Avis juridique important

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (Text with EEA relevance) Official Journal L 047 , 18/02/2004 P. 0001 - 0010

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (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 manufacture 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 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 regulation, as each modification of that Directive and its Annexes would trigger national implementation measures in 25 Member States. (5) By decisions taken at its 35th 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 should be laid down in this Regulation in order to 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 the United Nations Convention are based on a system of monitoring trade in the substances in question. Most trade in these substances is entirely lawful. The documentation of consignments and labelling of these substances should be sufficiently explicit. It is furthermore important, whilst providing competent authorities with the necessary means of action, to develop, within the spirit of the United Nations Convention, mechanisms based on close cooperation with the operators concerned and on the development of intelligence gathering. (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 States regard it as a natural product not subject to controls. Inserting a reference to natural products in the definition of "scheduled substances" will resolve this 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. (8) Substances commonly used in the illicit manufacture of narcotic drugs or psychotropic substances should be listed in an Annex. (9) It should be ensured that the manufacture or use of certain scheduled substances listed in Annex I is subject 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 rules concerning the customer declaration should be laid down in Annex III. (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 should apply to transactions involving substances of category 2 of Annex I where the quantities involved do not exceed those indicated in Annex II. (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 Regulation, might be used in the illicit manufacture of synthetic drugs and psychotropic substances, guidelines should be drawn up aimed at helping the chemical industry. (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 States should be free to choose the most dissuasive penalties available under their national legislation. (16) 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(7). (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 proportionality, 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(8), 2001/8/EC(9) and 2003/101/EC(10) and Commission Regulations (EC) No 1485/96(11) and (EC) No 1533/2000(12) should be repealed, 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. Article 2 Definitions 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(13), pharmaceutical 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 economically viable means; (b) "non-scheduled substance" means any substance which, although not listed in Annex I, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances; (c) "placing on the market" means any supply, whether in return for payment or free of charge, of scheduled substances in the Community; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the Community; (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 licence" means a licence that is granted to a particular type of operator; (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 1. Operators wishing to place on the market scheduled 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 shall ensure that the trade in scheduled substances conducted by the operator takes place in compliance with this Regulation. The officer shall be empowered to represent the operator and to take the decisions necessary for performing the tasks specified above. 2. Operators shall be required to obtain a licence from the 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 a licence and have signed a customer declaration as provided for in Article 4(1). 4. When considering whether to grant a licence, the competent authorities shall take into account in particular 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 applicant or 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. 5. Without prejudice to Article 14, the competent authorities 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. Article 4 Customer declaration 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. 2. As an alternative to the above declaration for an individual 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 substance on at least three occasions in the preceding 12 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 authorities responsible for checking vehicle contents during transport operations. 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 pursuant to Article 3(2) and (6) respectively. 2. Commercial documents such as invoices, cargo manifests, administrative documents, transport and other shipping documents shall contain sufficient information to identify positively: (a) the name of the scheduled substance as given in categories 1 and 2 of Annex I; (b) the quantity and weight of the scheduled substance and, where a mixture or natural product is concerned, the quantity and weight, if available, of 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; (c) the name and address of the supplier, distributor, consignee, and, if possible, of other operators directly involved in the transaction, as referred to in Article 2(c) and (d). 3. The documentation must also contain a customer declaration as referred to in Article 4. 4. Operators shall keep such detailed records of their activities as are required to comply with their obligations under paragraph 1. 5. The documentation and records referred to in paragraphs 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 according to 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. Article 8 Notification of the competent authorities 1. Operators shall notify the competent 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 1. In order to facilitate cooperation between the competent authorities, the operators, and the chemical industry, in particular as regards non-scheduled substances, the Commission shall, in accordance with the procedure referred to in Article 15(2), draw up and update guidelines to assist the chemical industry. 2. The guidelines shall provide in particular: (a) information on how to recognise 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; (c) other information which may be deemed useful. 3. The competent authorities shall ensure that the guidelines and the list of non-scheduled substances are regularly disseminated in a manner deemed appropriate by the competent authorities in accordance with the objectives of the guidelines. 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; (c) where necessary, to detain consignments that fail to comply with this Regulation. 2. The competent authorities shall respect confidential business information. Article 11 Cooperation between the Member States and the Commission 1. Each Member State shall designate the competent authority or authorities responsible for ensuring the application of this Regulation and shall inform the Commission thereof. 2. For the purposes of applying this Regulation and without 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(14), and in particular those on confidentiality, 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 1. To permit any necessary adjustments to the arrangements for monitoring trade in scheduled substances and non-scheduled substances, the competent authorities in each Member State shall each year communicate to the Commission all information on the implementation of the monitoring measures laid down in this Regulation, in particular as regards substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances and methods of diversion and illicit manufacture. 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 consultation with the Member States. Article 14 Implementation Where necessary, the following measures for the implementation of this Regulation shall be adopted in accordance with the procedure referred to in Article 15(2): (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; (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 to Annex I made necessary by amendments to the tables in the Annex to the United Nations Convention; (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 1. The Commission shall be assisted by the committee set 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. Article 16 Information about measures adopted by Member States Each Member State shall inform the Commission of the measures it adopts pursuant to this Regulation, and in particular of the measures adopted pursuant to Articles 10 and 12. They shall also notify any subsequent amendments thereof. 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 2003/101/EC and Commission Regulations (EC) No 1485/96 and (EC) No 1533/2000 are hereby repealed. 2. References to the repealed directives or regulations shall be construed as being made to this Regulation. 3. The validity of any register established, any licences granted and any customer declarations issued under the repealed directives or regulations shall not be affected. Article 18 Entry into force This Regulation shall enter into force on 18 August 2005, except for Articles 9, 14 and 15, which shall enter into force on the day of publication 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 18 August 2005. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 February 2004. For the European Parliament The President P. Cox For the Council The President M. McDowell (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 (OJ C 277 E, 18.11.2003, p. 31) and position of the European Parliament of 16 December 2003 (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). (6) OJ L 370 19.12.1992, p. 76. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). (7) OJ L 184, 17.7.1999, p. 23. (8) 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). (9) 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). (10) Commission Directive 2003/101/EC of 3 November 2003 amending 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 286, 4.11.2003, p. 14). (11) Commission Regulation (EC) No 1485/96 of 26 July 1996 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 (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). (12) 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. (13) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46). (14) 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). ANNEX I Scheduled substances within the meaning of Article 2(a) CATEGORY 1 >TABLE> CATEGORY 2 >TABLE> CATEGORY 3 >TABLE> ANNEX II >TABLE> ANNEX III 1. Model declaration relating to individual transactions (category 1 or 2) >PIC FILE= "L_2004047EN.000902.TIF"> 2. Model declaration relating to multiple transactions (category 2) >PIC FILE= "L_2004047EN.001001.TIF">

