.

(2) The Member States will regularly forward to the Commission
the information concerning their licensed and registered operators and users
trading or possessing drug precursors, their respective transactions.

(3) The Commission in turn will regularly compile a report on
the basis of the information collected from Member States and will yearly
submit the overall EU information on seizures and stopped shipments of drug
precursors in the Union to the Member States and to the International Narcotics
Control Board. Furthermore the Commission will prepare for public release its
annual report on EU drug precursor's seizures and stopped shipments.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

The main risks are:

- Failure of
Members States to comply with their reporting obligations and/or the provision
of information on licensed/registered operators and users;

- Non uniform implementation of the
legislation in the Member States;

- Insufficient control systems in the
Members States in particular on licensed and/or registered operators and users.

2.2.2.     Control method(s) envisaged

The Member States have already designated authorities responsible
for overseeing the implementation of the legislation and for granting licenses
& registration to legitimate operators & users involved in the trade of
drug precursors;

Implementation of the legislation is monitored through regular
meetings of the designated national competent authorities responsible for the
EU Drug Precursors legislation;

The day to day management of the EU Database on Drug Precursors will
fall under the responsibility of the Commission Services in charge of following
the EU Drug Precursors legislation, mainly DG ENTR and DG TAXUD.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

No particular risk of fraud or irregularities has been identified.

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 [Description........................................] || Diff./non-diff ([31]) || from EFTA[32] countries || from candidate countries[33] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

1a. Competitiveness for growth and employment || Article 02.03.01 Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation || Diff./ DA || YES || 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 18(1)(aa) of the Financial Regulation

|| || || || || ||

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || Number 1a || Competitiveness for growth and employment

DG: ENTR || || || Year 2014[34] || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020[35] || TOTAL

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

Article 02.03.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation || Commitments || (1) || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.315

Payments || (2) || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.315

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

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

Appropriations of an administrative nature financed from the envelope for specific programmes[36] || || || || || || || ||

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

TOTAL appropriations for DG ENTR || Commitments || = 1+1a +3 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.315

Payments || = 2+2a +3 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.045 || 0.315

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 HEADING <....> of the multiannual financial framework || Commitments || = 4+ 6 || || || || || || || ||

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

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

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 3 decimal places)

DG: ENTR || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 || Year 2019 || Year 2020 || TOTAL

Ÿ Human resources || || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.756

Ÿ Other administrative expenditure || || || || || || || ||

TOTAL DG ENTR || Appropriations || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.756

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.756

EUR million (to 3 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 || 0.153 || 0.153 || 0.153 || 0.153 || 0.153 || 0.153 || 0.153 || 1.071

Payments || 0.153 || 0.153 || 0.153 || 0.153 || 0.153 || 0.153 || 0.153 || 1.071

3.2.2.     Estimated
impact on operational appropriations

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

–
x The proposal/initiative requires the use of operational
appropriations, as explained below[37]:

Commitment appropriations in EUR million (to 3 decimal
places)

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

|| OUTPUTS ||

|| || Type of output[38] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE No 1[39]... || || || || || || || || || || || || || || || || ||

- Output || || || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 7 || 0.315 ||

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

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

Sub-total for specific objective N°1 || || || || || || || || || || || || || || || || ||

SPECIFIC OBJECTIVE No 2... || || || || || || || || || || || || || || || || ||

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

Sub-total for specific objective No 2 || || || || || || || || || || || || || || || || ||

TOTAL COST || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 1 || 0.045 || 7 || 0.315 ||

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 administrative
appropriations

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

EUR million (to 3
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 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.756

Other administrative expenditure || || || || || || || ||

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

Outside HEADING 5[40] of the multiannual financial framework || || || || || || || ||

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

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

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

TOTAL || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.756

3.2.3.2.  Estimated requirements of
human resources

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

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

Estimate to be expressed in full amounts
(or at most to one decimal place)

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

Ÿ Establishment plan posts (officials and temporary agents) ||

|| 02 01 01 01 (Headquarters and Commission’s Representation Offices) || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108

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

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

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

|| Ÿ External personnel (in Full Time Equivalent unit: FTE)[41] ||

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

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

|| XX 01 04 yy [42] || - at Headquarters[43] || || || || || || ||

|| - in delegations || || || || || || ||

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

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

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

|| TOTAL || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108 || 0.108

02 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 agents || Management and development of EU legislation ensuring a Single Market for chemicals – in particular for drug precursors. Prepare, chair and write reports of meetings of working groups and regulatory committees to ensure uniform implementation of the legislation. Assist Member States and industry. Prepare relevant guidance documents, as well as agreed 'questions and answers' in close co-operation with Member States authorities and other stakeholders. Publish annual reports on seizures and stopped shipments. Oversee maintenance and further development of European Database on Drug Precursors. Answer parliamentary questions. Prepare adaptations to technical progress and conduct interservices consultations. Ensure close co-operation with DG TAXUD, who is responsible for monitoring external trade in drug precursors.

