2017/0353(COD) Compliance with and enforcement of Union harmonisation legislation on products
Lead committee dossier:
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | IMCO |
DANTI Nicola ( S&D)
|
KARAS Othmar ( PPE),
DALTON Daniel ( ECR),
SELIMOVIC Jasenko ( ALDE),
DURAND Pascal ( Verts/ALE),
ZULLO Marco ( EFDD)
|
| Committee Opinion | ENVI |
MIKOLÁŠIK Miroslav ( PPE)
|
Guillaume BALAS ( S&D),
Urszula KRUPA ( ECR),
Gesine MEISSNER ( ALDE)
|
| Committee Opinion | INTA | ||
| Committee Opinion | ITRE |
Lead committee dossier:
Legal Basis:
TFEU 033, TFEU 114, TFEU 207
Legal Basis:
TFEU 033, TFEU 114, TFEU 207Subjects
Events
2019/08/08
EC - Commission response to text adopted in plenary
Documents
2019/06/25
Final act published in Official Journal
Details
PURPOSE: to improve the functioning of the internal market by strengthening product surveillance in the market.
LEGISLATIVE ACT: Regulation (EU) 2019/1020 of the European Parliament and of the Council on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011.
CONTENT: the Regulation aims to ensure that only compliant products which comply with the requirements guaranteeing a high level of protection of public interests such as health and safety in general, health and safety at work, consumer protection, protection of the environment and public safety and any other public interest protected by the said legislation, are placed on the market in the Union.
The Regulation establishes rules and procedures for economic operators with regard to products subject to certain provisions of EU harmonisation legislation and creates a framework for cooperation with economic operators. It also sets out a framework for controls on products entering the Union market.
Tasks of economic operators
Economic operators (manufacturers, importers, agents, fulfilment service providers established in the Union in respect of the products they handle) shall in particular be required to:
- verify that the EU declaration of conformity or the declaration of performance and technical documentation have been drawn up and ensure that the technical documentation can be made available to the supervisory authorities at their request;
- provide the authorities with all the information and documents necessary to demonstrate the conformity of the product in a language that can be easily understood by that authority;
- cooperate with market surveillance authorities, including, following a reasoned request, and ensure that the immediate and necessary corrective action is taken to remedy any case of non-compliance.
Joint activities to promote compliance with legislation
Market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or end users on the carrying out of joint activities that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonisation legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online.
Activities of market surveillance authorities
Each Member State shall designate one or more market surveillance authorities in its territory. Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities, using the information and communication system.
Each Member State shall appoint a single liaison office.
These authorities shall ensure effective market surveillance of products made available online and offline on their territory and the adoption of appropriate and proportionate measures if the operator does not take corrective measures.
Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias.
They shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples. This shall be based on a risk-based approach taking into account factors such as potential hazards associated with the product, the economic operator's history of non-compliance and consumer complaints.
In order to assist market surveillance authorities to strengthen consistency in their activities related to the application of this Regulation, an effective peer review system should be established for those market surveillance authorities wishing to participate.
Market surveillance powers and measures
The Regulation establishes a set of powers for market surveillance authorities to ensure the effective enforcement of EU product legislation in a cross-border context. This includes power:
- to access data related to a non-compliance event,
- to obtain information on the supply chain or for the purpose of identifying the owner of a website,
- to carry out on-site inspections,
- to make test purchases, including under a false identity,
- to bring the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk;
- to prevent the product from being made available on the market;
- to withdraw or recall the product immediately and alerting the public to the risk presented;
- to impose sanctions and
- to alert the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market.
Union Product Compliance Network
The Regulation establishes a Union product compliance network within the Commission which will serve as a platform for coordination and structured cooperation between the supervisory authorities of the Member States and the Commission.
Information and communication system for market surveillance (ICSMS) and RAPEX have been developed in order to increase the level of cooperation and exchange of information between Member States and the Commission.
The Regulation also sets out a reinforced framework for controls on products entering the EU market and reinforces the exchange of information between market surveillance and customs authorities.
ENTRY INTO FORCE: 15.7.2019.
APPLICATION: from 16.7.2021. However, certain provisions are applicable from 1.1.2021.
2019/06/20
CSL - Draft final act
Documents
2019/06/20
CSL - Final act signed
2019/06/20
EP - End of procedure in Parliament
2019/06/14
EP/CSL - Act adopted by Council after Parliament's 1st reading
2019/06/14
CSL - Council Meeting
2019/04/17
EP - Results of vote in Parliament
Documents
2019/04/17
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 562 votes to 60, with 33 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council.
The European Parliament’s position adopted at first reading under the ordinary legislative procedure amended the Commission proposal as follows:
Strengthening market surveillance
The proposed Regulation aims to improve the functioning of the internal market by strengthening the market surveillance of products covered by the Union harmonisation legislation, with a view to ensuring that only compliant products that fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, the protection of the environment and public security and any other public interests protected by that legislation, are made available on the Union market.
This Regulation lays down rules and procedures for economic operators regarding products subject to certain Union harmonisation legislation and establishes a framework for cooperation with economic operators.
Tasks of economic operators
A product covered by Union legislation may only be placed on the market if an economic operator established in the Union performs the following tasks with regard to that product:
- verify that the EU declaration of conformity or the declaration of performance and technical documentation have been drawn up and ensure that the technical documentation can be made available to these authorities upon request;
- provide the authorities with all the information and documentation necessary to demonstrate the conformity of the product in a language that can be easily understood by that authority;
- cooperate with market surveillance authorities, including, following a reasoned request, ensuring that the immediate and necessary corrective action is taken to remedy any case of non-compliance with the requirements laid down in the Union harmonisation legislation applicable to the product in question.
Economic operators shall be required to cooperate with market surveillance authorities with a view to adopting measures that would eliminate or reduce the risks posed by products made available on the market by these operators.
Activities of market surveillance authorities
These authorities shall ensure effective market surveillance of products made available online and offline on their territory and the adoption of appropriate and proportionate measures if the operator does not take corrective measures.
Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias.
They shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples. This shall be based on a risk-based approach taking into account factors such as potential hazards associated with the product, the economic operator's history of non-compliance and consumer complaints.
In order to assist market surveillance authorities to strengthen consistency in their activities related to the application of this Regulation, an effective peer review system should be established for those market surveillance authorities wishing to participate.
Market surveillance powers and measures
The powers conferred on market surveillance authorities shall include at least the following:
- to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product;
- to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites;
- to carry out unannounced on-site inspections and physical checks of products;
- to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk;
- to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled;
- to impose penalties in accordance with Article 41;
- the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence;
- to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface. or
Corrective actions that may be imposed on the economic operator shall include (i) bringing the product into compliance, (ii) preventing the product from being made available on the market, (iii) immediately withdrawing or recalling the product and warning the public of the risk involved, (iv) destroying the product or rendering it inoperable, (v) immediately alerting end-users exposed to the risk, including by publishing specific warnings in the language or languages determined by the Member State in which the product is made available on the market.
Union Product Compliance Network
The amended text specifies that the purpose of the Network is to serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective.
The role of the network shall be strengthened. In particular, it would be able to (i) adopt its work programme defining priorities for joint market surveillance actions; (ii) facilitate the identification of common priorities for market surveillance activities and the exchange of information across sectors on evaluations of products; (iii) promote cooperation and the exchange of expertise and best practices between market surveillance authorities and authorities in charge of controls at the Union’s external borders.
Lastly, a number of existing tools, such as the information and communication system for market surveillance (ICSMS) and RAPEX have been developed in order to increase the level of cooperation and exchange of information between Member States and the Commission.
Documents
2019/02/20
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2019/02/15
CSL - Coreper letter confirming interinstitutional agreement
Documents
2019/02/15
EP - Text agreed during interinstitutional negotiations
Documents
2018/09/12
EP - Committee decision to enter into interinstitutional negotiations confirmed by plenary (Rule 71)
2018/09/10
EP - Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 71)
2018/09/06
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on the Internal Market and Consumer Protection adopted the report by Nicola DANTI (S&D, IT) on the proposal for a regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council.
The committee recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the Commission's proposal as follows.
Strengthen market surveillance : the proposed Regulation shall aim to improve the functioning of the internal market by strengthening product surveillance of products with a view to ensure that only compliant products that fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment and public security, are made available on the Union market.
Under the amended text, market surveillance authorities shall take appropriate measures, including ensuring that the making available of the product on the market is prohibited or restricted or that a product is withdrawn or recalled from the market if the product is liable to compromise the health or safety of end-users; if the product does not conform to applicable requirements under Union harmonisation legislation or if it is counterfeit.
Reference person : all companies wishing to sell products on the single market, including those from third countries, shall first designate a reference person in the EU for these products. This person shall be responsible for contacting the manufacturer in the event of non-compliance and taking action to remedy any case of non-compliance.
Compliance partnership agreements : the proposal introduces the possibility for a market surveillance authority to enter into partnership agreement with an economic operator established in its territory. Members are against harmonised provisions on compliance partnership agreements.
Enhanced cooperation between Member States' supervisory authorities : market surveillance authorities shall develop appropriate and effective communication and cooperation mechanisms with customs authorities for the identification and examination of potential risks related to counterfeit products and withdrawal of such products from the market.
To ensure that the same rules are applied in the same manner by the different market surveillance authorities in the Member States, Members propose harmonising the methodology and criteria for assessing risks and the checks in order to ensure a level playing field for all economic operators. They also suggested creating an effective peer review system to help market surveillance authorities ensure the uniform implementation of the Regulation.
EU Product Compliance Network : Members specified that the purpose of the Network is to serve as a platform for structured cooperation between authorities of the Member States and the Commission and to streamline the practices of market surveillance within the Union making market surveillance activities more effective.
It is proposed to strengthen the role of the Network , in particular by providing it with the possibility of (i) adopting its bi-annual work programme setting out priorities for common market surveillance actions, (ii) regularly discussing a general risk assessment methodology, (iii) discussing the uniform conditions of checks, criteria for determination of the frequency of checks or amount of samples to be checked in relation to certain products, and (iv) facilitating the exchange of information on non-compliant products.
E-commerce and Internet of Things : the development of e-commerce poses certain challenges for market surveillance authorities with regard to ensuring the compliance of products sold online and effectively enforcing the Union harmonisation legislation.
Members proposed that each Member State should provide for the efficient organisation of market surveillance activities for products sold online and ensure that there is an appropriate number of inspectors , dealing with products sold online (“online inspectors”), within their national market surveillance authorities.
Economic operators offering a product for sale online shall indicate with their offer for sale the name, registered trade name or registered trade mark and the contacts details of a reference person with respect to the product.
Information and communication system : the system shall allow data to be shared between Member States and allow the Commission to monitor market surveillance activities. This system shall have a public interface with key information in all Union languages and inform end-users about market surveillance activities and their results.
Consumers who have purchased non-compliant products shall be informed, through an online portal, of rights relating to non-compliant products which they have acquired, such as the right to obtain a replacement for a product or to receive compensation, the right of recourse and contacts from which all appropriate information can be obtained.
Documents
2018/09/03
EP - Vote in committee, 1st reading
2018/09/03
EP - Committee decision to open interinstitutional negotiations with report adopted in committee
2018/07/12
EP - Committee opinion
Documents
2018/05/24
EP - Amendments tabled in committee
Documents
2018/05/24
EP - Amendments tabled in committee
Documents
2018/04/29
CZ_SENATE - Contribution
Documents
2018/04/17
EP - Committee draft report
Documents
2018/03/26
PT_PARLIAMENT - Contribution
Documents
2018/03/25
CZ_CHAMBER - Contribution
Documents
2018/03/13
RO_SENATE - Contribution
Documents
2018/03/01
EP - MIKOLÁŠIK Miroslav (PPE) appointed as rapporteur in ENVI
2018/02/05
EP - Committee referral announced in Parliament, 1st reading
2018/01/23
EP - DANTI Nicola (S&D) appointed as rapporteur in IMCO
2017/12/19
EC - Document attached to the procedure
Documents
2017/12/19
EC - Document attached to the procedure
Documents
2017/12/19
EC - Document attached to the procedure
Documents
2017/12/19
EC - Document attached to the procedure
Documents
2017/12/19
EC - Document attached to the procedure
Documents
2017/12/19
EC - Legislative proposal published
Details
PURPOSE: to ensure that products placed on the Union market comply with the requirements of Union harmonisation legislation.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure on an equal footing with the Council
BACKGROUND: within the single market, the free movement of goods generates around 25% of EU GDP and 75% of intra-EU trade. However, much remains to be done to achieve a deep and fair European Single Market. The increasing number of illegal and non-compliant products on the market distorts competition and puts consumers at risk.
The evaluation of Regulation (EC) No 765/2008 indicated that it has been only partly effective in achieving its specific and strategic objectives. This is mainly because coordination and cooperation have still not reached a satisfactory level. Tools such as the Union Rapid Alert System for dangerous non-food products (RAPEX) and the Information and Communication System on Market Surveillance (ICSMS) are in place to ensure cross-border market surveillance cooperation, but they are not sufficiently used by Member States.
Furthermore, Regulation (EC) No 765/2008 is not yet uniformly applied , due to the significant differences in how Member States implement it. This concerns the organisation of market surveillance at national level, the availability of financial, human and technical resources, the strategies of market surveillance, the powers of inspection and of sanctions and the systems of monitoring and reporting.
Lastly, border controls on imported products seem insufficient.
As announced by the Commission in the 2017 work programme, the initiative aims to address the growing number of non-compliant products on the Union market , while offering incentives to boost compliance with the regulation and ensure fair and equal treatment that will benefit businesses and citizens. In particular, it provides for appropriate incentives for businesses, increased compliance checks and enhanced cross-border law enforcement cooperation.
IMPACT ANALYSIS: the preferred option is to improve existing tools and cooperation mechanisms. In addition, effective enforcement strategies deployed by Member States that include control activities and capacity building at the national level require the establishment of a Union product compliance network.
