Regulation (EU) No 1259/2013 of the European Parliament and of the Council of 20 November 2013 amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors

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.’;

1 Unless otherwise provided, operators established in the Union, other than customs agents and transporters when acting solely in that capacity, engaged in import, export or intermediary activities involving scheduled substances listed in Category 2 of the Annex, or in the export of scheduled substances listed in Category 3 of the Annex, shall hold a registration. The competent authority in the Member State in which the operator is established shall issue the registration. 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.

2 The competent authority may suspend or revoke the registration where the conditions under which the registration was issued are no longer fulfilled or where there are reasonable grounds for suspecting that there is a risk of diversion of scheduled substances.’;

1 When the scheduled substances are entered into the customs territory of the Union for unloading or transhipment, for temporary storage, for their storage in a free zone of control type I or a free warehouse, or for their placing under the external Union transit procedure, the licit purposes must be demonstrated by the operator, upon request by the competent authorities.

2 The Commission shall be empowered to adopt delegated acts in accordance with Article 30b to establish the criteria to determine how the licit purposes of the transaction may be demonstrated, in order to ensure that all movements of scheduled substances within the customs territory of the Union can be monitored by the competent authorities and the risk of diversion be minimised.’;

1 Operators established in the Union shall notify the competent authorities immediately of any circumstances, such as unusual orders and transactions involving scheduled substances, which suggest that such substances intended for import, export or intermediary activities might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances. 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.

2 Operators shall provide the competent authorities with information in summary form about their export, import or intermediary activities. 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 (“the European database”). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

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.’;

In addition to the measures referred to in Article 26, the Commission shall be empowered to lay down, where necessary, by means of implementing acts, measures to ensure the effective monitoring of trade between the Union and third countries in drug precursors, in particular with regard to the design and use of export and import authorisation forms, for the purpose of preventing the diversion of drug precursors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).’;

1 The Commission shall be assisted by the Drug Precursors Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council .

2 Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

The Commission shall be empowered to adopt delegated acts in accordance with Article 30b of this Regulation in order to adapt the Annex hereto to new trends in diversion of drug precursors, in particular substances which can be easily transformed into scheduled substances, and to follow any amendment to the tables in the Annex to the United Nations Convention.

1 The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2 The power to adopt delegated acts referred to in the third subparagraph of Article 6(1), the third subparagraph of Article 7(1), Article 8(2), the second subparagraph of Article 9(2), Article 10(5), Article 11(1) and (3), Articles 19 and 30a and Article 32(2) shall be conferred on the Commission for a period of five years from 30 December 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3 The delegation of power referred to in the third subparagraph of Article 6(1), the third subparagraph of Article 7(1), Article 8(2), the second subparagraph of Article 9(2), Article 10(5), Article 11(1) and (3), Articles 19 and 30a and Article 32(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4 As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5 A delegated act adopted pursuant to the third subparagraph of Article 6(1), the third subparagraph of Article 7(1), Article 8(2), the second subparagraph of Article 9(2), Article 10(5), Article 11(1) and (3), Articles 19 and 30a and Article 32(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

1 The competent authorities in each Member State shall communicate to the Commission in electronic form via the European database in a timely manner all relevant information on the implementation of the monitoring measures laid down in this Regulation, in particular as regards substances used for the illicit manufacture of narcotic drugs or psychotropic substances and methods of diversion and illicit manufacture, and their licit trade.

2 The Commission shall be empowered to adopt delegated acts in accordance with Article 30b in order to specify the conditions and requirements concerning the information to be provided under paragraph 1 of this Article.

3 On the basis of the information referred to in paragraph 1 of this Article, the Commission shall, in consultation with the Member States, evaluate the effectiveness of this Regulation and, in accordance with Article 12(12) of the United Nations Convention, draw up an annual report to be submitted to the International Narcotics Control Board.

4 The Commission shall submit by 31 December 2019 a report to the European Parliament and to the Council on the implementation and functioning of this Regulation, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances’;

The competent authorities of the Member States and the Commission shall use the European database under the conditions for its use for the following functions: (a) to facilitate the communication of information pursuant to Article 32(1) as well as the reporting to the International Narcotics Control Board pursuant to Article 32(3); (b) to manage a European register of operators, which have been granted a licence or registration; (c) to enable operators to provide the competent authorities with information about their export, import or intermediary activities according to Article 9(2), in electronic form.’;

1 The processing of personal data by the competent authorities in the Member States shall be carried out in accordance with national laws, regulations and administrative provisions transposing Directive 95/46/EC of the European Parliament and of the Council and under the supervision of the supervisory authority of the Member State referred to in Article 28 of that Directive.

2 The processing of personal data by the Commission, including for the purpose of the European database, shall be carried out in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council and under the supervision of the European Data Protection Supervisor.

3 No special categories of data within the meaning of Article 8(1) of Directive 95/46/EC shall be processed for the purposes of this Regulation.

4 The personal data collected for the purposes of this Regulation shall not be further processed in a way inconsistent with Directive 95/46/EC or Regulation (EC) No 45/2001 and shall not be retained longer than necessary for the purposes for which it was collected.

5 Member States and the Commission shall not process personal data in a manner incompatible with the purposes set out in Article 32a. Without prejudice to Article 13 of Directive 95/46/EC, personal data obtained or processed pursuant to this Regulation shall be used for the purpose of preventing the diversion of scheduled substances.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.