BETA


2013/0048(COD) Market surveillance of products

Progress: Procedure lapsed or withdrawn

RoleCommitteeRapporteurShadows
Lead IMCO
Committee Opinion AGRI
Committee Opinion ENVI
Committee Opinion BUDG
Committee Opinion ITRE
Committee Opinion ECON
Committee Opinion LIBE
Committee Opinion INTA
Committee Opinion JURI
Lead committee dossier:
Legal Basis:
TFEU 033, TFEU 114, TFEU 207

Events

2020/09/29
   EC - Proposal withdrawn by Commission
2019/04/16
   EP - Debate in Parliament
2014/12/04
   CSL - Debate in Council
Documents
2014/12/04
   CSL - Council Meeting
2014/07/09
   EC - Commission response to text adopted in plenary
Documents
2014/04/15
   EP - Results of vote in Parliament
2014/04/15
   EP - Debate in Parliament
2014/04/15
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 573 votes to 18, with 52 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council.

Parliament adopted its position at first reading following the ordinary legislative procedure, and amend the Commission proposal as follows:

Precautionary principle : Parliament wanted the provisions of the Regulation to be based on the precautionary principle. The principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account by market surveillance authorities when assessing the safety of a product.

This Regulation should apply to all forms of supply of products, including distance selling. Member States and the Commission should develop a common approach for the market surveillance of products sold online.

Intermediary service providers : these intermediaries, such as online hosts and registrars, should be obliged to cooperate with market surveillance authorities and take corrective actions where required, like other economic operators, in order to prevent the selling of unsafe or otherwise non-compliant products online.

Product presenting an emerging risk : market surveillance authorities should also tackle products presenting an emerging risk. A definition was proposed in order to be easily applied in a harmonised manner across the EU

Market surveillance : this should be carried out with a view to ensuring that products presenting a risk and non-compliant products are not placed or made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to resolve non-compliance.

Member States should report on the market surveillance activities and external border controls to the Commission every year. The Commission should make that information available to the public electronically and, where appropriate, by other means.

Market surveillance authorities : each Member State shall grant market surveillance authorities the powers and entrust them with the resources and means necessary for the proper performance of their tasks. The Commission shall evaluate whether those powers and resources are sufficient for the proper performance of that Member State's market surveillance obligations.

Effective surveillance : Market surveillance authorities should organise their activities in such a way that maximum effectiveness can be achieved. They should, accordingly, carry out the sample checks on sufficient numbers of products made available on the market, enabling conformity and the real risk posed to be assessed.

Market surveillance authorities should also:

alert users in their territories without delay of the identity of products that those authorities have identified as presenting a risk. Where available, that information shall also include data on the manufacturer, retail channel and period of sales; cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products; follow up consumer complaints within a reasonable time frame; verify that corrective action has been taken in a timely manner; monitor accidents and damage to health which are suspected to have been caused by those products; be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission.

Market surveillance programmes : general and sector-specific programmes should be drawn up with the input of key stakeholders concerned , including professional organisations, business organisations and consumer organisations. The Commission should evaluate the general and sector-specific programmes and, if appropriate, make recommendations to the Member States based on that evaluation.

The levels and methods for calculation of fees applicable to economic operators must be included in the general market surveillance programmes.

General obligations of economic operators : the latter must make available to market surveillance authorities information that enables the precise identification of the product and facilitates the tracing of the product. Market surveillance authorities should ensure confidentiality when that documentation and information is made available.

Economic operators shall cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by or non-compliance of products that they have placed or made available on the market.

Products presenting a risk : if the products in question present a serious risk, Members considered that preventing the product from being placed or made available on the market must be done Immediately.

Measures taken by market surveillance authorities : according to the amended text, the relevant economic operator should bear all of the expenses related to the destruction of products and the expenses incurred by the market surveillance authorities. Furthermore, market surveillance authorities shall charge fees for the relevant economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market. Such fee should not exceed the actual costs of the market surveillance activity performed and may partly or entirely reflect the time taken by the staff of the market surveillance authorities to perform the market surveillance controls.

The Union rapid information system (RAPEX): this system must be constantly updated . RAPEX should also include notifications related to Food Contact Materials, moved there from the Rapid Alert System for Food and Feed (RASFF) platform.

Risk assessment : Parliament proposed using a European Union reference laboratory to carry out risk assessments. It should settle any disputes arising out of a divergent risk assessment among the market surveillance authorities of different Member States, the economic operators and the conformity assessment bodies.

Pan-European Injuries Database: the report required the Commission to adopt, two years after entry into force of the Regulation, delegated acts establishing a Pan-European Injuries Database which would cover all types of injuries, and in particular those related to products used at home and for leisure, transportation and work activities. The database shall be coordinated and operated by the Commission.

Cooperation and exchange of information : Parliament suggested establishing a European Market Surveillance Forum composed of representatives from market surveillance authorities. The Forum should serve as a platform for structured cooperation between the authorities of the Member States and should provide a continuous and permanent means of involving all stakeholders concerned, including professional organisations, business organisations and consumer organisations.

It wished to strengthen the future role of the Forum and suggest that the Commission should consider proposing, when this Regulation is next reviewed, that the Forum is given the power to set binding recommendations as to the quality and practices of market surveillance.

Deterrent penalties : Members proposed the introduction of EU-wide, harmonised administrative penalties. Administrative penalties applicable to infringements shall at least offset the economic advantage sought through the infringement, but shall not exceed 10 % of the annual turnover or an estimate thereof. To add to the deterrent effect sought, the penalties imposed under the Regulation should also be made public. In addition to this the report proposed establishing a public blacklist of operators who repeatedly breach this Regulation.

Documents
2013/12/03
   CSL - Debate in Council
Documents
2013/12/03
   CSL - Council Meeting
2013/10/22
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on the Internal Market and Consumer Protection adopted the report by Sirpa PIETIKÄINEN (EPP, FI) on the proposal for a regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council.

The committee recommended that Parliament adopt its position in first reading following the ordinary legislative procedure, and amend the Commission proposal as follows:

Precautionary principle : Members wanted the provisions of the Regulation to be based on the precautionary principle. The principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account by market surveillance authorities when assessing the safety of a product.

Intermediary service providers : these intermediaries, such as online hosts and registrars, should be obliged to cooperate with market surveillance authorities and take corrective actions where required, like other economic operators, in order to prevent the selling of unsafe or otherwise non-compliant products online.

Product presenting an emerging risk : market surveillance authorities should also tackle products presenting an emerging risk. A definition is proposed in order to be easily applied in a harmonised manner across the EU

Market surveillance : this should be carried out with a view to ensuring that products presenting a risk and non-compliant products are not placed or made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to resolve non-compliance.

Member States shall report on the market surveillance activities and external border controls to the Commission every year. The Commission shall make that information available to the public electronically and, where appropriate, by other means.

Market surveillance authorities : each Member State shall grant market surveillance authorities the powers and entrust them with the resources and means necessary for the proper performance of their tasks. The Commission shall evaluate whether those powers and resources are sufficient for the proper performance of that Member State's market surveillance obligations.

Effective surveillance : Market surveillance authorities shall organise their activities in such a way that maximum effectiveness can be achieved. They shall, accordingly, carry out the sample checks on sufficient numbers of products made available on the market, enabling conformity and the real risk posed to be assessed.

Market surveillance authorities must also:

· alert users in their territories without delay of the identity of products that those authorities have identified as presenting a risk. Where available, that information shall also include data on the manufacturer, retail channel and period of sales;

· cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products;

· follow up consumer complaints within a reasonable time frame;

· verify that corrective action has been taken in a timely manner;

· monitor accidents and damage to health which are suspected to have been caused by those products;

· be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission.

The levels and methods for calculation of fees applicable to economic operators must be included in the general market surveillance programmes.

Market surveillance programmes : general and sector-specific programmes must be drawn up with the input of key stakeholders concerned , including professional organisations, business organisations and consumer organisations,

General obligations of economic operators : the latter must make available to market surveillance authorities information that enables the precise identification of the product and facilitates the tracing of the product.

Economic operators shall cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by or non-compliance of products that they have placed or made available on the market.

Cooperation and exchange of information : Members considered that the European Market Surveillance Forum should serve as a platform for cooperation not only between the authorities but also between the authorities and the economic operators as well as other stakeholders such as consumer groups.

They stressed the importance of structured cooperation under the auspices of this Forum, which is yet to be established. They wished to strengthen the future role of the Forum and suggest that the Commission should consider proposing, when this Regulation is next reviewed, that the Forum is given the power to set binding recommendations as to the quality and practices of market surveillance.

