10.12.2013 |
EN |
Official Journal of the European Union |
L 330/21 |
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
On 7 January 2010, the Commission adopted a report pursuant to Article 16 of Regulation (EC) No 273/2004 of the European Parliament and of the Council (3) on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors. |
(2) |
In that report, the Commission recommended further analysing ways to strengthen the control of the trade of acetic anhydride, a scheduled substance in category 2 of Annex I to Regulation (EC) No 273/2004, pursuant to Article 2(a) of that Regulation, in order to better prevent the diversion of acetic anhydride for the illicit production of heroin. |
(3) |
In its Conclusions of 25 May 2010 on the functioning and implementation of the EU drug precursors legislation, the Council invited the Commission to propose legislative amendments after carefully assessing their potential impact on Member States’ authorities and economic operators. |
(4) |
This Regulation clarifies the definition of a scheduled substance: in this regard, the term ‘pharmaceutical preparation’, which stems from the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances adopted in Vienna on 19 December 1988, is deleted as it is already covered by the relevant terminology of Union legal acts, namely ‘medicinal products’. Moreover, the term ‘other preparations’ is deleted as it duplicates the term ‘mixtures’ already used in that definition. |
(5) |
A definition of the term ‘user’ should be introduced for persons possessing substances for purposes other than placing them on the market and it should be clarified that persons using scheduled substances in category 1 of Annex I to Regulation (EC) No 273/2004 for other purposes than placing them on the market are obliged to obtain a licence. |
(6) |
More detailed rules on registration should be introduced to ensure uniform conditions of registration in all Member States for scheduled substances in category 2 of Annex I to Regulation (EC) No 273/2004. For substances scheduled in a new subcategory 2A of Annex I to that Regulation, in addition to operators users should also be subject to a registration requirement. |
(7) |
Where fees are levied for obtaining a licence or registration, Member States should consider adjusting such fees in order to safeguard the competitiveness of microenterprises. |
(8) |
It should be made clear that Member States have the possibility to act with regard to suspicious transactions involving non-scheduled substances in order to enable them to react more quickly with regard to new trends in the illicit production of drugs. |
(9) |
A European database on drug precursors (‘the European database’) should be created to simplify the reporting by Member States with regard to seizures and stopped shipments, where possible in an aggregated and anonymised manner and in the least intrusive manner as regards the processing of personal data, taking into account the state of the art of privacy-enhancing technologies and the principle of data limitation. The European database should also serve as a European register of operators and users holding a licence or registration which will facilitate verification of the legitimacy of commercial transactions involving scheduled substances, and should enable operators to provide the competent authorities with information about their transactions involving scheduled substances. |
(10) |
Regulation (EC) No 273/2004, as amended by this Regulation, envisages the processing of information, including the processing of personal data, for the purposes of enabling the competent authorities to monitor the placing on the market of drug precursors and to prevent the diversion of scheduled substances. The processing of personal data should be carried out in a manner compatible with the purpose of that Regulation and in accordance with Directive 95/46/EC of the European Parliament and of the Council (4) and Regulation (EC) No 45/2001 of the European Parliament and of the Council (5) and, in particular, with Union requirements relating to data quality, proportionality, purpose limitation, and rights to information, access, rectification of data, erasure and blocking, organisational and technical measures and international transfers of personal data. |
(11) |
The processing of personal data for the purposes of Regulation (EC) No 273/2004, as amended by this Regulation, and any delegated and implementing acts adopted pursuant thereto should respect the fundamental right to respect for private and family life recognised by Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms as well as the rights to respect for private and family life, and the right to the protection of personal data recognised, respectively, by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union. The delegated and implementing acts should also ensure that any processing of personal data takes place in accordance with Directive 95/46/EC and Regulation (EC) No 45/2001. |
(12) |
Acetic anhydride, currently scheduled in category 2 of Annex I to Regulation (EC) No 273/2004, should be included in a new subcategory 2A of Annex I thereto to allow increased control of its trade. The remaining substances of category 2 of Annex I to Regulation (EC) No 273/2004 should be listed as subcategory 2B of Annex I thereto. |
(13) |
Regulation (EC) No 273/2004 confers powers on the Commission in order to implement some of its provisions, to be exercised in accordance with the procedures laid down in Council Decision 1999/468/EC (6). |
(14) |
As a consequence of the entry into force of the Treaty of Lisbon, those powers should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union (TFEU). |
(15) |
In order to achieve the objectives of Regulation (EC) No 273/2004, as amended by this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to specify the requirements and conditions for the granting of the licence and registration, for listing operators and users having obtained a licence or registration in the European database, for obtaining and using customer declarations, for the documentation and labelling of mixtures containing scheduled substances, for the provision of information by the operators on transactions involving scheduled substances, and for information to be provided by Member States on the implementation of the monitoring measures laid down in Regulation (EC) No 273/2004, and in order to amend the Annexes thereto. Such delegated acts should also determine the categories of personal data which can be processed by Member States and operators pursuant to Regulation (EC) No 273/2004, the categories of personal data which can be stored in the European database and the safeguards for the processing of personal data. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure the simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. |
