Regulation (EU) No 1258/2013 of the European Parliament and of the Council of 20 November 2013 amending Regulation (EC) No 273/2004 on drug precursors Text with EEA relevance

This Regulation establishes harmonised measures for the intra-Union 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.’;

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. To that end, operators shall provide any available information allowing the competent authorities to verify the legitimacy of the relevant order or transaction.

2 Operators shall provide the competent authorities with relevant information in summary form about their transactions involving scheduled substances.

3 The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for operators to provide information as referred to in paragraph 2 of this Article including, where relevant, the categories of personal data to be processed for that purpose and the safeguards for processing such personal data.

4 Operators shall not disclose any personal data collected pursuant to this Regulation other than to the competent authorities.’;

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 communicate to the Commission in electronic form via the European database referred to in Article 13a 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 15a specifying the conditions and requirements concerning the information to be provided under paragraph 1 of this Article.

3 A summary of the communications made pursuant to paragraph 1 of this Article 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.

1 The Commission shall establish a European database on drug precursors with the following functions: (a) to facilitate the communication of information, where possible in an aggregated and anonymised manner, pursuant to Article 13(1), the synthesis and analysis of that information at the Union level, and the reporting to the International Narcotics Control Board pursuant to Article 13(3); (b) to create a European register of operators and users, which have been granted a licence or registration; (c) to enable operators to provide the competent authorities with information about their transactions in accordance with Article 8(2) in electronic form, as specified in implementing measures adopted pursuant to Article 14. Personal data shall be included in the European database only after the adoption of the delegated acts referred to in Articles 3(8) and 8(3).

2 The Commission and the competent authorities shall take all necessary measures to ensure the security, confidentiality and accuracy of personal data contained in the European database and to ensure that the rights of data subjects are protected in accordance with Directive 95/46/EC and Regulation (EC) No 45/2001 of the European Parliament and of the Council .

3 Information obtained pursuant to this Regulation, including personal data, shall be used in accordance with the applicable law on personal data protection and shall not be retained for longer than necessary for the purposes of this Regulation. The processing of special categories of data as referred to in Article 8(1) of Directive 95/46/EC and in Article 10(1) of Regulation (EC) No 45/2001 shall be prohibited.

4 The Commission shall make publicly available, in a clear, comprehensive and understandable manner, information concerning the European database in accordance with Articles 10 and 11 of Regulation (EC) No 45/2001.

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 and under the supervision of the supervisory authority of the Member State referred to in Article 28 of that Directive.

2 Without prejudice to Article 13 of Directive 95/46/EC, personal data obtained or processed pursuant to this Regulation shall be used solely for the purpose of preventing the diversion of scheduled substances.

3 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 and under the supervision of the European Data Protection Supervisor.

4 Member States and the Commission shall not process personal data in a manner incompatible with the purposes set out in Article 13a.

1 The Commission may adopt the following implementing acts: (a) rules on how to provide customer declarations referred to in Article 4 in electronic form, where appropriate; (b) rules on how to provide the information referred to in Article 8(2), including, where appropriate, in electronic form to a European database; (c) procedural rules for granting licences and registrations and for listing operators and users in the European database, as referred to in Article 3(2), (6) and (7).

2 Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14a(2).

1 The Commission shall be assisted by the Drug Precursors Committee established by Article 30 of Council Regulation (EC) No 111/2005 . 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 15a in order to adapt Annexes I, II and III to new trends in diversion of drug precursors 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 Articles 3(8), 4(4) and 5(7), the second paragraph of Article 7, Articles 8(3) and 13(2) and Article 15 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 Articles 3(8), 4(4) and 5(7), the second paragraph of Article 7, Articles 8(3) and 13(2) and Article 15 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 Articles 3(8), 4(4) and 5(7), the second paragraph of Article 7, Articles 8(3) and 13(2) and Article 15 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 Member States shall inform the Commission of the measures they adopt 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.

2 The Commission shall communicate that information to the other Member States.

3 The Commission shall, by 31 December 2019, submit 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.

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