Products presenting a risk : if the products in question present a serious risk, Members considered that preventing the product from being placed or made available on the market must be done Immediately.

Measures taken by market surveillance authorities : the relevant economic operator shall bear all of the expenses related to the destruction of products and the expenses incurred by the market surveillance authorities. Furthermore, market surveillance authorities shall charge fees for the relevant economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market.

The Union rapid information system (RAPEX): this system must be constantly updated . RAPEX should also include notifications related to Food Contact Materials, moved there from the Rapid Alert System for Food and Feed (RASFF) platform.

Pan-European Injuries Database: the report required the Commission to adopt, two years after entry into force of the Regulation, delegated acts establishing a Pan-European Injuries Database which would cover all types of injuries, and in particular those related to products used at home and for leisure, transportation and work activities. The database shall be coordinated and operated by the Commission.

Deterrent penalties : Members proposed the introduction of EU-wide, harmonised administrative penalties. To add to the deterrent effect sought, the penalties imposed under the Regulation should also be made public. In addition to this the report proposed establishing a public blacklist of operators who repeatedly breach this Regulation.

Documents
2013/10/17
   EP - Vote in committee, 1st reading
2013/09/18
   EP - Committee opinion
Documents
2013/09/11
   EP - Amendments tabled in committee
Documents
2013/07/03
   PT_PARLIAMENT - Contribution
Documents
2013/06/13
   EP - Committee draft report
Documents
2013/05/30
   EDPS - Document attached to the procedure
Details

Opinion of the European Data Protection Supervisor (EDPS).

The EDPS appreciates that the regulation of the European Parliament and of the Council on market surveillance of products takes into account data protection issues to a certain extent. However, he gives some recommendations on how the Proposal could be further improved :

The EDPD particularly recommends:

including a substantive provision to clarify that the Proposal is not meant to provide for general derogations from data protection principles and that relevant personal data processing legislation remain fully applicable in the market surveillance context; to amend the proposal so as to ensure that only personal information which is strictly necessary is processed for market surveillance purposes in the Rapid Information System (RAPEX) and the Information and Communication System on Market Surveillance (ICSMS), respectively; providing for fixed retention periods for the personal data processed in RAPEX and ICSMS; maintaining the approach whereby the public is informed about unsafe products (via the RAPEX website) without making public personal information on economic operator(s) responsible for those products; explicit substantive provisions that would at least specify what kind of personal data may be made public and for what purpose(s), if it is the intention of the legislator to provide for the publication of personal information on economic operators; supplementing the provisions on participation of applicant countries, third countries or international organisations in RAPEX, as well as on international exchange of confidential information with explicit references to specific provisions about personal data protection corresponding to those applicable in the Union.

2013/05/22
   ESC - Economic and Social Committee: opinion, report
Documents
2013/05/20
   DE_BUNDESRAT - Contribution
Documents
2013/03/12
   EP - Committee referral announced in Parliament, 1st reading
2013/02/13
   EC - Document attached to the procedure
2013/02/13
   EC - Document attached to the procedure
2013/02/13
   EC - Legislative proposal published
Details

PURPOSE: Commission proposal on a single regulation on market surveillance of products aimed at simplifying the Union framework on market surveillance (product safety and market surveillance package).

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

ROLE OF THE EUROPEAN PARLIAMENT: Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: in a single market in which products circulate freely through 27 Member States, market surveillance needs to be highly coordinated and capable of reacting rapidly over a huge area. However, market surveillance has not kept pace with developments in the Union regulatory framework . Whilst advances have been made over the last decade, in particular with the implementation of Directive 2001/95/EC (General Product Safety Directive) and Regulation (EC) 765/2008 setting out the requirements for accreditation and market surveillance, the overlap of market surveillance rules and the obligations of economic operators laid down in various pieces of Union legislation has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union. Different product evaluation requirements and procedures apply depending on the category of product involved. The proposal aims to simplify the rules.

It should be noted that in response to calls from the European Parliament, the proposal was added to the Product Safety and Market Surveillance Package , which also includes a proposal for a regulation on consumer product safety (replacing the GPSD) and a proposal on multi-annual action plan for market surveillance covering the period 2013-2015 .

IMPACT ASSESSMENT: the Commission carried out an impact assessment and a favourable opinion was delivered by the Impact Assessment Board in 2012.

LEGAL BASIS: Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union.

CONTENT: this proposal aims at clarifying the regulatory framework for market surveillance in the field of non-food products . It merges the rules on market surveillance of the GPSD, Regulation (EC) 765/2008 and many sector-specific pieces of Union harmonisation legislation into a single legal instrument that applies horizontally across all sectors. The main aims are as follows:

· to reduce the number of pieces of legislation containing market surveillance rules : the 3 tier system spread across the GPSD, Regulation (EC) 765/2008 and a range of sector-specific legislation will be reduced to a one tier system in which all those rules are brought together in a single instrument;

· to eliminate overlaps in the current system: the new regulation will (a) dispense with the distinction between consumer and professional products for market surveillance purposes; (b) avoid making a distinction between harmonised products and non-harmonised products except where this is unavoidable in applying certain specific provisions. To the greatest extent possible the applicable rules will be the same for all products;

· to dovetail the RAPEX and Union evaluation procedures : at present, there are two separate procedures operating, sometimes in parallel, which require Member States to notify to the Commission and to other Member States certain market surveillance action taken at national level. This is an especially problematic aspect of the overlapping categories of products mentioned above. Under the new Regulation the two procedures become a single procedural flow with certain events triggering a single notification to the other Member States and the Commission (made using either the proven RAPEX rapid alert system or the Information and Communication System for Market Surveillance in accordance with the distinction made in the Regulation). In urgent situations the Commission is empowered to adopt measures requiring consistent action across the EU against products presenting a serious risk;

· to make the legislation more accessible: current market surveillance provisions are not based around a chronological flow of events. The new Regulation sets out the whole process of a market surveillance exercise in a chronological, sequential manner. It presents a chain of events, incorporating relevant provisions on publication of information, notification etc. at each stage of the procedure. This approach substantially improves the accessibility and user-friendliness of the legislation, and hence its effectiveness.

BUDGETARY IMPLICATIONS: the budgetary implications are already envisaged in existing or proposed programmes and the initiative will be financed through redeployment of existing resources. According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 39 276 million in commitments for 2015-2020 .

Documents

Activities

Votes

A7-0346/2013 - Sirpa Pietikäinen - Am 61 #

2014/04/15 Outcome: +: 467, -: 163, 0: 13
IT DE ES FR RO HU PL PT SK AT IE HR BG EL LT FI LV MT BE SE DK CY CZ LU SI NL EE GB
Total
53
88
48
60
27
17
42
17
12
16
11
11
16
8
8
11
7
5
20
20
11
3
20
6
6
26
6
67
icon: PPE PPE
228

Greece PPE

1

Malta PPE

For (1)

1

Denmark PPE

For (1)

1

Cyprus PPE

1

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2

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3

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1
icon: S&D S&D
161

Ireland S&D

2

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1

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2

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1

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1

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3

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33

Spain GUE/NGL

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1

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1
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1

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6
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66

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51

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icon: Verts/ALE Verts/ALE
53

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4

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3

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5

A7-0346/2013 - Sirpa Pietikäinen - Am 87 #

2014/04/15 Outcome: +: 460, -: 162, 0: 13
DE IT ES FR RO HU PL PT SK IE HR AT BG EL LT FI LV MT BE SE DK CY CZ LU SI NL EE GB
Total
86
51
44
60
27
17
43
17
12
11
11
17
16
8
8
11
7
5
20
20
11
3
20
6
6
24
6
67
icon: PPE PPE
226

Greece PPE

1

Malta PPE

For (1)

1

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For (1)

1

Cyprus PPE

1

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2

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3

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For (1)

1
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157

Ireland S&D

2

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1

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1

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3

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32

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26

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1
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6
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24

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52

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4

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5

A7-0346/2013 - Sirpa Pietikäinen - Am 133/2 #

2014/04/15 Outcome: +: 501, -: 130, 0: 11
DE IT ES RO FR HU BG PT PL SE SK IE BE DK HR LT NL FI SI AT EL MT LU EE LV CY CZ GB
Total
87
53
48
27
60
18
16
17
43
20
12
11
20
11
11
7
26
11
6
17
7
5
6
6
7
3
20
66
icon: PPE PPE
230

Denmark PPE

For (1)

