REPORT on the proposal for a directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to making available on the market of measuring instruments (recast)
9.1.2013 - (COM(2011)0769 – C7‑0422/2011 – 2011/0353(COD)) - ***I
Committee on the Internal Market and Consumer Protection
Rapporteur: Zuzana Roithová
(Recast – Rule 87 of the Rules of Procedure)
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
on the proposal for a directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to making available on the market of measuring instruments (recast)
(COM(2011)0769 – C7‑0422/2011 – 2011/0353(COD))
(Ordinary legislative procedure – recast)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council (COM(2011)0769),
– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0422/2011),
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to the opinion of the European Economic and Social Committee of 28 March 2012[1],
– having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts[2],
– having regard to the letter of 6 November 2012 from the Committee on Legal Affairs to the Committee on the Internal Market and Consumer Protection in accordance with Rule 87(3) of its Rules of Procedure,
– having regard to Rules 87 and 55 of its Rules of Procedure,
– having regard to the report of the Committee on the Internal Market and Consumer Protection (A7-0376/2012),
A. whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;
1. Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;
2. Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;
3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Amendment 1 Proposal for a directive Recital 21 a (new) | |
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Text proposed by the Commission |
Amendment |
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(21a) All obligations imposed on economic operators by this Directive should also apply in the case of distance selling. |
Amendment 2 Proposal for a directive Recital 28 a (new) | |
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Text proposed by the Commission |
Amendment |
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(28a) When issuing a single EU declaration of conformity could cause specific problems due to the complexity or scope of that single EU declaration, it should be possible to replace that single EU declaration by individual EU declarations of conformity relevant for the particular measuring instrument. |
Amendment 3 Proposal for a directive Recital 46 | |
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Text proposed by the Commission |
Amendment |
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(46) It is necessary to provide for transitional arrangements that allow making available on the market and putting into use measuring instruments that have already been placed on the market in accordance with Directive 2004/22/EC. |
(46) It is necessary to provide for transitional arrangements that allow economic operators a reasonable period of time to make available on the market and put into service measuring instruments that have already been placed on the market in accordance with Directive 2004/22/EC. Economic operators should be able to sell stocks of measuring instruments that are already in the distribution chain on the date of application of national measures transposing this Directive. |
Amendment 4 Proposal for a directive Article 4 – point 2 | |
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Text proposed by the Commission |
Amendment |
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(2) ‘sub-assembly’ means a hardware device, mentioned as such in the specific annexes, that functions independently and makes up a measuring instrument together with other sub-assemblies with which it is compatible, or with a measuring instrument with which it is compatible; |
(2) ‘sub-assembly’ means a hardware device, mentioned as such in the instrument-specific annexes, that functions independently and makes up a measuring instrument together with other sub-assemblies with which it is compatible, or with a measuring instrument with which it is compatible; |
Amendment 5 Proposal for a directive Article 4 – point 7 | |
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Text proposed by the Commission |
Amendment |
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(7) ‘putting into use’ means the first use of an instrument intended for the end user for the purposes for which it was intended; |
(7) ‘putting into use’ means the first use of a measuring instrument intended for the end user for the purposes for which it was intended; |
Amendment 6 Proposal for a directive Article 4 – point 5 | |
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Text proposed by the Commission |
Amendment |
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(5) ’placing on the market' means the first making available of a measuring instrument on the Union market |
(5) 'making available on the market' means the supply of a measuring instrument for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; |
Amendment 7 Proposal for a directive Article 4 – point 6 | |
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Text proposed by the Commission |
Amendment |
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(6) ‘making available on the market’ means any supply of a measuring instrument for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; |
(6) 'placing on the market' means the first making available of a measuring instrument on the Union market; |
Amendment 8 Proposal for a directive Article 4 – point 12 | |
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Text proposed by the Commission |
Amendment |
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(12) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; |
(12) ‘economic operators’ means a manufacturer, an authorised representative, an importer or a distributor; |
Amendment 9 Proposal for a directive Article 4 – point 14 | |
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Text proposed by the Commission |
Amendment |
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(14) ‘harmonised standard’ means harmonised standard as defined in Article 2(1)(c) of Regulation (EU) No […/…] [on European Standardisation] ; |
(14) ‘harmonised standard’ means standard as defined in Article 2(1)(c) of Regulation (EU) No […/…] [on European Standardisation] ; |
Amendment 10 Proposal for a directive Article 5 – paragraph 1 | |
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Text proposed by the Commission |
Amendment |
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Where specific annexes exist, laying down the essential requirements for sub-assemblies, this Directive shall apply mutatis mutandis to such sub-assemblies. |