CONTENT: the purpose of this proposal for a Regulation on compliance with and enforcement of Union harmonisation legislation on products is to contribute to a deeper and fairer internal market for goods by promoting greater cooperation between national market surveillance authorities.
In concrete terms, the proposal:
introduces the concept of a ‘ person responsible for compliance information established within the Union ’ as a necessary condition for making the products available on the market. The person responsible for compliance information can be the manufacturer, the importer or any other economic operator designated by the manufacturer. The tasks of the person responsible for compliance information are essentially to provide information on the product to market surveillance authorities and to cooperate with the authorities; defines how to designate competent authorities and single liaison offices for this Regulation and clarifies the roles of the single liaison offices; sets out the Member States’ obligations as regards organisation of market surveillance within their territory and lays down the procedures they must establish to follow up complaints or issues relating to risks; monitor accidents and harm to the health of end-users; verify corrective actions taken by economic operators; and follow up scientific and technical knowledge of safety issues; provides for a set of powers for market surveillance authorities , defined with the view to ensure effective enforcement of Union harmonisation legislation on products is enforced effectively across borders. These powers include the power to access data and documents related to an instance of non-compliance, to require economic operators and public entities to provide all information related to an instance of non-compliance; to carry out on sit inspections; to initiate investigations or procedures aimed at ceasing non-compliance; to prohibit the supply of products, or withdraw and recall and destroy them; to impose penalties and order the recovery of profits obtained as a result of non-compliance; and to publish decisions; provides for the exchange of information on illegal products and on-going investigations so that governments can take effective action against non-compliant products; imposes stricter mutual assistance obligations and the legal presumption that products declared to be non-compliant in one Member State are also non-compliant across the EU; provides for a strengthened framework for controls on products entering the Union market and strengthens the exchange of information between market surveillance authorities and customs authorities, in particular through procedures for releasing products, suspending and refusing of release for free circulation; establishes a Union product compliance network (the network) within the Commission to coordinate enforcement tasks, thereby boosting market surveillance cooperation at EU level.
BUDGETARY IMPLICATIONS: the proposal requires human and administrative resources, as well as operational appropriations. The total impact on expenditure is estimated at EUR 12.576 million up to the year 2020 inclusive.
Documents
Documents
- Commission response to text adopted in plenary: SP(2019)440
- Final act published in Official Journal: Regulation 2019/1020
- Final act published in Official Journal: OJ L 169 25.06.2019, p. 0001
- Draft final act: 00045/2019/LEX
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading: T8-0397/2019
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE643.161
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: GEDA/A/(2019)003073
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2019)003073
- Text agreed during interinstitutional negotiations: PE643.161
- Committee report tabled for plenary, 1st reading: A8-0277/2018
- Committee opinion: PE620.896
- Amendments tabled in committee: PE622.181
- Amendments tabled in committee: PE622.182
- Contribution: COM(2017)0795
- Committee draft report: PE620.871
- Contribution: COM(2017)0795
- Contribution: COM(2017)0795
- Contribution: COM(2017)0795
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2017)0466
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2017)0467
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2017)0468
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2017)0470
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2017)0469
- Legislative proposal published: COM(2017)0795
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SWD(2017)0466
- Document attached to the procedure: EUR-Lex SWD(2017)0467
- Document attached to the procedure: EUR-Lex SWD(2017)0468
- Document attached to the procedure: EUR-Lex SWD(2017)0470
- Document attached to the procedure: EUR-Lex SWD(2017)0469
- Committee draft report: PE620.871
- Amendments tabled in committee: PE622.181
- Amendments tabled in committee: PE622.182
- Committee opinion: PE620.896
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2019)003073
- Text agreed during interinstitutional negotiations: PE643.161
- Draft final act: 00045/2019/LEX
- Commission response to text adopted in plenary: SP(2019)440
- Contribution: COM(2017)0795
- Contribution: COM(2017)0795
- Contribution: COM(2017)0795
- Contribution: COM(2017)0795
Activities
- Sergio Gaetano COFFERATI
Plenary Speeches (1)
- Miroslav MIKOLÁŠIK
Plenary Speeches (1)
- Marlene MIZZI
Plenary Speeches (1)
- Jasenko SELIMOVIC
Plenary Speeches (1)
- Dobromir SOŚNIERZ
Plenary Speeches (1)
Votes
A8-0277/2018 - Nicola Danti - Am 214 17/04/2019 12:55:17.000 #
2019/04/17 Outcome: +: 562, -: 60, 0: 33
GUE/NGL
NI
ENFA8-0277/2018 - Nicola Danti - Am 214 #
2019/04/17 Outcome: +: 562, -: 60, 0: 33
| Amendments | Dossier |
| 577 |
2017/0353(COD)
2018/05/24
IMCO
436 amendments...
Amendment 129 #
Proposal for a regulation – The European Parliament rejects [the Commission proposal].
Amendment 130 #
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 products are fully compliant with the EU law and 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 the environment and public security, similarly to requirements governing similar products produced within the EU Single Market. 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 market for goods can thrive. Rules are therefore necessary to ensure this enforcement throughout the internal market, including on products entering the Union from third countries.
Amendment 131 #
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 products 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 the environment 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 market for goods can thrive. Rules are therefore necessary to ensure this enforcement throughout the internal market,
Amendment 132 #
Proposal for a regulation Recital 1 a (new) (1a) The value of products subject to Union harmonisation rules amounts to more than EUR 2 400 billion per year representing 69 % of the overall value of manufacturing products in the Union.
Amendment 133 #
Proposal for a regulation Recital 1 b (new) (1a) Non-compliant products cause harm to buyers and law-abiding undertakings alike. In practice, non- compliance means that citizens are exposed to potentially dangerous products or that the environment is put at risk. Furthermore, non-compliance means that undertakings selling compliant products face distorted competition which cuts corners or deliberately flouts the rules in order to gain a competitive edge.
Amendment 134 #
Proposal for a regulation Recital 2 (2) Strengthening the Single Market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the Commission ‘Upgrading the Single Market: more opportunities for people and businesses’24
Amendment 135 #
Proposal for a regulation Recital 3 (3) Currently, the implementation of surveillance to guarantee compliance is insufficient. The framework for market surveillance should be strengthened in order to reach the set objectives, with a view to further improving compliance with and enforcement of Union harmonisation legislation on products. Surveillance of compliance should go beyond monitoring of safety of a product, and cover other EU standards such as labour, health and environmental standards.
Amendment 136 #
Proposal for a regulation Recital 3 (3) Currently, the implementation of surveillance to guarantee compliance is insufficient. The framework for market surveillance should be strengthened in order to reach the set objectives, with a view to further improving compliance with and enforcement of Union harmonisation legislation on products. Surveillance of compliance should go beyond monitoring of safety of a product, and cover other EU standards such as labour, health and environmental standards.
Amendment 137 #
Proposal for a regulation Recital 4 (4) Directive 2001/95/EC of the European Parliament and of the Council25 lays down the general safety requirements for all consumer products and provides for specific obligations and powers of the Member States in relation to dangerous products as well as for the exchange of information to that effect through the Union Rapid Alert System for dangerous non-food products (RAPEX). Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. In order to achieve a higher level of safety, quality and reliability for consumer products, the mechanisms for exchanges of information and rapid intervention situations provided for in Directive 2001/95/EC and reinforced by Regulation (EC) No 765/2008 of the European Parliament and of the Council26 should be complemented to make them more effective. _________________ 25 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). 26 Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for
Amendment 138 #
Proposal for a regulation Recital 5 (5) This Regulation should cover
Amendment 139 #
Proposal for a regulation Recital 5 (5) This Regulation should cover products that are subject to the Union harmonisation legislation listed in the Annex. The legislation listed in the Annex should cover all Union harmonisation legislation concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level and will increase consumer confidence in products on the market. Several instruments of Union harmonisation legislation on products need to be amended in consequence, in particular to remove references to certain provisions of Regulation (EC) No 765/2008. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to provide whether this Regulation is also to apply to that legislation.
Amendment 140 #
Proposal for a regulation Recital 5 (5) This Regulation should cover
Amendment 141 #
Proposal for a regulation Recital 8 a (new) (8a) Responsibility for compliance with the EU standards lies with the importer. For this end, self-monitoring and control of importers should be strengthened and the system for self-monitoring developed. This should be done by strengthening the liability for self-monitoring of the importer, who should be required to conduct an independent third party audit. The liability for compliance would also be held by the independent third party auditor regarding the accuracy of the audit.
Amendment 142 #
Proposal for a regulation Recital 9 (9) Responsibility for enforcing Union harmonisation legislation should lie with the Member States, whose market surveillance authorities should be required to ensure that the legislation is fully complied with. The Member States should, therefore, establish harmonised systematic approaches, including effective, proportionate and dissuasive penalties, to ensure effectiveness of market surveillance and other enforcement activities. In case of serious and recurrent breaches of compliance should be followed by sanctions, corresponding to 5% of the turnover of an entity.
Amendment 143 #
Proposal for a regulation Recital 11 a (new) (11a) The identification and traceability of products is a necessary prerequisite for verifying whether the compliance requirements laid down by this Regulation are respected.
Amendment 144 #
Proposal for a regulation Recital 11 b (new) (11b) Economic operators must always be able to identify their suppliers and downstream operators to whom a particular product has been supplied. Products should therefore bear information enabling them, their manufacturer and, where applicable, their importer to be identified.
Amendment 145 #
Proposal for a regulation Recital 11 c (new) (11c) As the indication of the country of origin helps to identify the actual place of manufacture, and as such information can facilitate the task of the market surveillance authorities in identifying the actual place of manufacture, the indication of origin should be added to the basic traceability requirements concerning the name and address of the manufacturer.
Amendment 146 #
Proposal for a regulation Recital 12 (12) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective role in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Products, which seek to enter the Union market should be held to the same production standards as those which are produced and sold within the EU. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Regulation (EC) No 273/2004 of the European Parliament and of the Council31
Amendment 147 #
Proposal for a regulation Recital 12 (12) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective role in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Products, which seek to enter the Union market should be held to the same production standards as those which are produced and sold within the EU. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Regulation (EC) No 273/2004 of the European Parliament and of the Council31
Amendment 148 #
Proposal for a regulation Recital 12 a (new) (12a) Within the internal market, there is an increasing number of products in circulation which have begun to put constraints on public resources and limit the possibility of increasing public market surveillance on an adequate scale. This could be alleviated by complementary and innovative market-based solutions to provide for more effective market surveillance on a larger scale such as independent third party auditing of quality control systems and products.
Amendment 149 #
Proposal for a regulation Recital 13 (13) The development of e-commerce is also due to a great extent to the proliferation of information society service providers, normally through platforms and for remuneration, which offer intermediary services by storing third party content, but without exercising any control over such content, thus not acting on behalf of an economic operator. Removal of content regarding non-compliant products or where it is not feasible blocking access to non- compliant products offered through their services should be without prejudice to the rules laid down in Directive 2000/31/EC of the European Parliament and of the Council55. In particular, no general obligation should be imposed on service providers to monitor the information which they transmit or store, nor should a general obligation be imposed upon them to actively seek facts or circumstances indicating illegal activity. Furthermore, hosting service providers should not be held liable as long as they do not have actual knowledge of illegal activity or information and are not aware of the facts or circumstances from which the illegal
Amendment 150 #
Proposal for a regulation Recital 13 a (new) (13a) While this Regulation does not deal with the protection of intellectual property rights, it should nevertheless be borne in mind that often counterfeit products do not comply with the requirements set out in the Union harmonisation legislation, pose serious risks to health and safety of end-users, distort competition, endanger public interests and support other illegal activities. Therefore Member States should continue taking effective measures in preventing the entry of counterfeit products to the Union’s market pursuant to Regulation (EU) 608/2013. In the interest of efficiency, customs authorities should be able to use their expertise and relevant information on risks, related to products infringing an intellectual property rights, also for the purpose of effective market surveillance of products entering the Union’s market pursuant to this Regulation.
Amendment 151 #
Proposal for a regulation Recital 13 a (new) (13a) The proliferation of E-Commerce and New Technologies such as Artificial Intelligence may pose new challenges to traditional market supervision. To avoid this, adapting Union harmonisation legislation on products to Digital is necessary. In this respect Member States should explore Blockchain potential for real-time market surveillance.
Amendment 152 #
Proposal for a regulation Recital 14 (14) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this purpose, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers, distributors and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product. It is important that there should be a contact person established in the Union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s
Amendment 153 #
Proposal for a regulation Recital 14 a (new) (14a) Ensuring product identification and traceability throughout the entire supply chain will help to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls. Product identification and traceability will thus ensure that consumers and economic operators obtain accurate information regarding unsafe products, which will enhance confidence in the market and avoid disrupting trade unnecessarily. Products should therefore bear information enabling them, their manufacturer and, where applicable, their importer to be identified. Manufacturers should also produce technical documentation regarding their products, for which they may choose the most appropriate and cost-efficient form, for example electronic form. Moreover, economic operators must be able to identify the operators who supplied them with a product and those to whom one of their products has been supplied.
Amendment 154 #
Proposal for a regulation Recital 14 b (new) (14b) The indication of origin is additional to the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture if the manufacturer cannot be traced or if the address supplied is different from that of the actual place of manufacture. This information can facilitate the task of the market surveillance authorities in identifying the actual place of manufacture and makes it possible to contact the authorities of the country of origin in the framework of bilateral or multilateral cooperation on consumer product safety with a view to appropriate subsequent monitoring.
Amendment 155 #
Proposal for a regulation Recital 16 a (new) (16a) Special attention should be given to a proliferation of Internet of Things (IoT) and the increasing number of Artificial Intelligence (AI) enabled devices, taking into account that consumers are increasingly using connected devices in their daily lives. The Union regulatory framework should address the current security threats of such devices which can be hacked and therefore present new risks remotely. In the IoT and AI area, both the safety and security of the products are key to ensuring the safety of their users. In this regard, this Regulation should be fully consistent with the ENISA Regulation [2017/0225(COD)] and the Communication on Artificial Intelligence for Europe COM(2018)237.
