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10.12.2013 Official
Journal
of
the
European
Union L
330/21
REGULATION (EU) No 1258/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 20 November 2013
amending Regulation (EC) No 273/2004 on drug precursors
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
19 December 1988, is deleted as it is already covered by
EUROPEAN UNION,
the relevant terminology of Union legal acts, namely
‘medicinal products’. Moreover, the term ‘other prepara
tions’ is deleted as it duplicates the term ‘mixtures’
Having regard to the Treaty on the Functioning of the European
already used in that definition.
Union, and in particular Article 114(1) thereof,
Having regard to the proposal from the European Commission,
(5) A
definition
of
the
term
‘user’
should
be
introduced
for
persons possessing substances for purposes other than
placing them on the market and it should be clarified
After transmission of the draft legislative act to the national
that persons using scheduled substances in category 1 of
parliaments,
Annex I to Regulation (EC) No 273/2004 for other
purposes than placing them on the market are obliged
to obtain a licence.
Having regard to the opinion of the European Economic and
Social Committee ( 1 ),
(6) More
detailed
rules
on
registration
should
be
introduced
to ensure uniform conditions of registration in all
Acting in accordance with the ordinary legislative procedure ( 2 ),
Member States for scheduled substances in category 2
of Annex I to Regulation (EC) No 273/2004. For
Whereas:
substances scheduled in a new subcategory 2A of
Annex I to that Regulation, in addition to operators
users should also be subject to a registration requirement.
(1) On
7
January
2010,
the
Commission
adopted
a
report
pursuant to Article 16 of Regulation (EC) No 273/2004
of the European Parliament and of the Council ( 3 ) on the
(7) Where
fees
are
levied
for
obtaining
a
licence
or
regis
implementation and functioning of the Community legis
tration, Member States should consider adjusting such
lation on monitoring and control of trade in drug
fees in order to safeguard the competitiveness of micro
precursors.
enterprises.
(2) In
that
report,
the
Commission
recommended
further (8) It
should
be
made
clear
that
Member
States
have
the
analysing ways to strengthen the control of the trade
possibility to act with regard to suspicious transactions
of acetic anhydride, a scheduled substance in category
involving non-scheduled substances in order to enable
2 of Annex I to Regulation (EC) No 273/2004,
them to react more quickly with regard to new trends
pursuant to Article 2(a) of that Regulation, in order to
in the illicit production of drugs.
better prevent the diversion of acetic anhydride for the
illicit production of heroin.
(9) A
European
database
on
drug
precursors
(‘the
European
database’) should be created to simplify the reporting by
(3) In
its
Conclusions
of
25
May
2010
on
the
functioning
Member States with regard to seizures and stopped ship
and implementation of the EU drug precursors legis
ments, where possible in an aggregated and anonymised
lation, the Council invited the Commission to propose
manner and in the least intrusive manner as regards the
legislative amendments after carefully assessing their
processing of personal data, taking into account the state
potential impact on Member States’ authorities and
of the art of privacy-enhancing technologies and the
economic operators.
principle of data limitation. The European database
should also serve as a European register of operators
and users holding a licence or registration which will
(4) This
Regulation
clarifies
the
definition
of
a
scheduled
substance: in this regard, the term ‘pharmaceutical prep
facilitate verification of the legitimacy of commercial
aration’, which stems from the United Nations
transactions involving scheduled substances, and should
Convention against Illicit Traffic in Narcotic Drugs and
enable operators to provide the competent authorities
Psychotropic Substances adopted in Vienna on
with information about their transactions involving
scheduled substances.
( 1 ) OJ C 76, 14.3.2013, p. 54.
