CELEX ID: 32005R0111

--- ENGLISH ---

Document:
26.1.2005
EN
Official Journal of the European Union
L 22/1
COUNCIL REGULATION (EC) No 111/2005
of 22 December 2004
laying down rules for the monitoring of trade between the Community and third countries in drug precursors
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 133 thereof,
Having regard to the proposal from the Commission,
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’, is part of the worldwide effort to combat illegal drugs. Within its sphere of competence, the Community participated in the negotiation and concluded the Convention on behalf of the Community by means of Council Decision 90/611/EEC 
(
1
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.
(2)
Article 12 of the United Nations Convention concerns trade in substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances. As provisions on trade in drug precursors affect Community rules in customs matters, it is appropriate to lay down Community rules on trade between the Community and third countries.
(3)
Article 12 of the United Nations Convention requires a system to monitor international trade in drug precursors, taking account of the fact that, in principle, trade in these substances is lawful. Consequently, measures have been taken to strike an appropriate balance between the desire to exploit all possible means to prevent drug precursors reaching illicit drug manufacturers and the commercial needs of the chemical industry and other operators.
(4)
To implement the requirements of Article 12 of the United Nations Convention and, taking account of the report of the Chemical Action Task Force created by the Houston Economic Summit (G-7) on 10 July 1990, 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 
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2
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, established a system for reporting suspicious transactions. This system, which is based on close cooperation with operators, is reinforced through measures such as documentation and labelling, licensing and registration of operators as well as procedures and requirements governing exports.
(5)
Following the European Union Action Plan on Drugs 2000 to 2004, endorsed by the European Council at Feira in June 2000, the Commission organised an assessment of the Community control system of trade in drug precursors to draw conclusions from the implementation of Community legislation in this field.
(6)
According to that assessment and in order to improve the control mechanisms aiming at preventing diversion of drug precursors, it is necessary to extend monitoring requirements with regard to operators based within the Community facilitating trade between third countries, to introduce a Community approach with regard to procedures for granting licences and to strengthen monitoring requirements governing suspensive customs procedures.
(7)
Procedures and requirements for exports should be further intensified to target and concentrate controls on the most sensitive drug precursors, whilst reducing excessive administrative burden through simplified procedures for exports of high volume substances. While the effectiveness and practicability of pre-export notifications is fully recognised, a strategy should be developed striving to exploit the system to the fullest extent possible.
(8)
In order to address the heightened concern about the production of amphetamine-type stimulants, import control mechanisms for the main synthetic drug precursors should be further strengthened through common procedures and requirements allowing individual consignment-based controls to be carried out.
(9)
So as to allow operators to fulfil these requirements, provisions governing external trade in drug precursors should, to the extent possible, be aligned with the provisions governing intra-Community trade in drug precursors wholly obtained or produced, or released for free circulation, in the Community.
(10)
Taking account of the requirements of the internal market, and in the interests of this Regulation’s effectiveness, uniform application of the provisions should be ensured through adoption of comparable and converging means of action by Member States.
(11)
Mutual assistance between the Member States and between the Member States and the Commission should be reinforced, in particular by recourse to 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 
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3
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.
(12)
In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of preventing the diversion of drug precursors for the illicit manufacture of narcotic drugs or psychotropic substances to lay down rules for the thorough monitoring of trade between the Community and third countries of these substances. This Regulation does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty.
(13)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission 
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4
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.
(14)
Regulation (EEC) No 3677/90 should therefore be repealed.
(15)
This Regulation respects the fundamental rights and observes the principles recognised, in particular, by the Charter of Fundamental Rights of the European Union,
HAS ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER AND DEFINITIONS
Article 1
This Regulation lays down rules for the monitoring of trade between the Community and third countries in certain substances frequently used for the illicit manufacture of narcotic drugs and psychotropic substances (hereinafter referred to as drug precursors) for the purpose of preventing the diversion of such substances. It applies to imports, exports and intermediary activities.
This Regulation shall be without prejudice to special rules in other fields pertaining to trade in goods between the Community and third countries.
