BETA


Events

2013/12/10
   Final act published in Official Journal
Details

PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride , the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors .

LEGISLATIVE ACT: Regulation (EU) No 1258/2013 of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors.

CONTENT: 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.

Definitions : several definitions have been amended such as:

“ user ”: this term has been clarified so that it concerns persons possessing substances for purposes other than placing them on the market (the aim being that it cannot be confused with an operator within the meaning of the Regulation); “ scheduled substance ”: this term has been clarified so as to delete 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, 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.

Registration : more detailed rules on registration should be introduced to ensure uniform conditions of registration in all Member States for scheduled substances as laid down in the Regulation (EC) No 273/2004. For acetic anhydride , in addition to operators users should also be subject to a registration requirement.

Licence : provisions as regards holding a licence for the placing on the market of a scheduled substance has been clarified. The competent authorities may either limit the validity of the licence to a period not exceeding three years.

For acetic anhydride , operators shall obtain registration from the competent authorities of the Member State in which they are established before placing the substance on the market. From 1 July 2015, users shall obtain a registration from the competent authorities of the Member State in which they are established before possessing this substance.

When considering whether to grant registration, the competent authorities shall take into account, in particular, the competence and integrity of the applicant. They shall refuse registration 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.

Fees : operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances. It is also provided that competent authorities may require operators and users to pay a fee for the application for a licence or for registration .

Where a fee is levied, competent authorities must consider adjusting the level of the fee depending on the size of the enterprise. Such a fee must be levied in a non-discriminatory manner and shall not exceed the cost of processing the application .

Database : a European database on drug precursors shall 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.

The kind of data which can be stored in the European database would be established through delegated acts.

Exchange and processing of personal data: Regulation (EC) No 273/2004 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. However, it is specified that the processing of personal data should be carried out in a manner compatible with EU legislation on data protection and, in particular, with 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.

Operators must not disclose any personal data collected pursuant to this Regulation other than to the competent authorities.

Notification of the competent authorities : 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.

Competent authorities will have the power where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.

Communication from Member States : 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 all relevant information on the implementation of the monitoring measures laid down in the 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.

The Commission shall be empowered to adopt delegated acts concerning the requirements and conditions for operators to provide information.

Report : 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.

Annex : 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.

ENTRY INTO FORCE: 30.12.2013.

DELEGATED ACTS: the power to adopt delegated acts shall be conferred on the Commission for a period of five years from 30 December 2013 . The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension.

The European Parliament or the Council may raise objections to a delegated act within a period of two months from the date of notification (this may be extended by two months.) If the European Parliament or Council express objections, the delegated act will not enter into force.

2013/11/27
   EC - Commission response to text adopted in plenary
Documents
2013/11/20
   CSL - Draft final act
Documents
2013/11/20
   CSL - Final act signed
2013/11/20
   EP - End of procedure in Parliament
2013/11/15
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2013/11/15
   CSL - Council Meeting
2013/10/23
   EP - Results of vote in Parliament
2013/10/23
   EP - Decision by Parliament, 1st reading/single reading
Details

The European Parliament adopted by 575 votes to 34 with 54 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors.

Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise negotiated between Parliament and Council.

Scope and objectives: the Regulation established 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.

Definitions: several definitions were clarified, including the definition of “placing on the market’ of scheduled substances within the meaning of the Regulation.

The meaning of ‘user’ has also been clarified so that it cannot be confused with an operator within the meaning of the Regulation.

Registration: operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances.

It is also provided that competent authorities may require operators and users to pay a fee for the application for a licence or for registration .

Where a fee is levied, competent authorities must consider adjusting the level of the fee depending on the size of the enterprise. Such a fee must be levied in a non-discriminatory manner and shall not exceed the cost of processing the application .

Database: the proposal provided for the creation of a European database to simplify the reporting by Member States with regard to seizures and stopped shipments. Data should, where possible, be 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 kind of data which can be stored in the European database would be established through delegated acts.

The Commission must make publicly available, in a clear, comprehensive and understandable manner, information concerning the European database.

Exchange and processing of personal data: Regulation (EC) No 273/2004 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. However, the amended text specified that the processing of personal data should be carried out in a manner compatible with EU legislation on data protection and, in particular, with 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.

Operators must not disclose any personal data collected pursuant to this Regulation other than to the competent authorities.

Seizure of certain substances : competent authorities will have the power where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.

Communication from Member States : 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 all relevant information on the implementation of the monitoring measures laid down in the 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.

The Commission will be empowered to adopt delegated acts specifying the conditions and requirements concerning the information to be provided in this context. .

Delegated acts regarding the processing of personal data : the scope of the delegation of power has been redefined so that the Commission would also be empowered to adopt delegated acts on:

· 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.

The Commission should seek the opinion of the European Data Protection Supervisor when preparing delegated acts relating to the processing of personal data.

The power to adopt delegated acts will be conferred on the Commission for a period of five years and 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.

Review: the Commission must submit a report to the European Parliament and to the Council on the implementation and functioning of the Regulation, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances.

Annex: the list of scheduled substances has been amended.

Documents
2013/05/15
   EP - Committee report tabled for plenary, 1st reading/single reading
Details

The Committee on Civil Liberties, Justice and Home Affairs adopted the report by Anna HEDH (S&D, SE) on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors.

The committee recommends that the European Parliament’s position adopted at first reading, following the ordinary legislative procedure, should amend the Commission proposal as follows:

Definitions : Members redefine the term ‘user’ so that it shall mean any natural or legal person who is not an operator under the terms of the Regulation.

Registration regime : Members make a number of amendments to ensure that operators should be discouraged from "shopping around" in the EU for the competent authorities with the lightest licensing/registration regime.

Database : the proposal seeks to establish a European Database on drug precursors 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 way as regards the processing of personal data . The Commission and the competent authorities shall take all necessary measures to ensure the security, confidentiality and accuracy of the information contained in the European Database. The rights of data subjects are protected in accordance with that Directive 95/46/EC.

Exchange and processing of personal data : Regulation (EC) No 273/2004 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. Members consider that the processing of personal data should be carried out in accordance with Union law on data protection and, in particular, with 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 . Data should be adequate, accurate, relevant and not excessive in relation to the purpose for which it is collected. It should not be processed for longer than necessary in relation to the purpose for which it is collected and its accuracy should be regularly reviewed.

Operators shall not disclose personal data processed pursuant to this Regulation other than to the competent authorities.

It is stipulated that a data subject shall be provided with information concerning the purposes of the processing and retention of data, the categories of data processed and retained, the identity of the controller of the data, the identity of the recipients of the data, information regarding the right of access, rectification or erasure of the data subject's personal data, the administrative and judicial remedies available and the contact details of the supervisory authority. Some or all of that specific information may be withheld only in so far as it would compromise administrative or judicial investigations or procedures, hamper the prevention, investigation, detection or prosecution of criminal offences or jeopardise public or national security.

Data protection law, the various elements of processing personal data, including the exercise of rights by data subjects, must be specified in delegated acts .

As regards the processing of data, this should be carried out under the supervision of the European Data Protection Supervisor , as regards the processing of personal data carried out by the Commission within the framework of Regulation (EC) No 273/2004.

Access by law enforcement agencies to personal data : in order to enable law enforcement authorities to detect, prevent, investigate or prosecute drug trafficking criminal offences, Members call on Member States should to adopt legislative measures to grant their competent authorities access to personal data processed in so far as is necessary, proportionate and subject to adequate safeguards. Such processing should only take place on a case-by-case basis and provided that the competent law enforcement authorities have reasonable grounds for believing that it will substantially assist them in preventing, detecting, or investigating drug trafficking criminal offences.

Delegated acts : the Commission shall be empowered to adopt delegated acts in respect of :

the categories of personal data to be processed for the purpose of the European Database, the retention period for personal data processed , the procedures by which data subjects can exercise their rights to access, rectify, erase and, where appropriate, object and block data.

Before developing delegated acts, the Commission shall consult the European Data Protection Supervisor.

Review : by 66 months after the date of entry into force of this Regulation (and not 78 as proposed by the commission), the Commission shall submit a report to the European Parliament and to the Council on the implementation and functioning of Regulation (EC) No 273/2004, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances.

Documents
2013/04/24
   EP - Vote in committee, 1st reading/single reading
2013/03/04
   EP - Amendments tabled in committee
Documents
2013/02/06
   EP - Committee draft report
Documents
2013/01/18
   EDPS - Document attached to the procedure
Details

Opinion of the European Data Protection Supervisor on the proposal for a regulation amending Regulation (EC) No 273/2004 on drug precursors and the proposal for a regulation amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors.

On 27 September 2012, the Commission adopted the proposal for a regulation amending Regulation (EC) No 273/2004 on drug precursors and the proposal for a Regulation amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors.

The EDPS was consulted on the same day.

The proposals aim to implement the 1988 UN Convention against illicit drug trafficking and psychotropic substances. The UN Convention and the Regulations aim at recognising and protecting legal trade of drug precursors while, at the same time, discouraging their diversion for illicit purposes .

Currently, measures to control intra-EU trade imply the processing of data of operators since they include the obligation for certain industry operators to appoint a responsible officer and notify his contact details to the competent authorities, obtain a licence or registration, ask customers to declare the uses of the drug precursors provided to them and immediately notify the competent authorities in case they suspect an order or transaction might be aimed at diverting drug precursors for illicit purposes.

As regards the control of external trade , the processing of data of operators is also necessary, as operators are obliged, for example, to apply to competent authorities for authorisation before importing or exporting drug precursors. Obligations for EU competent authorities include notifying certain third countries before an export of drug precursors takes place, and communicating to the Commission the result of their monitoring measures.

