Common Position (EC) No 59/2003 29 September 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a regulation of the European Parliament and of the Council on drug precursors (Text with EEA relevance)
Date: 2003-09-29
Institutions: Council of the European Union
Subjects: approximation of laws, chemical product, illicit trade, marketing, narcotic

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COMMON POSITION (EC) No 59/2003

adopted by the Council on 29 September 2003

with a view to the adoption of a Regulation (EC) No . . ./2003 of the European Parliament and of
the Council of . . . on drug precursors

(2003/C 277 E/03)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the European Economic and
Social Committee (2),

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) 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’, was concluded by the
Community, by Council Decision 90/611/EEC (4).

(2) The requirements of Article 12 of the United Nations
Convention in respect of trade in drug precursors (i.e.
substances frequently used in the illicit manufacture of
narcotic drugs and psychotropic substances) have been
implemented as far as trade between the Community
and third countries is concerned by Council Regulation
(EEC) No 3677/90 of 13 December 1990 laying down
measures to be taken to discourage the diversion of
certain substances to the illicit manufacture of narcotic
drugs and psychotropic substances (5).

(3) Article 12 of the United Nations Convention envisages
adoption of appropriate measures to monitor the manu-
facture and distribution of precursors. This requires the
adoption of measures relating to the trade in precursors
among Member States. Such measures were introduced by
Council Directive 92/109/EEC of 14 December 1992 on
the manufacture and the placing on the market of certain

(1) OJ C 20 E, 28.1.2003, p. 160.
(2) OJ C 95, 23.4.2003, p. 6.
(3) Opinion of the European Parliament of 11 March 2003 (not yet
published in the Official Journal), Council Common Position of 29
September 2003 and Decision of the European Parliament of . . .
(not yet published in the Official Journal).

(4) OJ L 326, 24.11.1990, p. 56.
(5) OJ L 357, 20.12.1990, p. 1. Regulation as last amended by
Commission Regulation (EC) No 1232/2002 (OJ L 180, 10.7.2002,
p. 5).

substances used in the illicit manufacture of narcotic drugs
and psychotropic substances (6). To better ensure that
harmonised rules are applied at
the same time in all
Member States, a Regulation is considered to be more
adequate than the current Directive.

(4)

In the context of the enlargement of the European Union,
it is important to replace Directive 92/109/EEC by a Regu-
lation, as each modification of
that Directive and its
Annexes would trigger national implementation measures
in 25 Member States.

(5) By decisions taken at its thirty-fifth session in 1992, the
United Nations Commission on Narcotic Drugs included
additional substances in the tables of the Annex to the
United Nations Convention. Corresponding provisions
to
should be laid down in this Regulation in order
detect possible cases of illicit diversion of drug precursors
in the Community and to ensure that common monitoring
rules are applied in the Community market.

(6) The provisions of Article 12 of

is

in question. Most

the United Nations
Convention are based on a system of monitoring trade
in the substances
trade in these
entirely lawful. The documentation of
substances
consignments and labelling of these substances should be
is furthermore important, whilst
sufficiently explicit.
authorities with the necessary
providing
means of action,
the
United Nations Convention, mechanisms based on close
cooperation with the operators concerned and on the
development of intelligence gathering.

to develop, within the spirit of

It
competent

(7) The measures applicable to Sassafras Oil are currently
interpreted in different ways in the Community, since in
some Member States it is regarded as a mixture containing
Safrole and is therefore controlled, while other Member
to
States regard it as a natural product not subject
controls. Inserting a reference to natural products in the
definition of
this
‘scheduled substance’ will
discrepancy and therefore allow controls to be applied
to Sassafras Oil; only natural products
from which
scheduled substances can be extracted easily should be
covered by the definition.

resolve

(8) Substances commonly used in the illicit manufacture of
should be

narcotic drugs or psychotropic substances
listed in an Annex.

(6) OJ L 370 19.12.1992, p. 76. Directive as last amended by
Commission Directive 2001/8/EC (OJ L 39, 9.2.2001, p. 31).