Where instrument-specific annexes exist, laying down the essential requirements for sub-assemblies, this Directive shall apply mutatis mutandis to such sub-assemblies. |
Amendment 11 Proposal for a directive Article 6 – title | |
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Text proposed by the Commission |
Amendment |
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Essential requirements and assessment of conformity |
Essential requirements |
Amendment 12 Proposal for a directive Article 8 – paragraph 5 | |
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Text proposed by the Commission |
Amendment |
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5. Manufacturers shall ensure that their measuring instruments bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the measuring instrument does not allow it, that the required information is provided on the packaging or in a document accompanying the measuring instrument. |
5. Manufacturers shall ensure that their measuring instruments bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the measuring instrument does not allow it, that the required information is provided on the packaging or in a document accompanying the measuring instrument in accordance with point 9.2 of Annex I. |
Amendment 13 Proposal for a directive Article 8 – paragraph 6 | |
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Text proposed by the Commission |
Amendment |
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6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the measuring instrument or, where that is not possible, on its packaging or in a document accompanying the measuring instrument. The address must indicate a single point at which the manufacturer can be contacted. |
6. Manufacturers shall indicate, on the measuring instrument, their name, registered trade name or registered trade mark and the postal or, if available, the website address at which they can be contacted or, where that is not reasonably possible, those details shall be provided on the packaging or in a document accompanying the measuring instrument in accordance with point 9.2 of Annex I. The address must indicate a single point at which the manufacturer can be contacted. The contact details shall be in the language easily understood by end-users and market surveillance authorities. |
Amendment 14 Proposal for a directive Article 8 – paragraph 7 | |
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Text proposed by the Commission |
Amendment |
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7. Manufacturers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end-users, as determined by the Member State concerned. |
7. Manufacturers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end-users, as determined by the Member State concerned. Such instructions and safety information as well as any labelling shall be clear, understandable and intelligible. |
Amendment 15 Proposal for a directive Article 10 – paragraph 3 | |
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Text proposed by the Commission |
Amendment |
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3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the measuring instrument or, where that is not possible, on its packaging or in a document accompanying the measuring instrument in accordance with point 9.2 of Annex I. |
3. Importers shall indicate, on the measuring instrument, their name, registered trade name or registered trade mark, and the postal or, if available, the website address at which they can be contacted or, where that is not reasonably possible, on its packaging or in a document accompanying the measuring instrument in accordance with point 9.2 of Annex I. The contact details shall be in the language easily understood by end-users and market surveillance authorities. |
Amendment 16 Proposal for a directive Article 10 – paragraph 4 | |
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Text proposed by the Commission |
Amendment |
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4. Importers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end-users, as determined by the Member State concerned. |
4. Importers shall ensure that the measuring instrument is accompanied by the required documentation, and by instructions and information in accordance with point 9.3 of Annex I, in a language which can be easily understood by end-users, as determined by the Member State concerned. |
Amendment 17 Proposal for a directive Article 11 – paragraph 5 a (new) | |
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Text proposed by the Commission |
Amendment |
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5a. Member States shall ensure that measuring instrument which was lawfully placed on the market before [the date set out in the second subparagraph of Article 51(1)] may be made available on the market by distributors without further product requirements. |
Amendment 18 Proposal for a directive Article 13 – paragraph 1 – introductory part | |
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Text proposed by the Commission |
Amendment |
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Economic operators shall, on request, identify the following to the market surveillance authorities, for 10 years: |
Economic operators shall, on request, specify the following to the market surveillance authorities, for 10 years: |
Amendment 19 Proposal for a directive Article 13 – paragraph 2 | |
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Text proposed by the Commission |
Amendment |
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Economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the measuring instrument and for a period of 10 years after they have supplied the measuring instrument. |
Economic operators shall present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the measuring instrument and for a period of 10 years after they have supplied the measuring instrument. Economic operators shall not be required to update that information after supply is finalised. |
Amendment 20 Proposal for a directive Article 13 a (new) | |
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Text proposed by the Commission |
Amendment |
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Article 13a |
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Obligation of economic operators concerning the products in stock |
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Member States shall ensure that the obligations of economic operators concerning the products in stock are applied in accordance with Article 50. |
Amendment 21 Proposal for a directive Article 16 – paragraph 1 – introductory part | |
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Text proposed by the Commission |