1

Greece PPE

1

Malta PPE

For (1)

1

Luxembourg PPE

3

Estonia PPE

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1

Cyprus PPE

1

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2
icon: S&D S&D
159

Ireland S&D

2

Lithuania S&D

1

Netherlands S&D

3

Finland S&D

2

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1

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1

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1
icon: ALDE ALDE
66
3

Lithuania ALDE

1

Finland ALDE

2

Slovenia ALDE

2

Luxembourg ALDE

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1
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33

Spain GUE/NGL

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1

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3

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1

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23

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1

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Belgium EFD

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1

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1

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1

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1
icon: NI NI
26

Italy NI

2

Spain NI

1
2

Hungary NI

Abstain (1)

1

Ireland NI

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1

Belgium NI

Against (1)

1

Austria NI

Abstain (1)

4
icon: ECR ECR
50

Italy ECR

Against (1)

2

Belgium ECR

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1

Croatia ECR

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1

Netherlands ECR

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1

Latvia ECR

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1
icon: Verts/ALE Verts/ALE
54

Portugal Verts/ALE

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1

Sweden Verts/ALE

Abstain (1)

4

Belgium Verts/ALE

4

Denmark Verts/ALE

Against (1)

1

Netherlands Verts/ALE

3

Finland Verts/ALE

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2

Austria Verts/ALE

2

Luxembourg Verts/ALE

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1

Estonia Verts/ALE

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1

Latvia Verts/ALE

Against (1)

1

United Kingdom Verts/ALE

5

A7-0346/2013 - Sirpa Pietikäinen - Résolution législative #

2014/04/15 Outcome: +: 573, 0: 52, -: 18
DE FR IT ES PL RO GB SE BE PT BG AT HU NL SK IE DK CZ FI HR LT LU SI EE EL LV MT CY
Total
87
62
53
46
43
27
67
20
20
17
16
17
17
26
12
11
11
20
10
11
8
6
6
6
8
7
5
3
icon: PPE PPE
229

Denmark PPE

For (1)

1

Czechia PPE

2

Luxembourg PPE

3

Estonia PPE

For (1)

1

Greece PPE

1

Malta PPE

For (1)

1

Cyprus PPE

1
icon: S&D S&D
161

Netherlands S&D

3

Ireland S&D

2

Finland S&D

1

Lithuania S&D

1

Luxembourg S&D

For (1)

1

Estonia S&D

For (1)

1

Cyprus S&D

1
icon: ALDE ALDE
65

Spain ALDE

1
3

Finland ALDE

2

Lithuania ALDE

1

Luxembourg ALDE

For (1)

1

Slovenia ALDE

2
icon: Verts/ALE Verts/ALE
54

United Kingdom Verts/ALE

5

Portugal Verts/ALE

For (1)

1

Austria Verts/ALE

2

Netherlands Verts/ALE

3

Denmark Verts/ALE

For (1)

1

Finland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Estonia Verts/ALE

For (1)

1

Latvia Verts/ALE

1
icon: GUE/NGL GUE/NGL
32

United Kingdom GUE/NGL

1

Sweden GUE/NGL

1

Portugal GUE/NGL

3

Netherlands GUE/NGL

2

Ireland GUE/NGL

For (1)

1

Denmark GUE/NGL

For (1)

1

Croatia GUE/NGL

1

Greece GUE/NGL

3

Latvia GUE/NGL

For (1)

1

Cyprus GUE/NGL

1
icon: ECR ECR
51

Italy ECR

Abstain (1)

2

Belgium ECR

For (1)

1

Netherlands ECR

For (1)

1

Croatia ECR

Abstain (1)

1

Latvia ECR

Abstain (1)

1
icon: EFD EFD
24

France EFD

Against (1)

1

Poland EFD

3

Belgium EFD

For (1)

1

Bulgaria EFD

For (1)

1

Netherlands EFD

Abstain (1)

1

Slovakia EFD

For (1)

1

Denmark EFD

1

Finland EFD

For (1)

1

Lithuania EFD

2
icon: NI NI
26

Italy NI

2

Spain NI

1
2
6

Belgium NI

Abstain (1)

1

Hungary NI

Abstain (1)

1

Ireland NI

For (1)

1
AmendmentsDossier
398 2013/0048(COD)
2013/06/27 INTA 71 amendments...
source: PE-514.716
2013/09/11 IMCO 327 amendments...
source: PE-516.934

