HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 330/30
EN
Official Journal of the European Union
10.12.2013
REGULATION (EU) No 1259/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 20 November 2013
amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade
between the Community and third countries in drug precursors
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
(5) This
Regulation
clarifies
the
definition
of
a
scheduled
EUROPEAN UNION,
substance: in this regard, the term ‘pharmaceutical prep
aration’, which stems from the United Nations
Convention against Illicit Traffic in Narcotic Drugs and
Having regard to the Treaty on the Functioning of the European
Psychotropic Substances adopted in Vienna on
Union, and in particular Article 207(2) thereof,
19 December 1988 (‘the United Nations Convention’),
is deleted as it is already covered by the relevant
terminology of Union legal acts, namely ‘medicinal prod
Having regard to the proposal from the European Commission,
ucts’. Moreover, the term ‘other preparations’ is deleted as
it duplicates the term ‘mixtures’ already used in that
definition.
After transmission of the draft legislative act to the national
parliaments,
(6) Rules
on
suspending
or
revoking
the
registration
of
an
Acting in accordance with the ordinary legislative procedure (
operator should be introduced in order to match the

1 ),
existing rules for suspending or revoking a licence.
Whereas:
(7) Medicinal
products
and
veterinary
medicinal
products
(‘medicinal products’) containing ephedrine or pseudoep
(1) On
7
January
2010,
the
Commission
adopted
a
report,
hedrine should be controlled without impeding their
pursuant to Article 32 of Council Regulation (EC) No
legitimate trade. To that end, a new category (Category
111/2005 ( 2 ), on the implementation and functioning
4) should be added to the Annex to Regulation (EC) No
of the Community legislation on monitoring and
111/2005 listing medicinal products containing certain
control of trade in drug precursors.
scheduled substances.
(2) Trade
in
medicinal
products
is
not
controlled
in
the
existing Union control system for drug precursors,
(8) The
export
of
medicinal
products
listed
in
Category
4
of
since they are currently excluded from the definition of
the Annex to Regulation (EC) No 111/2005, as amended
scheduled substances.
by this Regulation, should be preceded by an export
authorisation, and a pre-export notification sent by the
competent authorities in the Union to the competent
(3) The
Commission
report
pointed
out
that
medicinal
authorities of the country of destination.
products containing ephedrine and pseudoephedrine
were diverted into the illicit drug manufacture outside
the Union, as a substitute for internationally controlled
ephedrine and pseudoephedrine. The Commission
(9) Member
States’
competent
authorities
should
be
given
therefore recommended strengthening the control of
the powers to stop or seize those medicinal products
international trade in medicinal products containing
where there are reasonable grounds for suspecting that
ephedrine or pseudoephedrine exported from or tran
they are intended for the illicit manufacture of narcotic
siting through the customs territory of the Union in
drugs or psychotropic substances, when they are
order to prevent their diversion for the illicit manufacture
exported, imported or in transit.
of narcotic drugs or psychotropic substances.
(10) With a view to enabling Member States to react more
(4) In
its
Conclusions
of
25
May
2010
on
the
functioning
quickly with regard to new trends in drug precursors’
and implementation of EU drug precursors legislation,
diversion, their possibilities to act in cases of suspicious
the Council invited the Commission to propose legis
transactions involving non-scheduled substances should
lative amendments after carefully assessing their
be clarified. To that end, Member States should be able
potential impact on Member States’ authorities and
to empower their competent authorities to obtain
economic operators.
information on any orders for or operations involving
non-scheduled substances, or to enter business premises
( 1 ) Position of the European Parliament of 23 October 2013 (not yet
to obtain evidence of suspicious transactions involving
published in the Official Journal) and decision of the Council of
such substances. In addition, competent authorities
15 November 2013.
should prevent the introduction into, or the departure
( 2 ) Council Regulation (EC) No 111/2005 of 22 December 2004 laying
down rules for the monitoring of trade between the Community and
from, the customs territory of the Union of non-
third countries in drug precursors (OJ L 22, 26.1.2005, p. 1).
scheduled substances, where it can be demonstrated