Amendment |
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1. Where a normative document satisfies the requirements which it covers and which are set out in Annex I and in the relevant instrument specific Annexes, the Commission may. |
1. On request by a Member State or on its own initiative, the Commission shall, where appropriate. |
Amendment 22 Proposal for a directive Article 16 – paragraph 1 – subparagraph 1 | |
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Text proposed by the Commission |
Amendment |
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publish the reference of that normative document in the Official Journal of the European Union. |
deleted |
Amendment 23 Proposal for a directive Article 16 – paragraph 1 – point a (new) | |
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Text proposed by the Commission |
Amendment |
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(a) identify normative documents and, in a list, indicate the parts thereof that satisfy the requirements which they cover and which are set out in Annex I and in the relevant instrument-specific annexes; |
Amendment 24 Proposal for a directive Article 16 – paragraph 1 – point b (new) | |
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Text proposed by the Commission |
Amendment |
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(b) publish the reference of that normative document in the Official Journal of the European Union. |
Amendment 25 Proposal for a directive Article 20 – paragraph 2 | |
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Text proposed by the Commission |
Amendment |
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2. The EU declaration of conformity shall have the model structure set out in Annex III of Decision No 768/2008/EC, shall contain the elements specified in the relevant modules set out in Annex II to this Directive and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which market the measuring instrument is placed or made available. |
2. The EU declaration of conformity shall have the model structure set out in Annex III of Decision No 768/2008/EC, shall contain the elements specified in the relevant modules set out in Annex II to this Directive and shall be continuously updated. Upon the request of the market surveillance authorities, the economic operator shall provide a copy of the EU declaration of conformity in paper form or by electronic means, and shall ensure that it is translated into the language or languages required by the Member States in which market the measuring instrument is placed or made available. |
Amendment 26 Proposal for a directive Article 20 – paragraph 4 | |
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Text proposed by the Commission |
Amendment |
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4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the measuring instrument. |
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the measuring instrument with the requirements laid down this Directive. |
Amendment 27 Proposal for a directive Article 22 – paragraph 2 a (new) | |
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Text proposed by the Commission |
Amendment |
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The general principles set out in Article 30 of Regulation (EC) No 765/2008 shall apply, mutatis mutandis, to the supplementary metrology marking. |
Amendment 28 Proposal for a directive Article 24 – paragraph 1 | |
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Text proposed by the Commission |
Amendment |
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1. Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive. That notification shall include information on the kind(s) of measuring instrument(s) for which each body has been designated and, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification. |
1. Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive. |
Amendment 29 Proposal for a directive Article 25 – paragraph 1 | |
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Text proposed by the Commission |
Amendment |
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1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 30. |
1. Member States shall designate a single notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 30. |
Amendment 30 Proposal for a directive Article 32 – paragraph 3 | |
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Text proposed by the Commission |
Amendment |
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3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and measuring instrument or measuring instruments concerned and the relevant attestation of competence. |
3. The notification shall include information on the kinds of measuring instruments for which each body has been designated and, where relevant, the instrument accuracy classes, the measuring range, the measurement technology, and any other instrument characteristic limiting the scope of the notification. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and measuring instrument or measuring instruments concerned and the relevant attestation of competence. |
Amendment 31 Proposal for a directive Article 41 – paragraph 1 a (new) | |
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Text proposed by the Commission |
Amendment |
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Member States shall provide the Commission annually with details of the activities of their market surveillance authorities and of any plans for and increase of market surveillance, including the allocation of more resources, the increase of efficiency and the building of the necessary capacity for achieving those goals. |
Amendment 32 Proposal for a directive Article 41 a (new) | |
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Text proposed by the Commission |
Amendment |
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Article 41a |
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Funding of market surveillance authorities |
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Member States shall provide adequate funding to their market surveillance authorities in order to ensure that their activities are coherent and effective across the Union. |
Amendment 33 Proposal for a directive Article 42 – paragraph 1 – subparagraph 1 | |
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Text proposed by the Commission |
Amendment |