External personnel ||

3.2.4.     Compatibility with the
current multiannual financial framework

–
x Proposal/initiative is compatible with the multiannual financial
framework 2014-2020.

–
 ̈  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[44].

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

3.2.5.     Third-party contributions

–
x 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

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

–
 ̈  Proposal/initiative has the following financial impact:

–
 ̈         on own resources

–
 ̈         on miscellaneous revenue

EUR million (to 3 decimal places)

Budget revenue line: || Appropriations available for the ongoing budget year || Impact of the proposal/initiative[45]

Year N || Year N+1 || Year N+2 || Year N+3 || ... insert as many columns as necessary in order to reflect 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]               United Nations’ International Narcotics Control Board.

[2]               Report from the Commission
to the Council and the European Parliament pursuant to Article 16 of Regulation
(EC) No 273/2004 of the European Parliament and of the Council of 11
February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the
implementation and functioning of the Community legislation on monitoring and
control of trade in drug precursors, COM(2009)709 final, available at: http://eur‑lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0709:FIN:en:PDF.

[3]               For further details, see under Section 4.2.2
"Strength and weaknesses of the legislation" of the above-mentioned
Report COM(2009)709 final.

[4]               EU Drugs Strategy 2005-2012, endorsed by the European
Council of November 2004 (15074/04 CORDROGUE 77 SAN 187 ENFOPOL 187 RELEX 564).

[5]               EU
Drugs Action Plan for 2009-2012 (2008/C 326/09).

[6]               The EU Drug Strategy additionally complements these
two key dimensions with three cross-cutting themes: coordination; international
cooperation and information; research and evaluation.

[7]               For further details see http://ec.europa.eu/justice/newsroom/anti-drugs/opinion/111027_en.htm.

[8]               Article 168 TFEU (Treaty on the Functioning of the
European Union).

[9]               Article 67 TFEU.

[10]             See footnote 1.

[11]             Council conclusions on the functioning and
implementation of the EU drug precursor legislation – 3016th
Competitiveness Council meeting Brussels, 25 May 2010.

[12]             The
report on the impact assessment is available at: http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm.

[13]               OJ C , , p. .

[14]               OJ C...p....

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

[16]               Report from the Commission
to the Council and the European Parliament pursuant to Article 16 of Regulation
(EC) No 273/2004 of the European Parliament and of the Council of 11
February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the
implementation and functioning of the Community legislation on monitoring and
control of trade in drug precursors, COM(2009)709 final.

[17]               OJ L 184, 17.7.1999, p. 23.

[18]               OJ L 200, 22.7.2006, p. 11.

[19]               OJ L 55, 28.2.2011, p. 13.

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

[21]               OJ L 124, 20.5.2003, p.36.

[22]             OJ L 281, 23.11.1995, p. 31.

[23]             OJ L 8, 12.1.2001, p. 1.

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

[25]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[26]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[27]             Report from the Commission to
the Council and the European Parliament pursuant to Article 16 of Regulation
(EC) No 273/2004 of the European Parliament and of the Council of 11
February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the
implementation and functioning of the Community legislation on monitoring and
control of trade in drug precursors, COM(2009)709 final, available at:
http://eur‑lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0709:FIN:en:PDF.

[28]             For further details, see under Section 4.2.1
"Strength and weaknesses of the legislation" of the above-mentioned
Report COM(2009)209 final.

[29]             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

[30]             As referred to in Article 185 of the Financial
Regulation.

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

[32]             EFTA: European Free Trade Association.

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

[34]             Year N is the year in which implementation of the proposal/initiative
starts.

[35]             Costs also foreseen after 2020 because of the nature of
the project (database maintenance).

[36]             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.

[37]             No information on the outputs is yet available as the
pilot project of the European Database is not yet developed.

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

[39]             As described in Section 1.4.2. "Specific
objective(s)..."

[40]             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.

[41]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert.

[42]             Under the ceiling for external personnel from
operational appropriations (former "BA" lines).

[43]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[44]             See points 19 and 24 of the Interinstitutional
Agreement.

[45]             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.