History

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

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Legal Affairs
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ENVI
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Internal Market and Consumer Protection
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EP
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EP
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AGRI
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committees/6
body
EP
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committee_full
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JURI
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council
  • body: CSL type: Council Meeting council: Competitiveness (Internal Market, Industry, Research and Space) meeting_id: 3353 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=3353*&MEET_DATE=04/12/2014 date: 2014-12-04T00:00:00
  • body: CSL type: Council Meeting council: Competitiveness (Internal Market, Industry, Research and Space) meeting_id: 3276 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=3276*&MEET_DATE=03/12/2013 date: 2013-12-03T00:00:00
docs
  • date: 2013-02-13T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0033:FIN:EN:PDF title: EUR-Lex title: SWD(2013)0033 type: Document attached to the procedure body: EC
  • date: 2013-02-13T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0034:FIN:EN:PDF title: EUR-Lex title: SWD(2013)0034 type: Document attached to the procedure body: EC
  • date: 2013-05-22T00:00:00 docs: url: https://dm.eesc.europa.eu/EESCDocumentSearch/Pages/redresults.aspx?k=(documenttype:AC)(documentnumber:1607)(documentyear:2013)(documentlanguage:EN) title: CES1607/2013 type: Economic and Social Committee: opinion, report body: ESC
  • date: 2013-05-30T00:00:00 docs: url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2013:253:TOC title: OJ C 253 03.09.2013, p. 0008 title: N7-0091/2013 summary: Opinion of the European Data Protection Supervisor (EDPS). The EDPS appreciates that the regulation of the European Parliament and of the Council on market surveillance of products takes into account data protection issues to a certain extent. However, he gives some recommendations on how the Proposal could be further improved : The EDPD particularly recommends: including a substantive provision to clarify that the Proposal is not meant to provide for general derogations from data protection principles and that relevant personal data processing legislation remain fully applicable in the market surveillance context; to amend the proposal so as to ensure that only personal information which is strictly necessary is processed for market surveillance purposes in the Rapid Information System (RAPEX) and the Information and Communication System on Market Surveillance (ICSMS), respectively; providing for fixed retention periods for the personal data processed in RAPEX and ICSMS; maintaining the approach whereby the public is informed about unsafe products (via the RAPEX website) without making public personal information on economic operator(s) responsible for those products; explicit substantive provisions that would at least specify what kind of personal data may be made public and for what purpose(s), if it is the intention of the legislator to provide for the publication of personal information on economic operators; supplementing the provisions on participation of applicant countries, third countries or international organisations in RAPEX, as well as on international exchange of confidential information with explicit references to specific provisions about personal data protection corresponding to those applicable in the Union. type: Document attached to the procedure body: EDPS
  • date: 2013-06-13T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE513.324 title: PE513.324 type: Committee draft report body: EP
  • date: 2013-09-11T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE516.934 title: PE516.934 type: Amendments tabled in committee body: EP
  • date: 2013-09-18T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE513.014&secondRef=03 title: PE513.014 committee: INTA type: Committee opinion body: EP
  • date: 2014-07-09T00:00:00 docs: url: /oeil/spdoc.do?i=23597&j=0&l=en title: SP(2014)471 type: Commission response to text adopted in plenary
  • date: 2013-05-21T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2013)0075 title: COM(2013)0075 type: Contribution body: DE_BUNDESRAT
  • date: 2013-07-04T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2013)0075 title: COM(2013)0075 type: Contribution body: PT_PARLIAMENT
events
  • date: 2013-02-13T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2013/0075/COM_COM(2013)0075_EN.doc title: COM(2013)0075 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=75 title: EUR-Lex summary: PURPOSE: Commission proposal on a single regulation on market surveillance of products aimed at simplifying the Union framework on market surveillance (product safety and market surveillance package). PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: in a single market in which products circulate freely through 27 Member States, market surveillance needs to be highly coordinated and capable of reacting rapidly over a huge area. However, market surveillance has not kept pace with developments in the Union regulatory framework . Whilst advances have been made over the last decade, in particular with the implementation of Directive 2001/95/EC (General Product Safety Directive) and Regulation (EC) 765/2008 setting out the requirements for accreditation and market surveillance, the overlap of market surveillance rules and the obligations of economic operators laid down in various pieces of Union legislation has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union. Different product evaluation requirements and procedures apply depending on the category of product involved. The proposal aims to simplify the rules. It should be noted that in response to calls from the European Parliament, the proposal was added to the Product Safety and Market Surveillance Package , which also includes a proposal for a regulation on consumer product safety (replacing the GPSD) and a proposal on multi-annual action plan for market surveillance covering the period 2013-2015 . IMPACT ASSESSMENT: the Commission carried out an impact assessment and a favourable opinion was delivered by the Impact Assessment Board in 2012. LEGAL BASIS: Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union. CONTENT: this proposal aims at clarifying the regulatory framework for market surveillance in the field of non-food products . It merges the rules on market surveillance of the GPSD, Regulation (EC) 765/2008 and many sector-specific pieces of Union harmonisation legislation into a single legal instrument that applies horizontally across all sectors. The main aims are as follows: · to reduce the number of pieces of legislation containing market surveillance rules : the 3 tier system spread across the GPSD, Regulation (EC) 765/2008 and a range of sector-specific legislation will be reduced to a one tier system in which all those rules are brought together in a single instrument; · to eliminate overlaps in the current system: the new regulation will (a) dispense with the distinction between consumer and professional products for market surveillance purposes; (b) avoid making a distinction between harmonised products and non-harmonised products except where this is unavoidable in applying certain specific provisions. To the greatest extent possible the applicable rules will be the same for all products; · to dovetail the RAPEX and Union evaluation procedures : at present, there are two separate procedures operating, sometimes in parallel, which require Member States to notify to the Commission and to other Member States certain market surveillance action taken at national level. This is an especially problematic aspect of the overlapping categories of products mentioned above. Under the new Regulation the two procedures become a single procedural flow with certain events triggering a single notification to the other Member States and the Commission (made using either the proven RAPEX rapid alert system or the Information and Communication System for Market Surveillance in accordance with the distinction made in the Regulation). In urgent situations the Commission is empowered to adopt measures requiring consistent action across the EU against products presenting a serious risk; · to make the legislation more accessible: current market surveillance provisions are not based around a chronological flow of events. The new Regulation sets out the whole process of a market surveillance exercise in a chronological, sequential manner. It presents a chain of events, incorporating relevant provisions on publication of information, notification etc. at each stage of the procedure. This approach substantially improves the accessibility and user-friendliness of the legislation, and hence its effectiveness. BUDGETARY IMPLICATIONS: the budgetary implications are already envisaged in existing or proposed programmes and the initiative will be financed through redeployment of existing resources. According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 39 276 million in commitments for 2015-2020 .
  • date: 2013-03-12T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2013-10-17T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
  • date: 2013-10-22T00:00:00 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=A7-2013-346&language=EN title: A7-0346/2013 summary: The Committee on the Internal Market and Consumer Protection adopted the report by Sirpa PIETIKÄINEN (EPP, FI) on the proposal for a regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council. The committee recommended that Parliament adopt its position in first reading following the ordinary legislative procedure, and amend the Commission proposal as follows: Precautionary principle : Members wanted the provisions of the Regulation to be based on the precautionary principle. The principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account by market surveillance authorities when assessing the safety of a product. Intermediary service providers : these intermediaries, such as online hosts and registrars, should be obliged to cooperate with market surveillance authorities and take corrective actions where required, like other economic operators, in order to prevent the selling of unsafe or otherwise non-compliant products online. Product presenting an emerging risk : market surveillance authorities should also tackle products presenting an emerging risk. A definition is proposed in order to be easily applied in a harmonised manner across the EU Market surveillance : this should be carried out with a view to ensuring that products presenting a risk and non-compliant products are not placed or made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to resolve non-compliance. Member States shall report on the market surveillance activities and external border controls to the Commission every year. The Commission shall make that information available to the public electronically and, where appropriate, by other means. Market surveillance authorities : each Member State shall grant market surveillance authorities the powers and entrust them with the resources and means necessary for the proper performance of their tasks. The Commission shall evaluate whether those powers and resources are sufficient for the proper performance of that Member State's market surveillance obligations. Effective surveillance : Market surveillance authorities shall organise their activities in such a way that maximum effectiveness can be achieved. They shall, accordingly, carry out the sample checks on sufficient numbers of products made available on the market, enabling conformity and the real risk posed to be assessed. Market surveillance authorities must also: · alert users in their territories without delay of the identity of products that those authorities have identified as presenting a risk. Where available, that information shall also include data on the manufacturer, retail channel and period of sales; · cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products; · follow up consumer complaints within a reasonable time frame; · verify that corrective action has been taken in a timely manner; · monitor accidents and damage to health which are suspected to have been caused by those products; · be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission. The levels and methods for calculation of fees applicable to economic operators must be included in the general market surveillance programmes. Market surveillance programmes : general and sector-specific programmes must be drawn up with the input of key stakeholders concerned , including professional organisations, business organisations and consumer organisations, General obligations of economic operators : the latter must make available to market surveillance authorities information that enables the precise identification of the product and facilitates the tracing of the product. Economic operators shall cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by or non-compliance of products that they have placed or made available on the market. Cooperation and exchange of information : Members considered that the European Market Surveillance Forum should serve as a platform for cooperation not only between the authorities but also between the authorities and the economic operators as well as other stakeholders such as consumer groups. They stressed the importance of structured cooperation under the auspices of this Forum, which is yet to be established. They wished to strengthen the future role of the Forum and suggest that the Commission should consider proposing, when this Regulation is next reviewed, that the Forum is given the power to set binding recommendations as to the quality and practices of market surveillance. Products presenting a risk : if the products in question present a serious risk, Members considered that preventing the product from being placed or made available on the market must be done Immediately. Measures taken by market surveillance authorities : the relevant economic operator shall bear all of the expenses related to the destruction of products and the expenses incurred by the market surveillance authorities. Furthermore, market surveillance authorities shall charge fees for the relevant economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market. The Union rapid information system (RAPEX): this system must be constantly updated . RAPEX should also include notifications related to Food Contact Materials, moved there from the Rapid Alert System for Food and Feed (RASFF) platform. Pan-European Injuries Database: the report required the Commission to adopt, two years after entry into force of the Regulation, delegated acts establishing a Pan-European Injuries Database which would cover all types of injuries, and in particular those related to products used at home and for leisure, transportation and work activities. The database shall be coordinated and operated by the Commission. Deterrent penalties : Members proposed the introduction of EU-wide, harmonised administrative penalties. To add to the deterrent effect sought, the penalties imposed under the Regulation should also be made public. In addition to this the report proposed establishing a public blacklist of operators who repeatedly breach this Regulation.
  • date: 2013-12-03T00:00:00 type: Debate in Council body: CSL docs: 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=3276*&MEET_DATE=03/12/2013 title: 3276
  • date: 2014-04-15T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=23597&l=en title: Results of vote in Parliament
  • date: 2014-04-15T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20140415&type=CRE title: Debate in Parliament
  • date: 2014-04-15T00:00:00 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-2014-0384 title: T7-0384/2014 summary: The European Parliament adopted by 573 votes to 18, with 52 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council. Parliament adopted its position at first reading following the ordinary legislative procedure, and amend the Commission proposal as follows: Precautionary principle : Parliament wanted the provisions of the Regulation to be based on the precautionary principle. The principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account by market surveillance authorities when assessing the safety of a product. This Regulation should apply to all forms of supply of products, including distance selling. Member States and the Commission should develop a common approach for the market surveillance of products sold online. Intermediary service providers : these intermediaries, such as online hosts and registrars, should be obliged to cooperate with market surveillance authorities and take corrective actions where required, like other economic operators, in order to prevent the selling of unsafe or otherwise non-compliant products online. Product presenting an emerging risk : market surveillance authorities should also tackle products presenting an emerging risk. A definition was proposed in order to be easily applied in a harmonised manner across the EU Market surveillance : this should be carried out with a view to ensuring that products presenting a risk and non-compliant products are not placed or made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to resolve non-compliance. Member States should report on the market surveillance activities and external border controls to the Commission every year. The Commission should make that information available to the public electronically and, where appropriate, by other means. Market surveillance authorities : each Member State shall grant market surveillance authorities the powers and entrust them with the resources and means necessary for the proper performance of their tasks. The Commission shall evaluate whether those powers and resources are sufficient for the proper performance of that Member State's market surveillance obligations. Effective surveillance : Market surveillance authorities should organise their activities in such a way that maximum effectiveness can be achieved. They should, accordingly, carry out the sample checks on sufficient numbers of products made available on the market, enabling conformity and the real risk posed to be assessed. Market surveillance authorities should also: alert users in their territories without delay of the identity of products that those authorities have identified as presenting a risk. Where available, that information shall also include data on the manufacturer, retail