Awaiting Council 1st reading position / budgetary conciliation convocation
Next event: Vote in committee, 1st reading/single reading 2013/10/17 more...
- Debate in Parliament 2014/04/15
- Committee report tabled for plenary, 1st reading/single reading 2013/10/22
- Council Meeting 2013/12/03
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Opinion | AGRI | ||
Opinion | BUDG | ||
Opinion | ECON | ||
Opinion | ENVI | ||
Lead | IMCO | PIETIKÄINEN Sirpa (PPE) | SCHALDEMOSE Christel (S&D), HELLVIG Eduard-Raul (ALDE), RÜHLE Heide (Verts/ALE), FOX Ashley (ECR), SALVINI Matteo (EFD) |
Opinion | INTA | CUTAŞ George Sabin (S&D) | |
Opinion | ITRE | ||
Opinion | JURI | ||
Opinion | LIBE |
Legal Basis TFEU 033, TFEU 114, TFEU 207
- 2.10.03 Standardisation, EC 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
- 8.50.02 Legislative simplification, coordination, codification
Activites
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2014/04/15
Debate in Parliament
- Debate in Parliament
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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.
- #3276
- 2013/12/03 Council Meeting
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2013/10/22
Committee report tabled for plenary, 1st reading/single reading
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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.
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A7-0346/2013
summary
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2013/10/17
Vote in committee, 1st reading/single reading
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2013/03/12
Committee referral announced in Parliament, 1st reading/single reading
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2013/02/13
Legislative proposal published
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COM(2013)0075
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.
- DG {'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}, TAJANI Antonio
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COM(2013)0075
summary
Documents
- Legislative proposal published: COM(2013)0075
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T7-0384/2014
- Committee report tabled for plenary, 1st reading/single reading: A7-0346/2013
- Debate in Council: 3276
Amendments | Dossier |
71 |
2013/0048(COD)
2013/06/27
INTA
71 amendments...
Amendment 23 #
Proposal for a regulation Citation 1 Having regard to the Treaty on the Functioning of the European Union,
Amendment 24 #
Proposal for a regulation Recital 1 (1) In order to guarantee the
Amendment 25 #
Proposal for a regulation Recital 1 (1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, fair trading practices, protection of consumers, protection of the environment, protection of intellectual property right and public security. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union goods market, online and offline, can thrive. Rules are therefore necessary on market surveillance, online and offline, and on controls of products entering the Union from third countries.
Amendment 26 #
Proposal for a regulation Recital 1 (1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, protection of intellectual property, protection of the environment and public
Amendment 27 #
Proposal for a regulation Recital 3 a (new) (3a) Given the EU´s importance as a global trading bloc, it is necessary to use this position to enhance the protection of public interests such as health and safety, the protection of workers' rights and the environment in the countries the EU is trading with.
Amendment 28 #
Proposal for a regulation Recital 8 (8) This Regulation should therefore integrate the provisions of Regulation 765/2008, Directive 2001/95/EC and several sector-specific acts of Union harmonisation legislation relating to market surveillance into a single regulation
Amendment 29 #
Proposal for a regulation Recital 15 (15) Market surveillance should be based on the assessment of the risk presented by a product taking all relevant data into account, and on a duty of care for all relevant economic operators, especially intermediaries, regardless of whether the products are traded online or offline. A product that is subject to Union harmonisation legislation which lays down essential requirements relating to protection of certain public interests should be presumed not to present a risk to those public interests if it complies with those essential requirements.
Amendment 30 #
Proposal for a regulation Recital 17 a (new) (17a) In the case of non-harmonised products, market surveillance authorities should take into account documentation provided by economic operators as per (EU) No [.../...] [on consumer product safety].
Amendment 31 #
Proposal for a regulation Recital 18 (18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector- specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled. Market surveillance authorities shall continue to apply the precautionary principle in cases where scientific evidence does not give certainty of the safety of a product.
Amendment 32 #
Proposal for a regulation Recital 18 (18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector- specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned, applying a duty of care, to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled.