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1. Where the market surveillance authorities of one Member State have taken action pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason to believe that a measuring instrument covered by this Directive presents a risk to the aspects of public interest protection covered by this Directive, they shall carry out an evaluation in relation to the measuring instrument concerned covering all the requirements laid down in this Directive. The relevant economic operators shall cooperate as necessary with the market surveillance authorities. |
1. Where the market surveillance authorities of one Member State have taken action pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason to believe that a measuring instrument covered by this Directive presents a risk to the aspects of public interest protection covered by this Directive, they shall carry out an evaluation in relation to the measuring instrument concerned covering all the relevant requirements laid down in this Directive. The relevant economic operators shall cooperate as necessary with the market surveillance authorities. |
Amendment 34 Proposal for a directive Article 42 – paragraph 4 – subparagraph 1 | |
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Text proposed by the Commission |
Amendment |
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4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit the measuring instrument's being made available on their national market, to withdraw the measuring instrument from that market or to recall it. |
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the measuring instrument's being made available on their national market, to withdraw the measuring instrument from that market or to recall it. |
Amendment 35 Proposal for a directive Article 42 – paragraph 8 | |
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Text proposed by the Commission |
Amendment |
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8. Member States shall ensure that appropriate restrictive measures are taken in respect of the measuring instrument concerned. |
8. Member States shall ensure that appropriate restrictive measures are taken in respect of the measuring instrument concerned, such as withdrawal of the measuring instrument from the market, without delay. |
Amendment 36 Proposal for a directive Article 48 – paragraph 5 | |
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Text proposed by the Commission |
Amendment |
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5. A delegated act adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council. |
5. A delegated act adopted pursuant to Article 47 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council. |
Amendment 37 Proposal for a directive Article 49 – paragraph 1 | |
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Text proposed by the Commission |
Amendment |
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Member States shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. |
Member States shall build upon existing mechanism to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of the marking. Member States shall lay down rules on penalties applicable to infringements by economic operators of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules may include criminal penalties for serious infringements. |
Amendment 38 Proposal for a directive Article 49 – paragraph 2 | |
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Text proposed by the Commission |
Amendment |
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The penalties provided for shall be effective, proportionate and dissuasive. |
The penalties referred to in the first paragraph shall be effective, proportionate to the seriousness of the offence, and dissuasive. |
Amendment 39 Proposal for a directive Article 49 – paragraph 3 | |
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Text proposed by the Commission |
Amendment |
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Member States shall notify those provisions to the Commission by [the date set out in the second subparagraph of Article 51] at the latest and shall notify to it without delay any subsequent amendment affecting them. |
Member States shall notify those provisions to the Commission by [the date set out in the second subparagraph of Article 51] and shall notify to it without delay any subsequent amendment affecting them. The Commission shall make those provisions publicly available by publishing them on the internet. |
Amendment 40 Proposal for a directive Article 51 – paragraph 1 – subparagraph 1 | |
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Text proposed by the Commission |
Amendment |
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Member States shall adopt and publish by [insert date – 2 years after adoption] at the latest the laws, regulations and administrative provisions necessary to comply with Articles 4(5) to (22), 8, 9, 10, 11, 13, 14, [15], 20, 22, 23(1), 23(3), 23(5), 23(6), 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 49, 50 and Annex II. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. |
Member States shall adopt and publish by [insert date – three years after adoption] at the latest the laws, regulations and administrative provisions necessary to comply with Articles 4(5) to (22), 8, 9, 10, 11, 13, 14, [15], 20, 22, 23(1), 23(3), 23(5), 23(6), 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 49, 50 and Annex II. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. |
Amendment 41 Proposal for a directive Article 51 – paragraph 2 | |
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Text proposed by the Commission |
Amendment |
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2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. |
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. The Commission shall make those texts publicly available by publishing them on the internet. |
Amendment 42 Proposal for a directive Annex I – point 9 – point 9.2 | |
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Text proposed by the Commission |
Amendment |
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9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of this Directive suitably marked. |
9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, or the accompanying documents required by the provisions of this Directive suitably marked. |
Amendment 43 Proposal for a directive Annex II – part 2 – module A2 – point 4 – paragraph 1 | |
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Text proposed by the Commission |
Amendment |
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A notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out in appropriate intervals determined by the body , in order to verify the quality of the internal checks of the instrument , taking into account inter alia the technological complexity of the instruments and the quantity of production. An adequate sample of the final measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard, normative document and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the instruments with the relevant requirements of this Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. |
An accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out in appropriate intervals determined by the body, in order to verify the quality of the internal checks of the instrument, taking into account inter alia the technological complexity of the instruments and the quantity of production. An adequate sample of the final measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard, normative document and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the instruments with the relevant requirements of this Directive. In the absence of a relevant document, the notified body concerned shall decide on the appropriate tests to be carried out. |
Amendment 44 Proposal for a directive Annex II – part 5 – module C2 – point 3 – paragraph 1 | |
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Text proposed by the Commission |
Amendment |
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A notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out in appropriate intervals determined by the body , in order to verify the quality of the internal checks on the instrument , taking into account inter alia the technological complexity of the measuring instruments and the quantity of production. An adequate sample of the final measuring instrument, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant parts of the harmonised standards, normative documents and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the instrument with the type as described in the EU-type examination certificate and relevant requirements of this Directive. |
An accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out in appropriate intervals determined by the body, in order to verify the quality of the internal checks on the instrument, taking into account inter alia the technological complexity of the measuring instruments and the quantity of production. An adequate sample of the final measuring instrument, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant parts of the harmonised standards, normative documents and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the instrument with the type as described in the EU-type examination certificate and relevant requirements of this Directive. |
EXPLANATORY STATEMENT
Background
This report brings modifications to a proposal of the European Commission recasting Directive 2004/22/EC on the harmonisation of the laws of the Member States relating to measuring instruments. It has been presented in November 2011 in the framework of the implementation of the New Legislative Framework (NLF) adopted in 2008 as "the goods package" covering the complementary instruments, Decision 768/2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC and Regulation 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. The present proposal is part of a package, aligning nine product directives to the NLF.
The existing Directive 2004/22/EC on measuring instruments sets out essential requirements and selects the appropriate conformity assessment procedures which manufactures have to apply in order to demonstrate that their products comply with these essential requirements, before they are made available on the EU market.
The NLF was adopted to remedy shortcomings in existing Union harmonisation legislation in order to complete the Single Market, with fair competition and safe products. Inconsistent implementation and enforcement in the Member States of the existing Union harmonisation, together with complex regulation, has made it increasingly difficult for both economic operators and authorities to correctly interpret and apply legislation, which lead to unequal market conditions and also unsafe products placed on the market. "The goods package" gives the overall framework to streamline product legislation, in order to make it more uniform and comprehensible for both economic operators and market surveillance authorities. However, the provisions of the NLF Decision are not directly applicable. To ensure that all economic sectors subject to Union harmonisation legislation benefit from the improvements of the NLF, the provisions of the NLF Decision need to be integrated into the existing product legislation.
After the adoption of the legal framework in NLF in 2008 the Commission has started an evaluation process on harmonised European product legislation in order to identify instruments to be revised in order to implement the NLF.
A number of directives have been identified here while they will need revision within the next 3 - 5 years due to revision clauses or for sector specific reasons (need to clarify scope, need to up-date safety requirements, etc.). The vast majority of the existing European product legislation will need revision for these reasons and will be dealt with individually according to the Commission work programme.
The 9 proposals in the package presented in November 2011, including Directive 2004/22/EC are not part of the first mentioned group of product directives, but have been identified as suitable for an alignment with the NLF due to their common structure. The sectors covered by the directives are all very important industrial sectors which are subject to a strong international competition, and the assessments are, that those industries will benefit from the simplification and creation of a level playing field for European companies targeted by the NLF.
The changes made to the provisions of this Directive concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the Declaration of Conformity (DoC), CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. The intention of the proposal is restricted to a pure alignment with the horizontal provisions in 768/2008/EC and the new terminology within the Lisbon Treaty, including new rules on comitology.
Procedure
The alignment to the NLF Decision requires a number of substantive amendments to the provisions of this Directive. The technique of recasting has been chosen in line with the Interinstitutional Agreement of 28 November 2001.
Pursuant to Rule 87 of the Rules of Procedure of the European Parliament, the committee responsible for legal affairs has examined the proposal, based on the reports from the Consultative Working Party (legal services of the Parliament, the Council and the Commission), and considered that it entails no substantive changes other than those identified as such in the proposal or those indentified by the CWP.
Rapporteur's Position
Your Rapporteur considers this alignment of nine product directives with the NLF, as an important step towards the completion of the EU single market.
