# EUR-Lex - 52012PC0521 - EN

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# 52012PC0521

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors /* COM/2012/0521 final - 2012/0250 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

1.1.        Background

Drug precursors are chemical substances
having a wide variety of licit uses, such as in the synthesis of plastics,
pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded
for legitimate purposes on regional and global markets, but some of them can
also be diverted from the licit distribution channels for the illicit
manufacture of narcotic drugs.

Therefore,
controlling drug precursors is a key component in the fight against narcotic
drugs. Taking into account the wide legitimate uses of drug precursors, their
trade cannot be prohibited. A specific regulatory framework, both at
international and at EU level, has been put in place to monitor their legal
trade and to identify suspicious transactions, thus preventing their diversion
for illicit use.

Ephedrine and pseudoephedrine are chemical
substances used for the manufacture of cold or allergy medicines. These two
substances are also the main precursors for the manufacture of methamphetamine[1]. While ephedrine and
pseudoephedrine are controlled at international and EU level, the medicinal
products containing them are not controlled when they are exported from or
transiting through the Union customs territory. They are therefore targeted by
drug traffickers as a source of precursors for the illicit manufacture of
methamphetamine because the ephedrine or pseudoephedrine contained in these
products can be easily extracted (by using cheap home-made equipment and
through a simple chemical process).

The fact that medicinal products for human
use containing ephedrine or pseudoephedrine are excluded from the provisions of
Regulation (EC) 111/2005, which applies to trade in drug precursors between the
EU and third countries, has led to a situation where these products could not
be stopped or seized by Member States' competent authorities when these
products were exported from or transiting through the Union customs territory,
even though it was very likely that they would be misused for the illicit
manufacture of methamphetamine in their country of destination.

The EU is criticized internationally for
not taking adequate control measures across Member States to tackle this
weakness. Therefore, the EU is expected to close the loophole in the current
legislation as regards the powers conferred to customs and police authorities
who can stop and seize ephedrine and pseudoephedrine but cannot stop and seize
medicinal products containing ephedrine or pseudoephedrine.

In its Conclusions of 25 May 2010, the
Council invited the Commission to present a legislative proposal in this sense.

1.2.        Scale of the problem
(methamphetamine and its precursors)

In 2009 almost 7400 seizures of
methamphetamine, amounting to about 600 kg of the drug, were reported in
Europe. Both the number of seizures and quantities increased over 2004-2009. In
2009 illicit methamphetamine laboratories were seized for the first time in
several European countries. This is an indication that methamphetamine markets
may be expanding in Europe.

At global level, in 2009, North America
accounted for nearly half of global seizures of methamphetamine. Seizures in East and South-East Asia rose by more than one third and
there are signs that methamphetamine is reaching the region from Africa and the
Islamic Republic of Iran. West Africa is also emerging
as a new source of methamphetamine for the illicit Asian markets.

Ephedrine and pseudoephedrine are the main
precursors for methamphetamine. Seizures of methamphetamine precursors contained
in medicinal products have fluctuated considerably from 2007 until 2010. At
European level, while in 2007 hardly any preparations were recorded out of the
overall quantities seized, in 2008 and 2009 the amount of preparations out of
the total quantities seized increased sharply and decreased considerably again
in 2010[2].

After the continued
increase of seizures of medicinal products from 2007 to 2009, as a result of
strengthened controls of medicinal products containing ephedrine and
pseudoephedrine in several countries, particularly in Mexico and countries in
Central America, the total amount of medicinal products seized worldwide
decreased in 2010.

However, the increasing
or decreasing level of seizures is only one indicator to illustrate that
illicit manufacture is taking place in a given part of the world. The absence
of a control mechanism for medicinal products
containing ephedrine and pseudoephedrine remains a concern both at European and
at global level.

By imposing EU control over these medicinal
products, we are aiming to make it more difficult, expensive and risky for
criminals to source the chemicals they need to manufacture drugs. This proposal
should work as a deterrent: it focuses on preventing the diversion of
precursors. It concentrates on the supply reduction of the chemicals to make
drugs and not on the supply of the drugs for the consumers.