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(9)

It should be ensured that the manufacture or use of certain
scheduled substances listed in Annex I
to
possession of a licence. In addition, the supply of such
substances should be permitted only where the persons
to whom they are to be supplied are holders of a
licence and have signed a customer declaration. The
detailed
declaration
the
should be laid down in Annex III.

concerning

is subject

customer

rules

(10) Measures should be adopted to encourage operators to
notify the competent authorities of suspect transactions
involving scheduled substances listed in Annex I.

(11) Measures should be adopted in order to guarantee better
control of intra-Community trade in scheduled substances
listed in Annex I.

(12) All transactions leading to the placing on the market of
scheduled substances of categories 1 and 2 of Annex I
should be properly documented. Operators should notify
the competent authorities of any suspect
transactions
involving the substances listed in Annex I. However,
exemptions
involving
substances of category 2 of Annex I where the quantities
involved do not exceed those indicated in Annex II.

to transactions

should apply

(13) A significant number of other substances, many of them
traded legally in large quantities, have been identified as
precursors to the illicit manufacture of synthetic drugs and
psychotropic substances. To subject these substances to
the same strict controls as those listed in Annex I would
present an unnecessary obstacle to trade involving licences
to operate and documentation of transactions. Therefore, a
more flexible mechanism at Community level should be
established whereby the competent authorities
in the
Member States are notified of such transactions.

(14) The introduction of a cooperation procedure is provided
for in the European Union Action Plan against drugs
approved by the European Council of Santa-Maria-da-Feira
on 19 and 20 June 2000. In order to support cooperation
between the competent authorities of the Member States
and the chemicals industry,
in particular with regard to
substances which, although not referred to in this Regu-
lation, might be used in the illicit manufacture of synthetic
drugs and psychotropic substances, guidelines should be
drawn up aimed at helping the chemical industry.

States should be free to choose the most dissuasive
penalties available under their national legislation.

(16) The measures necessary for the implementation of this
adopted in accordance with
Regulation should be
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (1).

(17) Since the objectives of

this Regulation, namely the
harmonised monitoring of the trade in drug precursors
and the avoidance of its diversion to the illicit manufacture
of synthetic drugs and psychotropic substances, cannot be
sufficiently achieved by the Member States and can
therefore, by reason of the international and changeable
nature of such trade, be better achieved at Community
level, the Community may adopt measures, in accordance
with the principle of subsidiarity as set out in Article 5 of
the Treaty. In accordance with the principle of propor-
tionality, as set out in that Article, this Regulation does
not go beyond what is necessary in order to achieve those
objectives.

(18) Council Directive 92/109/EEC, Commission Directives
93/46/EEC (2), 2001/8/EC (3)
and
Commission Regulations (EC) No 1485/96 (5) and (EC)
No 1533/2000 (6) should be repealed,

and 2003/. . ./EC (4)

HAVE ADOPTED THIS REGULATION:

Article 1

Scope and objectives

This Regulation establishes harmonised measures for the intra-
Community control and monitoring of certain substances
frequently used for the illicit manufacture of narcotic drugs
or psychotropic substances with a view to preventing the
diversion of such substances.

(1) OJ L 184, 17.7.1999, p. 23.
(2) Commission Directive 93/46/EEC of 22 June 1993 replacing and
modifying the Annexes to Council Directive 92/109/EEC on the
manufacture and placing on the market of certain substances
used in the illicit manufacture of narcotic drugs and psychotropic
substances (OJ L 159, 1.7.1993, p. 134).

(3) Commission Directive 2001/8/EC of 8 February 2001 replacing
Annex I
to Council Directive 92/109/EEC on the manufacture
and placing on the market of certain substances used in the illicit
manufacture of narcotic drugs and psychotropic substances (OJ L
39, 9.2.2001, p. 31).

