Legal provisions of COM(2002)494 - Drug precursors

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dossier COM(2002)494 - Drug precursors.
document COM(2002)494 EN
date February 11, 2004


Contents

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.