channel and period of sales; cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products; follow up consumer complaints within a reasonable time frame; verify that corrective action has been taken in a timely manner; monitor accidents and damage to health which are suspected to have been caused by those products; be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission. Market surveillance programmes : general and sector-specific programmes should be drawn up with the input of key stakeholders concerned , including professional organisations, business organisations and consumer organisations. The Commission should evaluate the general and sector-specific programmes and, if appropriate, make recommendations to the Member States based on that evaluation. The levels and methods for calculation of fees applicable to economic operators must be included in the general market surveillance programmes. General obligations of economic operators : the latter must make available to market surveillance authorities information that enables the precise identification of the product and facilitates the tracing of the product. Market surveillance authorities should ensure confidentiality when that documentation and information is made available. Economic operators shall cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by or non-compliance of products that they have placed or made available on the market. Products presenting a risk : if the products in question present a serious risk, Members considered that preventing the product from being placed or made available on the market must be done Immediately. Measures taken by market surveillance authorities : according to the amended text, the relevant economic operator should bear all of the expenses related to the destruction of products and the expenses incurred by the market surveillance authorities. Furthermore, market surveillance authorities shall charge fees for the relevant economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market. Such fee should not exceed the actual costs of the market surveillance activity performed and may partly or entirely reflect the time taken by the staff of the market surveillance authorities to perform the market surveillance controls. The Union rapid information system (RAPEX): this system must be constantly updated . RAPEX should also include notifications related to Food Contact Materials, moved there from the Rapid Alert System for Food and Feed (RASFF) platform. Risk assessment : Parliament proposed using a European Union reference laboratory to carry out risk assessments. It should settle any disputes arising out of a divergent risk assessment among the market surveillance authorities of different Member States, the economic operators and the conformity assessment bodies. Pan-European Injuries Database: the report required the Commission to adopt, two years after entry into force of the Regulation, delegated acts establishing a Pan-European Injuries Database which would cover all types of injuries, and in particular those related to products used at home and for leisure, transportation and work activities. The database shall be coordinated and operated by the Commission. Cooperation and exchange of information : Parliament suggested establishing a European Market Surveillance Forum composed of representatives from market surveillance authorities. The Forum should serve as a platform for structured cooperation between the authorities of the Member States and should provide a continuous and permanent means of involving all stakeholders concerned, including professional organisations, business organisations and consumer organisations. It wished to strengthen the future role of the Forum and suggest that the Commission should consider proposing, when this Regulation is next reviewed, that the Forum is given the power to set binding recommendations as to the quality and practices of market surveillance. Deterrent penalties : Members proposed the introduction of EU-wide, harmonised administrative penalties. Administrative penalties applicable to infringements shall at least offset the economic advantage sought through the infringement, but shall not exceed 10 % of the annual turnover or an estimate thereof. To add to the deterrent effect sought, the penalties imposed under the Regulation should also be made public. In addition to this the report proposed establishing a public blacklist of operators who repeatedly breach this Regulation.
  • date: 2014-12-04T00:00:00 type: Debate in Council body: CSL docs: 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=3353*&MEET_DATE=04/12/2014 title: 3353
other
  • body: CSL type: Council Meeting council: Former Council configuration
  • body: EC dg: url: http://ec.europa.eu/info/departments/internal-market-industry-entrepreneurship-and-smes_en title: Internal Market, Industry, Entrepreneurship and SMEs commissioner: TAJANI Antonio
otherinst
  • name: European Economic and Social Committee
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European Economic and Social Committee
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Old
IMCO/7/11996
New
  • IMCO/7/11996
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Old
Regulation
New
  • Regulation
  • Amending Directives 89/686/EEC, 93/15/EEC, 94/9/EC, 94/25/EC Amending Directive 95/16/EC 1992/0394(COD) Amending Directive 97/23/EC 1993/0462(COD) Amending Directive 2000/9/EC 1994/0011(COD) Amending Directive 1999/5/EC 1997/0149(COD) Amending Directive 2000/14/EC 1998/0029(COD) Amending Directive 2001/95/EC 2000/0073(COD) Amending Directive 2006/42/EC 2001/0004(COD) Amending Directive 2004/108/EC 2002/0306(COD) Amending Directive 2006/95/EC 2003/0094(COD) Amending Directive 2007/23/EC 2005/0194(COD) Amending Directive 2008/57/EC 2006/0273(COD) Amending Regulation (EC) No 764/2008 2007/0028(COD) Amending Regulation (EC) No 765/2008 2007/0029(COD) Amending Directive 2009/142/EC 2007/0225(COD) Amending Directive 2009/48/EC 2008/0018(COD) Amending Directive 2009/105/EC 2008/0076(COD) Amending Regulation (EU) No 305/2011 2008/0098(COD) Amending Directive 2011/65/EU 2008/0240(COD) See also 2013/0049(COD)
procedure/other_consulted_institutions
European Economic and Social Committee
procedure/subject
Old
  • 2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
  • 2.80 Cooperation between administrations
  • 3.45.08 Business environment, reduction of the administrative burdens
  • 4.60 Consumers' protection in general
  • 4.60.08 Safety of products and services, product liability
  • 6.20.02 Export/import control, trade defence, trade barriers
  • 8.50.02 Legislative simplification, coordination, codification
New
2.10.03
Standardisation, EC/EU standards and trade mark, certification, compliance
2.80
Cooperation between administrations
3.45.08
Business environment, reduction of the administrative burdens
4.60
Consumers' protection in general
4.60.08
Safety of products and services, product liability
6.20.02
Export/import control, trade defence, trade barriers
8.50.02
Legislative simplification, coordination, codification
procedure/summary
  • Amending Directive 1999/5/EC
  • Amending Directive 2000/14/EC
  • Amending Directive 2000/9/EC
  • Amending Directive 2001/95/EC
  • Amending Directive 2004/108/EC
  • Amending Directive 2006/42/EC
  • Amending Directive 2006/95/EC
  • Amending Directive 2007/23/EC
  • Amending Directive 2008/57/EC
  • Amending Directive 2009/105/EC
  • Amending Directive 2009/142/EC
  • Amending Directive 2009/48/EC
  • Amending Directive 2011/65/EU
  • Amending Directive 95/16/EC
  • Amending Directive 97/23/EC
  • Amending Directives 89/686/EEC, 93/15/EEC, 94/9/EC, 94/25/EC
  • Amending Regulation (EC) No 764/2008
  • Amending Regulation (EC) No 765/2008
  • Amending Regulation (EU) No 305/2011
  • See also
procedure/subject/5
Old
6.20.02 Export/import control, trade defence
New
6.20.02 Export/import control, trade defence, trade barriers
activities/4/council
Competitiveness (Internal Market, Industry, Research and Space)
activities/4/docs
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Former Council configuration
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Rules of Procedure of the European Parliament EP 150
New
Rules of Procedure EP 150
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CELEX:52013PC0075:EN
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Competitiveness (Internal Market, Industry, Research and Space)
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3353
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procedure/legislative_priorities
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      procedure/selected_topics
        activities/0/commission/0/DG/title
        Old
        Enterprise and Industry
        New
        Internal Market, Industry, Entrepreneurship and SMEs
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        Old
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        New
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        Old
        Enterprise and Industry
        New
        Internal Market, Industry, Entrepreneurship and SMEs
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        Old
        http://ec.europa.eu/enterprise/
        New
        http://ec.europa.eu/info/departments/internal-market-industry-entrepreneurship-and-smes_en
        procedure/Mandatory consultation of other institutions
        Old
        Economic and Social Committee
        New
        European Economic and Social Committee
        activities/0/docs/0/url
        Old
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        New
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        procedure/subject/0
        Old
        2.10.03 Standardisation, EC standards and trademark, certification, compliance
        New
        2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
        activities/0/docs/0/celexid
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        links/European Commission/title
        Old
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        activities/1/committees/5/rapporteur/0/name
        Old
        CUTAŞ George Sabin
        New
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        activities/2/committees/5/rapporteur/0/name
        Old
        CUTAŞ George Sabin
        New
        CUTAȘ George Sabin
        activities/3/committees/5/rapporteur/0/name
        Old
        CUTAŞ George Sabin
        New
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        committees/5/rapporteur/0/name
        Old
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        New
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        activities/6
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        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=3353*&MEET_DATE=04/12/2014 type: Debate in Council title: 3353
        council
        Competitiveness (Internal Market, Industry, Research and Space)
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        2014-12-04T00:00:00
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        other/0
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        New
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        activities/1/committees/4/shadows/0/group
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        2013-10-17T00:00:00
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        New
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        activities/2/committees
        • body: EP responsible: False committee_full: Agriculture and Rural Development committee: AGRI
        • body: EP responsible: False committee_full: Budgets committee: BUDG
        • body: EP responsible: False committee_full: Economic and Monetary Affairs committee: ECON
        • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
        • body: EP shadows: group: S&D name: SCHALDEMOSE Christel group: ALDE name: HELLVIG Eduard-Raul group: Verts/ALE name: RÜHLE Heide group: ECR name: FOX Ashley group: EFD name: SALVINI Matteo responsible: True committee: IMCO date: 2013-02-20T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: PPE name: PIETIKÄINEN Sirpa
        • body: EP responsible: False committee: INTA date: 2013-03-21T00:00:00 committee_full: International Trade rapporteur: group: S&D name: CUTAŞ George Sabin
        • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
        • body: EP responsible: False committee_full: Legal Affairs committee: JURI
        • body: EP responsible: False committee_full: Civil Liberties, Justice and Home Affairs committee: LIBE
        activities/2/date
        Old
        2014-04-15T00:00:00
        New
        2013-10-17T00:00:00
        activities/2/docs
        • url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20140415&type=CRE type: Debate in Parliament title: Debate in Parliament
        • url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2014-0384 type: Decision by Parliament, 1st reading/single reading title: T7-0384/2014
        activities/2/type
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        activities/5/committees
        • body: EP responsible: False committee_full: Agriculture and Rural Development committee: AGRI
        • body: EP responsible: False committee_full: Budgets committee: BUDG
        • body: EP responsible: False committee_full: Economic and Monetary Affairs committee: ECON
        • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
        • body: EP shadows: group: S&D name: SCHALDEMOSE Christel group: ALDE name: HELLVIG Eduard-Raul group: Verts/ALE name: RÜHLE Heide group: ECR name: FOX Ashley group: EFD name: SALVINI Matteo responsible: True committee: IMCO date: 2013-02-20T00:00:00 committee_full: Internal Market and Consumer Protection rapporteur: group: PPE name: PIETIKÄINEN Sirpa
        • body: EP responsible: False committee: INTA date: 2013-03-21T00:00:00 committee_full: International Trade rapporteur: group: S&D name: CUTAŞ George Sabin
        • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
        • body: EP responsible: False committee_full: Legal Affairs committee: JURI
        • body: EP responsible: False committee_full: Civil Liberties, Justice and Home Affairs committee: LIBE
        activities/5/date
        Old
        2013-03-12T00:00:00
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        activities/5/docs
        • url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=23597&l=en type: Results of vote in Parliament title: Results of vote in Parliament
        • url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20140415&type=CRE type: Debate in Parliament title: Debate in Parliament
        • url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2014-0384 type: Decision by Parliament, 1st reading/single reading title: T7-0384/2014
        activities/5/type
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        New
        Results of vote in Parliament
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        activities/1/committees/4/date
        2013-02-20T00:00:00
        activities/1/committees/4/rapporteur
        • group: PPE name: PIETIKÄINEN Sirpa
        activities/1/committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: ALDE name: HELLVIG Eduard-Raul
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        activities/1/committees/5/date
        2013-03-21T00:00:00
        activities/1/committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        activities/2/committees/4/date
        2013-02-20T00:00:00
        activities/2/committees/4/rapporteur
        • group: PPE name: PIETIKÄINEN Sirpa
        activities/2/committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: ALDE name: HELLVIG Eduard-Raul
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        activities/2/committees/5/date
        2013-03-21T00:00:00
        activities/2/committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        activities/3/committees/4/date
        2013-02-20T00:00:00
        activities/3/committees/4/rapporteur
        • group: PPE name: PIETIKÄINEN Sirpa
        activities/3/committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: ALDE name: HELLVIG Eduard-Raul
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        activities/3/committees/5/date
        2013-03-21T00:00:00
        activities/3/committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        committees/4/date
        2013-02-20T00:00:00
        committees/4/rapporteur
        • group: PPE name: PIETIKÄINEN Sirpa
        committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: ALDE name: HELLVIG Eduard-Raul
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        committees/5/date
        2013-03-21T00:00:00
        committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        activities/1/committees/4/date
        2013-02-20T00:00:00
        activities/1/committees/4/rapporteur
        • group: EPP name: PIETIKÄINEN Sirpa
        activities/1/committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        activities/1/committees/5/date
        2013-03-21T00:00:00
        activities/1/committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        activities/2/committees/4/date
        2013-02-20T00:00:00
        activities/2/committees/4/rapporteur
        • group: EPP name: PIETIKÄINEN Sirpa
        activities/2/committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        activities/2/committees/5/date
        2013-03-21T00:00:00
        activities/2/committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        activities/3/committees/4/date
        2013-02-20T00:00:00
        activities/3/committees/4/rapporteur
        • group: EPP name: PIETIKÄINEN Sirpa
        activities/3/committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        activities/3/committees/5/date
        2013-03-21T00:00:00
        activities/3/committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        committees/4/date
        2013-02-20T00:00:00
        committees/4/rapporteur
        • group: EPP name: PIETIKÄINEN Sirpa
        committees/4/shadows
        • group: S&D name: SCHALDEMOSE Christel
        • group: Verts/ALE name: RÜHLE Heide
        • group: ECR name: FOX Ashley
        • group: EFD name: SALVINI Matteo
        committees/5/date
        2013-03-21T00:00:00
        committees/5/rapporteur
        • group: S&D name: CUTAŞ George Sabin
        procedure/Modified legal basis
        Rules of Procedure of the European Parliament EP 150
        activities/5/docs/1/url
        http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2014-0384
        activities/5/docs/1/text
        • The European Parliament adopted by 573 votes to 18, with 52 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council.