Amendment 33 #
Proposal for a regulation Recital 20 (20) Obliging the authorities responsible for the control of products entering the Union market to carry out checks on an adequate scale therefore contributes to a safer Union market for products. In order to increase the effectiveness of such checks, cooperation and exchange of information between those authorities and market surveillance authorities concerning products presenting a risk should be enhanced. Given the increasing importance of imports into the EU and worries expressed by stakeholders about insufficient border controls, the Commission will monitor and assess the overall functioning of external border controls and will address recommendations to Member States in case of relevant shortcoming.
Amendment 34 #
Proposal for a regulation Recital 21 (21) Market surveillance authorities should be given the power to destroy products, render inoperable or order their destruction or withdrawal by the relevant economic operator, operating online or offline, if they deem it necessary and proportionate to ensure that such goods cannot pose any further threats
Amendment 35 #
Proposal for a regulation Recital 25 a (new) (25a) The Commission should ensure the multi-annual action plan for market surveillance covering the period 2013- 2015 "20 actions for safe and compliant products for Europe: a multi-annual action plan for the surveillance of products in the EU" is effectively implemented. By the end of 2015, the Commission should report on the results achieved through the foreseen 20 actions and examine the need for legislative and non-legislative actions to reduce the number of unsafe or non-compliant products and ensure effectiveness of the surveillance of products both within the Union and on entry into the Union.
Amendment 36 #
Proposal for a regulation Recital 30 (30) This Regulation should strike a balance between transparency through the release of the maximum possible amount of information to the public and
Amendment 37 #
Proposal for a regulation Recital 31 (31) Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional secrecy and be handled in a way that investigations are not compromised
Amendment 38 #
Proposal for a regulation Recital 33 (33) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive, in order to discourage the rogue traders to deliberately introduce dangerous or non- compliant products on the internal market.
Amendment 39 #
Proposal for a regulation Recital 33 a (new) (33a) In order for the penalties imposed on economic operators by the Member States to be effective, they should be introduced in a coordinated manner.
Amendment 40 #
Proposal for a regulation Recital 34 (34) Market surveillance should be financed at least in part by fees charged to economic operators where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves. Those fees should not be borne by the consumer and therefore should have no bearing on the retail price of a product.
Amendment 41 #
Proposal for a regulation Recital 34 a (new) (34a) The revenues collected from the infringement of this regulation should be earmarked for market surveillance activities.
Amendment 42 #
Proposal for a regulation Recital 41 (41) Since the objective of this Regulation, namely to ensure that products on the market, online and offline, covered by Union legislation fulfil the requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market, both online and offline, by providing a framework for coherent market surveillance in the Union, cannot be sufficiently achieved by the Member States as the attainment of this objective requires a very high degree of cooperation, interaction and uniformity of operation among all of the competent authorities of all Member States, and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 43 #
Proposal for a regulation Recital 42 (42) This Regulation respects the
Amendment 44 #
Proposal for a regulation Recital 42 (42) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. in particular this Regulation seeks to ensure full respect for obligation to ensure a high level of human health protection
Amendment 45 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation lays down a framework for verifying that products available online or offline meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, fair trading practices, consumer protection, the environment, the protection of intellectual property right, the protection of public security and other public interests.
Amendment 46 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation lays down a framework for verifying that products meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace,
Amendment 47 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation lays down a framework
Amendment 48 #
Proposal for a regulation Article 2 – paragraph 1 1. Chapters I, II, III, V and VI of this Regulation shall apply to all products that are subject to Regulation (EU) No [… on Consumer Product Safety] or Union harmonisation legislation, including to products assembled or manufactured for the manufacturer's own exclusive use, and to the extent that Union harmonisation legislation does not contain a specific provision with the same objective.