---

EN
10.12.2013 Official
Journal
of
the
European
Union L
330/31
that such substances will be used in the illicit manu
by this Regulation, and the delegated and implementing
facture of narcotic drugs or psychotropic substances.
acts adopted pursuant thereto. Those data should be
Such non-scheduled substances should be considered as
processed in accordance with Union legislation
proposed for inclusion in the voluntary monitoring list
concerning the protection of individuals with regard to
of non-scheduled substances.
the processing of personal data, in particular Directive
95/46/EC of the European Parliament and of the Coun
cil ( 2 ) and Regulation (EC) No 45/2001 of the European
Parliament and of the Council ( 3 ).
(11) Member States’ competent authorities should share
between themselves and with the Commission, through
the European database on drug precursors (‘the European
database’), established under Regulation (EC) No
273/2004 of the European Parliament and of the Coun
(15) Regulation
(EC)
No
111/2005
confers
powers
on
the
cil ( 1 ), information on seizures and stopped shipments in
Commission in order to implement some of its provi
order to improve the overall level of information on
sions, to be exercised in accordance with the procedures
trade in drug precursors, including medicinal products.
laid down in Council Decision 1999/468/EC ( 4 ).
The European database should be used to simplify the
reporting by Member States with regard to seizures and
stopped shipments. It should also serve as a European
register of operators holding a licence or registration
which will facilitate verification of the legitimacy of
their transactions involving scheduled substances, and
(16) As a consequence of the entry into force of the Treaty of
should enable operators to provide the competent auth
Lisbon, those powers should be aligned to Articles 290
orities with information about their export, import or
and 291 of the Treaty on the Functioning of the
intermediary activities involving scheduled substances.
European Union (TFEU).
That European register should be regularly updated and
the information it contains should be used by the
Commission and Member States’ competent authorities
only for the purpose of preventing the diversion of
drug precursors onto the illegal market.
(17) In
order
to
achieve
the
objectives
of
Regulation
(EC)
No
111/2005, as amended by this Regulation, the power to
adopt acts in accordance with Article 290 TFEU should
be delegated to the Commission to set out the conditions
(12) Regulation (EC) No 111/2005 provides for the
for granting licences and registration and for determining
processing of data. Such processing may also cover
cases where a licence or a registration is not required, to
personal data and should be carried out in accordance
establish the criteria to determine how the licit purposes
with Union law.
of the transaction may be demonstrated, to determine the
information that is required by the competent authorities
and by the Commission to allow them to monitor
export, import or intermediary activities of operators,
to determine the lists of the countries of destination to
(13) The
processing
of
personal
data
for
the
purposes
of
which exports of scheduled substances of Categories 2
Regulation (EC) No 111/2005, as amended by this Regu
and 3 of the Annex to Regulation (EC) No 111/2005 are
lation, and any delegated and implementing acts adopted
to be preceded by a pre-export notification, to determine
pursuant thereto should respect the fundamental right to
simplified pre-export notification procedures and to
respect for private and family life recognised by Article 8
establish the common criteria to be applied by the
of the Convention for the Protection of Human Rights
competent authorities, to determine simplified export
and Fundamental Freedoms as well as the right to respect
authorisation procedures and to establish the common
for private and family life, and the right to the protection
criteria to be applied by the competent authorities, and
of personal data recognised, respectively, by Articles 7
to adapt the Annex to Regulation (EC) No 111/2005 in
and 8 of the Charter of Fundamental Rights of the
order to respond to new trends in diversion of drug
European Union.
precursors and to follow any amendment to the tables
( 2 ) Directive 95/46/EC of the European Parliament and of the Council
of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such
data (OJ L 281, 23.11.1995, p. 31).
(14) Member
States and the Commission should process
( 3 ) Regulation (EC) No 45/2001 of the European Parliament and of the
personal data only in a manner compatible with the
Council of 18 December 2000 on the protection of individuals with
purposes of Regulation (EC) No 111/2005, as amended
regard to the processing of personal data by the Community insti
tutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
( 1 ) Regulation (EC) No 273/2004 of the European Parliament and of
( 4 ) Council Decision 1999/468/EC of 28 June 1999 laying down the
the Council of 11 February 2004 on drug precursors (OJ L 47,
procedures for the exercise of implementing powers conferred on
18.2.2004, p. 1).
the Commission (OJ L 184, 17.7.1999, p. 23).