(16) |
It is also important that the Commission seek the opinion of the European Data Protection Supervisor when preparing delegated acts relating to the processing of personal data. |
(17) |
In order to ensure uniform conditions for the implementation of Regulation (EC) No 273/2004, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (7). The examination procedure should be used for the adoption of the implementing acts in order to set up details on how customer declarations should be provided in electronic form and on how to provide the information about transactions of operators with scheduled substances to a European database. |
(18) |
Since the objective of this Regulation, namely to strengthen the rules for registration of operators placing on the market or possessing scheduled substances of category 2 of Annex I to Regulation (EC) No 273/2004, in particular acetic anhydride, in order to prevent its diversion towards the illicit production of drugs, cannot be sufficiently achieved by the Member States because traffickers gain from national differences in registration and move their illicit business where drug precursors are easiest to divert, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. 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 that objective. |
(19) |
The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 18 January 2013 (8). |
(20) |
Regulation (EC) No 273/2004 should therefore be amended accordingly, |
HAVE ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 273/2004 is amended as follows:
(1) |
Article 1 is replaced by the following: ‘Article 1 Scope and objectives 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.’; |
(2) |
in Article 2:
|
(3) |
in Article 3:
|
(4) |
in Article 4:
|
(5) |
in Article 5, the following paragraph is added: ‘7. The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for the documentation of mixtures containing scheduled substances.’; |
(6) |
in Article 7, the following paragraph is added: ‘The Commission shall be empowered to adopt delegated acts in accordance with Article 15a concerning the requirements and conditions for the labelling of mixtures containing scheduled substances.’; |
(7) |
Article 8 is replaced by the following: ‘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. 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.’; |
(8) |
in Article 9, paragraph 1 is replaced by the following: ‘1. The Commission shall draw up, and keep up to date, guidelines to facilitate cooperation between the competent authorities, the operators, and the chemical industry, in particular as regards non-scheduled substances.’; |
(9) |
in Article 10:
|
(10) |
Articles 13 to 16 are replaced by the following: ‘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 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. Article 13a European database on drug precursors 1. The Commission shall establish a European database on drug precursors with the following functions:
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 (*5). 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. Article 13b Data protection 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. Article 14 Implementing acts 1. The Commission may adopt the following implementing acts:
2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14a(2). Article 14a Committee procedure 1. The Commission shall be assisted by the Drug Precursors Committee established by Article 30 of Council Regulation (EC) No 111/2005 (*6). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (*7). 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 15 Adaptation of Annexes 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. Article 15a Exercise of the delegation 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. Article 16 Information about measures adopted by Member States 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. (*5) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1)." (*6) 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 (OJ L 22, 26.1.2005, p. 1)." (*7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;" |
(11) |
in Annex I:
|
(12) |
in Annex III, the text ‘authorisation/’ is deleted. |
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 20 November 2013.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
V. LEŠKEVIČIUS
(1) OJ C 76, 14.3.2013, p. 54.
(2) Position of the European Parliament of 23 October 2013 (not yet published in the Official Journal) and decision of the Council of 15 November 2013.
(3) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (OJ L 47, 18.2.2004, p. 1).
(4) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(5) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(6) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23).
(7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(8) Not yet published in the Official Journal.
ANNEX
CATEGORY 2
SUBCATEGORY 2A
Substance |
CN designation (if different) |
CN code (1) |
CAS No (2) |
Acetic anhydride |
|
2915 24 00 |
108-24-7 |
The salts of the substances listed in this category, whenever the existence of such salts is possible. |
SUBCATEGORY 2B
Substance |
CN designation (if different) |
CN code (1) |
CAS No (2) |
Phenylacetic acid |
|
2916 34 00 |
103-82-2 |
Anthranilic acid |
|
2922 43 00 |
118-92-3 |
Piperidine |
|
2933 32 00 |
110-89-4 |
Potassium permanganate |
|
2841 61 00 |
7722-64-7 |
The salts of the substances listed in this category, whenever the existence of such salts is possible. |
(1) OJ L 290, 28.10.2002, p. 1.
(2) The CAS No is the ‘chemical abstracts service registry number’, which is a unique numeric identifier specific to each substance and its structure. The CAS No is specific to each isomer and to each salt of each isomer. It must be understood that the CAS Nos for the salts of the substances listed above will be different to those given.