Following criticisms by the UN International Narcotics Control Board (INCB) on specific weaknesses of the current measures, the new proposals include, among others, the following amendments to the Regulations:

the creation of a European Database on Drug Precursors, the reinforcement of the harmonised registration provisions, the extension of the registration requirement to users of acetic anhydride.

EDPS’s position : the EDPS welcomes the general references to the applicability of EU data protection legislation, the fact that many of the categories of data to be processed are specified and the fact that the principle of purpose limitation is mentioned in the external trade proposal.

However, he recommends laying down in the main legislative texts the essential elements of the processing operations such as the exclusion of the processing of sensitive data . All the categories of data to be processed should also be specified preferably in the proposals, and at least by delegated acts .

He also recommends:

adding to the intra-EU trade proposal that personal data on suspicious transactions may only be used for the purpose of preventing the diversion of scheduled substances , laying down maximum retention periods in the proposals for all processing operations and specifying in the proposals that data on suspicious transactions has to be deleted as soon as they are not necessary any more, adding a new article to the proposals on how information on the processing operations should be provided to data subjects, as regards international transfers of personal data, including data protection safeguards in the text of the external trade regulation and in an international binding text or in binding agreements with the recipient third countries, as regards the European Database, if operators need to have access to it or it is to be used for additional purposes, this should be specified in the substantive part of the proposals, ensuring the supervision of the European database by a system of coordinated supervision between the EDPS and national Data Protection Authorities, similar to what is foreseen for the Internal Market Information System, as regards the register of European operators and the processing of summaries of transactions through the European database, specific data protection and security safeguards should be added, preferably to the proposals and at least by delegated or implementing acts, if the European Database is to be used for purposes other than those stated in Article 1(9) of the intra- EU trade proposal (e.g., for the processing of customs declarations), this should be specified in the substantive part of the proposals.

As regards the principle of purpose limitation, the EDPS would like to remind that the interconnection and exchange or correlation of data of the European database with other databases managed by the Commission or by other entities for different purposes should in principle not be allowed .

2013/01/16
   ESC - Economic and Social Committee: opinion, report
Documents
2012/12/13
   PT_PARLIAMENT - Contribution
Documents
2012/12/10
   EP - HEDH Anna (S&D) appointed as rapporteur in LIBE
2012/11/26
   IT_SENATE - Contribution
Documents
2012/10/22
   EP - Committee referral announced in Parliament, 1st reading/single reading
2012/09/27
   EC - Document attached to the procedure
2012/09/27
   EC - Document attached to the procedure
2012/09/27
   EC - Legislative proposal published
Details

PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride, the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: drug precursors are chemical substances having a wide variety of licit uses, such as in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded for legitimate purposes on global markets, but some of them can also be diverted from the licit distribution channels for the illicit manufacture of narcotic drugs. Taking into account the wide legitimate uses of drug precursors, their trade cannot be prohibited. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The EU is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof.

In 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors, and recommended analysing ways to strengthen the control of the trade of acetic anhydride (scheduled substance in Category 2) in order to better prevent the diversion of acetic anhydride for the illicit production of heroin.

Heroin use accounts for the greatest share of morbidity and mortality-related drug use in the EU. Even though the quantities of acetic anhydride seized in the EU have decreased very substantially since 2008, certain reports consider that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade.

IMPACT ASSESSMENT: the main problem driver being the insufficient control by competent authorities over all economic players involved in the legitimate trade with drug precursors, all policy options examined seek to improve control via enhanced reporting, notification or registration obligations imposed on the economic players. The impacts of the following six policy options have been analysed:

Option 1 (baseline option): no action: the current EU legislation will remain unchanged; Option 2: strengthened reporting obligations; Option 3: strengthened rules and obligations on operators related to customer declarations from end-users; Option 4: require operators to systematically notify new end-users to the authorities to allow verification; Option 5: require registration for end-users and reinforce requirements regarding registration; Option 6: move acetic anhydride from category 2 to category 1 scheduled substances.

Option 5 is the preferred option. The overall conclusion of the impact assessment was that both, Option 4 and Option 5 would be good choices, but Option 5 would be less burdensome than Option 4 in terms of annual costs for enterprises (provided authorities do not pass on all costs to registrants by imposing fees), an argument which is particular relevant for SMEs. All in all the strong political support which Option 5 has from most Member States, combined with views expressed on international level that a more systematic control of (all) acetic anhydride end-users is lacking in the European legislation, and the somewhat lower burden on SMEs tip the balance in favour of Option 5.

LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: this proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU- internal trade: in 2008, 75% of the global seizures of Acetic anhydride happened in the EU. Until now only EU companies producing or trading Acetic anhydride have to register with their national authorities.

The Commission proposes to:

· extend the registration requirement , which so far applies only to operators placing Acetic anhydride on the market, to include users of the substance;

· enhance the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures. More detailed rules on registration are introduced to ensure uniform conditions of registration in all Member States for scheduled substances in category 2 of Annex I. For substances scheduled in a new subcategory 2A of Annex I, not only operators but also users will be subject to a registration requirement.

By ensuring that operators and users engaged in the legal trade of drug precursors are subject to harmonised rules, the proposal will ensure a proper functioning of the Union market by avoiding unnecessary barriers to such legitimate trade and by reducing administrative burdens for operators and competent authorities.

Additionally the Commission proposes to establish and maintain a European Database on Drug Precursors in order to modernize the collection of the information provided by Member States on drug precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation (EC) No 273/2004, and to maintain a list of EU licensed or registered operators and users legally trading or using drug precursors, as well as to enable operators to provide competent authorities in summary form with information about their transactions involving scheduled substances in accordance with current Article 8 (2) of Regulation (EC) No 273/2004.

In addition, it should be noted that the proposal is:

· subject to a notification to the WTO in the framework of the TBT Agreement;

· relevant for the European Economic Area (EEA);

· contains a transitional period for the coming into force of the new registration obligations for end-users of Acetic anhydride;

· includes a review clause to assess whether the amended Regulation will have been effective to prevent the diversion of Acetic anhydride.

Annex: the proposal does not extend the provisions for acetic anhydride to other scheduled substances in category 2. Acetic anhydride, currently scheduled in category 2 of Annex I, will be included in a new subcategory 2A of Annex I to allow increased control of its trade. The remaining substances of category 2 will be listed as subcategory 2B.

BUDGETARY IMPLICATIONS: the proposal has no impact on the European Union budget because no additional resources are required to implement the action proposed. The necessary resources to implement the European database are already included in the allocations granted during the budget procedure and within the Internal Market line.

DELEGATED ACTS: the Commission shall have the power, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to adopt certain acts for which provision is made in the proposal.

Documents

Votes

A7-0153/2013 - Anna Hedh - Résolution législative

2013/10/23 Outcome: +: 575, 0: 54, -: 34
IT DE FR PL GB ES RO CZ BG BE SE HU EL SK AT IE DK LT NL FI HR PT SI LV LU MT EE ?? CY
Total
61
82
61
45
68
45
30
20
17
19
16
15
17
13
17
12
12
11
23
10
11
18
8
9
6
5
5
2
5
icon: PPE PPE
239

Czechia PPE

2

Denmark PPE

For (1)

1

Luxembourg PPE

3

Malta PPE

2

Estonia PPE

For (1)

1
2

Cyprus PPE

1
icon: S&D S&D
164

Ireland S&D

2

Netherlands S&D

2

Finland S&D

2

Slovenia S&D

2

Latvia S&D

1

Luxembourg S&D

For (1)

1

Estonia S&D

For (1)

1
icon: ALDE ALDE
78

Greece ALDE

1

Slovakia ALDE

For (1)

1

Austria ALDE

1

Denmark ALDE

2

Lithuania ALDE

1

Slovenia ALDE

2

Latvia ALDE

For (1)

1

Luxembourg ALDE

For (1)

1

Estonia ALDE

2
icon: ECR ECR
50

Denmark ECR

For (1)

1

Lithuania ECR

1

Netherlands ECR

For (1)

1

Croatia ECR

For (1)

1

Latvia ECR

For (1)

1
icon: EFD EFD
26

Bulgaria EFD

For (1)

1

Belgium EFD

For (1)

1

Greece EFD

1

Slovakia EFD

For (1)

1

Denmark EFD

1

Lithuania EFD

For (1)

Abstain (1)

2

Netherlands EFD

For (1)

1

Finland EFD

For (1)

1
icon: NI NI
27

Italy NI

For (1)

1

Spain NI

1

Bulgaria NI

1

Belgium NI

Abstain (1)

1

Hungary NI

For (1)

1

Ireland NI

For (1)

1
icon: Verts/ALE Verts/ALE
49

United Kingdom Verts/ALE

5

Belgium Verts/ALE

3

Sweden Verts/ALE

Abstain (1)

3

Greece Verts/ALE

Abstain (1)

1

Austria Verts/ALE

2

Denmark Verts/ALE

Abstain (1)

1

Netherlands Verts/ALE

3

Finland Verts/ALE

Abstain (1)

1

Portugal Verts/ALE

Abstain (1)

1

Latvia Verts/ALE

Abstain (1)

1

Luxembourg Verts/ALE

Abstain (1)

1

Estonia Verts/ALE

Abstain (1)

1
icon: GUE/NGL GUE/NGL
30

France GUE/NGL

2

United Kingdom GUE/NGL

Abstain (1)

1

Spain GUE/NGL

Against (1)

1

Sweden GUE/NGL

1

Greece GUE/NGL

Against (1)

3

Ireland GUE/NGL

Abstain (1)

1

Denmark GUE/NGL

1

Netherlands GUE/NGL

For (1)