( 2 ) Position of the European Parliament of 23 October 2013 (not yet
(10) Regulation
(EC)
No
273/2004,
as
amended
by
this
Regu
published in the Official Journal) and decision of the Council of
lation, envisages the processing of information, including
15 November 2013.
the processing of personal data, for the purposes of
( 3 ) Regulation (EC) No 273/2004 of the European Parliament and of
the Council of 11 February 2004 on drug precursors (OJ L 47,
enabling the competent authorities to monitor the
18.2.2004, p. 1).
placing on the market of drug precursors and to

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L 330/22
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Official Journal of the European Union
10.12.2013
prevent the diversion of scheduled substances. The
be delegated to the Commission to specify the
processing of personal data should be carried out in a
requirements and conditions for the granting of the
manner compatible with the purpose of that Regulation
licence and registration, for listing operators and users
and in accordance with Directive 95/46/EC of the
having obtained a licence or registration in the
European Parliament and of the Council ( 1 ) and Regu
European database, for obtaining and using customer
lation (EC) No 45/2001 of the European Parliament
declarations, for the documentation and labelling of
and of the Council ( 2 ) and, in particular, with Union
mixtures containing scheduled substances, for the
requirements relating to data quality, proportionality,
provision of information by the operators on trans
purpose limitation, and rights to information, access,
actions involving scheduled substances, and for
rectification of data, erasure and blocking, organisational
information to be provided by Member States on the
and technical measures and international transfers of
implementation of the monitoring measures laid down
personal data.
in Regulation (EC) No 273/2004, and in order to amend
the Annexes thereto. Such delegated acts should also
determine the categories of personal data which can be
(11) The
processing
of
personal
data
for
the
purposes
of
processed by Member States and operators pursuant to
Regulation (EC) No 273/2004, as amended by this Regu
Regulation (EC) No 273/2004, the categories of personal
lation, and any delegated and implementing acts adopted
data which can be stored in the European database and
pursuant thereto should respect the fundamental right to
the safeguards for the processing of personal data. It is of
respect for private and family life recognised by Article 8
particular importance that the Commission carry out
of the Convention for the Protection of Human Rights
appropriate consultations during its preparatory work,
and Fundamental Freedoms as well as the rights to
including at expert level. The Commission, when
respect for private and family life, and the right to the
preparing and drawing up delegated acts, should ensure
protection of personal data recognised, respectively, by
the simultaneous, timely and appropriate transmission of
Articles 7 and 8 of the Charter of Fundamental Rights of
relevant documents to the European Parliament and to
the European Union. The delegated and implementing
the Council.
acts should also ensure that any processing of personal
data takes place in accordance with Directive 95/46/EC
and Regulation (EC) No 45/2001.
(16) It is also important that the Commission seek the
opinion of the European Data Protection Supervisor
when preparing delegated acts relating to the processing
(12) Acetic
anhydride,
currently
scheduled
in
category
2
of
of personal data.
Annex I to Regulation (EC) No 273/2004, should be
included in a new subcategory 2A of Annex I thereto
to allow increased control of its trade. The remaining
(17) In
order
to
ensure
uniform
conditions
for
the
implemen
substances of category 2 of Annex I to Regulation (EC)
tation of Regulation (EC) No 273/2004, implementing
No 273/2004 should be listed as subcategory 2B of
powers should be conferred on the Commission. Those
Annex I thereto.
powers should be exercised in accordance with Regu

lation (EU) No 182/2011 of the European Parliament
and of the Council ( 4 ). The examination procedure
should be used for the adoption of the implementing
(13) Regulation
(EC)
No
273/2004
confers
powers
on
the
acts in order to set up details on how customer declar
Commission in order to implement some of its provi
ations should be provided in electronic form and on how
sions, to be exercised in accordance with the procedures
to provide the information about transactions of
laid down in Council Decision 1999/468/EC ( 3 ).
operators with scheduled substances to a European
database.
(14) As a consequence of the entry into force of the Treaty of
Lisbon, those powers should be aligned to Articles 290
(18) Since the objective of this Regulation, namely to
and 291 of the Treaty on the Functioning of the
strengthen the rules for registration of operators
European Union (TFEU).