The NLF introduces a simplified regulatory environment for products and allows more consistent implementation of technical norms, which will help improving the functioning of the single market, by ensuring equal treatment of non-compliant products and of economic operators, as well as an equal assessment of notified bodies throughout the EU market.
It is your Rapporteur's opinion, that an alignment of the 9 product directives with the NLF will increase the confidence of both producers and consumers, by clarifying obligations for economic operators and provide Member States authorities with more effective tools to carry out market surveillance controls, all leading to a reduction of non-compliant and unsafe products on the market.
The Commission's proposals in the alignment package are based on a broad stakeholder consultation, including several hundreds of SMEs and their experiences with the Goods package, which is much appreciated by the Rapporteur.
Your Rapporteur supports the Commission's general intention of a pure alignment of the 9 product directives with the horizontal measures in Decision 768/2008, but would nevertheless suggest some changes to Directive 2004/22/EC on measuring instruments for further clarification and sectoral adjustments with the following objectives:
1. Further Align the Directive to the NLF and Ensure Legal Certainty
Your Rapporteur considers important to bring a number of changes to the proposed Directive in order to reach a higher level of consistency with the terms used by the Decision No 768/2008/EC and eliminate the possible inconsistencies in the text which could otherwise create legal uncertainty.
It is also important to clarify the legal situation for products which have been legally placed on the market in compliance with the current Directive before the new Directive applies, but which are still in stock. The non-retroactive nature of EU legislation should be emphasized and it should be clarified that these products can still be made available on the market after the date of application of the new Directive.
In addition, your Rapporteur considers that the Commission should have the obligation to publish on the Internet the national provisions of transposed Directive and relevant sanctions (principle of transparency).
2. Enhance Consumer Protection
The NLF contributes to increase consumer confidence in the single market. Therefore a number of modifications are also linked to your Rapporteur's objective to take full benefit of the NLF provisions related to consumer protection. In that respect, some amendments would allow the new directive to cover a wider scope of situations which fall under the essential safety requirements, when also the use reasonably foreseen should be taken in consideration during the design phase of the product (cf. article 16 on general requirements of regulation 765/2008). Consumer protection would also be deepened by precising that instructions, safety information and labelling must be reliable, understandable and transparent.
3. Cut Down Red Tape
The NLF should contribute to improving the free movement of goods within the European Union. However, a cumbersome bureaucracy would prevent the free flow of goods. Therefore, your Rapporteur has scrutinised the proposed Directive in order to cut-down red tape wherever possible. Thus, it is proposed in the report to modernise the current procedures by allowing the EU DoC to be supplied not only in paper form, but also through the electronic means and to bring down the red tape for economic operators regarding the identification of economic operators.
As expressed earlier, the Rapporteur supports the simplification and modernisation of procedures provided in the NLF, but wants to underline at the same time that a need for flexibility can be necessary regarding some obligations created by the new framework. For instance, it is proposed to add an exception to the rule on 'one single DoC' for cases where the providing a single document creates specific problems due to its complexity or extent. Here it should be possible to provide all relevant DoCs separately.
Higher flexibility is allowed to what concerns the single EU DoC, which as the rule coming from the Article 5 of the Decision is supplemented by an exception for the cases which create specific problems due to its complexity or extent.
4. Ensure a Better Market Surveillance for our Products
Even if the Rapporteur is aware of the forthcoming new regulation on market surveillance prepared by the Commission's services, the last set of changes is focusing on ensuring a higher level of market surveillance of products. To this end, your Rapporteur proposes to increase the market surveillance in distance selling through ensuring that all relevant information requirements are also displayed in electronic commerce, to establish an annual information requirement of Member States to the Commission about their market surveillance activities, to call on the Member States to provide the adequate funding to their market surveillance authorities. Finally, the Rapporteur stressed the need for appropriate actions to be taken by the Member States against improper use of CE marking.
Sectoral changes are also introduced by the Rapporteur on this text. In order to clarify the manufacturers right to use accredited in-house conformity assessment bodies under module A1, A2, C1 and Ca2, which were introduced by Decision 768/2008/EC and have been the practice for manufacturers of measuring instruments since, this is now explicitly included in the text of annex 2, part 2 and part 5.