---

L 330/32
EN
Official Journal of the European Union
10.12.2013
in the Annex to the United Nations Convention. It is of
Article 13(1), in the first subparagraph of Article 14(1), in
particular importance that the Commission carry out
Article 14(2), in Article 18 and in the first paragraph of
appropriate consultations during its preparatory work,
Article 22, the term ‘Community customs territory’ is
including at expert level. The Commission, when
replaced by the term ‘customs territory of the Union’. In
preparing and drawing up delegated acts, should ensure
the first subparagraph of Article 12(1), the term ‘Customs
a simultaneous, timely and appropriate transmission of
territory from the Community’ is replaced by the term
relevant documents to the European Parliament and to
‘customs territory of the Union’;
the Council.
(2) in Article 2:
(18) In
order
to
ensure
uniform
conditions
for
the
implemen
tation of Regulation (EC) No 111/2005, as amended by
this Regulation, implementing powers should be
(a) point (a) is replaced by the following:
conferred on the Commission, namely to establish a
model for licences, the procedural rules on the
provision of information that is required by the
‘(a) “scheduled substance” means any substance listed
competent authorities to monitor export, import or inter
in the Annex that can be used for the illicit manu
mediary activities of operators, and the measures to
facture of narcotic drugs or psychotropic
ensure the effective monitoring of trade between the
substances, including mixtures and natural
Union and third countries in drug precursors, in
products containing such substances, but
particular with regard to the design and use of export
excluding mixtures and natural products which
and import authorisation forms, for the purpose of
contain scheduled substances and which are
preventing the diversion of drug precursors. Those
compounded in such a way that the scheduled
powers should be exercised in accordance with Regu
substances cannot be easily used or extracted by
lation (EU) No 182/2011 of the European Parliament
readily applicable or economically viable means,
and of the Council ( 1 ).
medicinal products as defined in point 2 of
Article 1 of Directive 2001/83/EC of the
European Parliament and of the Council (*) and
(19) The
delegated
and
implementing
acts
adopted
pursuant
veterinary medicinal products as defined in point
to Regulation (EC) No 111/2005, as amended by this
2 of Article 1 of Directive 2001/82/EC of the
Regulation, should guarantee a systematic and consistent
European Parliament and of the Council (**),
control and monitoring of operators.
except medicinal products and veterinary
medicinal products listed in the Annex;
(20) The
European
Data
Protection
Supervisor
was
consulted
in accordance with Article 28(2) of Regulation (EC) No
___________
45/2001 and delivered an opinion on 18 January
(*) Directive 2001/83/EC of the European Parliament
2013 ( 2 ).
and of the Council of 6 November 2001 on the
Community code relating to medicinal products
for human use (OJ L 311, 28.11.2001, p. 67).
(**) Directive 2001/82/EC of the European Parliament
(21) Regulation (EC) No 111/2005 should therefore be
and of the Council of 6 November 2001 on the
amended accordingly,
Community code relating to veterinary medicinal
products (OJ L 311, 28.11.2001, p. 1).’;
HAVE ADOPTED THIS REGULATION:
(b) point (c) is replaced by the following:
Article 1
Regulation (EC) No 111/2005 is amended as follows:
‘(c) “import” means any entry of scheduled substances
having the status of non-Union goods into the
customs territory of the Union, including
(1) in the title of the Regulation and in Article 1, in points (d)
temporary storage, the placing in a free zone or
and (e) of Article 2, in Article 10(1), in the first paragraph
free warehouse, the placing under a suspensive
of Article 17, in the first paragraph of Article 20 and in
procedure and the release for free circulation
Article 25, the noun ‘Community’ is replaced by the noun
within the meaning of Council Regulation (EEC)
‘Union’. In point (e) of Article 2, in point (d) of
No 2913/92 (*);
( 1 ) 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
(*) Council Regulation (EEC) No 2913/92 of
of the Commission’s exercise of implementing powers (OJ L 55,
12 October 1992 establishing the Community
28.2.2011, p. 13).
Customs Code (OJ L 302, 19.10.1992, p. 1).’;
( 2 ) Not yet published in the Official Journal.