placing on the market or possessing scheduled substances
of category 2 of Annex I to Regulation (EC) No
273/2004, in particular acetic anhydride, in order to
(15) In
order
to
achieve
the
objectives
of
Regulation
(EC)
No
prevent its diversion towards the illicit production of
273/2004, as amended by this Regulation, the power to
drugs, cannot be sufficiently achieved by the Member
adopt acts in accordance with Article 290 TFEU should
States because traffickers gain from national differences
in registration and move their illicit business where drug
precursors are easiest to divert, but can rather, by reason
( 1 ) Directive 95/46/EC of the European Parliament and of the Council
of 24 October 1995 on the protection of individuals with regard to
of the scale or effects of the proposed action, be better
the processing of personal data and on the free movement of such
achieved at Union level, the Union may adopt measures,
data (OJ L 281, 23.11.1995, p. 31).
in accordance with the principle of subsidiarity as set out
( 2 ) Regulation (EC) No 45/2001 of the European Parliament and of the
in Article 5 of the Treaty on European Union. In
Council of 18 December 2000 on the protection of individuals with
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,
( 4 ) Regulation (EU) No 182/2011 of the European Parliament and of
12.1.2001, p. 1).
the Council of 16 February 2011 laying down the rules and general
( 3 ) Council Decision 1999/468/EC of 28 June 1999 laying down the
principles concerning mechanisms for control by the Member States
procedures for the exercise of implementing powers conferred on
of the Commission’s exercise of implementing powers (OJ L 55,
the Commission (OJ L 184, 17.7.1999, p. 23).
28.2.2011, p. 13).

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Union L
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accordance with the principle of proportionality, as set
‘(c) “placing on the market” means any supply, whether
out in that Article, this Regulation does not go beyond
in return for payment or free of charge, of
what is necessary in order to achieve that objective.
scheduled substances in the Union; or the
storage, manufacture, production, processing,
(19) The
European
Data
Protection
Supervisor
was
consulted
trade, distribution or brokering of these substances
in accordance with Article 28(2) of Regulation (EC) No
for the purpose of supply in the Union;’;
45/2001 and delivered an opinion on 18 January
2013 ( 1 ).
(c) the following points are added:
(20) Regulation (EC) No 273/2004 should therefore be
‘(h) “user” means a natural or legal person other than
amended accordingly,
an operator who possesses a scheduled substance
and is engaged in the processing, formulation,
HAVE ADOPTED THIS REGULATION:
consumption, storage, keeping, treatment, filling
into containers, transfer from one container to
another, mixing, transformation or any other utili
Article 1
sation of scheduled substances;
Regulation (EC) No 273/2004 is amended as follows:
(i) “natural product” means an organism or a part
thereof, in any form, or any substances which
(1) Article 1 is replaced by the following:
occur in nature as defined in point 39 of
Article 3 of Regulation (EC) No 1907/2006 of
‘Article 1
the European Parliament and of the Council (*).
Scope and objectives
___________
This Regulation establishes harmonised measures for the
(*) Regulation (EC) No 1907/2006 of the European
intra-Union control and monitoring of certain substances
Parliament and of the Council of 18 December
frequently used for the illicit manufacture of narcotic drugs
2006 concerning the Registration, Evaluation,
or psychotropic substances with a view to preventing the
Authorisation and Restriction of Chemicals
diversion of such substances.’;
(REACH), establishing a European Chemicals
Agency, amending Directive 1999/45/EC and
(2) in Article 2:
repealing Council Regulation (EEC) No 793/93
and Commission Regulation (EC) No 1488/94 as
(a) point (a) is replaced by the following:
well as Council Directive 76/769/EEC and
Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC (OJ L 396,
‘(a) “scheduled substance” means any substance listed
30.12.2006, p. 1).’;
in Annex I that can be used for the illicit manu
facture of narcotic drugs or psychotropic
substances, including mixtures and natural
products containing such substances but
(3) in Article 3:
excluding mixtures and natural products which
contain scheduled substances and which are
(a) paragraphs 2 and 3 are replaced by the following:
compounded in such a way that the scheduled
substances cannot be easily used or extracted by
‘2. Operators
and
users
shall
obtain
a
licence
from
readily applicable or economically viable means,
the competent authorities of the Member State in
medicinal products as defined in point 2 of
which they are established before they may possess
Article 1 of Directive 2001/83/EC of the
or place on the market scheduled substances of
European Parliament and of the Council (*) and
category 1 of Annex I. The competent authorities
veterinary medicinal products as defined in point
may grant special licences to pharmacies, dispensaries
2 of Article 1 of Directive 2001/82/EC of the
of veterinary medicine, certain types of public auth
European Parliament and of the Council (**);
orities or armed forces. Such special licences shall be
valid only for the use of scheduled substances of
___________
category 1 of Annex I within the scope of the
official duties of the operators concerned.