Article 2
For the purposes of this Regulation the following definitions shall apply:
(a)
‘scheduled substance’ means any substance listed in the Annex, including mixtures and natural products containing such substances, but excluding medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council 
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5
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, pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that such substances cannot be easily used or extracted by readily applicable or economically viable means;
(b)
‘non-scheduled substance’ means any substance which, although not listed in the Annex, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances;
(c)
‘import’ means any entry of scheduled substances having the status as non-Community goods into the customs territory of the Community, including temporary storage, the placing in a free zone or free warehouse, the placing under a suspensive procedure and the release for free circulation within the meaning of Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code 
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6
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;
(d)
‘export’ means any departure of scheduled substances from the customs territory of the Community, including the departure of scheduled substances that requires a customs declaration and the departure of scheduled substances after their storage in a free zone of control type I or free warehouse within the meaning of Regulation (EEC) No 2913/92;
(e)
‘intermediary activities’ means any activity to arrange purchase and sale or supply of scheduled substances carried out by any natural or legal person who aims to obtain agreement between two parties or to do so through acting on behalf of at least one of these parties without taking these substances into its possession or taking control of the carrying out of such transaction; this definition shall also include any activity carried out by any natural or legal person established in the Community involving purchase and sale or supply of scheduled substances without these substances being introduced into the Community customs territory;
(f)
‘operator’ means any natural or legal person engaged in import, export of scheduled substances or intermediary activities relating thereto, including persons pursuing the activity of making customs declarations for clients on a self-employed basis, either as their principal occupation or as a secondary activity related to another occupation;
(g)
‘exporter’ means the natural or legal person chiefly responsible for export activities by virtue of the economic and legal relationship to the scheduled substances and to the consignee and, where appropriate, who lodges the customs declaration or on whose behalf the customs declaration is lodged;
(h)
‘importer’ means the natural or legal person chiefly responsible for the import activities by virtue of the economic and legal relationship to the scheduled substances and to the consignor and who lodges the customs declaration or on whose behalf the customs declaration is lodged;
(i)
‘ultimate consignee’ means any natural or legal person to which the scheduled substances are delivered; this person may be different from the end-user;
(j)
‘committee procedure’ means the procedure provided for in Article 30(2);
(k)
‘International Narcotics Control Board’ means the Board established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol.
CHAPTER II
MONITORING OF TRADE
SECTION 1
Documentation and labelling
Article 3
All imports, exports or intermediary activities involving scheduled substances shall be documented by the operators by way of customs and commercial documents, such as summary declarations, customs declarations, invoices, cargo manifests, transport and other shipping documents.
Those documents shall contain the following information:
(a)
the name of the scheduled substance as stated in the Annex, or, in the case of a mixture or a natural product, its name and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product, followed by the term ‘DRUG PRECURSORS’;
(b)
the quantity and weight of the scheduled substance and, in the case of a mixture or a natural product, the quantity, weight, and, if available, the percentage of any scheduled substance contained therein; and
(c)
the names and addresses of the exporter, the importer, the ultimate consignee and, where applicable, the person involved in the intermediary activities.
Article 4
The documentation referred to in Article 3 shall be kept by the operators for a period of three years from the end of the calendar year in which the operation took place. The documentation shall be organised in such a way, electronically or in paper form, that it is readily available for inspection by the competent authorities upon request. The documentation may be provided via image medium or other data medium, provided that the data, when made readable, match the documentation in appearance and content, are available at all times, can be made readable without delay and can be analysed by automated means.
Article 5
Operators shall ensure that labels are affixed on any packaging containing scheduled substances indicating their name as stated in the Annex, or, in the case of a mixture or a natural product, its name and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product. Operators may, in addition, affix their customary labels.
SECTION 2
Licensing and registration of operators
Article 6
1.   Operators established in the Community, other than customs agents and transporters when acting solely in that capacity, engaged in import, export or intermediary activities involving scheduled substances listed in Category 1 of the Annex, shall hold a licence. The licence shall be issued by the competent authority of the Member State in which the operator is established.
In considering whether to grant a licence, the competent authority shall take into account the competence and integrity of the applicant.
The committee procedure shall be used to lay down provisions determining cases where a licence is not required, setting out further conditions for the granting of licences and establishing a model for licences. These provisions shall guarantee a systematic and consistent control and monitoring of operators.
2.   The licence may be suspended or revoked by the competent authorities whenever the conditions under which the licence was issued are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled substances.