2

Croatia GUE/NGL

Against (1)

1
4

Latvia GUE/NGL

Against (1)

1

Cyprus GUE/NGL

2
AmendmentsDossier
25 2012/0261(COD)
2013/03/04 LIBE 25 amendments...
source: PE-506.184

History

(these mark the time of scraping, not the official date of the change)

committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Civil Liberties, Justice and Home Affairs
committee
LIBE
rapporteur
name: HEDH Anna date: 2012-12-10T00:00:00 group: Progressive Alliance of Socialists and Democrats abbr: S&D
shadows
committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Civil Liberties, Justice and Home Affairs
committee
LIBE
date
2012-12-10T00:00:00
rapporteur
name: HEDH Anna group: Progressive Alliance of Socialists and Democrats abbr: S&D
shadows
docs/7/body
EC
events/3/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2013-153&language=EN
New
http://www.europarl.europa.eu/doceo/document/A-7-2013-0153_EN.html
events/5/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-442
New
http://www.europarl.europa.eu/doceo/document/TA-7-2013-0442_EN.html
activities
  • date: 2012-09-27T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2012/0548/COM_COM(2012)0548_EN.pdf title: COM(2012)0548 type: Legislative proposal published celexid: CELEX:52012PC0548:EN body: EC commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: TAJANI Antonio type: Legislative proposal published
  • date: 2012-10-22T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: International Trade committee: INTA body: EP shadows: group: PPE name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Ska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna
  • date: 2013-04-24T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: International Trade committee: INTA body: EP shadows: group: PPE name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Ska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna
  • body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2013-153&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A7-0153/2013 type: Committee report tabled for plenary, 1st reading/single reading committees: body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: International Trade committee: INTA body: EP shadows: group: PPE name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Ska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna date: 2013-05-15T00:00:00
  • date: 2013-10-23T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=22899&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-442 type: Decision by Parliament, 1st reading/single reading title: T7-0442/2013 body: EP type: Results of vote in Parliament
  • date: 2013-11-15T00:00:00 body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3271
  • date: 2013-11-15T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2013-11-20T00:00:00 body: CSL type: Final act signed
  • date: 2013-11-20T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2013-12-10T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32013R1258 title: Regulation 2013/1258 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2013:330:TOC title: OJ L 330 10.12.2013, p. 0021
commission
  • body: EC dg: Internal Market, Industry, Entrepreneurship and SMEs commissioner: TAJANI Antonio
committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Civil Liberties, Justice and Home Affairs
committee
LIBE
date
2012-12-10T00:00:00
rapporteur
name: HEDH Anna group: Progressive Alliance of Socialists and Democrats abbr: S&D
shadows
committees/0
body
EP
responsible
False
committee_full
Environment, Public Health and Food Safety
committee
ENVI
committees/1
type
Committee Opinion
body
EP
associated
False
committee_full
International Trade
committee
INTA
opinion
False
committees/1
body
EP
responsible
False
committee_full
Internal Market and Consumer Protection
committee
IMCO
committees/2
type
Committee Opinion
body
EP
associated
False
committee_full
Environment, Public Health and Food Safety
committee
ENVI
opinion
False
committees/2
body
EP
responsible
False
committee_full
International Trade
committee
INTA
committees/3
type
Committee Opinion
body
EP
associated
False
committee_full
Internal Market and Consumer Protection
committee
IMCO
opinion
False
committees/3
body
EP
shadows
responsible
True
committee
LIBE
date
2012-12-10T00:00:00
committee_full
Civil Liberties, Justice and Home Affairs
rapporteur
group: S&D name: HEDH Anna
council
  • body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3271 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3271*&MEET_DATE=15/11/2013 date: 2013-11-15T00:00:00
docs
  • date: 2012-09-27T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0278:FIN:EN:PDF title: EUR-Lex title: SWD(2012)0278 type: Document attached to the procedure body: EC
  • date: 2012-09-27T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0279:FIN:EN:PDF title: EUR-Lex title: SWD(2012)0279 type: Document attached to the procedure body: EC
  • date: 2013-01-16T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:2301)(documentyear:2012)(documentlanguage:EN) title: CES2301/2012 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2013-01-18T00:00:00 docs: url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2013:357:TOC title: OJ C 357 06.12.2013, p. 0009 title: N7-0047/2014 summary: Opinion of the European Data Protection Supervisor on the proposal for a regulation amending Regulation (EC) No 273/2004 on drug precursors and the proposal for a regulation amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors. On 27 September 2012, the Commission adopted the proposal for a regulation amending Regulation (EC) No 273/2004 on drug precursors and the proposal for a Regulation amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors. The EDPS was consulted on the same day. The proposals aim to implement the 1988 UN Convention against illicit drug trafficking and psychotropic substances. The UN Convention and the Regulations aim at recognising and protecting legal trade of drug precursors while, at the same time, discouraging their diversion for illicit purposes . Currently, measures to control intra-EU trade imply the processing of data of operators since they include the obligation for certain industry operators to appoint a responsible officer and notify his contact details to the competent authorities, obtain a licence or registration, ask customers to declare the uses of the drug precursors provided to them and immediately notify the competent authorities in case they suspect an order or transaction might be aimed at diverting drug precursors for illicit purposes. As regards the control of external trade , the processing of data of operators is also necessary, as operators are obliged, for example, to apply to competent authorities for authorisation before importing or exporting drug precursors. Obligations for EU competent authorities include notifying certain third countries before an export of drug precursors takes place, and communicating to the Commission the result of their monitoring measures. Following criticisms by the UN International Narcotics Control Board (INCB) on specific weaknesses of the current measures, the new proposals include, among others, the following amendments to the Regulations: the creation of a European Database on Drug Precursors, the reinforcement of the harmonised registration provisions, the extension of the registration requirement to users of acetic anhydride. EDPS’s position : the EDPS welcomes the general references to the applicability of EU data protection legislation, the fact that many of the categories of data to be processed are specified and the fact that the principle of purpose limitation is mentioned in the external trade proposal. However, he recommends laying down in the main legislative texts the essential elements of the processing operations such as the exclusion of the processing of sensitive data . All the categories of data to be processed should also be specified preferably in the proposals, and at least by delegated acts . He also recommends: adding to the intra-EU trade proposal that personal data on suspicious transactions may only be used for the purpose of preventing the diversion of scheduled substances , laying down maximum retention periods in the proposals for all processing operations and specifying in the proposals that data on suspicious transactions has to be deleted as soon as they are not necessary any more, adding a new article to the proposals on how information on the processing operations should be provided to data subjects, as regards international transfers of personal data, including data protection safeguards in the text of the external trade regulation and in an international binding text or in binding agreements with the recipient third countries, as regards the European Database, if operators need to have access to it or it is to be used for additional purposes, this should be specified in the substantive part of the proposals, ensuring the supervision of the European database by a system of coordinated supervision between the EDPS and national Data Protection Authorities, similar to what is foreseen for the Internal Market Information System, as regards the register of European operators and the processing of summaries of transactions through the European database, specific data protection and security safeguards should be added, preferably to the proposals and at least by delegated or implementing acts, if the European Database is to be used for purposes other than those stated in Article 1(9) of the intra- EU trade proposal (e.g., for the processing of customs declarations), this should be specified in the substantive part of the proposals. As regards the principle of purpose limitation, the EDPS would like to remind that the interconnection and exchange or correlation of data of the European database with other databases managed by the Commission or by other entities for different purposes should in principle not be allowed . type: Document attached to the procedure body: EDPS
  • date: 2013-02-06T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE504.107 title: PE504.107 type: Committee draft report body: EP
  • date: 2013-03-04T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE506.184 title: PE506.184 type: Amendments tabled in committee body: EP
  • date: 2013-11-20T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F13&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 00061/2013/LEX type: Draft final act body: CSL
  • date: 2013-11-27T00:00:00 docs: url: /oeil/spdoc.do?i=22899&j=0&l=en title: SP(2013)872 type: Commission response to text adopted in plenary
  • date: 2012-11-26T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2012)0548 title: COM(2012)0548 type: Contribution body: IT_SENATE
  • date: 2012-12-13T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2012)0548 title: COM(2012)0548 type: Contribution body: PT_PARLIAMENT
events
  • date: 2012-09-27T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0548/COM_COM(2012)0548_EN.pdf title: COM(2012)0548 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=548 title: EUR-Lex summary: PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride, the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors PROPOSED ACT: Regulation of the European Parliament and of the Council. BACKGROUND: drug precursors are chemical substances having a wide variety of licit uses, such as in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded for legitimate purposes on global markets, but some of them can also be diverted from the licit distribution channels for the illicit manufacture of narcotic drugs. Taking into account the wide legitimate uses of drug precursors, their trade cannot be prohibited. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The EU is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof. In 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors, and recommended analysing ways to strengthen the control of the trade of acetic anhydride (scheduled substance in Category 2) in order to better prevent the diversion of acetic anhydride for the illicit production of heroin. Heroin use accounts for the greatest share of morbidity and mortality-related drug use in the EU. Even though the quantities of acetic anhydride seized in the EU have decreased very substantially since 2008, certain reports consider that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade. IMPACT ASSESSMENT: the main problem driver being the insufficient control by competent authorities over all economic players involved in the legitimate trade with drug precursors, all policy options examined seek to improve control via enhanced reporting, notification or registration obligations imposed on the economic players. The impacts of the following six policy options have been analysed: Option 1 (baseline option): no action: the current EU legislation will remain unchanged; Option 2: strengthened reporting obligations; Option 3: strengthened rules and obligations on operators related to customer declarations from end-users; Option 4: require operators to systematically notify new end-users to the authorities to allow verification; Option 5: require registration for end-users and reinforce requirements regarding registration; Option 6: move acetic anhydride from category 2 to category 1 scheduled substances. Option 5 is the preferred option. The overall conclusion of the impact assessment was that both, Option 4 and Option 5 would be good choices, but Option 5 would be less burdensome than Option 4 in terms of annual costs for enterprises (provided authorities do not pass on all costs to registrants by imposing fees), an argument which is particular relevant for SMEs. All in all the strong political support which Option 5 has from most Member States, combined with views expressed on international level that a more systematic control of (all) acetic anhydride end-users is lacking in the European legislation, and the somewhat lower burden on SMEs tip the balance in favour of Option 5. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). CONTENT: this proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU- internal trade: in 2008, 75% of the global seizures of Acetic anhydride happened in the EU. Until now only EU companies producing or trading Acetic anhydride have to register with their national authorities. The Commission proposes to: · extend the registration requirement , which so far applies only to operators placing Acetic anhydride on the market, to include users of the substance; · enhance the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures. More detailed rules on registration are introduced to ensure uniform conditions of registration in all Member States for scheduled substances in category 2 of Annex I. For substances scheduled in a new subcategory 2A of Annex I, not only operators but also users will be subject to a registration requirement. By ensuring that operators and users engaged in the legal trade of drug precursors are subject to harmonised rules, the proposal will ensure a proper functioning of the Union market by avoiding unnecessary barriers to such legitimate trade and by reducing administrative burdens for operators and competent authorities. Additionally the Commission proposes to establish and maintain a European Database on Drug Precursors in order to modernize the collection of the information provided by Member States on drug precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation (EC) No 273/2004, and to maintain a list of EU licensed or registered operators and users legally trading or using drug precursors, as well as to enable operators to provide competent authorities in summary form with information about their transactions involving scheduled substances in accordance with current Article 8 (2) of Regulation (EC) No 273/2004. In addition, it should be noted that the proposal is: · subject to a notification to the WTO in the framework of the TBT Agreement; · relevant for the European Economic Area (EEA); · contains a transitional period for the coming into force of the new registration obligations for end-users of Acetic anhydride; · includes a review clause to assess whether the amended Regulation will have been effective to prevent the diversion of Acetic anhydride. Annex: the proposal does not extend the provisions for acetic anhydride to other scheduled substances in category 2. Acetic anhydride, currently scheduled in category 2 of Annex I, will be included in a new subcategory 2A of Annex I to allow increased control of its trade. The remaining substances of category 2 will be listed as subcategory 2B. BUDGETARY IMPLICATIONS: the proposal has no impact on the European Union budget because no additional resources are required to implement the action proposed. The necessary resources to implement the European database are already included in the allocations granted during the budget procedure and within the Internal Market line. DELEGATED ACTS: the Commission shall have the power, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to adopt certain acts for which provision is made in the proposal.
  • date: 2012-10-22T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2013-04-24T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