1.3.        Consistency with other EU
policies

Effectively preventing the diversion of
drug precursors to the production of illicit drugs aims to reduce the supply of
illicit drugs. It is thus consistent with the drug policy outlined in the EU
Drugs Strategy 2005-2012, providing for action to reduce the supply of
precursors, and, thereby, decrease the production of drugs.

This initiative aims to regulate the external
trade in medicinal products containing ephedrine and pseudo-ephedrine. These
products are regulated by Directive 2001/83/EC. However, the objective pursued
by that Directive is of a different nature, i.e. to safeguard public health by
controlling the production, distribution and use of medicinal products in order
to ensure their quality, safety and efficacy. This explains why the control
mechanisms foreseen in Directive 2001/83/EC and in Regulation (EC) 111/2005 are
different.

The medicinal products legislation has
recently been amended by Directive 2011/62/EU which relates to the prevention
of the entry into the legal supply chain of falsified medicinal products. The
Directive addresses inter alia the distribution chain for medicines
within the EU, importation of active substances, and 'introduction' of
medicines, i.e. medicines brought into the customs territory without the
intention of placing them on the market. These provisions are focused on
preventing products that fall within the definition of falsified
medicinal products from entering the legal supply chain. Given that the
principal issue with drug precursors is one of legitimately produced
products leaving the legal supply chain, it is unlikely that these new
provisions will make a significant contribution to tackling the issue of
controlling medicinal products containing ephedrine or pseudoephedrine being
exported or transiting through the EU.

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

2.1.        Consultation of interested
parties

A stakeholder consultation was held. This
was not a public consultation, given the sensitivity and the peculiarity of the
matter at stake[3].
Only the most concerned stakeholders were therefore
consulted, namely national competent authorities (customs, police and health)
and the pharmaceutical industry. To avoid providing
sensitive information to traffickers, the responses of the stakeholders were treated confidentially.

In response to this
consultation the Commission received 31 contributions. Of these, 22 were from
national authorities (3 of which were partial replies) and 8 from the industry
(6 manufacturing companies and 2 pharmaceutical associations).

In general terms, the industry is satisfied
with the current situation but would not be opposed to improve it to the extent
that it would not impose increased administrative burden on exporting
companies. Among Member States' competent authorities two thirds plead for an
amendment of the legislation, though to different degrees, while one third is
in favour of maintaining the current situation, thus not amending the
legislation.

2.2.        Impact Assessment

The impact assessment report identified and
assessed policy options aiming to prevent the diversion of medicinal products
containing ephedrine or pseudoephedrine to the illicit manufacture of
methamphetamine by introducing control measures over these products when traded
between the Union and third countries while maintaining their free flow.

The impact assessment report contains five
policy options. The first one provides for the so-called "baseline
scenario", where the Commission would take no action and the status quo would
be maintained. Option 2 considers contributing to improve the situation through
voluntary measures by Member States, while options 3, 4 and 5 consider
resolving it through compulsory control measures. The last three options have
been built as a crescendo as to the number and strength of the control measures
envisaged. Another policy option suggesting a trade ban on these products has
been considered and discarded without further analysis of its impact.

Option 1 should be excluded if the
Commission was to respond adequately to the Council's request to address the
weaknesses identified in the control system of the drug precursor legislation
and to concerns expressed by the international community.

Option 2 would only partially address the
identified problem. It suggests voluntary measures which will not be effective
unless adopted across all Member States. A compulsory application of these
measures cannot be enforced by the instrument foreseen under this option.

Options 3, 4 and 5 would all provide a
clear legal basis for competent authorities to stop and/or seize medicinal
products containing ephedrine or pseudoephedrine at export from or in transit
through the Union customs territory. They would all reduce the criticism
expressed by the UN International Narcotics Control Board on the alleged lack
of EU action to control these products. They would all increase the chances to
prevent the diversion of these products, thus reducing the supply of ephedrine
and pseudoephedrine for the illicit manufacture of methamphetamine, though to
different degrees.