ANNEX: OPINION OF THE CONSULTATIVE WORKING PARTY OF THE LEGAL SERVICES OF THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE COMMISSION
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CONSULTATIVE WORKING PARTY OF THE LEGAL SERVICES |
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Brussels, 8 October 2012
OPINION
FOR THE ATTENTION OF THE EUROPEAN PARLIAMENT
THE COUNCIL
THE COMMISSION
Proposal for a directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to making available on the market of measuring instruments
COM(2011) 769 of 21.11.2011 – 2011/0353(COD)
Having regard to the Inter-institutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts, and in particular to point 9 thereof, the Consultative Working Party consisting of the respective legal services of the European Parliament, the Council and the Commission met on 13 February, 24 May and 5 July 2012 for the purpose of examining, among others, the aforementioned proposal submitted by the Commission.
At those meetings[1], an examination of the proposal for a directive of the European Parliament and of the Council recasting Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments resulted in the Consultative Working Party’s establishing, by common accord, as follows.
1) As far as the explanatory memorandum is concerned, in order to be drafted in full compliance with the relevant requirements laid down by the Inter-institutional Agreement such a document should have specified which provisions of the earlier act remain unchanged in the proposal, as is provided for under point 6(a)(iii) of that agreement.
2) In the recast text, the following should have been identified by using the grey-shaded type generally used for marking substantive changes:
- in Article 17, first paragraph, the proposed deletion of the words "that Member State or", currently contained in Article 16(3), first paragraph, of Directive 2004/22/EC;
- in Article 43(4), the proposed replacement of the final words "after consulting the parties concerned, bring the matter as soon as possible before the appropriate Committee referred to in Articles 14 or 15" with the words "apply the procedure provided for in Article 17";
- the entire text of paragraph 2 of Article 46;
- in Article 51(1), first subparagraph, the words "Articles 4(5) to (22), 8, 9, 10, 11, 13, 14, [15], 20, 22, 23(1), 23(3), 23(5), 23(6), 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 49, 50 and Annex II", as well as the entire text of the final sentence which reads as follows: "They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive";
- in Article 51(1), second subparagraph, the words "from [day after the date set out in the first subparagraph]";
- in points 2.2, 3.3, second subparagraph, third indent, 7.2, 9.2, 11.2, first subparagraph, and 12.2, first subparagraph, of Annex II, the wording "The technical documentation shall specify the applicable requirements";
- in points 3.3, second subparagraph, third indent, 7.2, 9.2, 11.2, first subparagraph, 12.2, first subparagraph, and 14.4.2, second subparagraph, third indent, of Annex II, the words "and shall include an adequate analysis and assessment of the risk(s)";
- in points 2.4, first subparagraph, 3.3, third subparagraph, second indent, 3.4.2, 3.4.3, 3.4.4, 5.3, first subparagraph, 6.3.3, second subparagraph, 7.5.3, second subparagraph, 8.3.3, second subparagraph, 9.5.3, second subparagraph, 10.4.1, first subparagraph, 10.5.2, 11.5.1, 11.6.3, 12.4, first subparagraph, 13.3.2, third subparagraph, second indent, 13.3.3, second subparagraph, 14.3.3, first subparagraph, and 14.4.2, second subparagraph, fourth indent, of Annex II, the proposed adding of the words "and/or technical specification" or "and/or technical specifications";
- in point 3.8 of Annex II, the proposed deletion of the words "or the conditions for validity of the certificate";
- in points 3.9, first subparagraph, 14.3.6 and 14.4.5 of Annex II, the words "inform its notifying authorities";
- in point 3.9, third subparagraph, of Annex II, the proposed adding of the wording "keep a copy of the EU-type examination certificate, its annexes and additions";
- in point 5.1 of Annex II, the proposed adding of the words "on his sole responsibility";
- in points 6.3.3, second subparagraph, 7.5.3, second subparagraph, 8.3.3, second subparagraph, 9.5.3, second subparagraph, 13.3.3, second subparagraph, and 14.3.3, first subparagraph, of Annex II, the proposed adding of the words "the elements of";
- in point 10.6.1 of Annex II, the adding of the words "and, under the responsibility of the notified body referred to in point 3, the latter's identification number";
- in point 11.7.1 of Annex II, the adding of the words "and under the responsibility of the notified body referred to in point 4, the latter's identification number";
- in point 13.3.3, third subparagraph, of Annex II, the adding of the words "as an assessor";
- in point 14.3.6 of Annex II, the adding of the words "or upon request" and "to its notifying authorities";
- in point 14.4.4, second subparagraph, of Annex II, the proposed deletions of the words "fundamental" and "or the prescribed conditions for use of the instrument".