  • date: 2013-05-15T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2013-153&language=EN title: A7-0153/2013 summary: The Committee on Civil Liberties, Justice and Home Affairs adopted the report by Anna HEDH (S&D, SE) on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors. The committee recommends that the European Parliament’s position adopted at first reading, following the ordinary legislative procedure, should amend the Commission proposal as follows: Definitions : Members redefine the term ‘user’ so that it shall mean any natural or legal person who is not an operator under the terms of the Regulation. Registration regime : Members make a number of amendments to ensure that operators should be discouraged from "shopping around" in the EU for the competent authorities with the lightest licensing/registration regime. Database : the proposal seeks to establish a European Database on drug precursors 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 way as regards the processing of personal data . The Commission and the competent authorities shall take all necessary measures to ensure the security, confidentiality and accuracy of the information contained in the European Database. The rights of data subjects are protected in accordance with that Directive 95/46/EC. Exchange and processing of personal data : Regulation (EC) No 273/2004 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. Members consider that the processing of personal data should be carried out in accordance with Union law on data protection and, in particular, with 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 . Data should be adequate, accurate, relevant and not excessive in relation to the purpose for which it is collected. It should not be processed for longer than necessary in relation to the purpose for which it is collected and its accuracy should be regularly reviewed. Operators shall not disclose personal data processed pursuant to this Regulation other than to the competent authorities. It is stipulated that a data subject shall be provided with information concerning the purposes of the processing and retention of data, the categories of data processed and retained, the identity of the controller of the data, the identity of the recipients of the data, information regarding the right of access, rectification or erasure of the data subject's personal data, the administrative and judicial remedies available and the contact details of the supervisory authority. Some or all of that specific information may be withheld only in so far as it would compromise administrative or judicial investigations or procedures, hamper the prevention, investigation, detection or prosecution of criminal offences or jeopardise public or national security. Data protection law, the various elements of processing personal data, including the exercise of rights by data subjects, must be specified in delegated acts . As regards the processing of data, this should be carried out under the supervision of the European Data Protection Supervisor , as regards the processing of personal data carried out by the Commission within the framework of Regulation (EC) No 273/2004. Access by law enforcement agencies to personal data : in order to enable law enforcement authorities to detect, prevent, investigate or prosecute drug trafficking criminal offences, Members call on Member States should to adopt legislative measures to grant their competent authorities access to personal data processed in so far as is necessary, proportionate and subject to adequate safeguards. Such processing should only take place on a case-by-case basis and provided that the competent law enforcement authorities have reasonable grounds for believing that it will substantially assist them in preventing, detecting, or investigating drug trafficking criminal offences. Delegated acts : the Commission shall be empowered to adopt delegated acts in respect of : the categories of personal data to be processed for the purpose of the European Database, the retention period for personal data processed , the procedures by which data subjects can exercise their rights to access, rectify, erase and, where appropriate, object and block data. Before developing delegated acts, the Commission shall consult the European Data Protection Supervisor. Review : by 66 months after the date of entry into force of this Regulation (and not 78 as proposed by the commission), the Commission shall submit a report to the European Parliament and to the Council on the implementation and functioning of Regulation (EC) No 273/2004, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances.
  • date: 2013-10-23T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=22899&l=en title: Results of vote in Parliament
  • date: 2013-10-23T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-442 title: T7-0442/2013 summary: The European Parliament adopted by 575 votes to 34 with 54 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors. Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise negotiated between Parliament and Council. Scope and objectives: the Regulation established 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. Definitions: several definitions were clarified, including the definition of “placing on the market’ of scheduled substances within the meaning of the Regulation. The meaning of ‘user’ has also been clarified so that it cannot be confused with an operator within the meaning of the Regulation. Registration: operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances. It is also provided that competent authorities may require operators and users to pay a fee for the application for a licence or for registration . Where a fee is levied, competent authorities must consider adjusting the level of the fee depending on the size of the enterprise. Such a fee must be levied in a non-discriminatory manner and shall not exceed the cost of processing the application . Database: the proposal provided for the creation of a European database to simplify the reporting by Member States with regard to seizures and stopped shipments. Data should, where possible, be 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 kind of data which can be stored in the European database would be established through delegated acts. The Commission must make publicly available, in a clear, comprehensive and understandable manner, information concerning the European database. Exchange and processing of personal data: Regulation (EC) No 273/2004 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. However, the amended text specified that the processing of personal data should be carried out in a manner compatible with EU legislation on data protection and, in particular, with 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. Operators must not disclose any personal data collected pursuant to this Regulation other than to the competent authorities. Seizure of certain substances : competent authorities will have the power where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances. Communication from Member States : 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 all relevant information on the implementation of the monitoring measures laid down in the 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. The Commission will be empowered to adopt delegated acts specifying the conditions and requirements concerning the information to be provided in this context. . Delegated acts regarding the processing of personal data : the scope of the delegation of power has been redefined so that the Commission would also be empowered to adopt delegated acts on: · 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. The Commission should seek the opinion of the European Data Protection Supervisor when preparing delegated acts relating to the processing of personal data. The power to adopt delegated acts will be conferred on the Commission for a period of five years and 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. Review: the Commission must submit a report to the European Parliament and to the Council on the implementation and functioning of the Regulation, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances. Annex: the list of scheduled substances has been amended.
  • date: 2013-11-15T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2013-11-20T00:00:00 type: Final act signed body: CSL
  • date: 2013-11-20T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2013-12-10T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride , the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors . LEGISLATIVE ACT: Regulation (EU) No 1258/2013 of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors. CONTENT: 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. Definitions : several definitions have been amended such as: “ user ”: this term has been clarified so that it concerns persons possessing substances for purposes other than placing them on the market (the aim being that it cannot be confused with an operator within the meaning of the Regulation); “ scheduled substance ”: this term has been clarified so as to delete 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, 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. Registration : more detailed rules on registration should be introduced to ensure uniform conditions of registration in all Member States for scheduled substances as laid down in the Regulation (EC) No 273/2004. For acetic anhydride , in addition to operators users should also be subject to a registration requirement. Licence : provisions as regards holding a licence for the placing on the market of a scheduled substance has been clarified. The competent authorities may either limit the validity of the licence to a period not exceeding three years. For acetic anhydride , operators shall obtain registration from the competent authorities of the Member State in which they are established before placing the substance on the market. From 1 July 2015, users shall obtain a registration from the competent authorities of the Member State in which they are established before possessing this substance. When considering whether to grant registration, the competent authorities shall take into account, in particular, the competence and integrity of the applicant. They shall refuse registration 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. Fees : operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances. It is also provided that competent authorities may require operators and users to pay a fee for the application for a licence or for registration . Where a fee is levied, competent authorities must consider adjusting the level of the fee depending on the size of the enterprise. Such a fee must be levied in a non-discriminatory manner and shall not exceed the cost of processing the application . Database : a European database on drug precursors shall 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. The kind of data which can be stored in the European database would be established through delegated acts. Exchange and processing of personal data: Regulation (EC) No 273/2004 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. However, it is specified that the processing of personal data should be carried out in a manner compatible with EU legislation on data protection and, in particular, with 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. Operators must not disclose any personal data collected pursuant to this Regulation other than to the competent authorities. Notification of the competent authorities : 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. Competent authorities will have the power where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances. Communication from Member States : 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 all relevant information on the implementation of the monitoring measures laid down in the 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. The Commission shall be empowered to adopt delegated acts concerning the requirements and conditions for operators to provide information. Report : 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. Annex : 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. ENTRY INTO FORCE: 30.12.2013. DELEGATED ACTS: the power to adopt delegated acts shall be conferred on the Commission for a period of five years from 30 December 2013 . The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension. The European Parliament or the Council may raise objections to a delegated act within a period of two months from the date of notification (this may be extended by two months.) If the European Parliament or Council express objections, the delegated act will not enter into force. docs: title: Regulation 2013/1258 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32013R1258 title: OJ L 330 10.12.2013, p. 0021 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2013:330:TOC
other
  • body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: TAJANI Antonio
otherinst
  • name: European Economic and Social Committee
procedure/Mandatory consultation of other institutions
Economic and Social Committee
procedure/Modified legal basis
Old
Rules of Procedure of the European Parliament EP 150
New
Rules of Procedure EP 150
procedure/dossier_of_the_committee
Old
LIBE/7/10801
New
  • LIBE/7/10801
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32013R1258
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32013R1258
procedure/instrument
Old
Regulation
New
  • Regulation
  • Amending Regulation (EC) No 273/2004 2002/0217(COD)
procedure/other_consulted_institutions
European Economic and Social Committee
procedure/subject
Old
  • 2.10.01 Customs union, tax and duty-free, Community transit
  • 2.80 Cooperation between administrations
  • 4.20.04 Pharmaceutical products and industry
  • 6.40.13 Relations with/in the context of international organisations: UN, OSCE, OECD, Council of Europe, EBRD
  • 7.30.30.04 Action to combat drugs and drug-trafficking
New
2.10.01
Customs union, tax and duty-free, Community transit
2.80
Cooperation between administrations
4.20.04
Pharmaceutical products and industry
6.40.13
Relations with/in the context of international organisations: UN, OSCE, OECD, Council of Europe, EBRD
7.30.30.04
Action to combat drugs and drug-trafficking
procedure/summary
  • Amending Regulation (EC) No 273/2004
activities/0/docs/0/celexid
CELEX:52012PC0548:EN
activities/0/docs/0/celexid
CELEX:52012PC0548:EN
activities/0/docs/0/url
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0548/COM_COM(2012)0548_EN.pdf
New
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2012/0548/COM_COM(2012)0548_EN.pdf
links/European Commission/title
Old
PreLex
New
EUR-Lex
procedure/subject/0
Old
2.10.01 Customs Union, tax and duty-free, Community transit
New
2.10.01 Customs union, tax and duty-free, Community transit
activities/1/committees/3/shadows/1/mepref
Old
545fc318d1d1c57f99000000
New
4f1ac934b819f25efd00011a
activities/2/committees/3/shadows/1/mepref
Old
545fc318d1d1c57f99000000
New
4f1ac934b819f25efd00011a
activities/3/committees/3/shadows/1/mepref
Old
545fc318d1d1c57f99000000
New
4f1ac934b819f25efd00011a
committees/3/shadows/1/mepref
Old
545fc318d1d1c57f99000000
New
4f1ac934b819f25efd00011a
activities/0/docs/1
url
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0278:FIN:EN:PDF
type
Document attached to the procedure
title
SWD(2012)0278
activities/0/docs/2
url
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0279:FIN:EN:PDF
type
Document attached to the procedure
title
SWD(2012)0279
activities/0/type
Old
Legislative proposal
New
Legislative proposal published
activities/1/committees
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: International Trade committee: INTA
  • body: EP shadows: group: PPE name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Ska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna
activities/1/date
Old
2013-02-06T00:00:00
New
2012-10-22T00:00:00
activities/1/docs
  • url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE504.107 type: Committee draft report title: PE504.107
activities/1/type
Old
Committee draft report
New
Committee referral announced in Parliament, 1st reading/single reading
activities/2
date
2013-01-16T00:00:00
docs
url: http://eescopinions.eesc.europa.eu/eescopiniondocument.aspx?language=EN&docnr=2301&year=2012 title: CES2301/2012 type: Economic and Social Committee: opinion, report celexid: CELEX:52012AE2301:EN
body
ESOC
type
Economic and Social Committee: opinion, report
activities/2/committees
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: International Trade committee: INTA
  • body: EP shadows: group: PPE name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Ska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna
activities/2/date
Old
2013-03-04T00:00:00
New
2013-04-24T00:00:00
activities/2/docs
  • url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE506.184 type: Amendments tabled in committee title: PE506.184
activities/2/type
Old
Amendments tabled in committee
New
Vote in committee, 1st reading/single reading
activities/3/committees/3/rapporteur/0/mepref
Old
4de185620fb8127435bdbee9
New
4f1ac900b819f25efd000105
activities/3/committees/3/shadows/0/group
Old
EPP
New
PPE
activities/3/committees/3/shadows/0/mepref
Old
4de1876b0fb8127435bdc1c7
New
4f1ac446b819f25896000001
activities/3/committees/3/shadows/1/mepref
Old
4de1858b0fb8127435bdbf1a
New
545fc318d1d1c57f99000000
activities/3/committees/3/shadows/2/mepref
Old
4de186010fb8127435bdbfc5
New
4f1ac98ab819f25efd000140
activities/3/committees/3/shadows/2/name
Old
KELLER Franziska
New
KELLER Ska
activities/3/committees/3/shadows/3/mepref
Old
4de185d80fb8127435bdbf86
New
4f1ac998b819f25efd000144
activities/3/committees/3/shadows/4/mepref
Old
4de188e10fb8127435bdc3e4
New
4f1adc10b819f207b30000fc
activities/4/committees
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: International Trade committee: INTA
  • body: EP shadows: group: EPP name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Franziska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna
activities/4/date
Old
2013-04-24T00:00:00
New
2013-10-23T00:00:00
activities/4/docs
  • url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=22899&l=en type: Results of vote in Parliament title: Results of vote in Parliament
  • url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-442 type: Decision by Parliament, 1st reading/single reading title: T7-0442/2013
activities/4/type
Old
Vote in committee, 1st reading/single reading
New
Results of vote in Parliament
activities/7
date
2013-10-23T00:00:00
docs
url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-442 type: Decision by Parliament, 1st reading/single reading title: T7-0442/2013
body
EP
type
Text adopted by Parliament, 1st reading/single reading
activities/9/body
EP
activities/9/committees
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: International Trade committee: INTA
  • body: EP shadows: group: EPP name: PIRKER Hubert group: ALDE name: IN 'T VELD Sophia group: Verts/ALE name: KELLER Franziska group: ECR name: KIRKHOPE Timothy group: GUE/NGL name: TRIANTAPHYLLIDES Kyriacos responsible: True committee: LIBE date: 2012-12-10T00:00:00 committee_full: Civil Liberties, Justice and Home Affairs rapporteur: group: S&D name: HEDH Anna
activities/9/date
Old
2012-10-22T00:00:00
New
2013-12-10T00:00:00
activities/9/docs
  • url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32013R1258 title: Regulation 2013/1258
  • url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2013:330:TOC title: OJ L 330 10.12.2013, p. 0021
activities/9/text
  • PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride, the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors.