(*) Directive 2001/83/EC of the European Parliament
and of the Council of 6 November 2001 on the
Community code relating to medicinal products
3. Any
operator
holding
a
licence
shall
supply
for human use (OJ L 311, 28.11.2001, p. 67).
scheduled substances of category 1 of Annex I only
(**) Directive 2001/82/EC of the European Parliament
to operators or users who also hold a licence and have
and of the Council of 6 November 2001 on the
signed a customer declaration as provided for in
Community code relating to veterinary medicinal
Article 4(1).’;
products (OJ L 311, 28.11.2001, p. 1).’;
(b) paragraphs 5, 6 and 7 are replaced by the following:
(b) point (c) is replaced by the following:
‘5. Without prejudice to paragraph 8, the
competent authorities may either limit the validity of
( 1 ) Not yet published in the Official Journal.
the licence to a period not exceeding three years or

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may oblige the operators and users to demonstrate at
8. The
Commission
shall
be
empowered
to
adopt
intervals not exceeding three years that the conditions
delegated acts in accordance with Article 15a
under which the licence was granted are still fulfilled.
concerning the requirements and conditions for:
The licence shall mention the operation or operations
for which it is valid, as well as the scheduled
substances concerned. The competent authorities
(a) granting the licence, including, where relevant, the
shall, in principle, grant special licences for an
categories of personal data to be provided;
unlimited duration but may suspend or revoke them
where there are reasonable grounds for believing that
the holder is no longer a fit and proper person to hold
(b) granting registration, including where relevant the
a licence, or that the conditions under which the
categories of personal data to be provided;
licence was granted are no longer fulfilled.
6. Operators
shall
obtain
registration
from
the
(c) listing operators and users in the European
competent authorities of the Member State in which
database referred to in Article 13a, in accordance
they are established before placing on the market
with paragraph 7 of this Article.
scheduled substances of category 2 of Annex I. From
1 July 2015 users shall obtain a registration from the
competent authorities of the Member State in which
The categories of personal data referred to in points (a)
they are established before possessing scheduled
and (b) of the first subparagraph of this paragraph
substances of subcategory 2A of Annex I. The
shall not include special categories of data as referred
competent authorities may grant special registrations
to in Article 8(1) of Directive 95/46/EC of the
to pharmacies, dispensaries of veterinary medicine,
European Parliament and of the Council (*).
certain types of public authorities or the armed
forces. Such special registrations shall be considered
valid only for the use of scheduled substances of
___________
category 2 of Annex I within the scope of the
(*) Directive 95/46/EC of the European Parliament and
official duties of the operators or users concerned.
of the Council of 24 October 1995 on the
protection of individuals with regard to the
processing of personal data and on the free
6a. Any
operator
holding
a
registration
shall
supply
movement of such data (OJ L 281, 23.11.1995,
scheduled substances of subcategory 2A of Annex I
p. 31).’;
only to other operators or users who also hold a regis
tration and have signed a customer declaration as
provided for in Article 4(1).
(4) in Article 4:
6b. When
considering
whether
to
grant
registration,
the competent authorities shall take into account, in
(a) paragraph 1 is replaced by the following:
particular, the competence and integrity of the
applicant. They shall refuse registration if there are
reasonable grounds for doubting the suitability and
reliability of the applicant or of the officer responsible
‘1. Without
prejudice
to
paragraph
4
of
this
Article,
for the trade in scheduled substances. They may
and to Articles 6 and 14, any operator established
suspend or revoke registration where there are
within the Union who supplies a customer with a
reasonable grounds for believing that the holder is
scheduled substance of category 1 or 2 of Annex I
no longer a fit and proper person to hold a regis
shall obtain a declaration from the customer which
tration, or that the conditions under which registration
shows the specific use or uses of the scheduled
was granted are no longer fulfilled.
substances. The operator shall obtain a separate
declaration for each scheduled substance. That
declaration shall conform to the model set out in
6c. The competent authorities may require
point 1 of Annex III. In the case of legal persons,
operators and users to pay a fee for the application
the declaration shall be made on headed notepaper.’;
for a licence or for registration.