          Parliament adopted its position at first reading following the ordinary legislative procedure, and amend the Commission proposal as follows:

          Precautionary principle: Parliament wanted the provisions of the Regulation to be based on the precautionary principle. The principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account by market surveillance authorities when assessing the safety of a product.

          This Regulation should apply to all forms of supply of products, including distance selling. Member States and the Commission should develop a common approach for the market surveillance of products sold online.

          Intermediary service providers: these intermediaries, such as online hosts and registrars, should be obliged to cooperate with market surveillance authorities and take corrective actions where required, like other economic operators, in order to prevent the selling of unsafe or otherwise non-compliant products online.

          Product presenting an emerging risk: market surveillance authorities should also tackle products presenting an emerging risk. A definition was proposed in order to be easily applied in a harmonised manner across the EU

          Market surveillance: this should be carried out with a view to ensuring that products presenting a risk and non-compliant products are not placed or made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to resolve non-compliance.

          Member States should report on the market surveillance activities and external border controls to the Commission every year. The Commission should make that information available to the public electronically and, where appropriate, by other means.

          Market surveillance authorities: each Member State shall grant market surveillance authorities the powers and entrust them with the resources and means necessary for the proper performance of their tasks.   The Commission shall evaluate whether those powers and resources are sufficient for the proper performance of that Member State's market surveillance obligations.

          Effective surveillance: Market surveillance authorities should organise their activities in such a way that maximum effectiveness can be achieved. They should, accordingly, carry out the sample checks on sufficient numbers of products made available on the market, enabling conformity and the real risk posed to be assessed. 

          Market surveillance authorities should also:

          • alert users in their territories without delay of the identity of products that those authorities have identified as presenting a risk. Where available, that information shall also include data on the manufacturer, retail channel and period of sales;
          • cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products;
          • follow up consumer complaints within a reasonable time frame;
          • verify that corrective action has been taken in a timely manner;
          • monitor accidents and damage to health which are suspected to have been caused by those products;
          • be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission.

          Market surveillance programmes: general and sector-specific programmes should be drawn up with the input of key stakeholders concerned, including professional organisations, business organisations and consumer organisations. The Commission should evaluate the general and sector-specific programmes and, if appropriate, make recommendations to the Member States based on that evaluation.

          The levels and methods for calculation of fees applicable to economic operators must be included in the general market surveillance programmes.

          General obligations of economic operators: the latter must make available to market surveillance authorities information that enables the precise identification of the product and facilitates the tracing of the product. Market surveillance authorities should ensure confidentiality when that documentation and information is made available.