(4) OJ L . . .
(5) Commission Regulation (EC) No 1485/96 of 26 July 1996 laying
the application of Council Directive
down detailed rules
92/109/EEC, as
specific use
relating to certain substances used in the illicit manufacture of
narcotic drugs and psychotropic substances (OJ L 188, 27.7.1996,
p. 28). Regulation as amended by Regulation (EC) No 1533/2000
(OJ L 175, 14.7.2000, p. 75).

regards customer declarations of

for

(15) It is appropriate to make provision for the Member States
to lay down rules on penalties applicable for infringement
of the provisions of this Regulation. Given that the trade
in drug precursors may lead to the illicit manufacture of
synthetic drugs and psychotropic substances, Member

(6) Commission Regulation (EC) No 1533/2000 of 13 July 2000
amending Regulation (EC) No 1485/96 laying down detailed rules
for the application of Council Directive 92/109/EEC, as regards
customer declarations of specific use relating to certain substances
used in the illicit manufacture of narcotic drugs and psychotropic
substances.

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Article 2

Definitions

the
empowered to represent
decisions necessary for performing the tasks specified above.

the operator and to take

For the purposes of this Regulation the following definitions
shall apply:

(a) ‘scheduled substance’ means any substance listed in Annex
I, including mixtures and natural products containing such
substances. This excludes medicinal products as defined by
Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code
relating to medicinal products for human use (1), phar-
maceutical preparations, mixtures, natural products and
other preparations containing scheduled substances that
are compounded in such a way that
they cannot be
easily used or extracted by readily applicable or econ-
omically viable means;

(b) ‘non-scheduled substance’ means any substance which,
although not
is identified as having
been used for the illicit manufacture of narcotic drugs or
psychotropic substances;

listed in Annex I

(c) ‘placing on the market’ means any supply, whether in
return for payment or
scheduled
substances in the Community; or the storage, manufacture,
production, processing, trade, distribution or brokering of
these
supply in the
Community;

free of charge, of

the purpose of

substances

for

(d) ‘operator’ means any natural or legal person engaged in the

placing on the market of scheduled substances;

(e) ‘International Narcotics Control Board’ means the Board
established by the Single Convention on Narcotic Drugs,
1961, as amended by the 1972 Protocol;

(f)

‘special
particular type of operator;

licence’ means a licence that

is granted to a

(g) ‘special registration’ means a registration that is made for a

particular type of operator.

Article 3

Requirements for the placing on the market of scheduled
substances

Operators wishing to place on the market scheduled
1.
substances of categories 1 and 2 of Annex I
shall be
required to appoint an officer responsible for the trade in
scheduled substances, to notify the competent authorities of
the name and contact details of that officer and to notify
them immediately of any subsequent modification of
this
information. The officer
trade in
scheduled substances conducted by the operator takes place
shall be
in compliance with this Regulation. The officer

shall ensure

that

the

(1) OJ L 311, 28.11.2001, p. 67. Directive as amended by Directive

2002/98/EC (OJ L 33, 8.2.2003, p. 30).

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

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

take into account

to grant a licence,

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

the applicant or of

5. Without prejudice to Article 14, the competent auth-
orities may either limit the validity of the licence to a period
not exceeding three years or may oblige the operators to
demonstrate at intervals not exceeding three years that the
conditions under which the licence was granted are still
fulfilled. The licence shall mention the operation or operations
for which it is valid, as well as the substances concerned.
Special
licences within the meaning of paragraph 2 shall be
granted in principle for an unlimited duration but may be
suspended or revoked by the competent authorities under the
conditions of paragraph 4, third sentence.

6. Without prejudice to Article 6, operators engaged in the
placing on the market of scheduled substances of category 2 of
Annex I shall be required to register and update with the
competent authorities without delay the addresses of
the
premises at which they manufacture or from which they
trade in these substances, before placing them on the market.
Pharmacies, dispensaries of veterinary medicine, certain types
of public authorities or the armed forces may be made subject
to a special registration. Such registrations shall be considered
valid only for the use of precursors within the scope of the
official duties of the operators concerned.