---

EN
10.12.2013 Official
Journal
of
the
European
Union L
330/33
(c) point (j) is replaced by the following:
Annex, shall hold a licence. The competent authority
of the Member State in which the operator is estab
lished shall issue the licence.
‘(j) “natural product” means an organism or a part
thereof, in any form, or any substances which
occur in nature as defined in point 39 of
In considering whether to grant a licence, the
Article 3 of Regulation (EC) No 1907/2006 of
competent authority shall take into account the
the European Parliament and of the Council (*);
competence and integrity of the applicant, in particular
the absence of any serious infringement or repeated
infringements of legislation in the field of drug
___________
precursors and the absence of a record of any
(*) Regulation (EC) No 1907/2006 of the European
serious criminal offence.
Parliament and of the Council of 18 December
2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
The Commission shall be empowered to adopt
(REACH), establishing a European Chemicals
delegated acts in accordance with Article 30b to set
Agency, amending Directive 1999/45/EC and
out the conditions for granting licences and for deter
repealing Council Regulation (EEC) No 793/93
mining cases where a licence is not required.’;
and Commission Regulation (EC) No 1488/94 as
well as Council Directive 76/769/EEC and
Commission Directives 91/155/EEC, 93/67/EEC,
(b) the following paragraph is added:
93/105/EC and 2000/21/EC (OJ L 396,
30.12.2006, p. 1).’;
‘3. The
Commission
shall
establish
a
model
for
licences by means of implementing acts. Those imple
menting acts shall be adopted in accordance with the
(3) the first paragraph of Article 3 is replaced by the
examination procedure referred to in Article 30(2).’;
following:
‘All imports, exports or intermediary activities involving
(6) Article 7 is replaced by the following:
scheduled substances, with the exception of substances
listed in Category 4 of the Annex, shall be documented
by the operator by way of customs and commercial docu
‘Article 7
ments, such as summary declarations, customs declar
1. Unless
otherwise
provided,
operators
established
in
ations, invoices, cargo manifests, transport and other
the Union, other than customs agents and transporters
shipping documents.’;
when acting solely in that capacity, engaged in import,
export or intermediary activities involving scheduled
substances listed in Category 2 of the Annex, or in the
(4) Article 5 is replaced by the following:
export of scheduled substances listed in Category 3 of the
Annex, shall hold a registration. The competent authority
in the Member State in which the operator is established
‘Article 5
shall issue the registration.
Operators shall ensure that labels are affixed on any
packaging containing scheduled substances, except
substances listed in Category 4 of the Annex, indicating
In considering whether to grant a registration, the
their name as stated in the Annex, or, in the case of a
competent authority shall take into account the
mixture or a natural product, its name and the name of
competence and integrity of the applicant, in particular
any scheduled substance, except substances listed in
the absence of any serious infringement or repeated
Category 4 of the Annex, as stated in the Annex,
infringements of legislation in the field of drug precursors
contained in the mixture or in the natural product.
and the absence of a record of any serious criminal
Operators may, in addition, affix their customary labels.’;
offence.
(5) in Article 6:
The Commission shall be empowered to adopt delegated
acts in accordance with Article 30b to set out the
conditions for granting registrations and for determining
(a) paragraph 1 is replaced by the following:
cases where a registration is not required.
‘1. Unless
otherwise
provided,
operators
established
2. The
competent
authority
may
suspend
or
revoke
the
in the Union, other than customs agents and trans
registration where the conditions under which the regis
porters when acting solely in that capacity, engaged
tration was issued are no longer fulfilled or where there
in import, export or intermediary activities involving
are reasonable grounds for suspecting that there is a risk
scheduled substances listed in Category 1 of the
of diversion of scheduled substances.’;