(b) paragraph 3 is replaced by the following:
Where a fee is levied, competent authorities shall
consider adjusting the level of the fee depending on
the size of the enterprise. Such a fee shall be levied in
‘3. An
operator
supplying
scheduled
substances
of
a non-discriminatory manner and shall not exceed the
category 1 of Annex I shall stamp and date a copy of
cost of processing the application.
the declaration, certifying it to be a true copy of the
original. Such copy shall always accompany those
substances being moved within the Union and shall
7. The
competent
authorities
shall
list
the
operators
be presented on request to the authorities responsible
and users that have obtained a licence or a registration
for checking vehicle contents during transport oper
in the European database referred to in Article 13a.
ations.

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4. The
Commission
shall
be
empowered
to
adopt
(a) points (b) and (c) of paragraph 1 are replaced by the
delegated acts in accordance with Article 15a
following:
concerning the requirements and conditions for
obtaining and using customer declarations.’;
‘(b) to enter operators’ and users’ business premises in
order to obtain evidence of irregularities;
(5) in Article 5, the following paragraph is added:
‘7. The
Commission
shall
be
empowered
to
adopt
(c) where necessary, to detain and seize consignments
delegated acts in accordance with Article 15a concerning
that fail to comply with this Regulation.’;
the requirements and conditions for the documentation of
mixtures containing scheduled substances.’;
(b) paragraph 2 is replaced by the following:
(6) in Article 7, the following paragraph is added:
‘2. Each
Member
State
may
adopt
the
measures
necessary to enable its competent authorities to
‘The Commission shall be empowered to adopt delegated
control and monitor suspicious transactions involving
acts in accordance with Article 15a concerning the
non-scheduled substances, and in particular:
requirements and conditions for the labelling of mixtures
containing scheduled substances.’;
(a) to obtain information on any orders for non-
(7) Article 8 is replaced by the following:
scheduled substances or operations involving
non-scheduled substances;
‘Article 8
(b) to enter business premises in order to obtain
Notification of the competent authorities
evidence of suspicious transactions involving
1. Operators
shall
notify
the
competent
authorities
non-scheduled substances;
immediately of any circumstances, such as unusual
orders or transactions involving scheduled substances to
be placed on the market, which suggest that such
(c) where necessary, to detain and seize consignments
substances might be diverted for the illicit manufacture
to prevent the use of specific non-scheduled
of narcotic drugs or psychotropic substances. To that
substances for the illicit manufacture of narcotic
end, operators shall provide any available information
drugs or psychotropic substances.
allowing the competent authorities to verify the legitimacy
of the relevant order or transaction.
3. The competent authorities shall respect
confidential business information.’;
2. Operators
shall
provide
the
competent
authorities
with relevant information in summary form about their
transactions involving scheduled substances.
(10) Articles 13 to 16 are replaced by the following:
3. The
Commission
shall
be
empowered
to
adopt
‘Article 13
delegated acts in accordance with Article 15a concerning
the requirements and conditions for operators to provide
Communications from Member States
information as referred to in paragraph 2 of this Article
including, where relevant, the categories of personal data
1. To permit any necessary adjustments to the
to be processed for that purpose and the safeguards for
arrangements for monitoring trade in scheduled substances
processing such personal data.
and non-scheduled substances, the competent authorities
in each Member State shall communicate to the
Commission in electronic form via the European
4. Operators
shall
not
disclose
any
personal
data
database referred to in Article 13a in a timely manner
collected pursuant to this Regulation other than to the
all relevant information on the implementation of the
competent authorities.’;
monitoring measures laid down in this Regulation, in
particular as regards substances used for the illicit manu
facture of narcotic drugs or psychotropic substances and
(8) in Article 9, paragraph 1 is replaced by the following:
methods of diversion and illicit manufacture, and their licit
trade.