          Economic operators shall cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by or non-compliance of products that they have placed or made available on the market.

          Products presenting a risk: if the products in question present a serious risk, Members considered that preventing the product from being placed or made available on the market must be done Immediately.

          Measures taken by market surveillance authorities: according to the amended text, the relevant economic operator should bear all of the expenses related to the destruction of products and the expenses incurred by the market surveillance authorities. Furthermore, market surveillance authorities shall charge fees for the relevant economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market. Such fee should not exceed the actual costs of the market surveillance activity performed and may partly or entirely reflect the time taken by the staff of the market surveillance authorities to perform the market surveillance controls.

          The Union rapid information system (RAPEX): this system must be constantly updated. RAPEX should also include notifications related to Food Contact Materials, moved there from the Rapid Alert System for Food and Feed (RASFF) platform.

          Risk assessment: Parliament proposed using a European Union reference laboratory to carry out risk assessments. It should settle any disputes arising out of a divergent risk assessment among the market surveillance authorities of different Member States, the economic operators and the conformity assessment bodies.

          Pan-European Injuries Database: the report required the Commission to adopt, two years after entry into force of the Regulation, delegated acts establishing a Pan-European Injuries Database which would cover all types of injuries, and in particular those related to products used at home and for leisure, transportation and work activities. The database shall be coordinated and operated by the Commission.

          Cooperation and exchange of information: Parliament suggested establishing a European Market Surveillance Forum composed of representatives from market surveillance authorities. The Forum should serve as a platform for structured cooperation between the authorities of the Member States and should provide a continuous and permanent means of involving all stakeholders concerned, including professional organisations, business organisations and consumer organisations.

          It wished to strengthen the future role of the Forum and suggest that the Commission should consider proposing, when this Regulation is next reviewed, that the Forum is given the power to set binding recommendations as to the quality and practices of market surveillance.

          Deterrent penalties: Members proposed the introduction of EU-wide, harmonised administrative penalties. Administrative penalties applicable to infringements shall at least offset the economic advantage sought through the infringement, but shall not exceed 10 % of the annual turnover or an estimate thereof. To add to the deterrent effect sought, the penalties imposed under the Regulation should also be made public. In addition to this the report proposed establishing a public blacklist of operators who repeatedly breach this Regulation.

        procedure/selected_topics
          activities/5/docs/0
          url
          http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20140415&type=CRE
          type
          Debate in Parliament
          title
          Debate in Parliament
          activities/5/docs
          • type: Decision by Parliament, 1st reading/single reading title: T7-0384/2014
          activities/5/type
          Old
          Debate in plenary scheduled
          New
          Debate in Parliament
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          Old
          Awaiting Parliament 1st reading / single reading / budget 1st stage
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          Awaiting Council 1st reading position / budgetary conciliation convocation
          activities/4/docs
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          Opinion of the European Data Protection Supervisor (EDPS).

          The EDPS appreciates that the regulation of the European Parliament and of the Council on market surveillance of products takes into account data protection issues to a certain extent. However, he gives some recommendations on how the Proposal could be further improved:

          The EDPD particularly recommends:

          • including a substantive provision to clarify that the Proposal is not meant to provide for general derogations from data protection principles and that relevant personal data processing legislation remain fully applicable in the market surveillance context;
          • to amend the proposal so as to ensure that only personal information which is strictly necessary is processed for market surveillance purposes in the Rapid Information System (RAPEX) and the Information and Communication System on Market Surveillance (ICSMS), respectively;
          • providing for fixed retention periods for the personal data processed in RAPEX and ICSMS;
          • maintaining the approach whereby the public is informed about unsafe products (via the RAPEX website) without making public personal information on economic operator(s) responsible for those products;
          • explicit substantive provisions that would at least specify what kind of personal data may be made public and for what purpose(s), if it is the intention of the legislator to provide for the publication of personal information on economic operators;
          • supplementing the provisions on participation of applicant countries, third countries or international organisations in RAPEX, as well as on international exchange of confidential information with explicit references to specific provisions about personal data protection corresponding to those applicable in the Union.
          New

          PURPOSE: Commission proposal on a single regulation on market surveillance of products aimed at simplifying the Union framework on market surveillance (product safety and market surveillance package).

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

          ROLE OF THE EUROPEAN PARLIAMENT: Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

          BACKGROUND: in a single market in which products circulate freely through 27 Member States, market surveillance needs to be highly coordinated and capable of reacting rapidly over a huge area. However, market surveillance has not kept pace with developments in the Union regulatory framework. Whilst advances have been made over the last decade, in particular with the implementation of Directive 2001/95/EC (General Product Safety Directive) and Regulation (EC) 765/2008 setting out the requirements for accreditation and market surveillance, the overlap of market surveillance rules and the obligations of economic operators laid down in various pieces of Union legislation has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union. Different product evaluation requirements and procedures apply depending on the category of product involved. The proposal aims to simplify the rules.

          It should be noted that in response to calls from the European Parliament, the proposal was added to the Product Safety and Market Surveillance Package, which also includes a proposal for a regulation on consumer product safety (replacing the GPSD) and a proposal on multi-annual action plan for market surveillance covering the period 2013-2015.

          IMPACT ASSESSMENT: the Commission carried out an impact assessment and a favourable opinion was delivered by the Impact Assessment Board in 2012.

          LEGAL BASIS: Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union.

          CONTENT: this proposal aims at clarifying the regulatory framework for market surveillance in the field of non-food products. It merges the rules on market surveillance of the GPSD, Regulation (EC) 765/2008 and many sector-specific pieces of Union harmonisation legislation into a single legal instrument that applies horizontally across all sectors. The main aims are as follows:

          ·        to reduce the number of pieces of legislation containing market surveillance rules: the 3 tier system spread across the GPSD, Regulation (EC) 765/2008 and a range of sector-specific legislation will be reduced to a one tier system in which all those rules are brought together in a single instrument;

          ·        to eliminate overlaps in the current system: the new regulation will (a) dispense with the distinction between consumer and professional products for market surveillance purposes; (b) avoid making a distinction between harmonised products and non-harmonised products except where this is unavoidable in applying certain specific provisions. To the greatest extent possible the applicable rules will be the same for all products;

          ·        to dovetail the RAPEX and Union evaluation procedures: at present, there are two separate procedures operating, sometimes in parallel, which require Member States to notify to the Commission and to other Member States certain market surveillance action taken at national level. This is an especially problematic aspect of the overlapping categories of products mentioned above. Under the new Regulation the two procedures become a single procedural flow with certain events triggering a single notification to the other Member States and the Commission (made using either the proven RAPEX rapid alert system or the Information and Communication System for Market Surveillance in accordance with the distinction made in the Regulation). In urgent situations the Commission is empowered to adopt measures requiring consistent action across the EU against products presenting a serious risk;

          ·        to make the legislation more accessible: current market surveillance provisions are not based around a chronological flow of events. The new Regulation sets out the whole process of a market surveillance exercise in a chronological, sequential manner. It presents a chain of events, incorporating relevant provisions on publication of information, notification etc. at each stage of the procedure. This approach substantially improves the accessibility and user-friendliness of the legislation, and hence its effectiveness.

          BUDGETARY IMPLICATIONS: the budgetary implications are already envisaged in existing or proposed programmes and the initiative will be financed through redeployment of existing resources. According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 39 276 million in commitments for 2015-2020.

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          • The Committee on the Internal Market and Consumer Protection adopted the report by Sirpa PIETIKÄINEN (EPP, FI) on the proposal for a regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council.

            The committee recommended that Parliament adopt its position in first reading following the ordinary legislative procedure, and amend the Commission proposal as follows:

            Precautionary principle: Members wanted the provisions of the Regulation to be based on the precautionary principle. The principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account by market surveillance authorities when assessing the safety of a product.

            Intermediary service providers: these intermediaries, such as online hosts and registrars, should be obliged to cooperate with market surveillance authorities and take corrective actions where required, like other economic operators, in order to prevent the selling of unsafe or otherwise non-compliant products online.

            Product presenting an emerging risk: market surveillance authorities should also tackle products presenting an emerging risk. A definition is proposed in order to be easily applied in a harmonised manner across the EU

            Market surveillance: this should be carried out with a view to ensuring that products presenting a risk and non-compliant products are not placed or made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to resolve non-compliance.

            Member States shall report on the market surveillance activities and external border controls to the Commission every year. The Commission shall make that information available to the public electronically and, where appropriate, by other means.