Article 7
1.   Operators established in the Community, other than customs agents and transporters 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 export of scheduled substances listed in Category 3 of the Annex, shall register immediately and update as necessary the addresses of the premises at which they conduct those activities. This obligation shall be carried out with the competent authority in the Member State in which the operator is established.
2.   The committee procedure shall be used to establish the conditions for exemption from the controls of certain categories of operators and of operators engaged in the export of small quantities of scheduled substances listed in Category 3. These conditions shall ensure that the risk of diversion of scheduled substances is minimised.
Article 8
1.   When the scheduled substances are entered into the customs territory of the Community for unloading or transhipment, for temporary storage, for their storage in a free zone of control type I or a free warehouse, or for their placing under the Community external transit procedure, the licit purposes must be demonstrated by the operator, upon request by the competent authorities.
2.   The committee procedure shall be used to establish the criteria to determine how the licit purposes of the transaction may be demonstrated, in order to ensure that all movements of scheduled substances within the Community customs territory can be monitored by the competent authorities and the risk of diversion be minimised.
SECTION 3
Provision of information
Article 9
1.   Operators established in the Community shall notify the competent authorities immediately of any circumstances, such as unusual orders and transactions involving 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.
2.   Operators shall provide the competent authorities with information in summary form about their export, import or intermediary activities. The committee procedure shall be used to determine the information that is required by the competent authorities in order to allow them to monitor these activities.
Article 10
1.   In order to facilitate cooperation between the competent authorities of the Member States, operators established in the Community and the chemical industry, in particular as regards non-scheduled substances, the Commission shall, in consultation with the Member States, draw up and update guidelines.
2.   These guidelines shall provide, in particular:
(a)
information on how to identify and notify suspect transactions;
(b)
a regularly updated list of non-scheduled substances to enable the industry to monitor on a voluntary basis the trade in such substances.
3.   The competent authorities shall ensure that the guidelines are regularly disseminated in accordance with the objectives of these guidelines.
SECTION 4
Pre-export notification
Article 11
1.   All exports of scheduled substances listed in Category 1 of the Annex and exports of 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 competent authorities in the Community to the competent authorities of the country of destination, in accordance with Article 12(10) of the United Nations Convention. The committee procedure shall be used to determine the list of the countries of destination in order to minimise the risk of diversion by ensuring systematic and consistent monitoring of exports of scheduled substances to these countries.
The country of destination shall be allowed a period of 15 working days to reply, at the end of which the export operation may be authorised by the competent authorities of the Member State of export, if no advice from the competent authorities of the country of destination is received indicating that this export operation might be intended for the illicit manufacture of narcotic drugs or psychotropic substances.
2.   In the case of the scheduled substances to be notified in accordance with paragraph 1, the competent authorities of the Member State concerned shall, prior to the export of such substances, supply the information specified in Article 13(1) to the competent authorities of the country of destination.
The authority supplying such information shall require the authority in the third country receiving the information to keep confidential any trade, business, commercial or professional secret or any trade process referred to therein.
3.   Simplified pre-export notification procedures may be applied by the competent authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances. The committee procedure shall be used to determine such procedures and to establish the common criteria to be applied by the competent authorities.
SECTION 5
Export authorisation
Article 12
1.   Exports of scheduled substances that require a customs declaration, including exports of scheduled substances leaving the customs territory from the Community following their storage in a free zone of control type I or free warehouse for a period of at least 10 days, shall be subject to an export authorisation.
Where scheduled substances are re-exported within 10 days from the date of their placing into a suspensive procedure or under a free zone of control type II, an export authorisation shall not be required.
However, exports of scheduled substances listed in Category 3 of the Annex shall only be subject to an export authorisation where pre-export notifications are required, or where these substances are exported to certain countries of destination to be determined in accordance with the committee procedure in order to ensure an appropriate level of control.
2.   Export authorisations shall be issued by the competent authorities of the Member State where the exporter is established.