7.
The competent authorities may require operators to pay a
fee for the application for a licence or a registration. Such fees
shall be levied in a non-discriminatory way and shall not
exceed the cost of processing the application.

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Article 4

(a) the name of the scheduled substance as given in categories

Customer declaration

1 and 2 of Annex I;

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

As an alternative to the above declaration for an indi-
2.
vidual
transaction, an operator who regularly supplies a
customer with a scheduled substance of category 2 of Annex
I may accept a single declaration in respect of a number of
transactions involving this scheduled substance over a period
not exceeding one year, provided that the operator is satisfied
that the following criteria have been met:

(a) the customer has been supplied by the operator with the
three occasions in the preceding

least

substance on at
twelve months;

(b) the operator has no reason to suppose that the substance

will be used for illicit purposes;

(c) the quantities ordered are consistent with the usual

consumption for that customer.

This declaration shall conform to the model set out in point 2
of Annex III. In the case of legal persons, the declaration shall
be made on headed notepaper.

3.
An operator supplying scheduled substances of category
1 of Annex I shall stamp and date a copy of the declaration,
certifying it to be a true copy of the original. Such copy must
always accompany category 1 substances being moved within
the Community and must be presented on request to the auth-
orities
contents during
transport operations.

checking vehicle

responsible

for

Article 5

Documentation

1. Without prejudice to Article 6, operators shall ensure that
all
transactions leading to the placing on the market of
scheduled substances of categories 1 and 2 of Annex I are
properly documented in accordance with paragraphs 2 to 5
below. This obligation shall not apply to those operators who
hold special licences or are subject to special registration under
Article 3(2) and (6) respectively.

Commercial documents such as invoices, cargo manifests,
shipping
transport
information to identify

2.
administrative documents,
documents shall contain sufficient
positively:

and other

(b) the quantity and weight of the scheduled substance and,
the
where a mixture or natural product
quantity and weight,
the mixture or
natural product as well as the quantity and weight, or
the percentage by weight, of any substance or substances
of categories 1 and 2 of Annex I which are contained in
the mixture;

if available, of

is concerned,

(c)

and address of

the name
supplier, distributor,
if possible, of other operators directly
consignee, and,
involved in the transaction, as referred to in Article 2(c)
and (d).

the

The documentation must
3.
declaration as referred to in Article 4.

also contain a

customer

Operators

their
4.
activities as are required to comply with their obligations
under paragraph 1.

shall keep such detailed records of

The documentation and records referred to in paragraphs
5.
1 to 4 shall be kept for at least three years from the end of the
calendar year in which the transaction referred to in paragraph
1 took place, and must be readily available for inspection by
the competent authorities upon request.

6.
The documentation may also be kept in the form of
reproductions on an image medium or other data media. It
must be ensured that the data stored:

(a) match the documentation in appearance and content when

made readable, and

(b) are readily available at all times, can be made readable
without delay and can be analysed by automated means
for the duration of the period specified in paragraph 5.

Article 6

Exemptions

The obligations under Articles 3, 4 and 5 shall not apply to
transactions involving scheduled substances of category 2 of
Annex I where the quantities involved do not exceed those
indicated in Annex II over a period of one year.

Article 7

Labelling

Operators shall ensure that
labels are affixed to scheduled
substances of categories 1 and 2 of Annex I before they are
supplied. The labels must show the names of the substances as
given in Annex I. Operators may in addition affix their
customary labels.

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Article 8

Article 11

Notification of the competent authorities

Cooperation between the Member States

and the

the

shall

notify

Operators

competent

1.
authorities
immediately of any circumstances, such as unusual orders or
transactions involving scheduled substances to be placed on the
market, which suggest that such substances might be diverted
for the illicit manufacture of narcotic drugs or psychotropic
substances.

2.
Operators shall provide the competent authorities in
summary form with such information about their transactions
involving scheduled substances as is specified in implementing
measures adopted pursuant to Article 14.