            Market surveillance authorities: each Member State shall grant market surveillance authorities the powers and entrust them with the resources and means necessary for the proper performance of their tasks.   The Commission shall evaluate whether those powers and resources are sufficient for the proper performance of that Member State's market surveillance obligations.

            Effective surveillance: Market surveillance authorities shall organise their activities in such a way that maximum effectiveness can be achieved. They shall, accordingly, carry out the sample checks on sufficient numbers of products made available on the market, enabling conformity and the real risk posed to be assessed. 

            Market surveillance authorities must also:

            ·        alert users in their territories without delay of the identity of products that those authorities have identified as presenting a risk. Where available, that information shall also include data on the manufacturer, retail channel and period of sales;

            ·        cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products;

            ·        follow up consumer complaints within a reasonable time frame;

            ·        verify that corrective action has been taken in a timely manner;

            ·        monitor accidents and damage to health which are suspected to have been caused by those products;

            ·        be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission.

            The levels and methods for calculation of fees applicable to economic operators must be included in the general market surveillance programmes.

            Market surveillance programmes: general and sector-specific programmes must be drawn up with the input of key stakeholders concerned, including professional organisations, business organisations and consumer organisations,

            General obligations of economic operators: the latter must make available to market surveillance authorities information that enables the precise identification of the product and facilitates the tracing of the product.

            Economic operators shall cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by or non-compliance of products that they have placed or made available on the market.

            Cooperation and exchange of information: Members considered that the European Market Surveillance Forum should serve as a platform for cooperation not only between the authorities but also between the authorities and the economic operators as well as other stakeholders such as consumer groups. 

            They stressed the importance of structured cooperation under the auspices of this Forum, which is yet to be established. They wished to strengthen the future role of the Forum and suggest that the Commission should consider proposing, when this Regulation is next reviewed, that the Forum is given the power to set binding recommendations as to the quality and practices of market surveillance.

            Products presenting a risk: if the products in question present a serious risk, Members considered that preventing the product from being placed or made available on the market must be done Immediately.

            Measures taken by market surveillance authorities: the relevant economic operator shall bear all of the expenses related to the destruction of products and the expenses incurred by the market surveillance authorities. Furthermore, market surveillance authorities shall charge fees for the relevant economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market. 

            The Union rapid information system (RAPEX): this system must be constantly updated.   RAPEX should also include notifications related to Food Contact Materials, moved there from the Rapid Alert System for Food and Feed (RASFF) platform.

            Pan-European Injuries Database: the report required the Commission to adopt, two years after entry into force of the Regulation, delegated acts establishing a Pan-European Injuries Database which would cover all types of injuries, and in particular those related to products used at home and for leisure, transportation and work activities. The database shall be coordinated and operated by the Commission.

            Deterrent penalties: Members proposed the introduction of EU-wide, harmonised administrative penalties. To add to the deterrent effect sought, the penalties imposed under the Regulation should also be made public. In addition to this the report proposed establishing a public blacklist of operators who repeatedly breach this Regulation.

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          • Opinion of the European Data Protection Supervisor (EDPS).

            The EDPS appreciates that the regulation of the European Parliament and of the Council on market surveillance of products takes into account data protection issues to a certain extent. However, he gives some recommendations on how the Proposal could be further improved:

            The EDPD particularly recommends:

            • including a substantive provision to clarify that the Proposal is not meant to provide for general derogations from data protection principles and that relevant personal data processing legislation remain fully applicable in the market surveillance context;
            • to amend the proposal so as to ensure that only personal information which is strictly necessary is processed for market surveillance purposes in the Rapid Information System (RAPEX) and the Information and Communication System on Market Surveillance (ICSMS), respectively;
            • providing for fixed retention periods for the personal data processed in RAPEX and ICSMS;
            • maintaining the approach whereby the public is informed about unsafe products (via the RAPEX website) without making public personal information on economic operator(s) responsible for those products;
            • explicit substantive provisions that would at least specify what kind of personal data may be made public and for what purpose(s), if it is the intention of the legislator to provide for the publication of personal information on economic operators;
            • supplementing the provisions on participation of applicant countries, third countries or international organisations in RAPEX, as well as on international exchange of confidential information with explicit references to specific provisions about personal data protection corresponding to those applicable in the Union.
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          • group: S&D name: CUTAŞ George Sabin
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          • PURPOSE: Commission proposal on a single regulation on market surveillance of products aimed at simplifying the Union framework on market surveillance (product safety and market surveillance package).

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

            ROLE OF THE EUROPEAN PARLIAMENT: Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

            BACKGROUND: in a single market in which products circulate freely through 27 Member States, market surveillance needs to be highly coordinated and capable of reacting rapidly over a huge area. However, market surveillance has not kept pace with developments in the Union regulatory framework. Whilst advances have been made over the last decade, in particular with the implementation of Directive 2001/95/EC (General Product Safety Directive) and Regulation (EC) 765/2008 setting out the requirements for accreditation and market surveillance, the overlap of market surveillance rules and the obligations of economic operators laid down in various pieces of Union legislation has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union. Different product evaluation requirements and procedures apply depending on the category of product involved. The proposal aims to simplify the rules.

            It should be noted that in response to calls from the European Parliament, the proposal was added to the Product Safety and Market Surveillance Package, which also includes a proposal for a regulation on consumer product safety (replacing the GPSD) and a proposal on multi-annual action plan for market surveillance covering the period 2013-2015.

            IMPACT ASSESSMENT: the Commission carried out an impact assessment and a favourable opinion was delivered by the Impact Assessment Board in 2012.

            LEGAL BASIS: Articles 33, 114 and 207 of the Treaty on the Functioning of the European Union.

            CONTENT: this proposal aims at clarifying the regulatory framework for market surveillance in the field of non-food products. It merges the rules on market surveillance of the GPSD, Regulation (EC) 765/2008 and many sector-specific pieces of Union harmonisation legislation into a single legal instrument that applies horizontally across all sectors. The main aims are as follows:

            ·        to reduce the number of pieces of legislation containing market surveillance rules: the 3 tier system spread across the GPSD, Regulation (EC) 765/2008 and a range of sector-specific legislation will be reduced to a one tier system in which all those rules are brought together in a single instrument;

            ·        to eliminate overlaps in the current system: the new regulation will (a) dispense with the distinction between consumer and professional products for market surveillance purposes; (b) avoid making a distinction between harmonised products and non-harmonised products except where this is unavoidable in applying certain specific provisions. To the greatest extent possible the applicable rules will be the same for all products;

            ·        to dovetail the RAPEX and Union evaluation procedures: at present, there are two separate procedures operating, sometimes in parallel, which require Member States to notify to the Commission and to other Member States certain market surveillance action taken at national level. This is an especially problematic aspect of the overlapping categories of products mentioned above. Under the new Regulation the two procedures become a single procedural flow with certain events triggering a single notification to the other Member States and the Commission (made using either the proven RAPEX rapid alert system or the Information and Communication System for Market Surveillance in accordance with the distinction made in the Regulation). In urgent situations the Commission is empowered to adopt measures requiring consistent action across the EU against products presenting a serious risk;

            ·        to make the legislation more accessible: current market surveillance provisions are not based around a chronological flow of events. The new Regulation sets out the whole process of a market surveillance exercise in a chronological, sequential manner. It presents a chain of events, incorporating relevant provisions on publication of information, notification etc. at each stage of the procedure. This approach substantially improves the accessibility and user-friendliness of the legislation, and hence its effectiveness.

            BUDGETARY IMPLICATIONS: the budgetary implications are already envisaged in existing or proposed programmes and the initiative will be financed through redeployment of existing resources. According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 39 276 million in commitments for 2015-2020.

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          BUŞOI Cristian Silviu
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          committees
          • body: EP responsible: False committee_full: Agriculture and Rural Development committee: AGRI
          • body: EP responsible: False committee_full: Budgets committee: BUDG
          • body: EP responsible: False committee_full: Economic and Monetary Affairs committee: ECON
          • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
          • body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO
          • body: EP responsible: False committee_full: International Trade committee: INTA
          • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
          • body: EP responsible: False committee_full: Legal Affairs committee: JURI
          • body: EP responsible: False 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
          Mandatory consultation of other institutions
          Economic and Social Committee
          reference
          2013/0048(COD)
          subtype
          Legislation
          legal_basis
          stage_reached
          Preparatory phase in Parliament
          summary
          instrument
          Regulation
          title
          Market surveillance of products
          type
          COD - Ordinary legislative procedure (ex-codecision procedure)
          subject