Amendment 156 #
Proposal for a regulation Recital 17 (17) It is necessary to establish a
Amendment 157 #
Proposal for a regulation Recital 19 (19) Regulation (EC) No 765/2008 does not set explicit obligations on how market surveillance is to be organised at national level and leaves it to the prerogative of Member States. As a consequence, market surveillance remains fragmented in the Union and market surveillance authorities find it difficult to enforce their decisions in other Member States, due to the territoriality of their administrative decisions, their enforceability and language issues. In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should therefore have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the
Amendment 158 #
Proposal for a regulation Recital 19 (19) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Severe and recurrent breaches of compliance should be followed by adequate sanctions. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic
Amendment 159 #
Proposal for a regulation Recital 19 (19) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Severe and recurrent breaches of compliance should be followed by adequate sanctions. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member
Amendment 160 #
Proposal for a regulation Recital 19 a (new) (19a) There should be effective, speedy and accurate exchange of information among the Member States and between the Member States and the Commission. Regulation (EC) No 765/2008 includes a number of legal, administrative and financial tools (e.g. Information and Communication System on Market Surveillance (ICSMS) and Rapid Alert System for dangerous non-food products (RAPEX)) which enable coordination among market surveillance authorities in the Union. However, evidence shows that those tools are not exploited to the extent sufficient to trigger effective coordination and efficient work sharing among the market surveillance authorities. The overall degree of cross-border cooperation therefore remains insufficient and should be increased.
Amendment 161 #
Proposal for a regulation Recital 19 a (new) (19a) Stricter traceability rules should be ensured to guarantee that products can be traced along the whole supply chain and unambiguously linked to the responsible person.
Amendment 162 #
Proposal for a regulation Recital 19 b (new) (19a) The provisions of Regulation (EC) No 765/2008 have been implemented in many different and specific forms at national levels. Differences emerge not only in terms of distribution of competences between market surveillance authorities but also in terms of internal coordination mechanisms at national level, level of deployed financial resources dedicated to market surveillance, market surveillance strategies and approaches, powers of inspections, sanctions and penalties for product non-compliance. The lack of uniformity leads to market surveillance being more rigorous in some Member States than in others. This might result in a less effective deterrence power, and an unequal playing field among businesses in some Member States also potentially imbalances in the level of product safety throughout the Union.
Amendment 163 #
Proposal for a regulation Recital 23 (23) Market surveillance authorities should be able to carry out the necessary on-site inspections, and should have the power to enter any premises, land or means of transport
Amendment 164 #
Proposal for a regulation Recital 24 (24) Market surveillance authorities should be able to require any representative or member of staff of the economic operator concerned to give explanations or provide facts, information or documents relating to the subject matter of the on-site inspection, and to record the answers given by that representative or staff member, but only if the economic operator agrees to this and only in his presence.
Amendment 165 #
Proposal for a regulation Recital 27 (27) Market surveillance authorities act in the interest of economic operators, end-
Amendment 166 #
Proposal for a regulation Recital 27 (27) Market surveillance authorities act in the interest of economic operators, end- users, and of the general public, to ensure that public interests established by Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement action, and that compliance with such legislation is ensured across the supply chain through
Amendment 167 #
Proposal for a regulation Recital 38 (38) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Customs authorities, as authorities in charge of the control on products entering the customs territory of the Union, enjoy a complete overview of trade flows across the external borders, and should therefore be required to carry out adequate controls on a risk assessment basis, to contribute to a safer market place, which ensures a high level of human health, consumer and environmental protection. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of
Amendment 168 #
Proposal for a regulation Recital 38 (38) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Customs authorities, as authorities in charge of the control on products entering the customs territory of the Union, enjoy a complete overview of trade flows across the external borders, and should therefore be required to carry out adequate controls on a risk
Amendment 169 #
Proposal for a regulation Recital 39 (39) In order to support customs and market surveillance authorities in carrying out tasks related to controls on products entering the customs territory of the Union, a more favourable treatment should be granted for products declared for free
Amendment 170 #
Proposal for a regulation Recital 39 (39) In order to support customs and market surveillance authorities in carrying out tasks related to controls on products entering the customs territory of the Union, a more favourable treatment should be granted for products declared for free circulation by an authorised economic operator, as defined in Article 38(2) of Regulation (EU) No 952/2013, pending the establishment of the procedure for the exchange of information on the status of the authorised economic operators and their record of compliance
Amendment 171 #
Proposal for a regulation Recital 42 (42) The Commission should carry out an evaluation of this Regulation against the objectives it pursues, also taking into consideration new technological, economic, commercial and legal developments and paying special attention to IoT and AI-enabled devices. Pursuant to point 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law Making59
Amendment 172 #
Proposal for a regulation Article 1 – paragraph 1 Th
Amendment 173 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation has the objective to improve the functioning of the single market of goods by strengthening market surveillance of goods covered by legislative acts of the Union harmonising the conditions of their marketing, in order to ensure that they meet the requirements guaranteeing a high level protection of public interests. To that end, this Regulation lays down rules and procedures for the provision of compliance information about certain products that are the subject of Union acts harmonising the conditions for the marketing of those products. It establishes a framework for cooperation with economic operators in relation to such products.
Amendment 174 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation lays down rules and procedures for the provision of
Amendment 175 #
Proposal for a regulation Article 1 – paragraph 2 It also provides a framework for the market surveillance and traceability of such products to ensure that those products fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, the protection of consumers, information about the country of origin, protection of the environment and security.
Amendment 176 #
Proposal for a regulation Article 1 – paragraph 2 Amendment 177 #
Proposal for a regulation Article premier – paragraph 2 It also provides a framework for the market surveillance of such products to ensure that
Amendment 178 #
Proposal for a regulation Article 1 – paragraph 2 It is intended to ensure that only safe and compliant products are placed on the market and also provides a framework for the market surveillance of such products to ensure that those products fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment and security.
Amendment 179 #
Proposal for a regulation Article premier – paragraph 2 It also provides a framework for the market surveillance of such products to ensure that those products fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment
Amendment 180 #
It also provides a framework for the market surveillance of such products to ensure that those products fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment
Amendment 181 #
Proposal for a regulation Article 1 – paragraph 2 a (new) In order to ensure the market surveillance of products this Regulation lays down rules and procedures for the provision of information about certain products that are subject of Union acts harmonising market access conditions of those products. It establishes a framework for cooperation with economic operators in relation to such products.
Amendment 182 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products
Amendment 183 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation shall appl
Amendment 184 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all
Amendment 185 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products that are subject to the Union harmonisation legislation
Amendment 186 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products or parts of these products that are subject to the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
Amendment 187 #
Proposal for a regulation Article 2 – paragraph 1 a (new) 1a. Articles 7, 8, 12, 14, 15 and 16 of this Regulation apply also to products that are subject to Directive 2001/95/EC on General Product Safety.
Amendment 188 #
Proposal for a regulation Article 2 – paragraph 2 a (new) 2a. This Regulation shall not apply to the construction products subject to the Regulation 2011/305.
Amendment 189 #
4a. Articles 26, 27, 28 and 29 shall apply to all products covered by Union legislation in so far as other Union legislation does not contain specific provisions relating to the organisation of border controls.
Amendment 190 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 a (new) (2a) ‘country of origin’ defined on the basis of the non-preferential origin rules set out in Articles 59 to 61 of Regulation (EEC) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code;
Amendment 191 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements under Union harmonisation legislation and
Amendment 192 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – introductory part (12) ‘economic operator’ means the manufacturer, the authorised representative, the importer or the distributor, the intermediaries or any other natural or legal person participating in the placing on the market of the products, and including:
Amendment 193 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘serious risk’ means a
Amendment 194 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘serious risk’ means any serious risk
Amendment 195 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 a (new) (22a) ‘distinct models’ means models of products that are considered to be distinct as presenting different essential characteristics from one another, and that may have an impact on their safety.
Amendment 196 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 a (new) (22a) ‘formal non-compliance’ means any non-compliance that does not lead to a breach of the essential requirements, including but not limited to the non- compliances as defined in article R34 of the reference provisions in Decision No. 768/2008/EC;
Amendment 197 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 a (new) (22a) ‘online marketplace’ means a service provider which allows consumers to conclude online contracts with traders and consumers on the online marketplace’s online interface;
Amendment 198 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 b (new) (22a) ‘formal non-compliance’ means a situation where a product does not comply either with substance or with rules laid down by Union law, and does not present a risk to health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment, security and cyber-security;
Amendment 199 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 b (new) (22a) ‘distinct models ‘means models of products that are considered to be distinct as presenting different essential characteristics from one another, and that may have an impact on their safety.
Amendment 200 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 c (new) (22c) ‘Internet of Things’ means a cyber-physical ecosystem of interconnected sensors and actuators, which enables intelligent decision making.
Amendment 202 #
Proposal for a regulation Article 4 – title Amendment 203 #
Proposal for a regulation Article 4 – paragraph 1 – introductory part 1. A product may be made available on the market only if
Amendment 204 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point ii (ii) a natural or legal person established in the Union who has a written mandate from the manufacturer designating him as a person responsible for
Amendment 205 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point ii (ii) a natural or legal person established in the Union who has a written mandate from the manufacturer designating him as a
Amendment 206 #
Proposal for a regulation Article 4 – paragraph 1 – point b (b) the identity and contact details of the manufacturer, importer or
Amendment 207 #
Proposal for a regulation Article 4 – paragraph 1 a (new) 1a. The mandate shall be valid only when: (a) signed by the authorised representative to proof its acceptance; (b) signed by the issuing manufacturer.
Amendment 208 #
Proposal for a regulation Article 4 – paragraph 1 b (new) 1b. In addition to the provisions laid down in Article 4(3), the authorised representative or where applicable an importer shall perform the following tasks: (a) immediately informing the manufacturer about complaints and reports from users about suspected incidents related to a product for which they have been designated; (b) terminating the mandate or the import of products concerned, if the manufacturer acts contrary to its obligations under this Regulation; (c) informing the competent authority of the Member State of any termination of a mandate as authorised representative.
Amendment 209 #
Proposal for a regulation Article 4 – paragraph 2 Amendment 210 #
Proposal for a regulation Article 4 – paragraph 2 Amendment 211 #
Proposal for a regulation Article 4 – paragraph 3 Amendment 212 #
Proposal for a regulation Article 4 – paragraph 3 – introductory part 3. The
Amendment 213 #
Proposal for a regulation Article 4 – paragraph 3 – point a (a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity and technical documentation, verifying that the EU declaration of conformity and technical documentation have been drawn up and keeping the declaration of conformity and technical documentation at the disposal of market surveillance authorities for
Amendment 214 #
Proposal for a regulation Article 4 – paragraph 3 – point b (b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language
Amendment 215 #
Proposal for a regulation Article 4 – paragraph 3 – point b (b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language determined by the Member State concerned and to demonstrate the existence of different essential characteristics between its models within the meaning of the definition given in point (22a) of Article 3 of this Regulation;
Amendment 216 #
Proposal for a regulation Article 4 – paragraph 3 – point c (c) cooperating with the market surveillance authorities
Amendment 217 #
Proposal for a regulation Article 4 – paragraph 3 – point c (c) cooperating with the market surveillance authorities
Amendment 218 #
Proposal for a regulation Article 4 – paragraph 3 – point c a (new) (ca) when considering or having reason to believe that a product in question presents a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;
Amendment 219 #
Proposal for a regulation Article 4 – paragraph 3 – point c a (new) (ca) when considering or having reason to believe that a product in question present a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;
Amendment 220 #
Proposal for a regulation Article 4 – paragraph 4 Amendment 221 #
Proposal for a regulation Article 4 – paragraph 4 4. Manufacturers, or if not the importer, shall make the identity and contacts details of the person responsible for compliance
Amendment 222 #
Proposal for a regulation Article 4 – paragraph 5 5. The
Amendment 223 #
Proposal for a regulation Article 4 – paragraph 5 5. The
Amendment 224 #
Proposal for a regulation Article 4 – paragraph 5 5. The identity and contact details of the person responsible for compliance information with respect to the product shall be indicated on
Amendment 225 #
Proposal for a regulation Article 4 – paragraph 5 5. The identity and contact details of the manufacturer and the person responsible for compliance information with respect to the product shall be indicated on or identifiable from information indicated on the product, its packaging, the parcel or an accompanying document.
Amendment 226 #
Proposal for a regulation Article 4 – paragraph 5 5. The identity and contact details of the person responsible for compliance
Amendment 227 #
Proposal for a regulation Article 4 – paragraph 5 a (new) 5a. The manufacturer, importer and the other person meeting the requirements of point (a) should make available to the public and other economic operators by any appropriate means, lists of their product models, accompanied by a picture, in particular for products that are or have been the subject of a decision by the Commission under Article13 of the Directive 2001/95/CE on General product safety and for products that are the subject of widespread distribution.
Amendment 228 #
Proposal for a regulation Article 4 – paragraph 5 a (new) 5a. Economic operators who offer a product for sale online shall display with their offer for sale the identity and contacts details of the person responsible for compliance information with respect to the product. Online marketplaces should facilitate the display of the identity and contact details of the person responsible for compliance information designed by manufacturers for the products sold through them.
Amendment 229 #
Proposal for a regulation Article 4 – paragraph 6 Amendment 230 #
Proposal for a regulation Article 4 a (new) Article 4 a Obligations of distributors 1. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in the applicable harmonisation legislation, harmonised standard or the directive on General Product Safety. 2. Distributors who consider or have reason to believe that a product which they have made available on the market is not compliant shall make sure that the corrective action necessary to bring that product into conformity is taken, while withdrawing or recalling the non- compliant products. Furthermore, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 231 #
Proposal for a regulation Article 4 a (new) Article 4a Traceability of products 1. The Commission may stipulate that economic operators should establish, or join, a traceability system for certain products, product groups and product categories they have placed on the market or made available there which may pose a serious risk to the safety and health of persons due to their specific characteristics or specific conditions of distribution or use. 2. The traceability system shall entail the collection and storage of electronic data enabling a product and the economic operators in the supply chain to be identified, as well as the placing on the product, its packaging or its accompanying documents of a unique barcode, hologram, chip or other data carrier enabling access to that data.