When comparing these three options requiring legislative
amendments, option 3 (possibility for authorities to stop suspicious shipments)
would generate only minor administrative burden; the same can be expected for
option 4 (possibility for authorities to stop suspicious shipments and
pre-export notification of legal shipments), while option 5 (full control of
trade in medicinal products containing ephedrine and pseudoephedrine) would
impose the highest administrative burden for both competent authorities and
economic operators. Even though option 5 could be considered the most effective
by applying the strictest controls, the requirements would be disproportionate
to the objective pursued by the present initiative. The added value provided by
option 4 if compared to option 3 is that, under this option, the synergy of two
combined measures increases the effectiveness of each
individual measure, with a limited additional burden given that the pre-export
notification system is up and running and that the number of pre-export
notifications that could be seemingly sent per year by Member States' competent
authorities is relatively small. Moreover, as pre-export notifications are
already compulsory for scheduled substances of category 1, it would seem
logical to make them compulsory also for the products containing them, such as
medicinal products containing ephedrine or pseudoephedrine.

The impact assessment concluded that option
4 would be the most suitable one to address the identified problem, as it would
provide for a legal basis, impose only one extra control requirement and
generate hardly any additional administrative burden.

3.           LEGAL BASIS AND SUBSIDIARITY

The legal basis of the proposal is
Article 207 of the Treaty on the Functioning of the European Union (TFEU). Article 207 defines the EU common
commercial policy. Moreover, Article 3(1) of the TFEU provides exclusive
competence of the European Union in the area of common commercial policy.

Council Regulation (EC) No 111/2005 lays
down rules for the monitoring of trade in drug precursors between the Union and
third countries, and therefore falls under the common commercial policy.

4.           BUDGETARY IMPLICATION

The proposal will not have an impact on human resources and
on the European Union budget and is therefore not accompanied by the financial
statement foreseen under Article 28 of the Financial Regulation (Council
Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the
Financial Regulation applicable to the general budget of the European
Communities).

5.           ADDITIONAL INFORMATION

The proposal contains some other amendments
aiming at facilitating the implementation of the Regulation and at increasing
its effectiveness.

The proposal includes:

- the possibility to amend the Annex to the
Regulation in order to react more quickly to new emerging trends in precursors
diversion;

- a reference to the database, created by
Regulation (EC) No 273/2004 as amended, to simplify the reporting by Member
States' authorities in accordance with Article 12(12) of the United Nations
Convention;

- a review clause to assess whether the
amended Regulation will have been effective to prevent the diversion of
medicinal products containing ephedrine or pseudoephedrine;

- the adaptation of the provisions of
Regulation (EC) No 111/2005 in accordance with the rules on delegated and
implementing acts under the Treaty on the Functioning of the European Union
(TFEU).

The Commission has been granted
implementing powers under the current Regulation in accordance with Articles 4
and 7 of Decision 1999/468/EC. As this Regulation is being amended, these
powers have to be aligned in accordance with Articles 290 and 291 of the TFEU.
The alignment in the proposal has been made in accordance with the provisions
of the Common Understanding on Delegated Acts between the European Parliament,
the Council and the Commission and Regulation (EU) No 182/2011 laying down the
rules and general principles concerning mechanisms for control by Member States
of the Commission’s exercise of implementing powers.

The proposal is subject to the WTO-TBT
Agreement, thus subject to a notification to the WTO.

2012/0250 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

amending Council Regulation (EC) No
111/2005 laying down rules for the monitoring of trade between the Community
and third countries in 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 207 thereof,

Having regard to the proposal from the
European Commission,

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

After consulting the European Data
Protection Supervisor[4],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Pursuant to Article 32 of
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[5],
the Commission presented on 7 January 2010 a report to the Council and
the European Parliament on the implementation and functioning of the Community
legislation on monitoring and control of trade in drug precursors[6].

(2)       The Commission
report pointed out that, in the existing Union control system for drug
precursors, medicinal products containing ephedrine and pseudoephedrine, whose
trade was not controlled, were diverted into the illicit drug manufacture
outside the Union, as a substitute to internationally controlled ephedrine and
pseudoephedrine. The Commission therefore recommended strengthening the control
of international trade in medicinal products containing ephedrine or
pseudoephedrine exported from or transiting through the Union customs territory
which are diverted for the illicit manufacture of drugs.