Article 9

Guidelines

the operators, and the chemical
as

In order to facilitate cooperation between the competent
1.
in
authorities,
particular
the
Commission shall, in accordance with the procedure referred
to in Article 15(2), draw up and update guidelines to assist the
chemical industry.

non-scheduled

substances,

industry,

regards

2.

The guidelines shall provide in particular:

(a)

information on how to recognise and notify suspect trans-
actions;

(b) a regularly updated list of non-scheduled substances to
enable industry to monitor on a voluntary basis the trade
in such substances;

(c) other information which may be deemed useful.

list of non-scheduled substances

The competent authorities shall ensure that the guidelines
3.
and the
regularly
disseminated in a manner deemed appropriate by the
competent authorities in accordance with the objectives of
the guidelines.

are

Commission

Each Member State

competent
1.
authority or authorities responsible for ensuring the application
of this Regulation and shall inform the Commission thereof.

shall designate

the

For the purposes of applying this Regulation and without
2.
prejudice to Article 15, the provisions of Council Regulation
(EC) No 515/97 of 13 March 1997 on mutual assistance
between the administrative authorities of the Member States
and cooperation between the latter and the Commission to
ensure the correct application of the law on customs and
agricultural matters (1), and in particular those on confiden-
tiality, shall apply mutatis mutandis. The competent authority
or authorities designated under paragraph 1 of this Article shall
act as competent authorities within the meaning of Article 2(2)
of Regulation (EC) No 515/97.

Article 12

Penalties

The Member State shall
lay down the rules on penalties
applicable for infringement of the provisions of this Regulation
and shall take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective,
proportionate and dissuasive.

Article 13

Communications from Member States

in

trade

scheduled

substances

To permit any necessary adjustments to the arrangements
1.
for monitoring
and
non-scheduled substances, the competent authorities in each
Member State shall each year communicate to the Commission
the monitoring
all
measures
in particular as
regards substances frequently used for the illicit manufacture
of narcotic drugs or psychotropic substances and methods of
diversion and illicit manufacture.

information on the implementation of

laid down in this Regulation,

Article 10

Powers and obligations of competent authorities

1.
In order to ensure the correct application of Articles 3 to
8, each Member State shall adopt the measures necessary to
enable its competent authorities to perform their control and
monitoring duties, and in particular:

(a) to obtain information on any orders

for

scheduled

substances or operations involving scheduled substances;

(b) to enter operators' business premises in order to obtain

evidence of irregularities;

2.
A summary of the communications made pursuant to
paragraph 1 shall be submitted by the Commission to the
International Narcotics Control Board.
in accordance with
Article 12(12) of the United Nations Convention and in consul-
tation with the Member States.

Article 14

Implementation

Where necessary, the following measures for the implemen-
tation of this Regulation shall be adopted in accordance with
the procedure referred to in Article 15(2):

(c) where necessary, to detain consignments that fail to comply

with this Regulation.

(a) Determination of the requirements and conditions for the
granting of the licence as provided for in Article 3 and the
details pertaining to the licence;

The competent authorities

2.
business information.

shall

respect

confidential

(1) OJ L 82, 22.3.1997, p. 1. Regulation as amended by Regulation

(EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

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(b) Determination, whenever necessary, of

the conditions
which shall apply to the documentation and labelling of
mixtures and preparations containing substances listed in
Annex I, as provided for in Articles 5 to 7;

(c) Any

amendments

I made necessary by
amendments to the tables in the Annex to the United
Nations Convention;

to Annex

Article 16

Information about measures adopted by Member States

it adopts pursuant

inform the Commission of

Each Member State shall
the
to this Regulation, and in
measures
particular of the measures adopted pursuant to Articles 10
and 12. They shall also notify any subsequent amendments
thereof.

(d) Amendments to the thresholds set in Annex II;

(e) Determination of

the requirements and conditions for
customer declarations referred to in Article 4, as well as
the detailed rules concerning their use. This shall include
rules on how to provide customer declarations in electronic
form, where appropriate;

(f) Other measures needed for the efficient implementation of

this Regulation.