Amendment 232 #
Proposal for a regulation Article 4 a (new) Article 4a Conditions for compliance A product may be made available on the market only if the following conditions are met: (a) the product shall be marked with an indication of the country of origin. Where the size or nature of the product does not allow that, the indication may be provided on the packaging or in a document accompanying the product; (b) if the country of origin referred to in Article 3(2) of this Regulation is a Member State of the Union, the indication of the country of origin may be related to the Union or to a particular Member State.
Amendment 233 #
Proposal for a regulation Article 4 a (new) Article 4 a Responsibility of the distributor A distributor who becomes aware of the non-conformity or a product shall inform the manufacturer or importer, as well as the market surveillance authority of the non-conformity.
Amendment 234 #
Proposal for a regulation Article 4 b (new) Article 4b Indication of origin 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. 2. For the purpose of identifying the country of origin referred to in paragraph 1, the non-preferential origin rules set out in Articles 60 to 63 of Regulation (EEC) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code shall apply. 3. Where the country of origin referred to in paragraph 2 is a Member State of the Union, manufacturers and importers may refer to the Union or to a particular Member State.
Amendment 235 #
Proposal for a regulation Article 5 Amendment 236 #
Proposal for a regulation Article 5 – paragraph 1 Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers
Amendment 237 #
Proposal for a regulation Article 5 – paragraph 1 Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, the manufacturer
Amendment 238 #
Proposal for a regulation Article 5 – paragraph 1 Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers shall make the declaration publicly available on their website or, in the absence of a website, by any other means that allows the declaration to be readily accessed by the general public in the Union free of charge. In the absence of a duty to draw up an EU declaration of conformity, and subject to respect of sector specific legislation, manufacturers shall make a declaration of performance by which they assume the responsibility that the conformity of the product complies to the declared performance.
Amendment 239 #
Proposal for a regulation Article 5 – paragraph 1 Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers shall make the declaration publicly available on their website or, in the absence of a website, by any other means that allows the declaration to be easily and readily accessed by the general public in the Union free of charge.
Amendment 240 #
Proposal for a regulation Article 5 – paragraph 1 – subparagraph 1 (new) The making available of a Declaration of Conformity in accordance with the first subparagraph shall be deemed sufficient in cases where the manufacturer is obliged to provide the Declaration of Conformity with the product under Union legislation.
Amendment 241 #
Proposal for a regulation Article 5 a (new) Article 5 a Electronic labelling Where a product is able to display information electronically through either an integral screen, via connection to an external screen or via a machine-readable code or where the product has a function allowing the end-user to select the display of the relevant information, the following requirements shall be deemed fulfilled where such information is provided electronically: (a) requirement to affix the CE marking and (where obligatory) the identification number of the notified body visibly, legibly and indelibly on the product or onto its data plate; (b) requirement to indicate the product type, batch or serial number or other element allowing for their identification; (c) requirement to indicate the manufacturer's name, registered trade name or registered trade mark and the address at which they can be contacted; and (d) requirement to indicate the importer’s name, registered trade name or registered trade mark and the address at which they can be contacted.
Amendment 242 #
Information to economic operators and end users
Amendment 243 #
Proposal for a regulation Article 6 – paragraph 1 The Product Contact Points referred to in [Regulation (EC) No 764/2008 of the European Parliament and the Council / Regulation (EU)…. of the European Parliament and the Council] shall provide economic operators and end users, at their request and free of charge, with information with respect to the Union harmonisation legislation applicable to a product.
Amendment 244 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 (new) The European Commission shall provide information with respect to the Union harmonisation legislation by means of the Your Europe portal referred to in [Regulation (EC) No XXX/XXX of the European Parliament and the Council].
Amendment 245 #
Proposal for a regulation Article 6 – paragraph 1 a (new) Member States shall take the necessary measures to ensure adequate visibility of the contact points for the products referred to in [Regulation(EC) No 764/2008 of the European Parliament and the Council / Regulation (EU)….of the European Parliament and the Council].
Amendment 246 #
Proposal for a regulation Article 6 – paragraph 1 a (new) The Product Contact Points shall, together with the Commission, prepare the general product requirements laid down by Union law and provide them to economic operators in a transparent, accessible and user-friendly way.
Amendment 247 #
Proposal for a regulation Article 6 – paragraph 1 b (new) Such information may be published online, in order to raise awareness about the general product requirements laid down by Union law among economic operators.
Amendment 248 #
Proposal for a regulation Article 7 Amendment 249 #
Proposal for a regulation Article 7 Amendment 250 #
Proposal for a regulation Article 7 Amendment 251 #
Proposal for a regulation Article 7 Amendment 252 #
Proposal for a regulation Article 7 – title Co
Amendment 253 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 A market surveillance authority may enter into a partnership arrangement with an economic operator established in its territory under which the authority agrees to provide the economic operator with advice and guidance in relation to the Union harmonisation legislation applicable to the products for which the economic operator is responsible. These arrangements shall not preclude an independent and unbiased assessment through market surveillance authorities and shall not result in unfair competition between economic operators within the European Union and within the European Union and third countries.
Amendment 254 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 Amendment 255 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 A market surveillance authority may enter into a partnership arrangement with
Amendment 256 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 a (new) The provision of advice by the market surveillance authorities shall not preclude independent, impartial and unbiased assessments by market surveillance authorities.
Amendment 257 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 Amendment 258 #
Proposal for a regulation Article 7 – paragraph 2 Amendment 259 #
Proposal for a regulation Article 7 – paragraph 3 Amendment 260 #
Proposal for a regulation Article 7 – paragraph 4 Amendment 261 #
Proposal for a regulation Article 7 – paragraph 4 Amendment 262 #
Proposal for a regulation Article 7 – paragraph 4 4. A market surveillance authority that enters into a partnership arrangement under paragraph 1 may
Amendment 263 #
Proposal for a regulation Article 7 – paragraph 4 4. A market surveillance authority that enters into a partnership arrangement under paragraph 1
Amendment 264 #
Proposal for a regulation Article 8 Amendment 265 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with
Amendment 266 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with businesses or organisations representing businesses or end-users for the carrying out, or financing, of joint activities aimed at raising awareness, providing guidance in relation to the general requirements laid down by Union law, as well as identifying non-compliance or promoting compliance in specific geographical areas or with respect to specific categories of product, in particular with respect to products presenting a serious risk or with respect to products that are often notified as dangerous in the Rapid Alert System for Non-Food Consumer Products (RAPEX).
Amendment 267 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with
Amendment 268 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with businesses or organisations representing businesses or end-users for the carrying out, or financing, of joint activities aimed at identifying non-compliance or promoting compliance in specific geographical areas or with respect to specific categories of product. The possibility to enter into memoranda of understanding shall not lead to a shift in responsibilities as regards the duties of the person responsible for compliance under the meaning of article 4.
Amendment 269 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 a (new) The market surveillance authority shall provide the draft memorandum to the Commission at least 2 months before its adoption and a report on its implementation every three years from the date of its adoption. The Commission shall provide an opinion to the market surveillance authorities on the draft memorandum and the implementation report.
Amendment 270 #
Proposal for a regulation Article 8 – paragraph 2 2. A market surveillance authority may use
Amendment 271 #
Proposal for a regulation Article 8 – paragraph 3 a (new) 3a. Any memorandum of understanding shall include strict provisions aimed at ensuring the confidentiality, the objectivity, the independence and impartiality of the parties, the information and the activities concerned. Where any of its parties is in breach of any such provisions, a memorandum of understanding shall be terminated.
Amendment 272 #
Proposal for a regulation Article 8 – paragraph 3 a (new) 3a. A market surveillance authority and the parties referred to in paragraph 1 entering into memorandum of understanding, shall ensure that such memorandum contains provisions so as to safeguard the confidentiality, the objectivity, independence and impartiality of the parties and the activities concerned.
Amendment 273 #
Proposal for a regulation Article 8 – paragraph 3 b (new) 3b. The Commission shall adopt implementing acts regarding the memoranda of understanding, which specify the procedures and criteria under which authorities could carry out their activity ensuring that the market surveillance activities are implemented in independence and impartiality. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63.
Amendment 274 #
Proposal for a regulation Article 9 – paragraph 3 a (new) 3a. Consumers must be informed, through an online portal, of rights relating to non-compliant products which they have acquired, such as the right to obtain a replacement for a product or to receive compensation, the right of recourse and contacts from which all appropriate information can be obtained.
Amendment 275 #
Proposal for a regulation Article 10 – paragraph 1 1. Market surveillance authorities shall establish appropriate communication and coordination mechanisms with other market surveillance authorities, such as customs authorities, in particular with regard to counterfeit products.
Amendment 276 #
Proposal for a regulation Article 10 – paragraph 1 1. Market surveillance authorities shall establish appropriate and effective communication and coordination mechanisms with other market surveillance authorities.
Amendment 277 #
Proposal for a regulation Article 10 – paragraph 1 1. M
Amendment 278 #
Proposal for a regulation Article 10 – paragraph 2 – introductory part 2. M
Amendment 279 #
Proposal for a regulation Article 10 – paragraph 2 – point a (a)
Amendment 280 #
Proposal for a regulation Article 10 – paragraph 2 – point b (b) procedures for monitoring any accidents or any harm to the health or safety of end-users which are suspected of having been caused by such products. The data collected on such accidents or harm should be stored in a European database developed by the Commission;
Amendment 281 #
(b)
Amendment 282 #
Proposal for a regulation Article 10 – paragraph 2 – point b a (new) (ba) procedures for monitoring any harm to the persons in general involved in the manufacturing of the product, health and safety conditions in the workplace, consumer protection, the environment and public security as well as other public interests, which are suspected of having been caused by such products;
Amendment 283 #
Proposal for a regulation Article 10 – paragraph 2 – point b a (new) Amendment 284 #
Proposal for a regulation Article 10 – paragraph 2 – point c (c)
Amendment 285 #
Proposal for a regulation Article 10 – paragraph 2 – point d (d)
Amendment 286 #
Proposal for a regulation Article 10 – paragraph 2 – point d a (new) Amendment 287 #
Proposal for a regulation Article 10 – paragraph 2 a (new) 2a. Member States shall establish appropriate communication and coordination mechanisms between market surveillance authorities and customs authorities, especially in view of counterfeit products. This includes standardised cooperation with customs authorities concerning identification and withdrawal of non-authentic and/or counterfeit products from the market.
Amendment 288 #
Proposal for a regulation Article 11 – paragraph 1 1. Each Member State shall designate one or more market surveillance authorities in its territory. It shall inform the Commission, through the
Amendment 289 #
Proposal for a regulation Article 11 – paragraph 3 3. The single liaison office of a Member State shall be responsible for coordinating the enforcement and market surveillance activities of the market surveillance authorities designated by that Member State. It shall also be responsible for the coordination of market surveillance activities performed in cooperation with other authorities responsible for the control of products entering Union territory, in particular with custom authorities.
Amendment 290 #
Proposal for a regulation Article 11 – paragraph 3 3. The single liaison office of a Member State shall be responsible for coordinating the enforcement and market surveillance activities of the market surveillance authorities and authorities responsible for the control of products entering the Union market designated by that Member State.
Amendment 291 #
Proposal for a regulation Article 11 – paragraph 4 4. Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources and trained personnel, including sufficient budgetary and other resources, expertise, procedures and other arrangements and personnel involved in monitoring on the ground, for the proper performance of their duties.
Amendment 292 #
Proposal for a regulation Article 11 – paragraph 4 4. Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary, financial and other resources, qualified staff and expertise, procedures and other arrangements for the proper performance of their duties.
Amendment 293 #
Proposal for a regulation Article 11 – paragraph 4 4. Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, such as staffing resources, expertise, procedures and other arrangements for the proper performance of their duties.
Amendment 294 #
Proposal for a regulation Article 11 – paragraph 4 4. Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, staffing, expertise, procedures and other arrangements for the proper performance of their duties.
Amendment 295 #
Proposal for a regulation Article 11 – paragraph 5 a (new) 5a. Each Member State shall designate one single liaison office at national customs authorities for the cooperation between customs and market surveillance authorities. The single liaison office at the customs authority shall be responsible for the control of products entering the Union market and serve as a point of reference for the market surveillance authorities within the respective territory of their Member State.
Amendment 296 #
Proposal for a regulation Article 12 – paragraph 1 – point b (b) the taking by them of appropriate and proportionate
Amendment 297 #
Proposal for a regulation Article 12 – paragraph 1 – point b a (new) (ba) the provision of the necessary assistance and advice to ensure that the operator remedies the non-compliance and prevents further occurrences of it.
Amendment 298 #
Proposal for a regulation Article 12 – paragraph 1 – point b a (new) (ba) the effective coordination with other market surveillance authorities in Union territory.
Amendment 299 #
Proposal for a regulation Article 12 – paragraph 1 – point b a (new) (ba) application of the precautionary principle.
Amendment 300 #
Proposal for a regulation Article 12 – paragraph 1 – point b b (new) (ba) the open, transparent and regular dialogue with economic operators and / or representative sector associations and foresee the necessary procedures for this in accordance with Article 7.
Amendment 301 #
1a. Market surveillance authorities shall establish appropriate and effective communication and cooperation mechanisms with other market surveillance authorities and other relevant authorities within the Union. In particular, market surveillance authorities shall also develop appropriate and effective communication and cooperation mechanisms with customs authorities for the identification and examination of potential counterfeit products.