Article 13
1.   The application for export authorisations referred to in Article 12 shall contain at least the following:
(a)
the names and addresses of the exporter, the importer in the third country, any other operator involved in the export operation or shipment, and the ultimate consignee;
(b)
the name of the scheduled substance as stated in the Annex or, in the case of a mixture or a natural product, its name and eight-digit CN code and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product;
(c)
the quantity and weight of the scheduled substance and, in the case of a mixture or a natural product, the quantity, weight, and, if available, the percentage of any scheduled substance contained therein;
(d)
details of the transport arrangements, such as the expected date of dispatch, method of transport, name of the customs office where the customs declaration is to be made and, where available at this stage, identification of the means of transport, itinerary, expected point of exit from Community customs territory and the point of entry into the importing country;
(e)
in the cases referred to in Article 17, a copy of the import authorisation issued by the country of destination; and
(f)
the number of the licence or registration referred to in Articles 6 and 7.
2.   A decision on the application for an export authorisation shall be taken within a period of 15 working days from the date on which the competent authority considers the file to be complete.
That period shall be extended if, in the cases referred to in Article 17, the competent authorities are obliged to make further enquiries under the second subparagraph of that Article.
Article 14
1.   If the details of the itinerary and means of transport are not provided in the application, the export authorisation shall state that the operator must supply those details to the customs office of exit or other competent authorities at the point of exit from the Community customs territory before the physical departure of the consignment. In such cases the export authorisation shall be annotated accordingly at the time of issue.
Where the export authorisation is presented to a customs office in a Member State other than that of the issuing authority, the exporter shall make available any certified translation of parts or all of the information contained on the authorisation, upon request.
2.   The export authorisation shall be presented to the customs office when the customs declaration is made, or in the absence of a customs declaration, at the customs office of exit or other competent authorities at the point of exit from the Community customs territory. The authorisation shall accompany the consignment to the third country of destination.
The customs office of exit or other competent authorities at the point of exit from the Community customs territory shall insert the necessary details referred to in Article 13(1)(d) in the authorisation and affix its stamp thereon.
Article 15
Without prejudice to measures adopted in accordance with Article 26(3), the granting of the export authorisation shall be refused if:
(a)
details supplied in accordance with Article 13(1) are incomplete;
(b)
there are reasonable grounds for suspecting that the details supplied in accordance with Article 13(1) are false or incorrect;
(c)
in the cases referred to in Article 17, it is established that the import of the scheduled substances has not been authorised by the competent authorities of the country of destination, or
(d)
there are reasonable grounds for suspecting that the substances in question are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Article 16
The competent authorities may suspend or revoke an export authorisation whenever there are reasonable grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Article 17
Whenever, under an agreement between the Community and a third country, exports are not to be authorised unless an import authorisation has been issued by the competent authorities of that third country for the substances in question, the Commission shall communicate to the competent authorities of the Member States the name and address of the competent authority of the third country, together with any operational information obtained from it.
The competent authorities in the Member States shall satisfy themselves as to the authenticity of such import authorisation, if necessary by requesting confirmation from the competent authority of the third country.
Article 18
The period of validity of the export authorisation within which the goods must have left the Community Customs territory shall not exceed six months from the date of issue of the export authorisation. Under exceptional circumstances, the period of validity may be extended, upon request.
Article 19
Simplified procedures to grant an export authorisation may be applied by the competent authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances. The committee procedure shall be used to determine such procedures and to establish the common criteria to be applied by the competent authorities.
SECTION 6
Import authorisation
Article 20
Imports of scheduled substances listed in Category 1 of the Annex shall be subject to an import authorisation. An import authorisation may only be granted to an operator established in the Community. The import authorisation shall be issued by the competent authorities of the Member State where the importer is established.
However, where the substances referred to in subparagraph 1 are unloaded or transhipped, under temporary storage, stored in a free zone of control type I or free warehouse, or placed into the Community transit procedure, such import authorisation shall not be required.
Article 21
1.   The application for the import authorisations referred to in Article 20 shall contain at least the following:
(a)
the names and addresses of the importer, the exporter of the third country, any other operator involved and the ultimate consignee;
(b)
the name of the scheduled substance as stated in the Annex or, in the case of a mixture or a natural product, its name and the eight-digit CN code and the name of any scheduled substance, as stated in the Annex, contained in the mixture or in the natural product;
(c)
the quantity and weight of the scheduled substance and, in the case of a mixture or a natural product, the quantity, weight, and, if available, the percentage of any scheduled substance contained therein;
(d)
if available, details of the transport arrangements, such as methods and means of transport, and date and place of envisaged import activities, and
(e)
the number of the licence or registration referred to in Articles 6 and 7.