‘1. The
Commission
shall
draw
up,
and
keep
up
to
date,
guidelines to facilitate cooperation between the competent
authorities, the operators, and the chemical industry, in
2. The
Commission
shall
be
empowered
to
adopt
particular as regards non-scheduled substances.’;
delegated acts in accordance with Article 15a specifying
the conditions and requirements concerning the
information to be provided under paragraph 1 of this
(9) in Article 10:
Article.

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3. A
summary
of
the
communications
made
pursuant
Article 13b
to paragraph 1 of this Article shall be submitted by the
Commission to the International Narcotics Control Board
Data protection
in accordance with Article 12(12) of the United Nations
1. The
processing
of
personal
data
by
the
competent
Convention and in consultation with the Member States.
authorities in the Member States shall be carried out in
accordance with national laws, regulations and adminis
trative provisions transposing Directive 95/46/EC and
Article 13a
under the supervision of the supervisory authority of the
Member State referred to in Article 28 of that Directive.
European database on drug precursors
1. The Commission shall establish a European database
on drug precursors with the following functions:
2. Without prejudice
to Article 13 of Directive
95/46/EC, personal data obtained or processed pursuant
to this Regulation shall be used solely for the purpose of
preventing the diversion of scheduled substances.
(a) to facilitate the communication of information, where
possible in an aggregated and anonymised manner,
pursuant to Article 13(1), the synthesis and analysis
3. The
processing
of
personal
data
by
the
Commission,
of that information at the Union level, and the
including for the purpose of the European database, shall
reporting to the International Narcotics Control
be carried out in accordance with Regulation (EC) No
Board pursuant to Article 13(3);
45/2001 and under the supervision of the European
Data Protection Supervisor.
(b) to create a European register of operators and users,
which have been granted a licence or registration;
4. Member
States
and
the
Commission
shall
not
process personal data in a manner incompatible with the
purposes set out in Article 13a.
(c) to enable operators to provide the competent auth
orities with information about their transactions in
accordance with Article 8(2) in electronic form, as
Article 14
specified in implementing measures adopted pursuant
Implementing acts
to Article 14.
1. The
Commission
may
adopt
the
following
imple
menting acts:
Personal data shall be included in the European database
only after the adoption of the delegated acts referred to in
Articles 3(8) and 8(3).
(a) rules on how to provide customer declarations referred
to in Article 4 in electronic form, where appropriate;
2. The
Commission
and
the
competent
authorities
shall
(b) rules on how to provide the information referred to in
take all necessary measures to ensure the security,
Article 8(2), including, where appropriate, in electronic
confidentiality and accuracy of personal data contained
form to a European database;
in the European database and to ensure that the rights
of data subjects are protected in accordance with
Directive 95/46/EC and Regulation (EC) No 45/2001 of
(c) procedural rules for granting licences and registrations
the European Parliament and of the Council (*).
and for listing operators and users in the European
database, as referred to in Article 3(2), (6) and (7).
3. Information
obtained
pursuant
to
this
Regulation,
including personal data, shall be used in accordance with
2. Those
implementing
acts
shall
be
adopted
in
the applicable law on personal data protection and shall
accordance with the examination procedure referred to
not be retained for longer than necessary for the purposes
in Article 14a(2).
of this Regulation. The processing of special categories of
data as referred to in Article 8(1) of Directive 95/46/EC
and in Article 10(1) of Regulation (EC) No 45/2001 shall
Article 14a
be prohibited.
Committee procedure
1. The
Commission
shall
be
assisted
by
the
Drug
4. The
Commission
shall
make
publicly
available,
in
a
Precursors Committee established by Article 30 of
clear, comprehensive and understandable manner,
Council Regulation (EC) No 111/2005
(**). That
information concerning the European database in
committee shall be a committee within the meaning of
accordance with Articles 10 and 11 of Regulation (EC)
Regulation (EU) No 182/2011 of the European Parliament
No 45/2001.
and of the Council (***).