Amendment 302 #
Proposal for a regulation Article 12 – paragraph 1 a (new) 1a. Market surveillance authorities shall perform appropriate checks on products on an adequate scale and with adequate frequency, by means of documentary, physical or laboratory checks, as appropriate, on the basis of adequate samples. When doing so, they shall take account of established principles of risk assessment, complaints and other information.
Amendment 303 #
Proposal for a regulation Article 12 – paragraph 2 – introductory part 2. Market surveillance authorities shall prioritise actions for the largest risk- reduction opportunities and act in accordance with the principle of proportionality; they shall perform controls as part of their activities set out in paragraph 1, on a risk-
Amendment 304 #
Proposal for a regulation Article 12 – paragraph 2 – introductory part 2. Market surveillance authorities shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach,
Amendment 305 #
Proposal for a regulation Article 12 – paragraph 2 – introductory part 2. Market surveillance authorities shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach, taking into account the precautionary principle and, as a minimum, the following factors:
Amendment 306 #
Proposal for a regulation Article 12 – paragraph 2 – point a – point i (i) the product, such as the number of products on the market and any hazards associated with that product, which have the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security;
Amendment 307 #
Proposal for a regulation Article 12 – paragraph 2 – point a – point i (i) the product, such as the number of products on the market and any hazards associated with that product, which have the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security;
Amendment 308 #
Proposal for a regulation Article 12 – paragraph 2 – point b (b) the economic operator's past record of non-compliance, including the risk profiling
Amendment 309 #
Proposal for a regulation Article 12 – paragraph 2 – point b (b) the economic operator's past record of non-compliance, including the risk profiling
Amendment 310 #
Proposal for a regulation Article 12 – paragraph 2 – point c a (new) (ca) market surveillance authorities shall work together in order to harmonise the methodology and criteria for assessing risks in all Member States in order to ensure a level playing field for all economic operators.
Amendment 311 #
Proposal for a regulation Article 12 – paragraph 2 a (new) 2a. The methodology and criteria for assessing risks shall be harmonised in all Member States in order to ensure a level playing field for all economic operators.
Amendment 312 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – introductory part Market surveillance authorities shall ensure that a product is withdrawn or recalled from the market or that the making available of the product on the market is prohibited or restricted if, when it is being used either in accordance with its intended purpose or under conditions that can be reasonably foreseen and it is properly installed and maintained,
Amendment 313 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b Amendment 314 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b Amendment 315 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b (b) the product does not conform to applicable requirements under Union harmonisation legislation
Amendment 316 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b (b) the product does not conform to applicable requirements under Union harmonisation legislation, including EU standards on labour laws and environmental protection.
Amendment 317 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b a (new) (ba) the product does not conform to applicable requirements as regards the declaration of performance.
Amendment 318 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b a (new) (ba) the product is recognized as non- compliant by any judicial or administrative court in the EU.
Amendment 319 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b a (new) (ba) the product is recognized as non- compliant by any judicial or administrative court in the EU;
Amendment 320 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b b (new) (ba) the product is a counterfeit.
Amendment 321 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b b (new) (ba) the product is counterfeit.
Amendment 322 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 2 Where the products are withdrawn, recalled, prohibited or restricted, the market surveillance authority shall ensure that the Commission through the
Amendment 323 #
Proposal for a regulation Article 12 – paragraph 3 a (new) Amendment 324 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3a. Without prejudice to the procedure set out in Union harmonisation legislation for dealing with products presenting a risk at national level, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non- compliance concerned: (a) the conformity marking has been affixed in violation of the general principles of the CE marking as set out in the applicable Union harmonisation legislation; (b) the conformity marking has not been affixed; (c) the EC declaration of conformity has not been drawn up; (d) the EC declaration of conformity has not been drawn up correctly; (e) technical documentation is either not available or not complete. Where the non-compliance persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.
Amendment 325 #
Proposal for a regulation Article 12 – paragraph 3 a (new) Amendment 326 #
Proposal for a regulation Article 12 – paragraph 3 b (new) 3b. Where the non-compliance referred to in paragraph 3a persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.
Amendment 327 #
Proposal for a regulation Article 12 – paragraph 4 – introductory part 4. Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the general public any
Amendment 328 #
Proposal for a regulation Article 12 – paragraph 4 – introductory part 4. Market surveillance authorities shall
Amendment 329 #
Proposal for a regulation Article 12 – paragraph 4 – introductory part 4. Market surveillance authorities
Amendment 330 #
Proposal for a regulation Article 12 – paragraph 4 – introductory part 4. Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the general public any information that they deem relevant for the general public. They shall also ensure that the following information is entered in the system referred to in Article 34:
Amendment 331 #
Proposal for a regulation Article 12 – paragraph 4 – point a Amendment 332 #
Proposal for a regulation Article 12 – paragraph 4 – point b Amendment 333 #
Proposal for a regulation Article 12 – paragraph 4 – point c Amendment 334 #
Proposal for a regulation Article 12 – paragraph 4 – point d Amendment 335 #
Proposal for a regulation Article 12 – paragraph 5 5. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias. They shall observe confidentiality in order to protect commercial secrets, subject to any obligations laid down in applicable Union legislation to make information available to the Commission and to other applicable disclosure requirements laid down in Union law in order to protect the interests of users in the Union.
Amendment 336 #
Proposal for a regulation Article 12 – paragraph 5 5. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias and in accordance with the principle of proportionality.
Amendment 337 #
Proposal for a regulation Article 12 – paragraph 5 5. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially
Amendment 338 #
Proposal for a regulation Article 12 – paragraph 5 a (new) 5a. Where the Commission considers or has reason to believe that an activity carried out under a memorandum of understanding set up under Article 8 is leading an authority to breach its obligations under Article 12 paragraph 5, it shall investigate the situation within three months and either call for a redress of the situation or terminate the memorandum after consultation of the Committee referred to in Article 63.
Amendment 339 #
Proposal for a regulation Article 12 – paragraph 5 a (new) Amendment 340 #
Proposal for a regulation Article 12 a (new) Article 12 a Specific activities of market surveillance authorities as regards to products sold online to end-users 1. Member States shall conduct their activities, as regards to products sold online to end-users located in Union territory, in order to ensure the compliance with points (a), (b) and (ba) of Article 12(1). 2. For the purpose of paragraph 1, Member States shall allocate adequate resources and ensure that there is a sufficient number of inspectors, dealing with products sold online to end-users (‘online inspectors’) within their territory, having appropriate expertise and awareness of the specificities of the online sphere. 3. Due to the proliferation of e-commerce, Member States shall perform an adequate number of controls of products sold online to end-users within the Union territory, based on the risk-based approach as referred to in Article 12.
Amendment 341 #
Proposal for a regulation Article 13 – paragraph 1 1. Each Member State shall draw up a national market surveillance strategy, as a minimum, every 3 years. The strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and enforcement of Union harmonisation legislation within the territory of the Member State, including market surveillance of products sold on line, and shall include all sectors and stages of the product supply chain, including imports and digital supply chains.
Amendment 342 #
Proposal for a regulation Article 13 – paragraph 1 1. Each Member State shall have the option to draw up a national market surveillance strategy, as a minimum, every 3 years. The strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and enforcement of Union harmonisation legislation within the territory of the Member State and shall include all sectors
Amendment 343 #
Proposal for a regulation Article 13 – paragraph 2 – point a (a) a
Amendment 344 #
Proposal for a regulation Article 13 – paragraph 2 – point b (b) the areas identified as a priority for the enforcement of Union harmonisation legislation
Amendment 345 #
Proposal for a regulation Article 13 – paragraph 2 – point b (b) the areas identified by Member States as a priority for the enforcement of Union harmonisation legislation;
Amendment 346 #
Proposal for a regulation Article 13 – paragraph 2 – point b a (new) (ba) the sectors prioritised for the surveillance of products sold online, such as training of staff in online investigations, the establishment of contact points for cooperation with the largest sales platforms and social media, and cooperation with providers of services in return for payment;
Amendment 347 #
Proposal for a regulation Article 13 – paragraph 2 – point c a (new) (ca) the specific enforcement actions planned in order to reduce the occurrence of non-compliance as regards products sold online to end-users within Union territory, including, where relevant, the minimum control levels envisaged for categories of those products which have significant levels of non-compliance;
Amendment 348 #
Proposal for a regulation Article 13 – paragraph 2 – point d Amendment 349 #
Proposal for a regulation Article 13 – paragraph 2 – point f Amendment 350 #
Proposal for a regulation Article 13 – paragraph 2 – point f a (new) (fa) the actions taken or envisaged in order to diminish the threats and risks related to Internet-of-Things devices, systems and services.
Amendment 351 #
Proposal for a regulation Article 13 – paragraph 2 a (new) 2a. When drawing up national market surveillance strategies, Member States shall give particular attention to products subject to an emergency decision based on Article13 of Directive 2001/95/EC.
Amendment 352 #
Proposal for a regulation Article 13 – paragraph 3 3. Member States shall communicate their national market surveillance strategy through the system referred to under Article 34. The Commission shall define by means of implementing acts which data will be made public.
Amendment 353 #
Proposal for a regulation Article 13 – paragraph 3 a (new) Amendment 354 #
Proposal for a regulation Article 14 – paragraph 1 1. Member States shall confer on their market surveillance authorities the powers of market surveillance, including the market surveillance of products sold online, investigation and enforcement necessary for the application of this Regulation and for the application of the Union harmonisation legislation set out in the Annex to this Regulation.
Amendment 355 #
Proposal for a regulation Article 14 – paragraph 1 a (new) 1a. Market surveillance authorities shall exercise their powers in accordance with the principle of proportionality.
Amendment 356 #
Proposal for a regulation Article 14 – paragraph 3 – introductory part 3. The powers conferred on market surveillance authorities under paragraph 1 shall include the following powers as a minimum to the extent that these relate to the subject matter and purpose of the inspection:
Amendment 357 #
Proposal for a regulation Article 14 – paragraph 3 – introductory part 3. The powers conferred on market surveillance authorities under paragraph 1 shall include the following powers
Amendment 358 #
Proposal for a regulation Article 14 – paragraph 3 – point b Amendment 359 #
Proposal for a regulation Article 14 – paragraph 3 – point b Amendment 360 #
Proposal for a regulation Article 14 – paragraph 3 – point c (c) the power to
Amendment 361 #
Proposal for a regulation Article 14 – paragraph 3 – point c (c) the power to have access to
Amendment 362 #
Proposal for a regulation Article 14 – paragraph 3 – point c (c) the power to have access to
Amendment 363 #
Proposal for a regulation Article 14 – paragraph 3 – point d Amendment 364 #
Proposal for a regulation Article 14 – paragraph 3 – point d (d) the power to require any public authority, body or agency within the market surveillance authority's Member State, or any natural or legal person, to provide any relevant information, data or document, in any form or format and irrespective of its storage medium or the place where it is stored, for the purposes of enabling the market surveillance authority to investigate whether any non-compliance has occurred or is occurring and to establish the details of that non- compliance, including in particular information, data or documents required for the purposes of identifying and tracing financial and data flows, ascertaining the identity and contact details of persons involved in financial and data flows and ascertaining bank account information and the ownership of websites;
Amendment 365 #
Proposal for a regulation Article 14 – paragraph 3 – point e – introductory part (e) the power to do any of the following, or to request another public authority to do any of the following on the basis of a duly justified and reasonable suspicion, for the purposes of an investigation by the market surveillance authority or at the request of an applicant authority:
Amendment 366 #
Proposal for a regulation Article 14 – paragraph 3 – point e – point 1 (1) to carry out on-site inspections, including power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to his trade, business, craft or profession, in order to examine,
Amendment 367 #
Proposal for a regulation Article 14 – paragraph 3 – point e – point 2 Amendment 368 #
Proposal for a regulation Article 14 – paragraph 3 – point e – point 3 (3) to request any representative or member of staff
Amendment 369 #
Proposal for a regulation Article 14 – paragraph 3 – point e – point 3 (3) to request a
Amendment 370 #
Proposal for a regulation Article 14 – paragraph 3 – point e – point 3 (3) to request a
Amendment 371 #
Proposal for a regulation Article 14 – paragraph 3 – point f Amendment 372 #
Proposal for a regulation Article 14 – paragraph 3 – point f (f) the power to take samples of products
Amendment 373 #
Proposal for a regulation Article 14 – paragraph 3 – point f (f) the power to take samples of products free of charge in order to detect non-compliance and obtain evidence to the extent that this is proportionate in view of the value of the product and the severity of non-compliance;
Amendment 374 #
Proposal for a regulation Article 14 – paragraph 3 – point f (f) the power to take samples of products
Amendment 375 #
Proposal for a regulation Article 14 – paragraph 3 – point g (g) the power to purchase products as test purchases, including on line and under a cover identity, in order to detect non- compliance and obtain evidence;
Amendment 376 #
Proposal for a regulation Article 14 – paragraph 3 – point h Amendment 377 #
Proposal for a regulation Article 14 – paragraph 3 – point h Amendment 378 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to take temporary measures, where there are no other effective means available to prevent a serious risk, including in particular temporary measures requiring hosting service providers to remove, disable or restrict access to content or to suspend or restrict access to a website, service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time; this power is exercised in accordance with the procedures set out under paragraph 2(c).