    LEGISLATIVE ACT: Regulation (EU) No 1258/2013 of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors.

    CONTENT: 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.

    Definitions: several definitions have been amended such as:

    • user”: this term has been clarified so that it concerns persons possessing substances for purposes other than placing them on the market (the aim being that it cannot be confused with an operator within the meaning of the Regulation);
    • scheduled substance”: this term has been clarified so as to delete 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, 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.

    Registration: more detailed rules on registration should be introduced to ensure uniform conditions of registration in all Member States for scheduled substances as laid down in the Regulation (EC) No 273/2004. For acetic anhydride, in addition to operators users should also be subject to a registration requirement.

    Licence: provisions as regards holding a licence for the placing on the market of a scheduled substance has been clarified. The competent authorities may either limit the validity of the licence to a period not exceeding three years.

    For acetic anhydride, operators shall obtain registration from the competent authorities of the Member State in which they are established before placing the substance on the market.  From 1 July 2015, users shall obtain a registration from the competent authorities of the Member State in which they are established before possessing this substance.

    When considering whether to grant registration, the competent authorities shall take into account, in particular, the competence and integrity of the applicant. They shall refuse registration 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.

    Fees: operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances. It is also provided that competent authorities may require operators and users to pay a fee for the application for a licence or for registration

    Where a fee is levied, competent authorities must consider adjusting the level of the fee depending on the size of the enterprise. Such a fee must be levied in a non-discriminatory manner and shall not exceed the cost of processing the application

    Database: a European database on drug precursors shall 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.

    The kind of data which can be stored in the European database would be established through delegated acts.

    Exchange and processing of personal data: Regulation (EC) No 273/2004 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. However, it is specified that the processing of personal data should be carried out in a manner compatible with EU legislation on data protection and, in particular, with 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.

    Operators must not disclose any personal data collected pursuant to this Regulation other than to the competent authorities.

    Notification of the competent authorities: 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.

    Competent authorities will have the power where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.

    Communication from Member States: 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 all relevant information on the implementation of the monitoring measures laid down in the 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.