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2. Where
reference
is
made
to
this
paragraph,
Article
5
Article 16
of Regulation (EU) No 182/2011 shall apply.
Information about measures adopted by Member
States
Article 15
1. Member
States
shall
inform
the
Commission
of
the
measures they adopt pursuant to this Regulation, and in
Adaptation of Annexes
particular of the measures adopted pursuant to Articles 10
The Commission shall be empowered to adopt delegated
and 12. They shall also notify any subsequent
acts in accordance with Article 15a in order to adapt
amendments thereof.
Annexes I, II and III to new trends in diversion of drug
precursors and to follow any amendment to the tables in
2. The Commission shall communicate that
the Annex to the United Nations Convention.
information to the other Member States.
3. The
Commission
shall,
by
31
December
2019,
Article 15a
submit a report to the European Parliament and to the
Council on the implementation and functioning of this
Exercise of the delegation
Regulation, and in particular on the possible need for
1. The
power
to
adopt
delegated
acts
is
conferred
on
additional action to monitor and control suspicious trans
the Commission subject to the conditions laid down in
actions with non-scheduled substances.
this Article.
___________
(*) Regulation (EC) No 45/2001 of the European
2. The power to adopt delegated acts referred to in
Parliament and of the Council of 18 December
Articles 3(8), 4(4) and 5(7), the second paragraph of
2000 on the protection of individuals with regard
Article 7, Articles 8(3) and 13(2) and Article 15 shall be
to the processing of personal data by the
conferred on the Commission for a period of five years
Community institutions and bodies and on the free
from 30 December 2013. The Commission shall draw up
movement of such data (OJ L 8, 12.1.2001, p. 1).
a report in respect of the delegation of power not later
(**) Council Regulation (EC) No 111/2005 of
than nine months before the end of the five-year period.
22 December 2004 laying down rules for the moni
The delegation of power shall be tacitly extended for
toring of trade between the Community and third
periods of an identical duration, unless the European
countries in drug precursors (OJ L 22, 26.1.2005,
Parliament or the Council opposes such extension not
p. 1).
later than three months before the end of each period.
(***) 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
3. The
delegation
of
power
referred
to
in
Articles
3(8),
States of the Commission’s exercise of implementing
4(4) and 5(7), the second paragraph of Article 7, Articles
powers (OJ L 55, 28.2.2011, p. 13).’;
8(3) and 13(2) and Article 15 may be revoked at any time
by the European Parliament or by the Council. A decision
to revoke shall put an end to the delegation of the power
specified in that decision. It shall take effect the day
(11) in Annex I:
following the publication of the decision in the Official
Journal of the European Union or at a later date specified
(a) the title is replaced by the following:
therein. It shall not affect the validity of any delegated acts
already in force.
‘List of scheduled substances’;
(b) in category 1, the CN code for Norephedrine is
4. As
soon
as
it
adopts
a
delegated
act,
the
Commission
replaced by the following:
shall notify it simultaneously to the European Parliament
and to the Council.
‘2939 44 00’;
5. A
delegated
act
adopted
pursuant
to
Articles
3(8),
(c) in category 1, the following substance is added to the
4(4) and 5(7), the second paragraph of Article 7, Articles
list of substances:
8(3) and 13(2) and Article 15 shall enter into force only if
no objection has been expressed either by the European
‘Alpha-phenylacetoacetonitrile, CN code 2926 90 95,
Parliament or the Council within a period of two months
CAS No 4468-48-8’;
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
(d) the text of category 2 is replaced by the text of the
informed the Commission that they will not object. That
Annex to this Regulation;
period shall be extended by two months at the initiative of
the European Parliament or of the Council.
(12) in Annex III, the text ‘authorisation/’ is deleted.

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L 330/28
EN
Official Journal of the European Union
10.12.2013
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 Strasbourg, 20 November 2013.
For the European Parliament
For the Council
The President
The President
M. SCHULZ
V. LEKEVIIUS

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EN
10.12.2013 Official
Journal
of
the
European
Union L
330/29
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.
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 L 290, 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.

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Document Outline

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