Amendment 379 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to
Amendment 380 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to take temporary measures, where there are no other effective means available to prevent a serious risk, including in particular temporary measures requiring hosting service providers to remove, disable or restrict access to content or to suspend or restrict access to a website, service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time until the operator has made the necessary corrections according to the comments given by the authority;
Amendment 381 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to take temporary measures, where there are no other effective means available to prevent a serious risk, including in particular temporary measures requiring hosting service providers to
Amendment 382 #
Proposal for a regulation Article 14 – paragraph 3 – point k (k) the power to prohibit the making available of products on the market or to withdraw, recall or destroy products,
Amendment 383 #
Proposal for a regulation Article 14 – paragraph 3 – point k (k) the power to
Amendment 384 #
Proposal for a regulation Article 14 – paragraph 3 – point m Amendment 385 #
Proposal for a regulation Article 14 – paragraph 3 – point m Amendment 386 #
Proposal for a regulation Article 14 – paragraph 3 – point m (m) the power to order the restitution of profits obtained as a result of an instance of non-compliance and the power to impose to economic operators, in cases of recall of products, to reimburse and compensate end-users which have acquired the recalled products;
Amendment 387 #
Proposal for a regulation Article 14 – paragraph 3 – point m (m) the power to order the restitution of profits obtained as a result of
Amendment 388 #
Proposal for a regulation Article 14 – paragraph 4 4. Market surveillance authorities shall publish any commitments given to them by economic operators, details of any corrective action taken by economic operators in their territory, and details of any temporary measures taken by the relevant market surveillance authority pursuant to this Regulation. Market surveillance authorities shall ensure that this information is regularly updated and that the economic operator shall be given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release.
Amendment 389 #
Proposal for a regulation Article 14 – paragraph 4 4. Market surveillance authorities shall publish, when they deem it relevant for the general public, any commitments given to them by economic operators, details of any corrective action taken by economic operators in their territory, and details of any temporary measures taken by the relevant market surveillance authority pursuant to this Regulation.
Amendment 390 #
Proposal for a regulation Article 14 – paragraph 4 – subparagraph 1 (new) Market surveillance authorities shall ensure that the economic operator shall be given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release, and take reasonable steps, where appropriate, to ensure that the information which is published or made otherwise available to the public takes into account the comments expressed by the economic operator concerned or is published or released together with such comments.
Amendment 391 #
Proposal for a regulation Article 14 – paragraph 4 a (new) 4a. The powers conferred on market surveillance authorities under paragraph 3 shall be also extended to counterfeit products.
Amendment 392 #
Proposal for a regulation Article 14 – paragraph 5 Amendment 393 #
Proposal for a regulation Article 14 – paragraph 5 Amendment 394 #
Proposal for a regulation Article 14 – paragraph 5 5. Market surveillance authorities shall exercise their powers in accordance with the principle of proportionality and based on a precautionary approach.
Amendment 395 #
Proposal for a regulation Article 14 – paragraph 5 5. Market surveillance authorities shall exercise their powers in accordance with the pr
Amendment 396 #
Proposal for a regulation Article 14 a (new) Article 14a Exercise of powers or duties of market surveillance authorities 1. Market surveillance authorities shall exercise powers set out in this Article proportionately, efficiently and effectively in accordance with Union law, including the principles of the Charter of Fundamental Rights of the European Union, applicable procedural safeguards and the Union rules on data protection, in particular Regulation (EU) 2016/679 of the European Parliament and of the Council 1a, and national law. 2. Market surveillance authorities shall in any case exercise the powers set out in point 1 of point (e) and in point (h) of Article 14(3) by application to courts competent to grant the necessary decision, including, where appropriate, by appeal, if the application to grant the necessary decision is not successful. 3. Investigation and enforcement measures adopted when applying this Regulation shall adequately reflect the nature and degree of the non-compliance and the overall actual and potential harm caused by it. 4. When a decision as to whether to impose a penalty and on the amount of such penalty to be imposed in each individual case is being made, due regard shall be given to the following: (a) the nature, gravity and duration of the non-compliance, taking into account the number of consumers affected and the level of damage suffered by them; (b) the intentional and negligent character of the non-compliance; (c) any action taken by the manufacturer to mitigate the damage suffered by consumers; (d) any relevant previous non- compliance committed by the manufacturer; (e) the degree to which the manufacturer has cooperated with market surveillance authorities in order to remedy the non-compliance and mitigate its potential adverse effects. _________________ 1a Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 397 #
Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a representative sample. The market surveillance by authorities shall be combined with self-check systems by importer, verified by an independent third party auditor.
Amendment 398 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 1 Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and
Amendment 399 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 1 Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a
Amendment 400 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 1 Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a representative sample that takes due account of the priorities set by the Union Product Compliance Network .
Amendment 401 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 1 Market surveillance authorities shall perform sufficient and appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a representative sample.
Amendment 402 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 1 a (new) For certain types of products or categories of products, where serious risks to health and safety in general, health and safety in the workplace, the protection of consumers, protection of the environment, security and cyber-security within Union territory or serious breaches to applicable products requirements laid down by Union legislation have been continuously identified, the Network established under Article 31 shall develop uniform conditions of checks and common criteria for the determination of the frequency of checks.
Amendment 403 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 2 In
Amendment 404 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 3 Where economic operators present test reports or certificates attesting conformity of their products with Union harmonisation legislation issued by an accredited conformity assessment body or any EU or non-EU laboratory accredited according to Regulation (EC) No 765/2008, market surveillance authorities shall take due account of such reports or certificates.
Amendment 405 #
Proposal for a regulation Article 15 – paragraph 2 – subparagraph 2 The
Amendment 406 #
Proposal for a regulation Article 15 – paragraph 3 3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State or placed on the market in another Member State, they shall inform the economic operator concerned without delay.
Amendment 407 #
Proposal for a regulation Article 15 – paragraph 3 3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State, they shall inform the economic operator concerned
Amendment 408 #
Proposal for a regulation Article 15 – paragraph 3 a (new) 3a. In cases of identification of known or emerging risk related to the objectives set out in Article 1 of this Regulation and with regard to a particular product or a category of products, the Commission may adopt implementing acts to establish uniform conditions for the carrying out of the checks performed by the market surveillance authorities in relation to that particular product or category of products and the characteristics of that known or emerging risk. These conditions may include requirements for a temporary increase of the scale and frequency of checks to be carried out and the adequacy of samples to be checked.
Amendment 409 #
Proposal for a regulation Article 15 a (new) Amendment 410 #
Proposal for a regulation Article 16 – title Use of information
Amendment 411 #
Proposal for a regulation Article 16 – paragraph 1 Market surveillance authorities shall observe the principle of confidentiality where necessary
Amendment 412 #
Proposal for a regulation Article 17 – paragraph 1 1. Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation to prohibit or restrict the making available of products on the market or to withdraw, recall or destroy products on the market shall be proportionate and shall state the exact grounds on which it is
Amendment 413 #
Proposal for a regulation Article 17 – paragraph 1 1. Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation to
Amendment 414 #
Proposal for a regulation Article 17 – paragraph 3 – subparagraph 1 Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless it is not possible to give him that opportunity because of the urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by the relevant Union harmonisation legislation.
Amendment 415 #
Proposal for a regulation Article 17 – paragraph 3 a (new) 3a. Where the products are recalled, market surveillance authorities shall ensure that consumers which have acquired the recalled products are reimbursed and adequately compensated by the economic operator.
Amendment 416 #
Proposal for a regulation Article 17 – paragraph 4 a (new) 4a. When the product is the object of an information in Article 18(1), market surveillance authorities at the origin of this information are considered to have informed the Commission and the other Member States of the results of the product assessment and the measures associated with the product.
Amendment 417 #
Proposal for a regulation Article 18 – title 18 Products presenting a serious risk or a breach of the Union harmonisation law
Amendment 418 #
Proposal for a regulation Article 18 – title Products presenting a serious risk or a breach of the Union harmonisation law
Amendment 419 #
Proposal for a regulation Article 18 – paragraph 1 1. Market surveillance authorities shall take measures to recall or withdraw products which present a serious risk to consumers, environment or the persons involved in the manufacturing of the product, or to prohibit the making available of
Amendment 420 #
Proposal for a regulation Article 18 – paragraph 1 1. Market surveillance authorities shall take measures without delay to recall or withdraw products which present a serious risk or to prohibit the making available of them on the market. They shall inform the Commission of such measures without delay, in accordance with Article 19.
Amendment 421 #
Proposal for a regulation Article 18 – paragraph 2 2. The decision whether or not a product presents a serious risk shall be based on an appropriate expert-based risk assessment
Amendment 422 #
Proposal for a regulation Article 18 – paragraph 2 2. The decision whether or not a product presents a
Amendment 423 #
Proposal for a regulation Article 18 – paragraph 2 2. The decision whether or not a product presents a
Amendment 424 #
Proposal for a regulation Article 18 – paragraph 2 a (new) 2a. Where the products are recalled, the market surveillance authorities shall ensure that consumers which have acquired the recalled products are reimbursed and adequately compensated by the economic operator.
Amendment 425 #
Proposal for a regulation Article 19 – paragraph 2 2. If a product presenting a serious risk has been made available on the market, market surveillance authorities shall immediately notify the Commission of any voluntary measures taken and communicated by an economic operator.
Amendment 426 #
Proposal for a regulation Article 20 – paragraph 1 1. The Commission may designate, after the consultation with the European Market Surveillance Forum Board referred to in Article 32, Union testing facilities for specific products or a specific category or group of products or for specific risks related to a
Amendment 427 #
Proposal for a regulation Article 20 – paragraph 1 a (new) 1a. The Union testing facilitates shall serve the purposes of ensuring sufficient public laboratory capacity for all market surveillance in the Union and reliability and consistency of testing across the Union in the market surveillance framework. Market surveillance authorities or the Commission, in the context of its tasks under the Forum established by Article 31, may call upon the Union testing facilities to conduct tests on products or provide information and advice related to testing.
Amendment 428 #
Proposal for a regulation Article 20 – paragraph 1 b (new) 1b. The establishment of Union testing facilities shall not affect the freedom of the market surveillance authorities to choose in which facilities products are tested for their market surveillance activities.
Amendment 429 #
Proposal for a regulation Article 20 – paragraph 3 a (new) 3a. The designated Union testing facilities shall not hamper competition between testing laboratories and reduce the availability of testing laboratories capacity for economic operators.
Amendment 430 #
Proposal for a regulation Article 20 – paragraph 4 – point a (a) carry out product-testing in relation to market surveillance activities and investigations, including, in particular, on behalf of the Member States that do not yet possess their own testing capacities;
Amendment 431 #
Proposal for a regulation Article 20 – paragraph 4 – point c (c) provide independent technical or scientific advice to the Commission including, the
Amendment 432 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4a. Market surveillance authorities shall take due account of the test, results, analysis and conclusions of the Union testing facilities to adopt the appropriate market surveillance measures.
Amendment 433 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4a. Duplication of efforts between Member States and Union testing facilities shall be avoided.
Amendment 434 #
4b. For any test by the Union testing facilities requested by a market surveillance authority or multiple market surveillance authorities and not financed by the Union, the market surveillance authority or market surveillance authorities shall be charged the costs reasonably incurred for that test.
Amendment 435 #
Proposal for a regulation Article 20 – paragraph 4 b (new) 4b. Market surveillance authorities shall recognise the tests performed by Union testing facilities.
Amendment 436 #
Proposal for a regulation Article 20 – paragraph 5 5. The Commission shall adopt implementing acts specifying the procedures for the designati
Amendment 437 #
Proposal for a regulation Article 20 – paragraph 5 a (new) 5a. An appropriate appeal procedure should be put in place for decisions of Union testing facilities following their tasks as described in paragraph 4.
Amendment 438 #
Proposal for a regulation Article 20 – paragraph 5 b (new) 5b. Union Testing Facilities should refrain from any commercial activities that could enter into competition with conformity assessment bodies.
Amendment 439 #
5a. In case of further dispute or disagreement by one or more Member States with the findings of Union testing facilities, an appropriate appeal procedure should be put in place for decisions of Union testing facilities.
Amendment 440 #
Proposal for a regulation Article 20 – paragraph 5 b (new) 5b. The test reports issued by any designated Union testing facility shall be recognized in any other Member State.
Amendment 441 #
Proposal for a regulation Article 21 – paragraph 2 2. Market surveillance authorities may charge economic operators administrative fees in relation to instances of non- compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non-compliance. Those costs shall be proportionate in relation to the non-compliance and may include the costs of carrying out testing for the purposes of a risk assessment, the costs of taking measures in accordance with Article 30(1) and (2), the costs and time taken by the staff of market surveillance authorities to perform the market surveillance controls and
Amendment 442 #
Proposal for a regulation Article 21 – paragraph 2 2. Market surveillance authorities may charge economic operators administrative fees in relation to instances of non- compliance by that economic operator in order to enable the authorities to recover the costs of their activities with respect to these instances of non-compliance. Those costs shall be proportionate in relation to the non-compliance. The costs may include the costs of carrying out testing for the purposes of a risk assessment, the costs of taking measures in accordance with Article 30(1) and (2) and the costs of their activities relating to products that are found to be non-
Amendment 443 #
Proposal for a regulation Article 21 – paragraph 2 a (new) 2a. Member States shall ensure that administrative fees referred to in paragraph 2, charged by the market surveillance authorities, are used for financing further market surveillance activities of these authorities.
Amendment 444 #
Proposal for a regulation Article 22 – title Amendment 445 #
Proposal for a regulation Article 22 – paragraph 1 1.
Amendment 446 #
Proposal for a regulation Article 22 – paragraph 1 1. At the request of an applicant authority, the requested authority shall supply any information that the requested authority deems relevant, while observing the principle of confidentiality and proportionality where necessary in order to protect professional and commercial secrets or to preserve personal data, to establish whether a product is non- compliant and to ensure that the non- compliance can be brought to an end.
Amendment 447 #
Proposal for a regulation Article 22 – paragraph 1 1. At the request of an applicant
Amendment 448 #
Proposal for a regulation Article 22 – paragraph 2 2.
Amendment 449 #
Proposal for a regulation Article 22 – paragraph 3 3.
Amendment 450 #
Proposal for a regulation Article 22 – paragraph 3 a (new) 3a. When in conflict with national law, a request pursuant to the first subparagraph may not be used to demand the disclosure of information or documents.
Amendment 451 #
Proposal for a regulation Article 22 – paragraph 4 Amendment 452 #
4. The requested authority shall keep the applicant authority informed on actions and reply to the request under paragraph 1 using the procedure and within the time limits specified by the Commission under paragraph 5.