2.   A decision on the application for an import authorisation shall be taken within a period of 15 working days from the date on which the competent authority considers the file to be complete.
Article 22
The import authorisation shall accompany the consignment from the point of entry into the Community customs territory to the premises of the importer or ultimate consignee.
The import authorisation shall be presented to the customs office when the scheduled substances are declared for a customs procedure.
Where the import authorisation is presented to a customs office in a Member State other than that of the issuing authority, the importer shall make available any certified translation of parts or all information contained on the authorisation, upon request.
Article 23
Without prejudice to measures adopted in accordance with Article 26(3), the granting of the import authorisation shall be refused if:
(a)
details supplied in accordance with Article 21(1) are incomplete;
(b)
there are reasonable grounds for suspecting that the details supplied in accordance with Article 21(1) in the application are false or incorrect, or
(c)
there are reasonable grounds for suspecting that the scheduled substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Article 24
The competent authorities may suspend or revoke the import authorisation whenever there are reasonable grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Article 25
The period of validity of the import authorisation within which the scheduled substances must have been entered into the customs territory of the Community shall not exceed six months from the date of issue of the import authorisation. Under exceptional circumstances, the period of validity may be extended, upon request.
CHAPTER III
POWERS OF COMPETENT AUTHORITIES
Article 26
1.   Without prejudice to the provisions of Articles 11 to 25 and of paragraphs 2 and 3 of this Article, the competent authorities of each Member State shall prohibit the introduction of scheduled substances into the Community customs territory or their departure from it, if there are reasonable grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
2.   The competent authorities shall detain or suspend release of the scheduled substances for the time necessary to verify the identification of the scheduled substances or compliance with the rules of this Regulation.
3.   Each Member State shall adopt the measures necessary to enable the competent authorities, in particular:
(a)
to obtain information on any orders for or operations involving scheduled substances;
(b)
to enter operators’ business premises in order to obtain evidence of irregularities;
(c)
to establish that a diversion or attempted diversion of scheduled substances has taken place.
4.   For the purpose of preventing specific risks of diversion in free zones as well as in other sensitive areas such as customs warehouses, Member States shall ensure that effective controls are applied to operations carried out in these areas at every stage of these operations, and that the controls are no less stringent than those applied in the other parts of the customs territory.
5.   The competent authorities may require the operators to pay a fee for the issuing of licences, registrations and authorisations. Such fees shall be levied in a non-discriminatory way and shall not exceed the approximate cost of processing the application.
CHAPTER IV
ADMINISTRATIVE COOPERATION
Article 27
For the purposes of applying this Regulation and without prejudice to Article 30, the provisions of Regulation (EC) No 515/97 shall apply 
mutatis mutandis
. Each Member State shall communicate to the other Member States and to the Commission the name of the competent authorities appointed to act as correspondents in accordance with Article 2(2) of that Regulation.
CHAPTER V
IMPLEMENTING MEASURES AND AMENDMENTS
Article 28
In addition to the implementing measures referred to in this Regulation, the Committee shall lay down, where necessary, detailed rules to ensure the effective monitoring of trade between the Community and third countries in drug precursors for the purpose of preventing the diversion of such substances, in particular with regard to the design and use of export and import authorisation forms.
Article 29
The committee procedure shall be used to adapt the Annex to this Regulation, to take account of any amendments to the Annex to the United Nations Convention.
Article 30
1.   The Commission shall be assisted by the Drug Precursors Committee (hereinafter referred to as the Committee).
2.   Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply.
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.
CHAPTER VI
FINAL PROVISIONS
Article 31
Member States shall lay down the rules on penalties applicable to infringements 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 32
The competent authorities in each Member State shall, at least once each year, communicate to the Commission all relevant information on the implementation of the monitoring measures laid down in this Regulation, and on scheduled substances used for the illicit manufacture of narcotic drugs or psychotropic substances and methods of diversion and illicit manufacture, and their licit trade, uses and needs.
On the basis of that information, the Commission shall, in consultation with the Member States, evaluate the effectiveness of this Regulation and, in accordance with Article 12 (12) of the United Nations Convention, draw up an annual report to be submitted to the International Narcotics Control Board.
The Commission shall report to the Council on the functioning of this Regulation by the end of August 2008.