As far as Article 47 of the draft recast text is concerned, it was discussed on whether or not the list of points (a), (b), (c) and (d) contained in that article should have been identified by using the grey-shaded type generally used for marking substantive changes. On the one hand, the Legal Services of the European Parliament and of the Commission considered that the presentation used in that article for identifying the replacement of the initial wording of paragraph 2 of Article 16 of Directive 2004/22/EC with a new wording, taken from standard texts agreed between the three institutions, sufficiently describes the substantive amendment proposed for that provision. On the other hand, the Legal Service of the Council considered that the change in procedure cannot be separated from the points to which that procedure relates and that the entire text of Article 47, including the said four points, should therefore have been identified by using that grey-shaded type. Nevertheless, the three legal services shared the view that the draft text submitted by the Commission for Article 47 should be understood as meaning that the Commission had intended to propose only that the reference to the regulatory procedure with scrutiny currently contained in paragraph 2 of Article 16 of Directive 2004/22/EC be replaced with a delegation to the Commission of the power to adopt acts in accordance with Article 290 TFEU. In that respect, it was also the common understanding of the three legal services that, as part of the recast exercise, the legislator could lay down a delegation of powers for the purpose of amending annexes in relation to points (a), (b), (c) and (d) of Article 47, or alternatively opt, with regard to one or more of those points, for not delegating its powers to the Commission (therefore rendering the ordinary legislative procedure applicable to the said amendments) or for conferring implementing powers on that institution or on the Council in accordance with Article 291 TFEU and Regulation (EU) No 182/2011.
In consequence, examination of the proposal has enabled the Consultative Working Party to conclude, without dissent, that the proposal does not comprise any substantive amendments other than those identified as such therein or in the present opinion. The Working Party also concluded, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, that the proposal contains a straightforward codification of the existing text, without any change in its substance.
C. PENNERA H. LEGAL L. ROMERO REQUENA
Jurisconsult Jurisconsult Director General
- [1] The Consultative Working Party had at its disposal the English, French and German language versions of the proposal and worked on the basis of the English version, being the master-copy language version of the text under discussion.
PROCEDURE
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Title |
Harmonisation of the laws of the Member States relating to making available on the market of measuring instruments (Recast) |
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References |
COM(2011)0769 – C7-0422/2011 – 2011/0353(COD) |
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Date submitted to Parliament |
21.11.2011 |
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Committee responsible Date announced in plenary |
IMCO 30.11.2011 |
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Committee(s) asked for opinion(s) Date announced in plenary |
ITRE 30.11.2011 |
JURI 30.11.2011 |
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Not delivering opinions Date of decision |
ITRE 19.12.2011 |
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Rapporteur(s) Date appointed |
Zuzana Roithová 29.11.2011 |
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Discussed in committee |
9.1.2012 |
28.2.2012 |
31.5.2012 |
10.7.2012 |
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Date adopted |
6.11.2012 |
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Result of final vote |
+: –: 0: |
36 0 0 |
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Members present for the final vote |
Pablo Arias Echeverría, Adam Bielan, Jorgo Chatzimarkakis, Sergio Gaetano Cofferati, Birgit Collin-Langen, Lara Comi, Anna Maria Corazza Bildt, António Fernando Correia de Campos, Cornelis de Jong, Christian Engström, Vicente Miguel Garcés Ramón, Louis Grech, Małgorzata Handzlik, Malcolm Harbour, Iliana Ivanova, Philippe Juvin, Sandra Kalniete, Edvard Kožušník, Toine Manders, Hans-Peter Mayer, Sirpa Pietikäinen, Konstantinos Poupakis, Phil Prendergast, Mitro Repo, Zuzana Roithová, Heide Rühle, Christel Schaldemose, Andreas Schwab, Catherine Stihler, Róża Gräfin von Thun und Hohenstein, Bernadette Vergnaud, Barbara Weiler |
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Substitute(s) present for the final vote |
Jürgen Creutzmann, Marielle Gallo, María Irigoyen Pérez, Kyriacos Triantaphyllides |
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Date tabled |
9.1.2013 |
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