Amendment 453 #
Proposal for a regulation Article 22 – paragraph 5 Amendment 454 #
Proposal for a regulation Article 23 Amendment 455 #
Proposal for a regulation Article 23 – paragraph 1 1. At the request of an applicant authority or the Commission or any other stakeholders bringing the evidence of non-compliance, the requested authority shall without delay take all necessary enforcement measures using the powers conferred on it under this Regulation in order to bring an instance of non- compliance to an end. In case the requested authority would not take action, the Commission could itself take all necessary enforcement measures.
Amendment 456 #
Proposal for a regulation Article 24 – paragraph 1 1. The applicant authority shall
Amendment 457 #
Proposal for a regulation Article 24 – paragraph 2 2. Requests for mutual assistance
Amendment 458 #
Proposal for a regulation Article 25 – paragraph 1 1. Market surveillance authorities may use any information, document or a certified true copy of a document, finding, statement, or any intelligence as evidence for the purpose of their investigations, irrespective of the format in which and medium on which they are stored to the extent that these relate to the subject- matter and purpose of the inspection.
Amendment 459 #
Proposal for a regulation Article 25 – paragraph 3 Amendment 460 #
Proposal for a regulation Article 25 – paragraph 3 3.
Amendment 461 #
Proposal for a regulation Article 25 – paragraph 3 3. Products deemed
Amendment 462 #
Proposal for a regulation Article 25 – paragraph 3 3. Products deemed to be non- compliant on the basis of a decision of a market surveillance authority in one Member State, shall be presumed to be non-compliant by market surveillance authorities in another Member State, unless economic operators can provide clear evidence to the contrary. However, this shall not prevent relevant market surveillance authority of that Member State from starting its own investigation with regard to the product in question and adopt, if supported by clear evidence, adequate decisions. The Network, established under Article 31, shall discuss, without delay, diverging interpretations of the different Member States with regard to the same product.
Amendment 463 #
Proposal for a regulation Article 25 – paragraph 3 3. Products deemed to be non- compliant on the basis of a decision of a market surveillance authority in one Member State, shall be temporarily and with reservations presumed to be
Amendment 464 #
Proposal for a regulation Article 25 – paragraph 3 – subparagraph 1 (new) The parties concerned shall, whenever feasible, be given an opportunity to submit their views before the adoption of the measure. If this has not been done in advance because of the urgency of the measures to be taken, they shall be given such opportunity in due course after the measure has been implemented.
Amendment 465 #
Proposal for a regulation Article 25 – paragraph 3 a (new) 3a. Paragraph 3 shall not apply in case of formal non-compliance of products as defined in point (22b) of Article 3.
Amendment 466 #
Proposal for a regulation Article 25 – paragraph 4 Amendment 467 #
Proposal for a regulation Article 25 – paragraph 4 a (new) 4a. Only the European Market Surveillance Forum established under Article 31 of this Regulation can issue decisions that establish a presumption of non-compliance in all Member States. The Forum shall decide which measures, if any, are appropriate in view of the risks, the associated urgency to act, the principle of proportionality and the intent of non-compliance.
Amendment 468 #
Proposal for a regulation Article 25 – paragraph 4 b (new) 4b. The decision of the Forum referred to in Article 25 (4) shall be subject to appeal to the Commission by the economic operators concerned. The Commission shall evaluate the reasoned decision by the Forum taking into account the risks, the associated urgency to act, the principle of proportionality and the intent of the unmet legal requirements. The Commission will take a final decision after consultation with the European Market Surveillance Forum within 6 months after the date of the appeal.
Amendment 469 #
Proposal for a regulation Article 25 – paragraph 4 c (new) 4c. The reasoned decisions of the Forum pursuant to Article 25(4) and the Commission decisions pursuant to Article 25(5) shall be made available to the general public; the public version of the decision shall not disclose business secrets or other confidential company information.
Amendment 470 #
Proposal for a regulation Article 26 – paragraph 1 – subparagraph 2 a (new) The Commission must ensure that the number of checks carried out and the checking techniques used in the Union are uniform at every customs office.
Amendment 471 #
Proposal for a regulation Article 26 – paragraph 2 a (new) 2a. An importer bears a responsibility for a self-monitoring the compliance of a product entering the Union market. Such compliance shall be subject to a mandatory independent third party audit. Liability for control check is held by the importer and the liability for verifying the control check is held by the independent third party auditor.
Amendment 472 #
Proposal for a regulation Article 26 – paragraph 3 3. Products subject to Union harmonisation legislation that are to be placed under the customs procedure ‘release for free circulation’ shall be subject to controls performed by the authorities designated under paragraph 1. They shall perform those controls in a uniform manner at every point of entry into the Union on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.
Amendment 473 #
Proposal for a regulation Article 26 – paragraph 4 a (new) 4a. The Commission shall specify by means of implementing acts uniform control rates to be applied by customs authorities for products entering the Union market, based on risk assessment for product types as well as the number of products entering the Union market per port.
Amendment 474 #
Proposal for a regulation Article 26 – paragraph 5 – subparagraph 2 Where, in relation to products subject to Union harmonisation legislation that are either in temporary storage or placed under a customs procedure other than release for free circulation, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union legislation or present a risk, they shall transmit all relevant information to the competent customs office of destination.
Amendment 475 #
Proposal for a regulation Article 26 – paragraph 5 a (new) 5a. Where customs authorities of one Member State have reason to believe that potentially non-compliant product might be entering Union’s market in another Member State, they shall transmit, without delay, all relevant information to the competent customs offices of other Member States.
Amendment 476 #
Proposal for a regulation Article 26 – paragraph 7 – subparagraph 1 – introductory part By 31 March each year, Member States shall submit to the Commission detailed statistical data covering controls performed by the authorities designated under paragraph 1 with respect to products subject to Union harmonisation legislation during the previous calendar year, including data covering:
Amendment 477 #
Proposal for a regulation Article 26 – paragraph 7 – subparagraph 1 – point a a (new) (aa) type of check carried out;
Amendment 478 #
Proposal for a regulation Article 26 – paragraph 7 – subparagraph 1 – point d (d) the
Amendment 479 #
Proposal for a regulation Article 26 – paragraph 7 – subparagraph 2 The Commission shall draw up a report each year by 30 June, containing the information submitted by the Member States for the previous calendar year, including a comparative analysis of customs operations and enforcement procedures in force in the Member States. The report shall be published in the system referred to in Article 34.
Amendment 480 #
Proposal for a regulation Article 26 – paragraph 8 8. Where the Commission becomes aware of a serious risk posed in a Member State by products subject to Union harmonisation legislation that are imported from a third country, it shall re
Amendment 481 #
Proposal for a regulation Article 27 – paragraph 1 – introductory part 1.
Amendment 482 #
Proposal for a regulation Article 27 – paragraph 1 – point a Amendment 483 #
Proposal for a regulation Article 27 – paragraph 1 – point b Amendment 484 #
Proposal for a regulation Article 27 – paragraph 1 – point c Amendment 485 #
Proposal for a regulation Article 27 – paragraph 1 – point d Amendment 486 #
Proposal for a regulation Article 27 – paragraph 1 – point d (d) the
Amendment 487 #
Proposal for a regulation Article 27 – paragraph 1 – point d a (new) (da) the product or any presentation of the product bears without authorisation a trade mark that is essentially similar to a registered trade mark for that product, thereby not allowing its authenticity or origin to be guaranteed;
Amendment 488 #
Proposal for a regulation Article 27 – paragraph 1 – point e Amendment 489 #
Proposal for a regulation Article 27 – paragraph 1 – point e Amendment 490 #
Proposal for a regulation Article 27 – paragraph 1 – point e (e) for any other reason, there is a reasonable and justified cause to believe that the product
Amendment 491 #
Proposal for a regulation Article 27 – paragraph 1 – point e (e) for any other reason, there is cause to believe that the product
Amendment 492 #
Proposal for a regulation Article 27 – paragraph 1 a (new) 1a. Where in the course of controls under Article 26(1) a market surveillance authority or an authority designated under Article 26(1) makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of relevant Articles of the applicable Union harmonisation legislation; (b) the CE marking has not been affixed; (c) the identification number of the notified body involved in the production control phase has been affixed in violation of relevant Articles of the applicable Union harmonisation legislation or has not been affixed; (d) the EU declaration of conformity has not been drawn up or has not been drawn up correctly; (e) the technical documentation is either not available or not complete; (f) any other administrative requirement provided for in relevant Articles of the applicable Union harmonisation legislation is not fulfilled.
Amendment 493 #
Proposal for a regulation Article 27 – paragraph 1 b (new) 1b. Where the non-compliance referred to in paragraph 1a persists, the relevant authority shall suspend the release of a product for free circulation.
Amendment 494 #
Proposal for a regulation Article 27 – paragraph 2 2.
Amendment 495 #
Proposal for a regulation Article 27 – paragraph 3 Amendment 496 #
Proposal for a regulation Article 27 – paragraph 3 3. Where the market surveillance authorities have a reasonable and justified reason to believe that a product will not comply with the Union
Amendment 497 #
Proposal for a regulation Article 28 – paragraph 2 Amendment 498 #
Proposal for a regulation Article 28 – paragraph 2 A product released for free circulation in accordance with point (a) shall not be deemed to be in compliance with Union harmonisation legislation merely by reason of having been released for free circulation. The product released for free circulation needs to be compliant with general EU standards applicable to similar products produced within the EU Single Market, including but not limited to safety.
Amendment 499 #
Proposal for a regulation Article 28 – paragraph 2 A product released for free circulation in accordance with point (a) shall not be deemed to be in compliance with Union harmonisation legislation merely by reason of having been released for free circulation. The product released for free circulation needs to be compliant with general EU standards applicable to similar products produced within the EU Single Market, including but not limited to safety.
Amendment 500 #
Proposal for a regulation Article 29 – paragraph 1 1. Market surveillance authorities shall treat
Amendment 501 #
Proposal for a regulation Article 29 – paragraph 3 3. Market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance
Amendment 502 #
Proposal for a regulation Article 29 – paragraph 3 3. Market surveillance authorities and the customs authorities shall exchange information on the type of customs checks performed, the status of the authorised economic operators and their record of compliance related to product safety. The information exchanged shall also be communicated, where appropriate, to the European Anti-Fraud Office (OLAF).
Amendment 503 #
Proposal for a regulation Article 29 – paragraph 3 3. Market surveillance authorities and the customs authorities shall exchange information on the status of the authorised economic operators and their record of compliance
Amendment 504 #
Proposal for a regulation Article 29 – paragraph 4 4. Where any non-compliance is identified in the course of controls described in the second subparagraph of paragraph 2, the market surveillance authorities shall suspend the favourable treatment provided for in paragraph 1 and the first subparagraph of paragraph 2. They shall inform the relevant customs authorities about the identified non- compliance and shall enter details of the non-compliance in the system referred to in Article 34.
Amendment 505 #
Proposal for a regulation Article 31 – title Amendment 506 #
Proposal for a regulation Article 31 – paragraph 1 A
Amendment 507 #
Proposal for a regulation Article 31 – paragraph 1 a (new) The Commission shall support cooperation between market surveillance authorities via the Forum. It shall participate in the meetings of the Forum and its sub-groups.
Amendment 508 #
Proposal for a regulation Article 31 – paragraph 1 b (new) To perform the tasks set out in Article 32, the Forum shall be assisted by the Commission by means of an executive secretariat, that provides technical and logistic support to the Forum and its sub- groups, and the ADCOs.
Amendment 509 #
Proposal for a regulation Article 32 – title Composition of the
Amendment 510 #
Proposal for a regulation Article 32 – paragraph 1 1. The
Amendment 511 #
Proposal for a regulation Article 32 – paragraph 2 2. The E
Amendment 512 #
Proposal for a regulation Article 32 – paragraph 3 3. The Commission shall establish separate or joint administrative coordination groups for all the instruments of Union harmonisation legislation listed in the Annex to this Regulation. Each administrative coordination group shall be composed of representatives of the competent national market surveillance authorities and, if appropriate, representatives of the single liaison offices, and representatives of the relevant business associations and of consumer associations. The Commission shall publish on its website the agendas and calendar of meetings of the administrative coordination groups.
Amendment 513 #
Proposal for a regulation Article 32 – paragraph 3 3. The Commission shall establish separate or joint administrative coordination groups for all the instruments of Union harmonisation legislation listed in the Annex to this Regulation. Each administrative coordination group shall be composed of representatives of the competent national market surveillance authorities and,
Amendment 514 #
Proposal for a regulation Article 32 – paragraph 5 5. The Commission m
Amendment 515 #
Proposal for a regulation Article 32 – paragraph 5 a (new) 5a. The Commission shall ensure that requirements relating to cooperation between surveillance authorities are complied with and that authorities take account of reports from stakeholders concerning cases of non- compliance.
Amendment 516 #
Proposal for a regulation Article 32 – paragraph 5 a (new) 5a. As much as possible, the meeting of the EUPC Board as well as the meetings of the administration groups shall be conducted in an open and transparent manner.
Amendment 517 #
Proposal for a regulation Article 32 a (new) Article 32a Composition of the European Market Surveillance Forum 1. Each Member State shall be represented in meetings of the Forum by one or more representatives from each of the single liaison offices referred to in Article 11, and two representatives from the Commission, and their respective alternates. 2. The Forum shall meet at regular intervals and, where necessary, at the duly motivated request of the Commission or a Member State. 3. The Forum shall use its best endeavours to reach consensus. If consensus cannot be reached, the Forum shall adopt its position by a simple majority of its members. Members may request that their positions and the grounds on which they are based are officially recorded. 4. The Forum may invite experts and other third parties to attend meetings or provide written contributions. 5. The Forum may establish standing or temporary sub-groups. 6. Administrative cooperation groups for market surveillance (ADCOs), set up by the Member States for the implementation of the different parts of Union harmonisation legislation, shall be part of the Forum. 7. ADCOs may organize open meetings inviting on a case by case basis organisations representing the interests at Union level of industry, small and medium-sized enterprises, consumers, laboratories and conformity assessment bodies. 8. The Forum shall establish its rules of procedure. 9. The Forum shall cooperate with the Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006.
