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

CHAPTER I

SUBJECT MATTER AND DEFINITIONS

Article 1

This Regulation lays down rules for the monitoring of trade between the  Union 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  Union 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 that can be used for the illicit manufacture of narcotic drugs or psychotropic substances, including mixtures and natural products containing such substances, but excluding 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 as defined in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council (¹) and veterinary medicinal products as defined in point 2 of Article 1 of Directive 2001/82/EC of the European Parliament and of the Council (²), except medicinal products and veterinary medicinal products listed in the Annex;

(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 of non-Union goods into the customs territory of the Union, 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 Council Regulation (EEC) No 2913/92 (³);

(d) ‘export’ means any departure of scheduled substances from the customs territory of the  Union, 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  Union involving purchase and sale or supply of scheduled substances without these substances being introduced into the  customs territory of the Union;

(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) ‘natural product’ means an organism or a part thereof, in any form, or any substances which occur in nature as defined in point 39 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (⁴);

(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, with the exception of substances listed in Category 4 of the Annex, shall be documented by the operator 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, except substances listed in Category 4 of the Annex, 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, except substances listed in Category 4 of the Annex, 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

In considering whether to grant a licence, the competent authority shall take into account the competence and integrity of the applicant, in particular the absence of any serious infringement or repeated infringements of legislation in the field of drug precursors and the absence of a record of any serious criminal offence.

The Commission shall be empowered to adopt delegated acts in accordance with Article 30b to set out the conditions for granting licences and for determining cases where a licence is not required.

Article 7

In considering whether to grant a registration, the competent authority shall take into account the competence and integrity of the applicant, in particular the absence of any serious infringement or repeated infringements of legislation in the field of drug precursors and the absence of a record of any serious criminal offence.

The Commission shall be empowered to adopt delegated acts in accordance with Article 30b to set out the conditions for granting registrations and for determining cases where a registration is not required.

Article 8

SECTION 3

Provision of information

Article 9

To that end, operators shall provide any available information, such as:

(a) the name of the scheduled substance;

(b) the quantity and weight of the scheduled substance;

(c) the names and addresses of the exporter, the importer, the ultimate consignee and, where applicable, the person involved in the intermediary activities.

That information shall only be collected for the purposes of preventing the diversion of scheduled substances.

The Commission shall be empowered to adopt delegated acts in accordance with Article 30b to determine the information that is required by the competent authorities in order to allow them to monitor those activities.

The Commission shall specify by means of implementing acts the procedural rules on the provision of such information, including, where appropriate, in electronic form to the European database on drug precursors established under Regulation (EC) No 273/2004 of the European Parliament and of the Council (⁵) (‘the European database’). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Article 10

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.

SECTION 4

Pre-export notification

Article 11

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.

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.

SECTION 5

Export authorisation

Article 12

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.

Article 13

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  customs territory of the Union 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.

An application for an export authorisation for exports of scheduled substances listed in Category 4 of the Annex shall contain the information set out in points (a) to (e) of the first subparagraph.

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

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.

The customs office of exit or other competent authorities at the point of exit from the  customs territory of the Union 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  Union 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  customs territory of the Union 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 Commission shall be empowered to adopt delegated acts in accordance with Article 30b 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  Union. 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 the first paragraph are unloaded or transhipped, under temporary storage, stored in a free zone of control type I or a free warehouse, or placed under the external Union transit procedure, such import authorisation shall not be required.

Article 21

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.

Article 22

The import authorisation shall accompany the consignment from the point of entry into the  customs territory of the Union 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  Union 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

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.

The competent authority shall immediately inform the competent authorities of the other Member States and the Commission thereof, using the procedure referred to in Article 27.