    The Commission shall be empowered to adopt delegated acts concerning the requirements and conditions for operators to provide information.

    Report: 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.

    Annex: 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.

    ENTRY INTO FORCE: 30.12.2013.

    DELEGATED ACTS: the power to adopt delegated acts shall be conferred on the Commission for a period of five years from 30 December 2013. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension. 

    The European Parliament or the Council may raise objections to a delegated act within a period of two months from the date of notification (this may be extended by two months.) If the European Parliament or Council express objections, the delegated act will not enter into force.

activities/9/type
Old
Committee referral announced in Parliament, 1st reading/single reading
New
Final act published in Official Journal
activities/12
date
2013-12-10T00:00:00
type
Final act published in Official Journal
committees/3/rapporteur/0/mepref
Old
4de185620fb8127435bdbee9
New
4f1ac900b819f25efd000105
committees/3/shadows/0/group
Old
EPP
New
PPE
committees/3/shadows/0/mepref
Old
4de1876b0fb8127435bdc1c7
New
4f1ac446b819f25896000001
committees/3/shadows/1/mepref
Old
4de1858b0fb8127435bdbf1a
New
545fc318d1d1c57f99000000
committees/3/shadows/2/mepref
Old
4de186010fb8127435bdbfc5
New
4f1ac98ab819f25efd000140
committees/3/shadows/2/name
Old
KELLER Franziska
New
KELLER Ska
committees/3/shadows/3/mepref
Old
4de185d80fb8127435bdbf86
New
4f1ac998b819f25efd000144
committees/3/shadows/4/mepref
Old
4de188e10fb8127435bdc3e4
New
4f1adc10b819f207b30000fc
procedure/Modified legal basis
Old
Rules of Procedure of the European Parliament EP 138
New
Rules of Procedure of the European Parliament EP 150
procedure/subject/3
Old
6.40.13 Relations with international organisations: UN, OSCE, OECD, Council of Europe, EBRD
New
6.40.13 Relations with/in the context of international organisations: UN, OSCE, OECD, Council of Europe, EBRD
activities/12
date
2013-12-10T00:00:00
type
Final act published in Official Journal
procedure/final
url
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32013R1258
title
Regulation 2013/1258
procedure/stage_reached
Old
Procedure completed, awaiting publication in Official Journal
New
Procedure completed
activities/0/docs/0/celexid
CELEX:52012PC0548:EN
activities/2/docs/0/celexid
CELEX:52012AE2301:EN
activities/0/docs/0/celexid
CELEX:52012PC0548:EN
activities/2/docs/0/celexid
CELEX:52012AE2301:EN
activities/10
date
2013-11-20T00:00:00
body
CSL
type
Final act signed
activities/11
date
2013-11-20T00:00:00
body
EP
type
End of procedure in Parliament
procedure/stage_reached
Old
Awaiting signature of act
New
Procedure completed, awaiting publication in Official Journal
activities/8
date
2013-11-15T00:00:00
body
CSL
type
Council Meeting
council
Economic and Financial Affairs ECOFIN
meeting_id
3271
activities/9
date
2013-11-15T00:00:00
body
EP/CSL
type
Act adopted by Council after Parliament's 1st reading
procedure/stage_reached
Old
Provisional agreement between Parliament and Council on final act
New
Awaiting signature of act
procedure/Modified legal basis
Rules of Procedure of the European Parliament EP 138
procedure/legal_basis/0
Rules of Procedure of the European Parliament EP 138
activities/7/docs/0/text
  • The European Parliament adopted by 575 votes to 34 with 54 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors.

    Parliament adopted its position in first reading following the ordinary legislative procedure. The amendments adopted in plenary are the result of a compromise negotiated between Parliament and Council.

    Scope and objectives: the Regulation established 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.

    Definitions: several definitions were clarified, including the definition of “placing on the market’ of scheduled substances within the meaning of the Regulation.

    The meaning of ‘user’ has also been clarified so that it cannot be confused with an operator within the meaning of the Regulation.

    Registration: operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances. 

    It is also provided that competent authorities may require operators and users to pay a fee for the application for a licence or for registration

    Where a fee is levied, competent authorities must consider adjusting the level of the fee depending on the size of the enterprise. Such a fee must be levied in a non-discriminatory manner and shall not exceed the cost of processing the application

    Database: the proposal provided for the creation of a European database to simplify the reporting by Member States with regard to seizures and stopped shipments. Data should, where possible, be 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 kind of data which can be stored in the European database would be established through delegated acts.

    The Commission must make publicly available, in a clear, comprehensive and understandable manner, information concerning the European database.

    Exchange and processing of personal data: Regulation (EC) No 273/2004 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. However, the amended text specified that the processing of personal data should be carried out in a manner compatible with EU legislation on data protection and, in particular, with 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.

    Operators must not disclose any personal data collected pursuant to this Regulation other than to the competent authorities.

    Seizure of certain substances: competent authorities will have the power where necessary, to detain and seize consignments to prevent the use of specific non-scheduled substances for the illicit manufacture of narcotic drugs or psychotropic substances.

    Communication from Member States: 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 all relevant information on the implementation of the monitoring measures laid down in the 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.

    The Commission will be empowered to adopt delegated acts specifying the conditions and requirements concerning the information to be provided in this context. .

    Delegated acts regarding the processing of personal data: the scope of the delegation of power has been redefined so that the Commission would also be empowered to adopt delegated acts on:

    ·        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. 

    The Commission should seek the opinion of the European Data Protection Supervisor when preparing delegated acts relating to the processing of personal data.

    The power to adopt delegated acts will be conferred on the Commission for a period of five years and 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.

    Review: the Commission must submit a report to the European Parliament and to the Council on the implementation and functioning of the Regulation, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances.

    Annex: the list of scheduled substances has been amended.

procedure/stage_reached
Old
Awaiting Council 1st reading position / budgetary conciliation convocation
New
Provisional agreement between Parliament and Council on final act
activities/7/docs/0/url
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2013-442
activities/7/docs
  • type: Decision by Parliament, 1st reading/single reading title: T7-0442/2013
activities/7/type
Old
Vote in plenary scheduled
New
Text adopted by Parliament, 1st reading/single reading
procedure/stage_reached
Old
Awaiting Parliament 1st reading / single reading / budget 1st stage
New
Awaiting Council 1st reading position / budgetary conciliation convocation
procedure/Modified legal basis
Rules of Procedure of the European Parliament EP 138
procedure/legal_basis/0
Rules of Procedure of the European Parliament EP 138
procedure/?!oeil-proposed_legal_basis!?
Rules of Procedure of the European Parliament EP 138
procedure/Modified legal basis
Rules of Procedure of the European Parliament EP 138
activities/7/type
Old
Indicative plenary sitting date, 1st reading/single reading
New
Vote in plenary scheduled
procedure/?!oeil-proposed_legal_basis!?
Rules of Procedure of the European Parliament EP 138
procedure/legal_basis/0
Rules of Procedure of the European Parliament EP 138
activities/6/docs/0/text
  • The Committee on Civil Liberties, Justice and Home Affairs adopted the report by Anna HEDH (S&D, SE) on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors.

    The committee recommends that the European Parliament’s position adopted at first reading, following the ordinary legislative procedure, should amend the Commission proposal as follows:

    Definitions: Members redefine the term ‘user’ so that it shall mean any natural or legal person who is not an operator under the terms of the Regulation.

    Registration regime: Members make a number of amendments to ensure that operators should be discouraged from "shopping around" in the EU for the competent authorities with the lightest licensing/registration regime.

    Database: the proposal seeks to establish a European Database on drug precursors 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 way as regards the processing of personal data. The Commission and the competent authorities shall take all necessary measures to ensure the security, confidentiality and accuracy of the information contained in the European Database. The rights of data subjects are protected in accordance with that Directive 95/46/EC.

    Exchange and processing of personal data: Regulation (EC) No 273/2004 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. Members consider that the processing of personal data should be carried out in accordance with Union law on data protection and, in particular, with 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. Data should be adequate, accurate, relevant and not excessive in relation to the purpose for which it is collected. It should not be processed for longer than necessary in relation to the purpose for which it is collected and its accuracy should be regularly reviewed.

    Operators shall not disclose personal data processed pursuant to this Regulation other than to the competent authorities.

    It is stipulated that a data subject shall be provided with information concerning the purposes of the processing and retention of data, the categories of data processed and retained, the identity of the controller of the data, the identity of the recipients of the data, information regarding the right of access, rectification or erasure of the data subject's personal data, the administrative and judicial remedies available and the contact details of the supervisory authority. Some or all of that specific information may be withheld only in so far as it would compromise administrative or judicial investigations or procedures, hamper the prevention, investigation, detection or prosecution of criminal offences or jeopardise public or national security.

    Data protection law, the various elements of processing personal data, including the exercise of rights by data subjects, must be specified in delegated acts.

    As regards the processing of data, this should be carried out under the supervision of the European Data Protection Supervisor, as regards the processing of personal data carried out by the Commission within the framework of Regulation (EC) No 273/2004.

    Access by law enforcement agencies to personal data: in order to enable law enforcement authorities to detect, prevent, investigate or prosecute drug trafficking criminal offences, Members call on Member States should to adopt legislative measures to grant their competent authorities access to personal data processed in so far as is necessary, proportionate and subject to adequate safeguards. Such processing should only take place on a case-by-case basis and provided that the competent law enforcement authorities have reasonable grounds for believing that it will substantially assist them in preventing, detecting, or investigating drug trafficking criminal offences.