---

L 330/34
EN
Official Journal of the European Union
10.12.2013
(7) Article 8 is replaced by the following:
The Commission shall specify by means of implementing
acts the procedural rules on the provision of such
information, including, where appropriate, in electronic
‘Article 8
form to the European database on drug precursors estab
lished under Regulation (EC) No 273/2004 of the
1. When the scheduled substances are entered into the
European Parliament and of the Council
(*) (“the
customs territory of the Union for unloading or trans
European database”). Those implementing acts shall be
hipment, for temporary storage, for their storage in a
adopted in accordance with the examination procedure
free zone of control type I or a free warehouse, or for
referred to in Article 30(2).
their placing under the external Union transit procedure,
the licit purposes must be demonstrated by the operator,
upon request by the competent authorities.
___________
(*) Regulation (EC) No 273/2004 of the European
2. The
Commission
shall
be
empowered
to
adopt
Parliament and of the Council of 11 February 2004
delegated acts in accordance with Article 30b to
on drug precursors (OJ L 47, 18.2.2004, p. 1).’;
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
customs territory of the Union can be monitored by the
competent authorities and the risk of diversion be mini
(9) in Article 10, the following paragraphs are added:
mised.’;
(8) Article 9 is replaced by the following:
‘4. In order to respond rapidly to new diversion trends,
the competent authorities of the Member States and the
Commission may propose to add a non-scheduled
‘Article 9
substance to the list referred to in paragraph 2(b) in
order to temporarily monitor its trade. Detailed
1. Operators
established
in
the
Union
shall
notify
the
arrangements and criteria for the inclusion or deletion
competent authorities immediately of any circumstances,
from that list shall be specified in the guidelines referred
such as unusual orders and transactions involving
to in paragraph 1.
scheduled substances, which suggest that such substances
intended for import, export or intermediary activities
might be diverted for the illicit manufacture of narcotic
drugs or psychotropic substances.
5. If
voluntary
monitoring
by
the
industry
is
considered
insufficient to prevent the use of a non-scheduled
substance for the illicit manufacture of narcotic drugs or
To that end, operators shall provide any available
psychotropic substances, the Commission may add the
information, such as:
non-scheduled substance to the Annex by means of
delegated acts in accordance with Article 30b.’;
(a) the name of the scheduled substance;
(10) in Article 11:
(b) the quantity and weight of the scheduled substance;
(a) in paragraph 1, the first subparagraph is replaced by
(c) the names and addresses of the exporter, the importer,
the following:
the ultimate consignee and, where applicable, the
person involved in the intermediary activities.
‘1. All
exports
of
scheduled
substances
listed
in
That information shall only be collected for the purposes
Categories 1 and 4 of the Annex and exports of
of preventing the diversion of scheduled substances.
scheduled substances listed in Categories 2 and 3 of
the Annex to certain countries of destination shall be
preceded by a pre-export notification sent from the
2. Operators
shall
provide
the
competent
authorities
competent authorities in the Union to the competent
with information in summary form about their export,
authorities of the country of destination, in accordance
import or intermediary activities.
with Article 12(10) of the United Nations Convention.
The Commission shall be empowered to adopt
delegated acts in accordance with Article 30b of this
The Commission shall be empowered to adopt delegated
Regulation to determine the lists of the countries of
acts in accordance with Article 30b to determine the
destination for export of scheduled substances listed in
information that is required by the competent authorities
Categories 2 and 3 of the Annex in order to minimise
in order to allow them to monitor those activities.
the risk of diversion of scheduled substances.’;

---

EN
10.12.2013 Official
Journal
of
the
European
Union L
330/35
(b) paragraph 3 is replaced by the following:
from it, where there are reasonable grounds for
suspecting that such substances are intended for the
illicit manufacture of narcotic drugs or psychotropic
‘3. Simplified
pre-export
notification
procedures
substances.’;
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
(b) the following paragraphs are inserted:
shall be empowered to adopt delegated acts in
accordance with Article 30b to determine such
procedures and to establish the common criteria to
‘3a. The
competent
authorities
of
each
Member
be applied by the competent authorities.’;
State shall prohibit the introduction of consignments
of non-scheduled substances into the customs territory
(11) in Article 12(1), the third subparagraph is replaced by the
of the Union or their departure from it where there is
following:
sufficient evidence that those substances are intended
for the illicit manufacture of narcotic drugs or psycho
tropic substances.
‘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
The competent authority shall immediately inform the
required.’;
competent authorities of the other Member States and
the Commission thereof, using the procedure referred
to in Article 27.
(12) in Article 13(1), the following subparagraph is added:
Those substances shall be considered as proposed for
‘An application for an export authorisation for exports of
inclusion in the list of non-scheduled substances
scheduled substances listed in Category 4 of the Annex
referred to in point (b) of Article 10(2).
shall contain the information set out in points (a) to (e)
of the first subparagraph.’;
3b. Each
Member
State
may
adopt
the
measures
(13) Article 19 is replaced by the following:
necessary to enable its competent authorities to
control and monitor suspicious transactions involving
non-scheduled substances, in particular:
‘Article 19
Simplified procedures to grant an export authorisation
(a) to obtain information on any orders for or oper
may be applied by the competent authorities where they
ations involving non-scheduled substances;
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
(b) to enter business premises in order to obtain
Article 30b to determine such procedures and to
evidence of suspicious transactions involving
establish the common criteria to be applied by the
non-scheduled substances.’;
competent authorities.’;
(14) in Article 20, the second paragraph is replaced by the
(16) the title of Chapter V is replaced by the following:
following:
‘DELEGATED AND IMPLEMENTING ACTS’;
‘However, where the substances referred to in the first
paragraph are unloaded or transhipped, under temporary
storage, stored in a free zone of control type I or a free
warehouse, or placed under the external Union transit
procedure, such import authorisation shall not be
(17) Article 28 is replaced by the following:
required.’;
‘Article 28
(15) in Article 26:
In addition to the measures referred to in Article 26, the
Commission shall be empowered to lay down, where
(a) paragraph 1 is replaced by the following:
necessary, by means of implementing acts, measures to
ensure the effective monitoring of trade between the
Union and third countries in drug precursors, in particular
‘1. Without prejudice to Articles 11 to 25 and to
with regard to the design and use of export and import
paragraphs 2 and 3 of this Article, the competent
authorisation forms, for the purpose of preventing the
authorities of each Member State shall prohibit the
diversion of drug precursors. Those implementing acts
introduction of scheduled substances into the
shall be adopted in accordance with the examination
customs territory of the Union or their departure
procedure referred to in Article 30(2).’;