Amendment 49 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) ‘making available on the market’ means any supply or presentation of a product for distribution, consumption or use on the Union market, online or offline, in the course of a commercial activity, whether in return for payment or free of charge;
Amendment 50 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘placing on the market’ means the first making available of a product on the Union market, either online or offline;
Amendment 51 #
Proposal for a regulation Article 3 – paragraph 1 – point 11 (11) ‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products available either online or offline do not endanger health, safety or any other aspect of public interest protection and, in the case of products falling within the scope of Union harmonisation legislation, that they comply with the requirements set out in that
Amendment 52 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 (12) ‘market surveillance authority’ means an authority of a Member State responsible for carrying out market surveillance, either online or offline, on its territory;
Amendment 53 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 (13) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, protection of intellectual property rights and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;
Amendment 54 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 (13) ‘product presenting a risk’ means a product
Amendment 55 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 (13) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general,
Amendment 56 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 a (new) (13a) ‘product presenting a regulatory risk’ means a product which fails to comply with applicable Union legislation;
Amendment 57 #
Proposal for a regulation Article 3 – paragraph 1 – point 18 (18) ‘Union harmonisation legislation’ means Union legislation harmonising the conditions
Amendment 58 #
Proposal for a regulation Article 4 – paragraph 2 2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products presenting a risk are not placed or made available on the Union market and, where such products have been made available, effective measures are taken to remove the risk presented by the product.
Amendment 59 #
Proposal for a regulation Article 4 – paragraph 2 2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products presenting a risk, and products that are not compliant with the applicable Union legislation are not made available on the Union market and, where such products have been made available, effective measures are taken to remove the risk presented by the product.
Amendment 60 #
Proposal for a regulation Article 4 – paragraph 3 3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls carried out
Amendment 61 #
Proposal for a regulation Article 5 – paragraph 2 2. Market surveillance authorities shall be given the powers and entrusted with the resources and means necessary for the proper performance of their tasks. Member States will inform the Commission annually about the resources allocated to market surveillance authorities. On this basis the Commission will evaluate the appropriateness of resource endowment and will send recommendations to the Member States in case of insufficient resources.
Amendment 62 #
Proposal for a regulation Article 5 – paragraph 5 a (new) 5a. The market surveillance authorities shall undertake to fast-track the harmonisation of customs control systems, with the support of the national authorities.
Amendment 63 #
Proposal for a regulation Article 5 – paragraph 5 a (new) 5a. Market surveillance authorities must fully contribute to stepping up the harmonisation of customs control systems in cooperation with the national authorities.
Amendment 64 #
Proposal for a regulation Article 6 – paragraph 2 – subparagraph 1 Amendment 65 #
Proposal for a regulation Article 6 – paragraph 2 – subparagraph 2 They shall cooperate with economic operators and trade unions to prevent or reduce risks caused by products made available by those
Amendment 66 #
Proposal for a regulation Article 6 – paragraph 5 – point a (a) provide consumers and other interested parties, including trade unions, with the opportunity to submit complaints on issues relating to product
Amendment 67 #
Proposal for a regulation Article 8 – title General obligations of
Amendment 68 #
Proposal for a regulation Article 8 – paragraph 1 1. On request,
Amendment 69 #
Proposal for a regulation Article 8 – paragraph 1 a (new) 1a. Manufacturers and importers shall ensure that their products are placed on the market and approved in accordance with the requirements set pout in the EU legislation that fall in the scope of this Regulation and safe for use
Amendment 70 #
Proposal for a regulation Article 8 – paragraph 1 b (new) 1b. Manufacturers and importers established outside the Union shall appoint a single representative established within the Union for the purposes of market surveillance.
Amendment 71 #
Proposal for a regulation Article 8 – paragraph 1 c (new) 1c. Manufacturers and importers shall indicate their name, registered trade name or registered trade mark and the address in the Union at which they can be contacted on or with the product that is placed in the market.
Amendment 72 #
Proposal for a regulation Article 8 – paragraph 2 2.
Amendment 73 #
Proposal for a regulation Article 8 – paragraph 2 a (new) 2a. Manufacturers established outside the Union shall appoint a single authorised representative established within the Union for the purposes of market surveillance
Amendment 74 #
Proposal for a regulation Article 8 – paragraph 2 b (new) 2b. Importers shall have the authorisation of the manufacturer established outside the EU to act as an authorised representative of the manufacturer for the purposes of market surveillance.