(3)       In its Conclusions
on the functioning and implementation of the Union drug precursors legislation
of 25 May 2010, the Council of the European Union invited the Commission to
make a proposal to amend Council Regulation (EC) No 111/2005 accordingly.

(4)       It is important
that the definition of scheduled substances 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)       Rules on suspending
or revoking a registration should be introduced in order to match the existing
rules for suspending or revoking a licence.

(6)       Medicinal products
containing ephedrine or pseudoephedrine should therefore be controlled without
impeding their legitimate trade.

(7)       To this end, any
export of medicinal products containing ephedrine or pseudoephedrine should be preceded by a pre-export notification sent by the
competent authorities in the Union to the competent authorities of the country
of destination.

(8)       Member States' competent
authorities should be given the powers to stop or seize
those products when there are reasonable grounds for suspecting that they are
intended for the illicit drug manufacture, when they are exported, imported or
in transit.

(9)       With a view to enabling
Member States to react more quickly with regard to new emerging trends in drug precursors'
diversion, their possibilities to act in cases of suspicious transactions
involving non-scheduled substances should be clarified.

(10)     The European Database on drug precursors should be used to simplify the reporting by Member States with regard to
seizures and stopped shipments, to establish a European register of operators
holding a licence or a registration, which will facilitate verification of the
legitimacy of their transactions involving scheduled substances and to enable
operators to provide the competent authorities with information about their
export, import or intermediary activities involving scheduled substances.

(11)     Regulation (EC) No 111/2005
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)     Regulation (EC) No 111/2005 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[7] as amended
by Council Decision 2006/512/EC[8].

(13)     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 (the Treaty).

(14)     In order to achieve
the objectives of Regulation (EC) No 111/2005, 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 in order to lay
down provisions determining cases where a licence is not required and to set
out further conditions for granting licences, to establish the conditions for
exemptions from the
controls of certain categories of operators and of operators engaged in the
export of small quantities
of scheduled substances listed in Category 3, to establish the criteria to
determine how the licit purposes of the transaction may be demonstrated, to
determine the information that is required by the competent authorities to
monitor export, import or intermediary activities of operators, to determine
the countries of destination to which exports of scheduled substances of
Category 2 and 3 of the Annex should be preceded by a pre-export notification, to
determine simplified pre-export procedures and to establish the common criteria
thereof, to determine the countries of destination to which exports of
scheduled substances listed in Category 3 of the Annex should be subject to an
export authorisation, to determine simplified export authorisation procedures
and to establish the common criteria thereof, and to introduce additional
substances into the Annex to this Regulation, as well as other amendments
necessary to respond to new trends of drug precursor diversion. It is of particular importance that the Commission carries out
appropriate consultations during its preparatory work, including at expert
level.

(15)     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.

(16)     In order to ensure uniform conditions
for the implementation of Regulation (EC) No 111/2005, implementing
powers should be conferred on the Commission, namely to
establish a model for licences. 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.[9]

(17)     Since this Regulation is
based on the common commercial policy, the examination procedure should be used
for the adoption of the implementing acts.

(18)     Regulation (EC) No 111/2005
should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 111/2005 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 the Annex, 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[10];"

(b)        point (j) is deleted.

(2)
Article 6 is amended as follows:

(a)        in paragraph 1, the third subparagraph
is replaced by the following:

"The Commission shall be empowered to
adopt delegated acts in accordance with Article 30b to lay down provisions for determining
cases where a licence is not required and to set out further conditions for
granting licences."

(b)        the following paragraphs 3 and 4
are added:

"3.        The Commission shall
establish a model for licences by means of implementing acts. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 30(2).

4.         The delegated acts referred to
in the third subparagraph of paragraph 1 and the implementing acts referred to
in paragraph 3 shall guarantee a systematic and consistent control and
monitoring of operators."

(3)
Article 7 is amended as follows:

(a)        in paragraph 1, the following subparagraph
is added:

"In considering whether to grant a
registration, the competent authority shall take into account the competence
and integrity of the applicant."