Article 15

Committee

The Commission shall be assisted by the committee set

1.
up by Article 10 of Regulation (EEC) No 3677/90.

2. Where reference is made to this paragraph, Articles 4 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC
shall be set at three months.

3.

The Committee shall adopt its rules of procedure.

The Commission shall communicate this information to the
other Member States. It shall evaluate the implementation of
the Regulation three years after its entry into force.

Article 17

Repeals

1.
Council Directive 92/109/EEC, Commission Directives
93/46/EEC, 2001/8/EC and 2003/. . ./EC and Commission
Regulations (EC) No 1485/96 and (EC) No 1533/2000 are
hereby repealed.

References to the repealed Directives or Regulations shall

2.
be construed as being made to this Regulation.

The validity of any register established, any licences
the

3.
granted and any customer declarations
repealed Directives or Regulations shall not be affected.

issued under

Article 18

Entry into force

This Regulation shall enter into force on . . . (*), except
for
Articles 9, 14 and 15, which shall enter into force on the
day of
this Regulation in the Official
Journal of the European Union, in order to permit the adoption
of the measures provided for in those Articles. Such measures
shall enter into force at the earliest on . . . (*).

the publication of

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

Done at . . .

For the European Parliament

The President

For the Council

The President

(*) 18 months after the date of publication in the Official Journal of the

European Union.

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SCHEDULED SUBSTANCES WITHIN THE MEANING OF ARTICLE 2(a)

ANNEX I

Substance

1-Phenyl-2-propanone

N-acetylanthranilic acid

Isosafrol (cis + trans)

3,4-Methylenedioxyphe-
nylpropan-2-one

Piperonal

Safrole

Ephedrine

Pseudoephedrine

Norephedrine

Ergometrine

Ergotamine

Lysergic acid

Category 1

CN designation
(if different)

Phenylacetone

2-Acetamidobenzoic acid

CN code (1)

CAS No (2)

2914 31 00

103-79-7

2924 23 00

89-52-1

2932 91 00

120-58-1

1-(1,3-Benzodioxol-5-yl)propan-2-one

2932 92 00

4676-39-5

2932 93 00

120-57-0

2932 94 00

94-59-7

2939 41 00

299-42-3

2939 42 00

90-82-4

ex 2939 49 00

14838-15-4

2939 61 00

60-79-7

2939 62 00

113-15-5

2939 63 00

82-58-6

The stereoisomeric forms of the substances listed in this Category not being cathine (3) whenever the existence of such
forms is possible.

The salts of the substances listed in this Category whenever the existence of such salts is possible and not being the salts
of cathine.

Substance

Acetic anhydride

Phenylacetic acid

Anthranilic acid

Piperidine

Potassium permanganate

Category 2

CN designation
(if different)

CN code (1)

CAS No (2)

2915 24 00

2916 34 00

2922 43 00

2933 32 00

108-24-7

103-82-2

118-92-3

110-89-4

2841 61 00

7722-64-7

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

Substance

Hydrochloric acid

Sulphuric acid

Toluene

Ethyl ether

Acetone

Category 3

CN designation
(if different)

Hydrogen chloride

Diethyl ether

Methylethylketone

Butanone

CN code (1)

CAS No (2)

2806 10 00

7647-01-0

2807 00 10

7664-93-9

2902 30 00

108-88-3

2909 11 00

2914 11 00

2914 12 00

60-29-7

67-64-1

78-93-3

The salts of the substances listed in this Category whenever the existence of such salts is possible and not being the salts
of hydrochloric acid and sulphuric acid.

(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.

(3) Also named (+)-norpseudoephedrine, CN code 2939 43 00, CAS No 492-39-7.

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ANNEX II

Substance

Acetic anhydride

Potassium Permanganate

Anthranilic acid and its salts

Phenylacetic acid and its salts

Piperidine and its salts

Threshold

100 l

100 kg

1 kg

1 kg

0,5 kg

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1. Model declaration relating to individual transactions (category 1 or 2)

ANNEX III

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2. Model declaration relating to multiple transactions (category 2)

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

The Commission submitted the above-mentioned proposal to the Council on 10 September 2002.