    Delegated acts: the Commission shall be empowered to adopt delegated acts in respect of :

    • the categories of personal data to be processed for the purpose of the European Database,
    • the retention period for personal data processed,
    • the procedures by which data subjects can exercise their rights to access, rectify, erase and, where appropriate, object and block data.

    Before developing delegated acts, the Commission shall consult the European Data Protection Supervisor.

    Review: by 66 months after the date of entry into force of this Regulation (and not 78 as proposed by the commission), the Commission shall submit a report to the European Parliament and to the Council on the implementation and functioning of Regulation (EC) No 273/2004, and in particular on the possible need for additional action to monitor and control suspicious transactions with non-scheduled substances.

activities/7/date
Old
2013-10-08T00:00:00
New
2013-10-23T00:00:00
activities/6/docs/0/url
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2013-153&language=EN
procedure/legal_basis/0
Rules of Procedure of the European Parliament EP 138
activities/6/date
Old
2013-04-30T00:00:00
New
2013-05-15T00:00:00
activities/7
date
2013-10-08T00:00:00
body
EP
type
Indicative plenary sitting date, 1st reading/single reading
activities/1/committees/3/shadows/3
group
ECR
name
KIRKHOPE Timothy
activities/5/committees/3/shadows/3
group
ECR
name
KIRKHOPE Timothy
activities/6
date
2013-04-30T00:00:00
docs
type: Committee report tabled for plenary, 1st reading/single reading title: A7-0153/2013
body
EP
committees
type
Committee report tabled for plenary, 1st reading/single reading
committees/3/shadows/3
group
ECR
name
KIRKHOPE Timothy
activities/5
date
2013-04-24T00:00:00
body
EP
type
Vote in committee, 1st reading/single reading
committees
activities/2/docs/0/celexid
CELEX:52012AE2301:EN
activities/4/docs/0/url
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE506.184
activities/1/committees/3/shadows/1
group
ALDE
name
IN 'T VELD Sophia
activities/1/committees/3/shadows/2
group
Verts/ALE
name
KELLER Franziska
activities/1/committees/3/shadows/3
group
GUE/NGL
name
TRIANTAPHYLLIDES Kyriacos
committees/3/shadows/1
group
ALDE
name
IN 'T VELD Sophia
committees/3/shadows/2
group
Verts/ALE
name
KELLER Franziska
committees/3/shadows/3
group
GUE/NGL
name
TRIANTAPHYLLIDES Kyriacos
activities/4/date
Old
2013-03-01T00:00:00
New
2013-03-04T00:00:00
activities/4
date
2013-03-01T00:00:00
docs
type: Amendments tabled in committee title: PE506.184
body
EP
type
Amendments tabled in committee
activities/0/docs/0/text/0
Old

PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride, the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: drug precursors are chemical substances having a wide variety of licit uses, such as in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded for legitimate purposes on global markets, but some of them can also be diverted from the licit distribution channels for the illicit manufacture of narcotic drugs. Taking into account the wide legitimate uses of drug precursors, their trade cannot be prohibited. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The EU is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof.

In 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors, and recommended analysing ways to strengthen the control of the trade of acetic anhydride (scheduled substance in Category 2) in order to better prevent the diversion of acetic anhydride for the illicit production of heroin.

Heroin use accounts for the greatest share of morbidity and mortality-related drug use in the EU. Even though the quantities of acetic anhydride seized in the EU have decreased very substantially since 2008, certain reports consider that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade.

IMPACT ASSESSMENT: the main problem driver being the insufficient control by competent authorities over all economic players involved in the legitimate trade with drug precursors, all policy options examined seek to improve control via enhanced reporting, notification or registration obligations imposed on the economic players. The impacts of the following six policy options have been analysed:

  • Option 1 (baseline option): no action: the current EU legislation will remain unchanged;
  • Option 2: strengthened reporting obligations;
  • Option 3: strengthened rules and obligations on operators related to customer declarations from end-users;
  • Option 4: require operators to systematically notify new end-users to the authorities to allow verification;
  • Option 5: require registration for end-users and reinforce requirements regarding registration;
  • Option 6: move acetic anhydride from category 2 to category 1 scheduled substances.

Option 5 is the preferred option. The overall conclusion of the impact assessment was that both, Option 4 and Option 5 would be good choices, but Option 5 would be less burdensome than Option 4 in terms of annual costs for enterprises (provided authorities do not pass on all costs to registrants by imposing fees), an argument which is particular relevant for SMEs. All in all the strong political support which Option 5 has from most Member States, combined with views expressed on international level that a more systematic control of (all) acetic anhydride end-users is lacking in the European legislation, and the somewhat lower burden on SMEs tip the balance in favour of Option 5.

LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). 

CONTENT: this proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU- internal trade: in 2008, 75% of the global seizures of Acetic anhydride happened in the EU. Until now only EU companies producing or trading Acetic anhydride have to register with their national authorities.

The Commission proposes to:

·        extend the registration requirement, which so far applies only to operators placing Acetic anhydride on the market, to include users of the substance;

·        enhance the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures. More detailed rules on registration are introduced to ensure uniform conditions of registration in all Member States for scheduled substances in category 2 of Annex I. For substances scheduled in a new subcategory 2A of Annex I, not only operators but also users will be subject to a registration requirement.

By ensuring that operators and users engaged in the legal trade of drug precursors are subject to harmonised rules, the proposal will ensure a proper functioning of the Union market by avoiding unnecessary barriers to such legitimate trade and by reducing administrative burdens for operators and competent authorities.

Additionally the Commission proposes to establish and maintain a European Database on Drug Precursors in order to modernize the collection of the information provided by Member States on drug precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation (EC) No 273/2004, and to maintain a list of EU licensed or registered operators and users legally trading or using drug precursors, as well as to enable operators to provide competent authorities in summary form with information about their transactions involving scheduled substances in accordance with current Article 8 (2) of Regulation (EC) No 273/2004.

In addition, it should be noted that the proposal is:

·        subject to a notification to the WTO in the framework of the TBT Agreement;

·        relevant for the European Economic Area (EEA);

·        contains a transitional period for the coming into force of the new registration obligations for end-users of Acetic anhydride;

·        includes a review clause to assess whether the amended Regulation will have been effective to prevent the diversion of Acetic anhydride.

Annex: the proposal does not extend the provisions for acetic anhydride to other scheduled substances in category 2. Acetic anhydride, currently scheduled in category 2 of Annex I, will be included in a new subcategory 2A of Annex I to allow increased control of its trade. The remaining substances of category 2 will be listed as subcategory 2B.

BUDGETARY IMPLICATIONS: the proposal has no impact on the European Union budget because no additional resources are required to implement the action proposed. The necessary resources to implement the European database are already included in the allocations granted during the budget procedure and within the Internal Market line.

DELEGATED ACTS: the Commission shall have the power, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to adopt certain acts for which provision is made in the proposal.

New

PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride, the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: drug precursors are chemical substances having a wide variety of licit uses, such as in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded for legitimate purposes on global markets, but some of them can also be diverted from the licit distribution channels for the illicit manufacture of narcotic drugs. Taking into account the wide legitimate uses of drug precursors, their trade cannot be prohibited. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The EU is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof.

In 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors, and recommended analysing ways to strengthen the control of the trade of acetic anhydride (scheduled substance in Category 2) in order to better prevent the diversion of acetic anhydride for the illicit production of heroin.

Heroin use accounts for the greatest share of morbidity and mortality-related drug use in the EU. Even though the quantities of acetic anhydride seized in the EU have decreased very substantially since 2008, certain reports consider that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade.

IMPACT ASSESSMENT: the main problem driver being the insufficient control by competent authorities over all economic players involved in the legitimate trade with drug precursors, all policy options examined seek to improve control via enhanced reporting, notification or registration obligations imposed on the economic players. The impacts of the following six policy options have been analysed:

  • Option 1 (baseline option): no action: the current EU legislation will remain unchanged;
  • Option 2: strengthened reporting obligations;
  • Option 3: strengthened rules and obligations on operators related to customer declarations from end-users;
  • Option 4: require operators to systematically notify new end-users to the authorities to allow verification;
  • Option 5: require registration for end-users and reinforce requirements regarding registration;
  • Option 6: move acetic anhydride from category 2 to category 1 scheduled substances.

Option 5 is the preferred option. The overall conclusion of the impact assessment was that both, Option 4 and Option 5 would be good choices, but Option 5 would be less burdensome than Option 4 in terms of annual costs for enterprises (provided authorities do not pass on all costs to registrants by imposing fees), an argument which is particular relevant for SMEs. All in all the strong political support which Option 5 has from most Member States, combined with views expressed on international level that a more systematic control of (all) acetic anhydride end-users is lacking in the European legislation, and the somewhat lower burden on SMEs tip the balance in favour of Option 5.

LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). 

CONTENT: this proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU- internal trade: in 2008, 75% of the global seizures of Acetic anhydride happened in the EU. Until now only EU companies producing or trading Acetic anhydride have to register with their national authorities.

The Commission proposes to:

·        extend the registration requirement, which so far applies only to operators placing Acetic anhydride on the market, to include users of the substance;

·        enhance the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures. More detailed rules on registration are introduced to ensure uniform conditions of registration in all Member States for scheduled substances in category 2 of Annex I. For substances scheduled in a new subcategory 2A of Annex I, not only operators but also users will be subject to a registration requirement.

By ensuring that operators and users engaged in the legal trade of drug precursors are subject to harmonised rules, the proposal will ensure a proper functioning of the Union market by avoiding unnecessary barriers to such legitimate trade and by reducing administrative burdens for operators and competent authorities.