Article 33
The Commission is hereby authorised to adopt a position, on behalf of the Community, in favour of amendments to tables I and II of the Annex to the United Nations Convention which conform to the Annex to this Regulation.
Article 34
Regulation (EEC) No 3677/90 is repealed with effect from 18 August 2005.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 35
This Regulation shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union
.
It shall apply from 18 August 2005. However, Articles 6(1), 7(2), 8(2), 9(2), 11(1) and (3), 12(1), 19, 28 and 30 shall apply as from the day of entry into force of this Regulation in order to permit the adoption of the measures provided for in those Articles. Such measures shall enter into force at the earliest on 18 August 2005.
This Regulation shall be binding in its entirety and directly applicable in all Member States
Done at Brussels, 22 December 2004.
For the Council
The President
C. VEERMAN
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OJ L 326, 24.11.1990, p. 56
.
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2
)
  
            
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
).
(
3
)
  
            
OJ L 82, 22.3.1997, p. 1
. Regulation as last amended by Regulation (EC) No 807/2003 (
OJ L 122, 16.5.2003, p. 36
).
(
4
)
  
            
OJ L 184, 17.7.1999, p. 23
.
(
5
)
  
            
OJ L 311, 28.11.2001, p. 67
. Directive as last amended by Directive 2004/27/EC of the European Parliament and of the Council (
OJ L 136, 30.4.2004, p. 34
).
(
6
)
  
            
OJ L 302, 19.10.1992, p. 1
. Regulation as last amended by the 2003 Act of Accession.
ANNEX
Scheduled substances Category 1
Substance
CN designation
(if different)
CN Code
 (
1
)
CAS No
 (
2
)
1-Phenyl-2-propanone
Phenylacetone
2914 31 00
103-79-7
N-acetylanthranilic acid
2-Acetamidobenzoic acid
2924 23 00
89-52-1
Isosafrol (cis + trans)
2932 91 00
120-58-1
3,4-Methylenedioxyphenylpropan-2-one
1-(1,3-Benzodioxol-5-yl)propan-2-one
2932 92 00
4676-39-5
Piperonal
2932 93 00
120-57-0
Safrole
2932 94 00
94-59-7
Ephedrine
2939 41 00
299-42-3
Pseudoephedrine
2939 42 00
90-82-4
Norephedrine
ex 2939 49 00
14838-15-4
Ergometrine
2939 61 00
60-79-7
Ergotamine
2939 62 00
113-15-5
Lysergic acid
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.
Category 2
Substance
CN designation
(if different)
CN Code
 (
4
)
CAS No
 (
5
)
Acetic anhydride
2915 24 00
108-24-7
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.
Category 3
Substance
CN designation
(if different)
CN Code
 (
6
)
CAS No
 (
7
)
Hydrochloric acid
Hydrogen chloride
2806 10 00
7647-01-0
Sulphuric acid
2807 00 10
7664-93-9
Toluene
2902 30 00
108-88-3
Ethyl ether
Diethyl ether
2909 11 00
60-29-7
Acetone
2914 11 00
67-64-1
Methylethylketone
Butanone
2914 12 00
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 from those given.
(
3
)
  Also named (+)-norpseudoephedrine, CN code 2939 43 00 , CAS No 492-39-7.
(
4
)
  
            
OJ L 290, 28.10.2002, p. 1
.
(
5
)
  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 from those given.
(
6
)
  
            
OJ L 290, 28.10.2002, p. 1
.
(
7
)
  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 from those given.

Summary:
Monitoring trade in drug precursors between the EU and non-EU countries
SUMMARY OF:
Regulation (EC) 
No 111/2005
 — rules for the monitoring of trade between the EU and non-EU countries in drug precursors
WHAT IS THE AIM OF THE REGULATION?
It implements the EU’s obligations under the 
United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances
, which requires measures to be taken to monitor the manufacture and distribution of drug precursors
1
.
It lays down measures to control and monitor trade between EU and non-EU countries.
It was amended by Regulation (EU) 
No 
1259/2013
, in particular to clarify certain definitions in the text, notably ‘scheduled substance’
2
, as well as the requirements of ‘users’
3
 and ‘operators’
4
.
A related regulation, Regulation (EC) 
No 
273/2004
 (see 
summary
), concerns the trade of drug precursors between EU countries.