The European Parliament delivered its Opinion at first reading on 11 March 2003, adopting three
amendments to the initial proposal.

In the light of
Commission submitted an amended proposal.

the outcome of

the European Parliament's first reading, on 27 May 2003 the

The Economic and Social Committee delivered its Opinion on 26 February 2003 (1).

Under the codecision procedure (Article 251 TEC), on 29 September 2003 the Council, having regard
to Parliament's first reading, adopted its common position on the draft Regulation.

II. OBJECTIVE

The objective of the proposed Regulation is to transform the existing Directive 92/109/EEC (2) into a
Regulation in order to simplify legislation and thus facilitate legitimate trade in precursors in the
internal market, avoiding at the same time the diversion of these chemicals to the manufacturing of
illegal drugs.

III. ANALYSIS OF THE COMMON POSITION

1. General

In its common position the Council shares the proposal's objective, which is to establish harmonised
measures for the intra-Community control and monitoring of certain substances frequently used for
the illicit manufacture of narcotic drugs and psychotropic substances with a view to preventing the
diversion of such substances.

2. EP Amendments

The Council took the following positions on the amendments adopted by the European Parliament:

— Amendment No 1 has been accepted by the Council and included as a new Recital 4 in the

common position.

— Amendment No 2 has not been incorporated into the common position since the list of
non-scheduled substances is examined by the Committee referred to in Article 15 four times
a year and modified when necessary. The Council shares the Commission's view that the
proposed amendment would not lead to an improvement of the current system.

— The Council has not accepted the first part of Amendment No 3, whereby each Member State
should inform the Commission annually of its implementation measures. However, the EP's
concern that such information be provided regularly is addressed by the requirement
for
Member States to notify the Commission of any amendments to their
implementation
measures (Article 16). The second part of this Amendment has been accepted by the Council.

3. New elements introduced by the Council

The main points of the common position which differ from the Commission's proposal are as
follows:

Recital 4

This new Recital explicitly states that in the context of the EU enlargement it is important to
transform the existing Directive into a Regulation, as each modification of the Directive and its
annexes would trigger national implementation measures in 25 Member States.

(1) OJ C 95, 23.4.2003, p. 6.
(2) OJ L 370, 19.12.1992, p. 76.

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Recital 15

The common position adds a new recital, Recital 15, to clarify that Member States which currently
provide for strict controls and penalties under national legislation are not required to downgrade
such legislation under this Regulation.

Article 2 — Definitions

— Under (c), ‘processing’ has been included in the definition of ‘placing on the market’ in order to
include processing within the scope of the Regulation. Processing was included in the definition
of ‘operator’ in Directive 92/109/EEC;

— Under (f) and (g) definitions have been added for ‘special licence’ and ‘special registration’ to

reflect additions to Article 3(2), (5) and Article 5.

Article 3 — Requirements for the placing on the market of scheduled substances

— A new paragraph 1 has been added by the Council to provide for the appointment by the
operator of a particular person to monitor that trade in scheduled substances is in compliance
with the Regulation. This provision enables the competent national authorities to assess whether
a particular operator should be granted a licence;

— in paragraph 2 the common position introduces the requirement for operators to hold a licence
before they possess scheduled substances, to facilitate more effective control. In addition, the
common position allows the competent authorities to exempt certain categories of public auth-
orities and operators from some of the obligations relating to the renewal of licences and the
documentation required for transactions. This exemption is provided for through the issue of a
special licence and registration. Exemption rules have been included in order to avoid creating
an excessive administrative burden for the competent authorities and certain categories of
operators. The introduction of exemptions is reflected in amendments to Article 3(5),
last
sentence, Article 3(6), 2nd sentence, Article 5(1), last sentence and Article 14(1);