(b)        paragraph 2 is replaced by the
following:

"2.        The Commission shall be
empowered to adopt delegated acts in accordance with Article 30b to establish the conditions for exemption from
the controls of certain categories of operators and of operators engaged in the
export of small quantities of
scheduled substances listed in Category 3, ensuring that the risk of diversion of scheduled substances
is minimised."

(c)        The following paragraph 3 is added:

"3.        The registration may be
suspended or revoked by the competent authorities whenever the conditions under
which the registration was issued are no longer fulfilled or where there are
reasonable grounds for suspecting that there is a risk of diversion of
scheduled substances."

(4)
In Article 8, paragraph 2 is replaced by the following:

"2.        The Commission shall be empowered to adopt
delegated acts in accordance with Article 30b to establish
the criteria to determine how the licit purposes of the transaction may be
demonstrated, in order to ensure that all movements of scheduled substances
within the Union customs territory can be monitored by the competent
authorities and the risk of diversion be minimised."

(5)
In Article 9,

(a)        The
following is added at the end of paragraph 1:

"To
this end, operators shall provide any available information allowing the
competent authorities to verify the legitimacy of the relevant order or
transaction, such as:

- the name of
the scheduled substance;

- the quantity
and weight of the scheduled substance; and

- the names
and addresses of the exporter, the importer, the ultimate consignee and, where
applicable, the person involved in the intermediary activities.

This
information will only be used for the purposes of preventing the diversion of
scheduled substances."

(b)        Paragraph 2 is replaced
by the following:

"2.        Operators shall provide the competent
authorities with information in summary form about their export, import or intermediary
activities. The Commission shall be empowered to adopt delegated acts in accordance with Article 30b to determine the information that is
required by the competent authorities
in order to allow them to monitor those activities, including rules on how to provide such information in electronic form
to a European database, where appropriate."

(6)
Article 11 is amended as follows:

(a)        in paragraph 1, the first subparagraph is replaced
by the following:

"1.        All exports of scheduled
substances listed in Category 1 of the Annex, exports of scheduled substances
listed in Category 2 and 3 of the Annex to certain countries of destination and all exports of medicinal products containing
ephedrine or pseudoephedrine, shall be preceded by a pre-export notification
sent from the competent authorities in the Union to the competent authorities of the country of destination, in accordance with
Article 12(10) of the United Nations Convention. The Commission shall be
empowered to adopt delegated acts in accordance with Article 30b to determine
the list of the countries of destination in order to minimise the risk of
diversion of scheduled substances and medicinal products containing
ephedrine or pseudoephedrine, by ensuring systematic and
consistent monitoring of exports of such substances and products to those
countries."

(b)        paragraph 3 is replaced by the following:

"3.        Simplified pre-export notification
procedures may be applied by the competent authorities where they are satisfied
that this will not result in any risk of diversion of scheduled substances and
of medicinal products containing ephedrine or pseudoephedrine. The Commission shall be empowered to adopt
delegated acts in accordance with Article 30b
to determine such procedures and to establish the common criteria to be
applied by the competent authorities."

(7)
In Article 12(1), the third subparagraph is replaced by the following:

"However, exports of scheduled
substances listed in Category 3 of the
Annex shall only be subject to an export authorisation where pre-export notifications are required, or
where those substances are exported to
certain countries of destination. The Commission shall be empowered to adopt
delegated acts in accordance with Article 30b
to determine the list of such
countries of destination in order to
ensure an appropriate level of control."

(8)
Article 19 is replaced by the following:

"Article
19

Simplified procedures to grant an export
authorisation may be applied by the
competent authorities where they are satisfied that this will not result
in any risk of diversion of scheduled substances.
The Commission shall be empowered to
adopt delegated acts in accordance with Article 30b to determine such procedures and to establish the common criteria to be applied
by the competent authorities."

(9)
Article 26 is amended as follows:

(a)        paragraph 1 is replaced by the
following:

"1.        Without prejudice to the
provisions of Articles 11 to 25 and to paragraphs 2 and 3 of this Article, the
competent authorities of each Member State shall prohibit the introduction of
scheduled substances, as well as of medicinal products containing ephedrine or
pseudoephedrine, into the Union customs territory or their departure from it,
if there are reasonable grounds for suspecting that such substances and
products are intended for the illicit manufacture of narcotic drugs or
psychotropic substances."