Three 
delegated acts
 (Delegated Regulations (EU) 
2015/1011
, (EU) 
2016/1443
 and (EU) 
2018/729
) amending the regulation as well as one 
implementing act
 (Implementing Regulation (EU) 
2015/1013
) have been adopted.
KEY POINTS
The regulation distinguishes between 
scheduled
 and 
non-scheduled
5
 substances.
There are 4 categories of scheduled substances in Annex I of the regulation. 
Category 1:
 the most sensitive substances, from which illicit drugs can be produced most easily (for example, 1-phenyl-2-propanone, piperonal).
Category 2:
 less sensitive substances (subcategory 2A: acetic anhydride; subcategory 2B: phenylacetic acid, anthranilic acid, piperidine and potassium permanganate).
Category 3:
 bulk chemicals which can have different types of uses in the manufacturing process (for example, acetone, hydrochloric acid).
Category 4:
 since December 2013, substances covering medicinal products for human and veterinary use containing ephedrine or pseudoephedrine.
Obligations of operators
Operators must document the 
import, export and transit of a scheduled substance
 in such a way as to disclose: 
the name of the substance,
its quantity and weight, and
the name and address of the exporter, importer, distributor and ultimate consignee.
Operators must 
keep records of all transactions
 for a period of 3 years.
Licence for category 1 substances
Operators (other than customs agents and transporters) must obtain a licence from the competent authorities of the country in which they are established if they are engaged in import, export or intermediary activities involving category 1 substances.
Before granting a licence, the competent authorities must take into account the competence and integrity of the applicant in particular.
The licence may be suspended or revoked by the authorities whenever the conditions under which the licence was issued are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled substances.
Registration for category 2 and category 3 substances
EU-based operators (other than customs agents and transporters) must obtain 
registration
 from the competent authorities of the EU country in which they are established if they are engaged in the 
import, export or intermediary activities involving category 2 substances
 or in the 
export of category 3
 substances.
Notification of the authorities
Operators
 must: 
notify the competent authorities immediately of any circumstances, such as unusual orders or transactions involving scheduled substances, that suggest that such substances intended for import, export or intermediary activities might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances;
provide any available information allowing the competent authorities to verify the legitimacy of the abovementioned relevant order or transaction;
provide the authorities with relevant information about their transactions involving scheduled substances, in the form of a summary.
Pre-export notification
All exports
 of categories 1 and 4 substances and all exports of category 2 and 3 substances to 
certain countries of destination
 require a 
pre-export notification
 to be sent from the competent authorities in the EU to the competent authorities of the country of destination, in accordance with the UN convention.
The country of destination has a period of 
15 working days to reply
, at the end of which the export operation may be authorised by the competent authorities of the EU country of export. This can only be if no advice from the competent authorities of the country of destination is received indicating that this export operation might be intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Simplified pre-export notification procedures may be applied by the competent authorities where they are satisfied that this will not result in any risk of diversion of scheduled substances.
Export authorisation
Exports of scheduled substances that require a 
customs declaration
 must receive an export authorisation.
An authorisation is required where scheduled substances are re-exported within 10 days from the date of their placing into a suspensive procedure or under a free zone of control.
Category 3 substances
 are only subject to such an authorisation where pre-export notifications are required.
The regulation lists the details to be included in the application.
Import authorisation
Imports of 
category 1 substances
 require an import authorisation.
An authorisation may only be granted to an operator established in the EU.
The authorisation is issued by the competent authorities of the EU country where the importer is established.
The regulation lists the details required in the authorisation application.
The authorisation must accompany the consignment from the point of entry into the EU customs territory to the premises of the importer or ultimate consignee.
EU countries’ competent authorities — powers and obligations
EU countries must:
prohibit the introduction of 
scheduled substances
 and of consignments of 
non-scheduled substances
 into EU customs territory or their departure from it, where there is suspicion that such substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances;
detain or suspend the release of the scheduled substances for the time necessary to 
verify their identification
 or compliance with this regulation;
adopt measures to enable their competent authorities, in particular: 
to obtain information on any orders for scheduled substances or operations involving scheduled substances
to enter operators’ and users’ business premises in order to obtain evidence of irregularities
to establish that a diversion or attempted diversion of scheduled substances has taken place;
ensure their competent authorities respect confidential business information;
lay down the rules on 
penalties
 applicable for infringing the rules and take all measures necessary to ensure that they are implemented — the penalties must be effective, proportionate and dissuasive.