Regulation (EC) No 273/2004 of the European Parliament and of the Council

of 11 February 2004

on drug precursors

(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 manufacture 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 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 regulation, as each modification of that Directive and its Annexes would trigger national implementation measures in 25 Member States.

(5) By decisions taken at its 35th 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 should be laid down in this Regulation in order to 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 the United Nations Convention are based on a system of monitoring trade in the substances in question. Most trade in these substances is entirely lawful. The documentation of consignments and labelling of these substances should be sufficiently explicit. It is furthermore important, whilst providing competent authorities with the necessary means of action, to develop, within the spirit of the United Nations Convention, mechanisms based on close cooperation with the operators concerned and on the development of intelligence gathering.

(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 States regard it as a natural product not subject to controls. Inserting a reference to natural products in the definition of "scheduled substances" will resolve this 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.

(8) Substances commonly used in the illicit manufacture of narcotic drugs or psychotropic substances should be listed in an Annex.

(9) It should be ensured that the manufacture or use of certain scheduled substances listed in Annex I is subject 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 rules concerning the customer declaration should be laid down in Annex III.

(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 should apply to transactions involving substances of category 2 of Annex I where the quantities involved do not exceed those indicated in Annex II.

(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 Regulation, might be used in the illicit manufacture of synthetic drugs and psychotropic substances, guidelines should be drawn up aimed at helping the chemical industry.