Amendment 75 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 a (new) In the case of products that are not subject to Union harmonisation legislation, market surveillance authorities will take in due consideration protocols, checklists and other relevant documents that economic operators will have provided with regard the to risk assessment of products as per Directive [...] on consumer products safety.
Amendment 76 #
Proposal for a regulation Article 9 – paragraph 2 – subparagraph 1 – point a a (new) (aa) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin.
Amendment 77 #
Proposal for a regulation Article 9 – paragraph 3 – subparagraph 2 The economic operator, applying a duty of care, shall ensure that all necessary corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.
Amendment 78 #
Proposal for a regulation Article 10 – paragraph 1 1. Where the identity of the relevant economic operator cannot be ascertained
Amendment 79 #
Proposal for a regulation Article 13 – paragraph 1 – subparagraph 1 Risk assessment shall be based on available scientific or technical evidence and, when there is a suspected risk of causing harm to public health in spite of lack of scientific consensus, the precautionary principle shall be invoked.
Amendment 80 #
Proposal for a regulation Article 13 – paragraph 2 – point c a (new) (ca) any ILO conventions signed and ratified by the countries involved in the manufacturing and/or processing of the product;
Amendment 81 #
Proposal for a regulation Article 14 – paragraph 3 – subparagraph 2 a (new) In the case of products that are not subject to Union harmonisation legislation, authorities in charge of external border controls will take in due consideration protocols, checklists and other relevant documents that economic operators will have provided with regard the to risk assessment of products as per Directive (EU) No [.../...] [on consumer products safety], and which market surveillance authorities will have made available to them, in order to assess product risks.
Amendment 82 #
Proposal for a regulation Article 14 – paragraph 3 – subparagraph 2 – point b a (new) (ba) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin.
Amendment 83 #
Proposal for a regulation Article 14 – paragraph 6 a (new) 6a. The Commission should ensure that authorities in charge of the control of products at external borders carry out checks in a uniform manner across the EU. The Commission should also evaluate whether authorities dispose of the necessary resources to execute their function effectively. To this purpose, Member States should send annually to the Commission a report explaining how national authorities have carried out checks and risk evaluations, reporting about available resources and including statistics regarding the number of controls carried out. On the basis of this reporting mechanism, the Commission may send recommendations to the Member States in case of important discrepancies and shortcomings.
Amendment 84 #
Proposal for a regulation Article 15 – paragraph 1 1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 14 shall be released if, within
Amendment 85 #
Proposal for a regulation Article 23 – paragraph 1 1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, among the different authorities within each Member State and between market surveillance authorities and the Commission and the relevant Union agencies regarding market surveillance programmes and all issues relating to
Amendment 86 #
Proposal for a regulation Article 23 – paragraph 1 1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, among the different authorities within each Member States and between market surveillance authorities and the Commission and the relevant Union agencies regarding market surveillance programmes and all issues relating to products presenting a risk, also in view of ensuring a full consistency in the management of the EU external borders.
Amendment 87 #
Proposal for a regulation Article 24 – paragraph 1 1.
Amendment 88 #
Proposal for a regulation Article 24 – paragraph 1 1.
Amendment 89 #
Proposal for a regulation Article 31 – paragraph 1 The Member States
Amendment 90 #
Proposal for a regulation Article 31 – paragraph 2 Amendment 91 #
Proposal for a regulation Article 31 – paragraph 2 a (new) The Commission shall establish the minimum penalties amounts as well as the conditions for collection of these penalties, including special provisions for small and medium-sized enterprises.
Amendment 92 #
Proposal for a regulation Article 31 – paragraph 2 a (new) The penalties shall be earmarked for market surveillance activities in the Member States concerned.
Amendment 93 #
Proposal for a regulation Article 31 – paragraph 2 b (new) The types of infringements which are subject to a penalty shall include at least the following: (a) products presenting a risk according to Article 9(2) until indent (d) or non compliant with the criteria referred to in points (a), (b) and (c) of Article 13(2); (b)making false declaration during approval procedures leading to a recall; (c) falsifying test results for type- approval; (d) refusal to provide access to information
source: PE-514.716
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(these mark the time of scraping, not the official date of the change)
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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:
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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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