European database
The 
European database on drug precursors
 set up under Regulation (EC) 
No 273/2004
 serves to: 
simplify the procedure for EU countries to report seizures and stopped shipments;
maintain a list of EU licensed or registered operators and users legally trading or using drug precursors;
enable operators to provide competent authorities with information about their export, import or intermediary activities, in the form of a summary.
Implementing and delegated acts
Implementing Regulation (EU) 2015/1013
 sets out rules as regards the licensing and registration of operators and users and their listing in the European database on drug precursors, the provision by operators of information required to monitor trade and the authorisation of exports and imports in the field of drug precursors.
Delegated Regulation (EU) 2015/1011
: 
lays down conditions for granting licences and registrations;
determines when a licence or registration are not required;
establishes the criteria to demonstrate the legal/licit purpose of a transaction and for determining simplified procedures for pre-export notifications and for export authorisations;
determines the information required to monitor trade; and
specifies the requirements concerning the information to be provided on the implementation of the monitoring measures as regards trade in drug precursors.
Delegated Regulation (EU) 2016/1443
 and 
Delegated Regulation (EU) 2018/729
 extend the list of category 1 substances.
Repeal
The regulation repeals Regulation (EEC) 
No 
3677/90
.
FROM WHEN DOES THE REGULATION APPLY?
Regulation (EC) 
No 111/2005
 has applied since 
18 August 2005
.
Amending Regulation (EU) 
No 1259/2013
 has applied since 
30 December 2013
.
BACKGROUND
For more information, see:
Drug precursors control
 (
European Commission
).
KEY TERMS
Drug precursor:
 chemicals that are primarily used for the legitimate (legal) production of a wide range of products including medicines, plastics and cosmetics. These substances may also be misused for illegal/illicit purposes, such as the production of methamphetamines, heroin or cocaine.
Scheduled substance:
 any substance listed in Annex I of Regulation (EC) 
No 111/2005
 that can be used for the illicit manufacture of narcotic drugs or psychotropic substances, including mixtures and natural products containing such substances. However, what is not included are mixtures and natural products which contain scheduled substances and which are compounded in such a way that the scheduled substances cannot be easily used or extracted by readily applicable or economically viable means: 
medicinal products for humans
 as defined in Directive 2001/83/EC and 
veterinary medicinal products
 as defined in Directive 2001/82/EC.
User:
 a natural or legal person other than an operator (see next entry) who possesses a scheduled substance and is engaged in the processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, transformation or any other utilisation of scheduled substances.
Operator:
 any natural or legal person engaged in the placing on the market of scheduled substances.
Non-scheduled substance:
 any substance which, although not listed in Annex I of this regulation, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.
MAIN DOCUMENT
Council Regulation (EC) 
No 
111/2005
 of 
22 December 2004
 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (OJ L 22, 
26.1.2005
, 
pp. 1-10
)
Successive amendments to Regulation (EC) 
No 111/2005
 have been incorporated into the original text. This 
consolidated version
 is of documentary value only.
RELATED DOCUMENTS
Commission Delegated Regulation (EU) 
2015/1011
 of 
24 April 2015
 supplementing Regulation (EC) 
No 273/2004
 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) 
No 111/2005
 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) 
No 1277/2005
 (OJ L 162, 
27.6.2015
, 
pp. 12-25
)
See 
consolidated version
.
Commission Implementing Regulation (EU) 
2015/1013
 of 
25 June 2015
 laying down rules in respect of Regulation (EC) 
No 273/2004
 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) 
No 111/2005
 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (OJ L 162, 
27.6.2015
, 
pp. 33-64
)
Regulation (EC) 
No 
273/2004
 of the European Parliament and of the Council of 
11 February 2004
 on drug precursors (OJ L 47, 
18.2.2004
, 
pp. 1-10
)
See 
consolidated version
.
Council Decision 
90/611/EEC
 of 
22 October 1990
 concerning the conclusion, on behalf of the European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (OJ L 326, 
24.11.1990
, 
pp. 56-57
)
last update 
12.10.2020

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