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

(16) 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(7).

(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 proportionality, 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(8), 2001/8/EC(9) and 2003/101/EC(10) and Commission Regulations (EC) No 1485/96(11) and (EC) No 1533/2000(12) should be repealed,

HAVE ADOPTED THIS REGULATION:

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.

Definitions

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(13), pharmaceutical 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 economically viable means;

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

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

(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 licence" means a licence that is granted to a particular type of operator;

(g) "special registration" means a registration that is made for a particular type of operator.

Requirements for the placing on the market of scheduled substances

1. Operators wishing to place on the market scheduled 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 shall ensure that the trade in scheduled substances conducted by the operator takes place in compliance with this Regulation. The officer shall be empowered to represent the operator and to take the decisions necessary for performing the tasks specified above.

2. Operators shall be required to obtain a licence from the 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 a licence and have signed a customer declaration as provided for in Article 4(1).

4. When considering whether to grant a licence, the competent authorities shall take into account in particular 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 applicant or 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.

5. Without prejudice to Article 14, the competent authorities 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.

Article 4

Customer declaration

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.

2. As an alternative to the above declaration for an individual 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 substance on at least three occasions in the preceding 12 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 authorities responsible for checking vehicle contents during transport operations.

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 pursuant to Article 3(2) and (6) respectively.

2. Commercial documents such as invoices, cargo manifests, administrative documents, transport and other shipping documents shall contain sufficient information to identify positively:

(a) the name of the scheduled substance as given in categories 1 and 2 of Annex I;

(b) the quantity and weight of the scheduled substance and, where a mixture or natural product is concerned, the quantity and weight, if available, of 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;

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

3. The documentation must also contain a customer declaration as referred to in Article 4.

4. Operators shall keep such detailed records of their activities as are required to comply with their obligations under paragraph 1.

5. The documentation and records referred to in paragraphs 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.

Exemptions

The obligations according to 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.

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.

Notification of the competent authorities

1. Operators shall notify the competent 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.

Guidelines

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

2. The guidelines shall provide in particular:

(a) information on how to recognise 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;

(c) other information which may be deemed useful.

3. The competent authorities shall ensure that the guidelines and the list of non-scheduled substances are regularly disseminated in a manner deemed appropriate by the competent authorities in accordance with the objectives of the guidelines.

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;

(c) where necessary, to detain consignments that fail to comply with this Regulation.

2. The competent authorities shall respect confidential business information.

Article 11

Cooperation between the Member States and the Commission

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

2. For the purposes of applying this Regulation and without 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(14), and in particular those on confidentiality, 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.

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.

Communications from Member States

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

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 consultation with the Member States.

Implementation

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

(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;

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

(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.

Committee

1. The Commission shall be assisted by the committee set 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.

Information about measures adopted by Member States

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

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 2003/101/EC and Commission Regulations (EC) No 1485/96 and (EC) No 1533/2000 are hereby repealed.

2. References to the repealed directives or regulations shall be construed as being made to this Regulation.

3. The validity of any register established, any licences granted and any customer declarations issued under the repealed directives or regulations shall not be affected.

Article 18

Entry into force

This Regulation shall enter into force on 18 August 2005, except for Articles 9, 14 and 15, which shall enter into force on the day of publication 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 18 August 2005.

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

Done at Strasbourg, 11 February 2004.

For the European Parliament

The President

P. Cox

For the Council

The President

M. McDowell

(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 (OJ C 277 E, 18.11.2003, p. 31) and position of the European Parliament of 16 December 2003 (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).

(6) OJ L 370 19.12.1992, p. 76. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(7) OJ L 184, 17.7.1999, p. 23.

(8) 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).

(9) 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).

(10) Commission Directive 2003/101/EC of 3 November 2003 amending 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 286, 4.11.2003, p. 14).

(11) Commission Regulation (EC) No 1485/96 of 26 July 1996 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 (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).

(12) 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.

(13) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).

(14) 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).

ANNEX I

Scheduled substances within the meaning of Article 2(a)

CATEGORY 1

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CATEGORY 2

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CATEGORY 3

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ANNEX II

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ANNEX III

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

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

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