---

L 330/36
EN
Official Journal of the European Union
10.12.2013
(18) Article 29 is deleted;
Article 9(2), Article 10(5), Article 11(1) and (3), Articles
19 and 30a and Article 32(2) may be revoked at any time
by the European Parliament or by the Council. A decision
(19) Article 30 is replaced by the following:
to revoke shall put an end to the delegation of the power
specified in that decision. It shall take effect the day
following the publication of the decision in the Official
‘Article 30
Journal of the European Union or at a later date specified
1. The
Commission
shall
be
assisted
by
the
Drug
therein. It shall not affect the validity of any delegated acts
Precursors Committee. That committee shall be a
already in force.
committee within the meaning of Regulation (EU) No
182/2011 of the European Parliament and of the Coun
cil (*).
4. As
soon
as
it
adopts
a
delegated
act,
the
Commission
shall notify it simultaneously to the European Parliament
2. Where
reference
is
made
to
this
paragraph,
Article
5
and to the Council.
of Regulation (EU) No 182/2011 shall apply.
___________
5. A
delegated
act
adopted
pursuant
to
the
third
(*) Regulation (EU) No 182/2011 of the European
subparagraph of Article 6(1), the third subparagraph of
Parliament and of the Council of 16 February 2011
Article 7(1), Article 8(2), the second subparagraph of
laying down the rules and general principles
Article 9(2), Article 10(5), Article 11(1) and (3), Articles
concerning mechanisms for control by the Member
19 and 30a and Article 32(2) shall enter into force only if
States of the Commission’s exercise of implementing
no objection has been expressed either by the European
powers (OJ L 55, 28.2.2011, p. 13).’;
Parliament or the Council within a period of two 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
(20) the following Articles are inserted:
informed the Commission that they will not object. That
period shall be extended by two months at the initiative of
the European Parliament or of the Council.’;
‘Article 30a
The Commission shall be empowered to adopt delegated
acts in accordance with Article 30b of this Regulation in
(21) Article 32 is replaced by the following:
order to adapt the Annex hereto to new trends in
diversion of drug precursors, in particular substances
which can be easily transformed into scheduled substances,
and to follow any amendment to the tables in the Annex
to the United Nations Convention.
‘Article 32
1. The
competent
authorities
in
each
Member
State
shall communicate to the Commission in electronic form
Article 30b
via the European database in a timely manner all relevant
1. The
power
to
adopt
delegated
acts
is
conferred
on
information on the implementation of the monitoring
the Commission subject to the conditions laid down in
measures laid down in this Regulation, in particular as
this Article.
regards substances used for the illicit manufacture of
narcotic drugs or psychotropic substances and methods
of diversion and illicit manufacture, and their licit trade.
2. The power to adopt delegated acts referred to in the
third subparagraph of Article 6(1), the third subparagraph
of Article 7(1), Article 8(2), the second subparagraph of
Article 9(2), Article 10(5), Article 11(1) and (3), Articles
2. The
Commission
shall
be
empowered
to
adopt
19 and 30a and Article 32(2) shall be conferred on the
delegated acts in accordance with Article 30b in order
Commission for a period of five years from 30 December
to specify the conditions and requirements concerning
2013. The Commission shall draw up a report in respect
the information to be provided under paragraph 1 of
of the delegation of power not later than nine months
this Article.
before the end of the five year period. The delegation of
power shall be tacitly extended for periods of an identical
duration, unless the European Parliament or the Council
opposes such extension not later than three months before
3. On the basis of the information referred to in
the end of each period.
paragraph 1 of this Article, the Commission shall, in
consultation with the Member States, evaluate the effec
tiveness of this Regulation and, in accordance with
3. The
delegation
of
power
referred
to
in
the
third
Article 12(12) of the United Nations Convention, draw
subparagraph of Article 6(1), the third subparagraph of
up an annual report to be submitted to the International
Article 7(1), Article 8(2), the second subparagraph of
Narcotics Control Board.