— The provisions of paragraph (3) stating that operators may only supply scheduled substances to
licence holders and signatories of customer declarations have been transferred from Article 4(3)
of the Commission's proposal;

— In paragraph 4 the Council has added a provision stating that competent authorities should
refuse to issue a licence if there are reasonable grounds to consider the applicant unsuitable;

— A new paragraph 5 has been inserted to empower the competent authorities either to limit the
duration of validity of the licence or to seek proof that the conditions for granting the licence
are still valid. This insertion allows stricter enforcement of the Regulation;

— In paragraph 7 the Council allows the competent authorities,

in accordance with national
practice in some Member States, to request a fee for licence or registration, which shall not
exceed the administrative costs incurred.

Article 5 — Documentation

— In paragraph 1, operators who hold special licences or are subject to special registration are

exempted from the obligation of documenting transactions;

— In paragraph 2 under (b), the common position includes natural products, in accordance with

the definition of scheduled substances set out in Article 2(a);

— In paragraph 2 under (c), the Council makes reference to all operators involved in transactions
in order to ensure that the whole chain of operators are identified on commercial documents,
where this proves possible;

— In paragraph 6, the common position adds the possibility for electronic means of storing

documentation.

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Article 6 — Exemptions

Article 6 has been amended to clarify that the thresholds for category 2 substances cover a one-year
period.

Article 8 — Notification of the Competent Authorities

The Council considered that implementing measures were necessary to determine the information
required from operators on transactions involving scheduled substances. Article 8(2) has therefore
been amended accordingly.

Article 10 — Powers and obligations of Competent Authorities

In paragraph 1 point (c) has been inserted to specify that competent authorities are empowered to
detain consignments that are not in compliance with the Regulation.

Article 12 — Penalties

In paragraph 1 the obligation of Member States to notify the Commission on the establishment of
rules on penalties or their amendment has been transferred to Article 16.

Article 14 — Implementation procedure

The Council considered that implementing measures were necessary in Article 14 to determine the
requirements and conditions for the granting of licences. A new paragraph 1 has been introduced to
meet this consideration. In addition,
in paragraph 5 the Council envisaged the possible estab-
lishment of rules on how to provide customer declarations in electronic form. Finally a new
paragraph 6 was added to cover other necessary implementing measures.

Article 16 – Information about measures taken by Member States

— Paragraph 1 has been amended in order to include the obligation for Member States to inform
the Commission about the measures they take with regard to penalties and to performing their
control and monitoring duties, and any amendments thereto. This obligation has been trans-
ferred from Article 12 of the Commission proposal;

— paragraph 2 has been redrafted to take account of an amendment adopted by the Parliament
which imposes on the Commission the obligation to evaluate the implementation of the Regu-
lation three years after its entry into force. Since Article 18 foresees that the Regulation shall
enter into force 18 months from its publication in the Official Journal, the Council believes that
it is reasonable to evaluate its implementation in five years from its publication approximately.

Article 17 — Repeal and Recital 18

Given that a period of 18 months is foreseen before the Regulation enters into force (Article 18), a
number of Member States have asked the Commission to propose the immediate amendment of the
annexes to the existing Directive 92/109/EEC via a Commission Directive. The adoption of this
Directive via comitology is foreseen before the summer recess 2003. This Directive should also be
repealed together with all current legal instruments specified in Article 17, when the new Regulation
enters into force. Article 17 and the corresponding Recital 18 have therefore been amended
accordingly.

Annex I

The common position:

— adds a title to Annex I;

— corrects the CN code and CAS number for Norephedrine;

— adds references to stereoisomeric forms of the substances listed in Category 1, wherever possible;

— excludes cathine from the substances included in Category 1; and

— adds technical explanatory notes.

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IV. CONCLUSION

The Common Position, which has been unanimously adopted by the Council, has been designed to
achieve the aim of this Regulation, which is to establish harmonised measures for the control and
monitoring of the intra-Community licit trade on drug precursors, preventing the diversion of such
chemicals for the illicit manufacture of narcotic drugs and psychotropic substances.