(b)        the following paragraph 3a is added:

"3a.      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 or operations involving non-scheduled substances;

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

(10)
Article 28 is replaced by the following:

"Article
28

In addition to the measures referred to in Article
26, the Commission shall be empowered to lay down, where necessary, by means of
implementing acts, measures to ensure the effective monitoring of trade between
the Union and third countries in drug precursors for the purpose of preventing
the diversion of such substances, in particular with regard to the design and
use of export and import authorisation forms. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 30(2)."

(11)
Article 29 is deleted.

(12)
Article 30 is replaced by the following:

"Article
30

1.         The Commission shall be assisted
by the Drug Precursors Committee (hereinafter referred to as the 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."

(13)
The following Articles 30a and 30b are inserted:

"Article
30a

The Commission shall
be empowered to adopt delegated acts in accordance with Article 30b in order to
adapt the Annex to new trends in diversion of drug precursors, in particular
substances which can be easily transformed into scheduled substances, and to
follow an amendment to the tables in the Annex to the
United Nations Convention.

Article
30b

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 Articles
6(3) third subparagraph, 7(2), 8(2), 9(2), 11(1) and (3), 12(1), 19, 28 and 30a
shall be conferred for an indeterminate period of time from [OPOCE insert date of entry into force of this amending Regulation]

3.         The delegation of powers referred to in Articles 6(3)
third subparagraph, 7(2), 8(2), 9(2), 11(1) and (3), 12(1), (19), 28 and 30a
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 specified
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 Articles 6(3)
third subparagraph, 7(2), 8(2), 9(2), 11(1) and (3), 12(1), (19), 28 and 30a
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 Parliament 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."

(14)
In Article 32, the third subparagraph is replaced by the
following:

"The Commission shall evaluate the implementation and
functioning of Articles 11 and 26 insofar as they concern
medicinal products containing ephedrine or pseudoephedrine and Article 30a by [OPOCE insert date 5
years after entry into force of this amending Regulation]".

(15)
The following Article 32a is inserted:

"Article 32a

Database

The
Commission shall use a European Database on drug precursors, as established by
Regulation (EC) No 273/2004 of the European Parliament and of the Council[11], with the following functions:

(a)
facilitating the communication of information
pursuant to Article 32 first subparagraph, as well as the reporting to the
International Narcotics Control Board pursuant to Article 32 second
subparagraph;

(b)
managing a European register of operators, which
have been granted a licence pursuant to Articles 6(1) or registration pursuant
to Articles 7(1);

(c)
enabling operators to provide the competent
authorities with information about their export, import or intermediary
activities according to Article 9(2)."

(16)
Article 33 is replaced by the following:

"Data protection provisions

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 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 referred
to under Article 32a, shall be carried out in accordance with Regulation (EC)
No 45/2001 and under the supervision of the European Data Protection
Supervisor."

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

[1]               Methamphetamine
is a synthetic drug which belongs to the amphetamines-group. This drug
manipulates pleasure centres of the brain and can be more potent than cocaine
and usually have a longer lasting effect. Taken as pills, smoked, inhaled or injected,
it is particularly attractive to young people because it produces a sense of
high energy, a release of social inhibitions and feelings of cleverness,
competence and power. The physical and psychological effects (feelings of
anxiety, hyper stimulation and paranoia) occur rapidly.

[2]               In
2007, 8mt of these precursors were seized of which nearly 4 % were in the form
of medicinal products; in 2008 3,5mt of which 51% were in the form of medicinal
products; in 2009 1,4mt of which 43% were in the form of medicinal products; in
2010 2.9mt out of which 3% were in the form of medicinal products. These
seizures were made on the basis of national legislation.

[3]               On
the one hand, the subject matter, drug precursors, is not widely known and
would have most likely entailed responses concerning the overall drug
situation, which would have been irrelevant for this exercise. On the other
hand, the problem at stake and the envisaged options only affect a very
specific aspect of drug precursor control.

[4]               OJ C , , p.

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

[6]               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.

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

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

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

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

[11]               OJ
L 86, 24.3.2004, p. 21