---

EN
10.12.2013 Official
Journal
of
the
European
Union L
330/37
4. The
Commission
shall
submit
by
31
December
2019
sistent with Directive 95/46/EC or Regulation (EC) No
a report to the European Parliament and to the Council on
45/2001 and shall not be retained longer than necessary
the implementation and functioning of this Regulation,
for the purposes for which it was collected.
and in particular on the possible need for additional
action to monitor and control suspicious transactions
with non-scheduled substances’;
5. Member
States
and
the
Commission
shall
not
process personal data in a manner incompatible with the
purposes set out in Article 32a.
(22) the following Article is inserted:
Without prejudice to Article 13 of Directive 95/46/EC,
‘Article 32a
personal data obtained or processed pursuant to this Regu
The competent authorities of the Member States and the
lation shall be used for the purpose of preventing the
Commission shall use the European database under the
diversion of scheduled substances.
conditions for its use for the following functions:
___________
(a) to facilitate the communication of information
(*) Directive 95/46/EC of the European Parliament and of
pursuant to Article 32(1) as well as the reporting to
the Council of 24 October 1995 on the protection of
the International Narcotics Control Board pursuant to
individuals with regard to the processing of personal
Article 32(3);
data and on the free movement of such data (OJ
L 281, 23.11.1995, p. 31).
(**) Regulation (EC) No 45/2001 of the European
(b) to manage a European register of operators, which
Parliament and of the Council of 18 December
have been granted a licence or registration;
2000 on the protection of individuals with regard
to the processing of personal data by the
Community institutions and bodies and on the free
movement of such data (OJ L 8, 12.1.2001, p. 1).’;
(c) to enable operators to provide the competent auth
orities with information about their export, import
or intermediary activities according to Article 9(2), in
electronic form.’;
(24) in the Annex:
(23) Article 33 is replaced by the following:
(a) the title is replaced by the following:
‘Article 33
1. The
processing
of
personal
data
by
the
competent
‘List of scheduled substances’;
authorities in the Member States shall be carried out in
accordance with national laws, regulations and adminis
trative provisions transposing Directive 95/46/EC of the
(b) before the first table, the following subtitle is inserted:
European Parliament and of the Council (*) and under
the supervision of the supervisory authority of the
Member State referred to in Article 28 of that Directive.
‘Category 1’;
2. The
processing
of
personal
data
by
the
Commission,
including for the purpose of the European database, shall
(c) in Category 1, the CN Code for Norephedrine is
be carried out in accordance with Regulation (EC) No
replaced by the following:
45/2001 of the European Parliament and of the Coun
cil (**) and under the supervision of the European Data
Protection Supervisor.
‘2939 44 00’;
3. No
special
categories
of
data
within
the
meaning
of
Article 8(1) of Directive 95/46/EC shall be processed for
(d) in Category 1, the following substance is added to the
the purposes of this Regulation.
list of substances:
4. The
personal
data
collected
for
the
purposes
of
this
‘Alpha-phenylacetoacetonitrile, CN Code 2926 90 95,
Regulation shall not be further processed in a way incon
CAS No 4468-48-8’;

---

L 330/38
EN
Official Journal of the European Union
10.12.2013
(e) the following category is added:
Substance
CN designation
(if different)
CN Code
‘Category 4
Medicinal products Containing
3003 40 30
and veterinary
pseudoep
3004 40 30’
medicinal products hedrine (INN)
containing pseudo- or its salts
Substance
CN designation
(if different)
CN Code
ephedrine or its
salts
Medicinal products Containing
3003 40 20
and veterinary
ephedrine or its
3004 40 20
medicinal products salts

Article 2
containing
ephedrine or its
This Regulation shall enter into force on the twentieth day
salts
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 Strasbourg, 20 November 2013.
For the European Parliament
For the Council
The President
The President
M. SCHULZ
V. LEKEVIIUS

---

Document Outline

• �

---