Additionally the Commission proposes to establish and maintain a European Database on Drug Precursors in order to modernize the collection of the information provided by Member States on drug precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation (EC) No 273/2004, and to maintain a list of EU licensed or registered operators and users legally trading or using drug precursors, as well as to enable operators to provide competent authorities in summary form with information about their transactions involving scheduled substances in accordance with current Article 8 (2) of Regulation (EC) No 273/2004.

In addition, it should be noted that the proposal is:

·        subject to a notification to the WTO in the framework of the TBT Agreement;

·        relevant for the European Economic Area (EEA);

·        contains a transitional period for the coming into force of the new registration obligations for end-users of Acetic anhydride;

·        includes a review clause to assess whether the amended Regulation will have been effective to prevent the diversion of Acetic anhydride.

Annex: the proposal does not extend the provisions for acetic anhydride to other scheduled substances in category 2. Acetic anhydride, currently scheduled in category 2 of Annex I, will be included in a new subcategory 2A of Annex I to allow increased control of its trade. The remaining substances of category 2 will be listed as subcategory 2B.

BUDGETARY IMPLICATIONS: the proposal has no impact on the European Union budget because no additional resources are required to implement the action proposed. The necessary resources to implement the European database are already included in the allocations granted during the budget procedure and within the Internal Market line.

DELEGATED ACTS: the Commission shall have the power, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to adopt certain acts for which provision is made in the proposal.

activities/3/docs/0/url
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE504.107
procedure/Mandatory consultation of other institutions
Economic and Social Committee
activities/3
date
2013-02-06T00:00:00
docs
type: Committee draft report title: PE504.107
body
EP
type
Committee draft report
procedure/type
Old
COD - Ordinary legislative procedure (ex-codecision)
New
COD - Ordinary legislative procedure (ex-codecision procedure)
activities/2/docs/0/url
http://eescopinions.eesc.europa.eu/eescopiniondocument.aspx?language=EN&docnr=2301&year=2012
activities/2
date
2013-01-16T00:00:00
docs
type: Economic and Social Committee: opinion, report title: CES2301/2012
body
ESOC
type
Economic and Social Committee: opinion, report
activities/0
body
EP
date
2012-09-27T00:00:00
type
EP officialisation
activities/2/committees/3/date
2012-12-10T00:00:00
activities/2/committees/3/rapporteur
  • group: S&D name: HEDH Anna
committees/3/date
2012-12-10T00:00:00
committees/3/rapporteur
  • group: S&D name: HEDH Anna
activities/1/docs/0/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=548
New
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0548/COM_COM(2012)0548_EN.pdf
activities/2/committees/3/shadows
  • group: EPP name: PIRKER Hubert
committees/3/shadows
  • group: EPP name: PIRKER Hubert
activities/1/docs/0/text
  • PURPOSE: to prevent the diversion from the EU-internal trade of acetic anhydride, the main drug precursor for heroin, by extending the registration requirement to include users of the substance, and amending Regulation (EC) No 273/2004 on drug precursors

    PROPOSED ACT: Regulation of the European Parliament and of the Council.

    BACKGROUND: drug precursors are chemical substances having a wide variety of licit uses, such as in the synthesis of plastics, pharmaceuticals, cosmetics, perfumes, detergents, or aromas. They are traded for legitimate purposes on global markets, but some of them can also be diverted from the licit distribution channels for the illicit manufacture of narcotic drugs. Taking into account the wide legitimate uses of drug precursors, their trade cannot be prohibited. However, in order to prevent their diversion to illicit drug production, a specific regulatory framework has been set up on international level through Article 12 of the United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The EU is a Party to the Convention and has implemented its obligations through Regulation (EC) No 273/2004 governing the monitoring of the intra-EU trade in drug precursors and Regulation (EC) No 111/2005 governing the external trade. The Union regulatory framework provides for the monitoring and control of the legitimate trade in drug precursors. Operators, i.e. manufacturers, distributors, brokers, importers, exporters and wholesalers of chemicals engaged in the legitimate trade of drug precursors are required to take measures against theft, check their customers, detect suspicious transactions and notify the authorities thereof.

    In 2010, the European Commission adopted a Report on the implementation and functioning of the existing EU legislation on drug precursors, and recommended analysing ways to strengthen the control of the trade of acetic anhydride (scheduled substance in Category 2) in order to better prevent the diversion of acetic anhydride for the illicit production of heroin.

    Heroin use accounts for the greatest share of morbidity and mortality-related drug use in the EU. Even though the quantities of acetic anhydride seized in the EU have decreased very substantially since 2008, certain reports consider that the European legislative control measures are not sufficiently strict to prevent the diversion of the main heroin precursor from the intra-EU trade.

    IMPACT ASSESSMENT: the main problem driver being the insufficient control by competent authorities over all economic players involved in the legitimate trade with drug precursors, all policy options examined seek to improve control via enhanced reporting, notification or registration obligations imposed on the economic players. The impacts of the following six policy options have been analysed:

    • Option 1 (baseline option): no action: the current EU legislation will remain unchanged;
    • Option 2: strengthened reporting obligations;
    • Option 3: strengthened rules and obligations on operators related to customer declarations from end-users;
    • Option 4: require operators to systematically notify new end-users to the authorities to allow verification;
    • Option 5: require registration for end-users and reinforce requirements regarding registration;
    • Option 6: move acetic anhydride from category 2 to category 1 scheduled substances.

    Option 5 is the preferred option. The overall conclusion of the impact assessment was that both, Option 4 and Option 5 would be good choices, but Option 5 would be less burdensome than Option 4 in terms of annual costs for enterprises (provided authorities do not pass on all costs to registrants by imposing fees), an argument which is particular relevant for SMEs. All in all the strong political support which Option 5 has from most Member States, combined with views expressed on international level that a more systematic control of (all) acetic anhydride end-users is lacking in the European legislation, and the somewhat lower burden on SMEs tip the balance in favour of Option 5.

    LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union (TFEU). 

    CONTENT: this proposal aims to address a specific weakness which has been detected in the European Union, when large quantities of acetic anhydride ("AA"), the main drug precursor for heroin, were diverted from the EU- internal trade: in 2008, 75% of the global seizures of Acetic anhydride happened in the EU. Until now only EU companies producing or trading Acetic anhydride have to register with their national authorities.

    The Commission proposes to:

    ·        extend the registration requirement, which so far applies only to operators placing Acetic anhydride on the market, to include users of the substance;

    ·        enhance the harmonised registration provisions to achieve a more robust level playing field preserving the internal market and avoiding adoption of divergent national measures. More detailed rules on registration are introduced to ensure uniform conditions of registration in all Member States for scheduled substances in category 2 of Annex I. For substances scheduled in a new subcategory 2A of Annex I, not only operators but also users will be subject to a registration requirement.

    By ensuring that operators and users engaged in the legal trade of drug precursors are subject to harmonised rules, the proposal will ensure a proper functioning of the Union market by avoiding unnecessary barriers to such legitimate trade and by reducing administrative burdens for operators and competent authorities.

    Additionally the Commission proposes to establish and maintain a European Database on Drug Precursors in order to modernize the collection of the information provided by Member States on drug precursor seizures and stopped shipments, in accordance with current Article 13 of Regulation (EC) No 273/2004, and to maintain a list of EU licensed or registered operators and users legally trading or using drug precursors, as well as to enable operators to provide competent authorities in summary form with information about their transactions involving scheduled substances in accordance with current Article 8 (2) of Regulation (EC) No 273/2004.

    In addition, it should be noted that the proposal is:

    ·        subject to a notification to the WTO in the framework of the TBT Agreement;

    ·        relevant for the European Economic Area (EEA);

    ·        contains a transitional period for the coming into force of the new registration obligations for end-users of Acetic anhydride;

    ·        includes a review clause to assess whether the amended Regulation will have been effective to prevent the diversion of Acetic anhydride.

    Annex: the proposal does not extend the provisions for acetic anhydride to other scheduled substances in category 2. Acetic anhydride, currently scheduled in category 2 of Annex I, will be included in a new subcategory 2A of Annex I to allow increased control of its trade. The remaining substances of category 2 will be listed as subcategory 2B.

    BUDGETARY IMPLICATIONS: the proposal has no impact on the European Union budget because no additional resources are required to implement the action proposed. The necessary resources to implement the European database are already included in the allocations granted during the budget procedure and within the Internal Market line.

    DELEGATED ACTS: the Commission shall have the power, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to adopt certain acts for which provision is made in the proposal.

activities/2
date
2012-10-22T00:00:00
body
EP
type
Committee referral announced in Parliament, 1st reading/single reading
committees
procedure/dossier_of_the_committee
LIBE/7/10801
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting Parliament 1st reading / single reading / budget 1st stage
activities
  • body: EP date: 2012-09-27T00:00:00 type: EP officialisation
  • date: 2012-09-27T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=548 title: COM(2012)0548 type: Legislative proposal published celexid: CELEX:52012PC0548:EN url: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0278:FIN:EN:PDF type: Document attached to the procedure title: SWD(2012)0278 url: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0279:FIN:EN:PDF type: Document attached to the procedure title: SWD(2012)0279 type: Legislative proposal body: EC commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: TAJANI Antonio
committees
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: International Trade committee: INTA
  • body: EP responsible: True committee_full: Civil Liberties, Justice and Home Affairs committee: LIBE
links
National parliaments
European Commission
other
  • body: EC dg: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry commissioner: TAJANI Antonio
procedure
reference
2012/0261(COD)
instrument
Regulation
legal_basis
Treaty on the Functioning of the EU TFEU 114-p1
stage_reached
Preparatory phase in Parliament
summary
Amending Regulation (EC) No 273/2004
subtype
Legislation
title
Monitoring intra-EU trade in drug precursors
type
COD - Ordinary legislative procedure (ex-codecision)
subject