Amendment 518 #
Proposal for a regulation Article 33 – paragraph –1 (new) -1. The Network shall have the following tasks: (a) to adopt a biennial work programme, which, inter alia, defines the priorities for common market surveillance actions, including the common actions with regard to the online market surveillance, and priority areas or categories of products; (b) to adopt rules of procedure for itself and for the functioning of the administrative coordination groups; (c) to update and regularly review a general risk assessment methodology and ensure a uniform application of that methodology; (d) to adopt sectorial guidelines for checks on the characteristic of products subject to this Regulation; (e) to define the uniform conditions of checks, criteria for determination of the frequency of checks or amount of samples to be checked in relation to certain products, as referred to in Article 15(1), in accordance with the priorities laid down in paragraph -1(a); (f) to facilitate the exchange of information on non-compliant products, recent scientific developments and new technologies, emerging risks and other aspects relevant to control activities; (g) to ensure the coordination and monitoring of the administrative coordination groups and their activities; (h) to assist, by request of a Member State, in the drawing up and implementation of the memoranda of understanding referred to in Article 8; (i) to facilitate an effective functioning of a peer evaluation system between market surveillance authorities and the Commission, as referred to in Article 12b, and to examine and monitor the results of those evaluations; (j) to analyse disputes between market surveillance authorities on the application of this Regulation, examine any other question in this regard and adopt guidelines, recommendations and best practices in order to encourage consistent application and uniform interpretation of this Regulation, including by creating a common methodology for defining and setting penalties; (k) to discuss how to ensure adequate ways of financing and recovery of costs of market surveillance in the Union and to propose the financing of activities provided for in Article 36; (l) to promote and facilitate collaboration with other relevant networks and groups, notably EU blockchain Observatory and Forum, with a view to explore possibilities on using new technologies, especially blockchain, for the purposes of market surveillance and traceability of products.
Amendment 519 #
Proposal for a regulation Article 33 – paragraph 1 – point h (h) to organise the meetings of the E
Amendment 520 #
Proposal for a regulation Article 33 – paragraph 1 – point m (m) to examine, on its own initiative or at the request of the E
Amendment 521 #
Proposal for a regulation Article 33 – paragraph 2 – introductory part 2. The E
Amendment 522 #
Proposal for a regulation Article 33 – paragraph 3 a (new) 3a. The following procedure should be followed when common approaches as specified in point (h) of Article 33(3) are discussed and agreed upon by the administrative coordination groups: (a) before administrative coordination groups discuss and agree upon common approaches, relevant business associations and the manufacturer concerned should have the possibility to submit comments. (b) the Commission shall inform relevant business associations of common approaches agreed upon by administrative coordination groups.
Amendment 523 #
Proposal for a regulation Article 33 a (new) Amendment 524 #
Proposal for a regulation Article 34 – paragraph 1 1. The Commission shall develop and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation. The aim is to enable sharing of relevant data between Member States and to allow the Commission to monitor market surveillance activities. The Commission, single liaison offices, market surveillance authorities and authorities designated in accordance with Article 26(1) shall have access to that system. The information and communication system shall be linked through a common interface to the existing electronic system of the customs administration, based on Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code as well as to the Community Rapid Information System RAPEX, based on Directive 2001/95/EC of the European Parliament and of the Council on General Product Safety.
Amendment 525 #
Proposal for a regulation Article 34 – paragraph 1 1. The Commission shall develop and maintain an information and
Amendment 526 #
Proposal for a regulation Article 34 – paragraph 1 1. The Commission shall develop and maintain an information and communication system for the collection and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation. This system should have a public interface with key information in all EU languages to inform consumers about the outcome of market surveillance. The Commission, single liaison offices, and authorities designated in accordance with Article 26(1) shall have access to that system.
Amendment 527 #
1. The Commission shall develop and maintain an information and communication system for the collection and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation, and for giving consumers access to all useful information regarding market surveillance activities and their results. The Commission, single liaison offices, and authorities designated in accordance with Article 26(1) shall have access to that system.
Amendment 528 #
Proposal for a regulation Article 34 – paragraph 3 – point b Amendment 529 #
Proposal for a regulation Article 34 – paragraph 5 a (new) Amendment 531 #
Proposal for a regulation Article 35 – paragraph 1 1. The Commission may exchange confidential market surveillance related information with regulatory authorities of third countries or international organisations where it has concluded confidentiality arrangements based on reciprocity with those authorities or
Amendment 532 #
Proposal for a regulation Article 35 – paragraph 1 1.
Amendment 533 #
Proposal for a regulation Article 35 – paragraph 1 1.
Amendment 534 #
Proposal for a regulation Article 35 – paragraph 1 a (new) 1a. The European Commission shall ensure that any information exchanged under paragraph 1 is in accordance with applicable law (including on the processing of personal data and on the free movement of such data), and that information is shared only with regulatory authorities of third countries or international organisations that guarantee an adequate level of protection to the fundamental rights of economic operators, by means of their domestic law or the international commitments they have entered into.
Amendment 535 #
Proposal for a regulation Article 35 – paragraph 2 – introductory part 2. The Commission may, following approval by the EMSF Board, set up a framework for cooperation and exchange
Amendment 536 #
Proposal for a regulation Article 35 – paragraph 3 3. The Commission may, following approval by the EMSF Board, approve a specific system of product-related pre- export control carried out by a third country on products immediately prior to their export into the Union in order to verify that those products satisfy the requirements of the Union harmonisation legislation applicable to them. The approval may be granted in respect of one or more products, in respect of one or more categories of product or in respect of products or categories of product manufactured by certain manufacturers.
Amendment 537 #
Proposal for a regulation Article 35 – paragraph 5 – introductory part 5. Approval may only be granted to a
Amendment 538 #
Proposal for a regulation Article 35 – paragraph 5 – introductory part 5. Approval may only be granted to a third country under paragraph 3 following
Amendment 539 #
Proposal for a regulation Article 35 – paragraph 5 – point –a (new) (-a) the third country possesses an efficient verification system of the compliance of the products exported to the Union;
Amendment 540 #
Proposal for a regulation Article 35 – paragraph 5 – point a a (new) (aa) the third country possesses an efficient verification system of the compliance of products exported to the Union;
Amendment 541 #
Proposal for a regulation Article 35 – paragraph 9 9. The Commission shall regularly monitor the correct functioning of the approval and shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. The Commission shall inform Member States and the affected third country.
Amendment 542 #
Proposal for a regulation Article 35 – paragraph 9 9. The Commission, following approval of the EMSF Board, shall withdraw an approval granted under paragraph 3 where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. The Commission shall immediately inform Member States and the affected third country.
Amendment 543 #
Proposal for a regulation Article 38 – title A
Amendment 544 #
Proposal for a regulation Article 38 – title Applicability of Regulation (EC) 765/2008
Amendment 545 #
Proposal for a regulation Article 38 – paragraph 1 Articles 15 to 29 of Regulation (EC) 765/2008
Amendment 546 #
Proposal for a regulation Article 38 – paragraph 1 Articles 15 to 29 of Regulation (EC) 765/2008
Amendment 547 #
Proposal for a regulation Article 61 – paragraph 2 – point a Amendment 548 #
Proposal for a regulation Article 61 – paragraph 2 – point a Amendment 549 #
Proposal for a regulation Article 61 – paragraph 2 – point a Amendment 550 #
Proposal for a regulation Article 61 – paragraph 2 – point b (b) the nature, gravity and duration of the non-compliance taking into account the harm caused to end-users as well as the environment, labour force involved in the manufacturing and animals where relevant;
Amendment 551 #
Proposal for a regulation Article 61 – paragraph 2 – point b (b) the nature, gravity and duration of the non-compliance taking into account the harm caused to end-users and traders marketing similar or comparable products;
Amendment 552 #
Proposal for a regulation Article 61 – paragraph 2 – point e (e) any relevant similar infringements previously committed by the economic operator
Amendment 553 #
Proposal for a regulation Article 61 – paragraph 2 – point e a (new) (ea) the financial situation of small and medium-sized enterprises.
Amendment 554 #
Proposal for a regulation Article 61 – paragraph 2 – point e a (new) (ea) the profit generated by the marketing of the non-compliant product.
Amendment 555 #
Proposal for a regulation Article 61 – paragraph 3 3. The penalties may be increased where the economic operator has previously committed a similar infringement and may include criminal penalties for serious infringements of Union harmonisation legislation. A penalty of 5 % of the turnover of an entity should be considered in such cases.
Amendment 556 #
Proposal for a regulation Article 61 – paragraph 5 a (new) 5a. Member States shall ensure, also, that financial penalties imposed for infringements of Union harmonisation legislation are used for financing further market surveillance activities.
Amendment 557 #
Proposal for a regulation Article 61 – paragraph 5 a (new) 5a. Member States have the possibility not to apply any penalties in cases of minor formal infringements and where the non-compliance is corrected by the operator in a timely manner.
Amendment 558 #
Proposal for a regulation Article 61 – paragraph 5 a (new) 5a. Member States may not apply any penalties in case of minor formal infringement, timely correction of the non-compliance by the operator or first time non-compliance.
Amendment 559 #
Proposal for a regulation Article 62 – paragraph 1 By [31 December 202
Amendment 560 #
Proposal for a regulation Article 62 – paragraph 1 By [31 December 2024] and every
Amendment 561 #
Proposal for a regulation Article 62 – paragraph 2 The report shall assess whether this Regulation achieved its objectives, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, whilst taking into account the impact on business and in particular on small and medium-sized enterprises.
Amendment 562 #
Proposal for a regulation Article 62 – paragraph 2 The report shall assess whether this Regulation achieved its objectives, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, whilst taking into account the impact on business and in particular on small and medium-sized enterprises. In addition, the evaluation should also assess the effectiveness of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and legislation, as well as explore and propose new market-based solutions that could effectively complement the market surveillance actions that are currently being carried out, and shall include, but not be limited to, exploring the potential of compulsory independent third party auditing schemes.
Amendment 563 #
Proposal for a regulation Article 62 – paragraph 2 The report shall assess whether this Regulation achieved its objectives, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, whilst taking into account the impact on business and in particular on small and medium-sized enterprises. In addition, the evaluation should also assess the effectiveness of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and legislation and the ability to ensure a high level of compliance and safety of related products and of products with integrated artificial intelligence systems.
Amendment 564 #
Proposal for a regulation Annex I – point 42 source: 622.181
2018/05/25
ENVI
141 amendments...
Amendment 100 #
Proposal for a regulation Article 5 – paragraph 1 Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers including those from third countries, or importers, shall make the declaration publicly available on their website or, in the absence of a website, by any other means that allows the declaration to be readily accessed by the general public in the Union free of charge.
Amendment 101 #
Proposal for a regulation Article 7 Amendment 102 #
Proposal for a regulation Article 7 Amendment 103 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with custom authorities, port and airport authorities, businesses or organisations representing businesses or end-users for the carrying out, or financing, of joint activities aimed at identifying non- compliance or promoting compliance in specific geographical areas or with respect to specific categories of products. The market surveillance authority shall provide a draft memorandum to the Commission at least 2 months before its adoption and a report on its implementation every year from the date of its adoption. The Commission shall provide an opinion to the market surveillance authorities on the draft memorandum and the implementation report.
Amendment 104 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with custom authorities, port and airport authorities, businesses or organisations representing businesses or end-users for the carrying out, or financing, of joint activities aimed at identifying non- compliance or promoting compliance in specific geographical areas or with respect to specific categories of products.
Amendment 105 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 Market surveillance authorities may enter into memoranda of understanding with the customs, port and airport authorities, businesses or organisations representing businesses or end-users for the carrying out, or financing, of joint activities aimed at identifying non-compliance or promoting compliance in specific geographical areas or with respect to specific categories of product.
Amendment 106 #
Proposal for a regulation Article 8 – paragraph 1 – subparagraph 1 a (new) The market surveillance authority shall provide a draft memorandum to the Commission at least 2 months before its adoption and a report on its implementation every year from the date of its adoption. The Commission shall provide an opinion to the market surveillance authorities on the draft memorandum and the implementation report.
Amendment 107 #
Proposal for a regulation Article 8 – paragraph 2 2. A market surveillance authority may use any information resulting from activities carried out or financed by other parties to a memorandum of understanding entered into by it under paragraph 1 as part of any investigation undertaken by it into non-compliance, but only if the activity in question was carried out independently, impartially and without bias. Information on how products have been tested and the results of such tests shall be made publicly available.
Amendment 108 #
Proposal for a regulation Article 8 – paragraph 3 3. Any exchange of information between market surveillance authorities, the Commission, or the EU Product Compliance Board and businesses or organisations referred to in paragraph 1 for the purposes of preparing or implementing a memorandum of understanding entered into by them under that paragraph shall be
Amendment 109 #
Proposal for a regulation Article 10 – paragraph 1 1.
Amendment 110 #
Proposal for a regulation Article 10 – paragraph 2 – introductory part 2.
Amendment 111 #
Proposal for a regulation Article 10 – paragraph 2 – introductory part 2. Market surveillance authorities shall establish the following procedures in connection with products subject to th
Amendment 112 #
Proposal for a regulation Article 10 – paragraph 2 – point b (b) procedures for monitoring any accidents or any harm to the health or safety of end-users which are suspected of having been caused by such products; to ensure consistency, the Commission shall set up a Pan-European harmonised database for the collection of accident and injury data.
Amendment 113 #
Proposal for a regulation Article 10 – paragraph 2 – point b (b) procedures for monitoring any accidents or any harm to the health
Amendment 114 #
Proposal for a regulation Article 10 – paragraph 2 – point d a (new) (d a) procedures for collecting and exploring scientific and technical knowledge concerning safety issues, impacting in particular health and environmental protection.
Amendment 115 #
4. The Commission shall adopt in cooperation with the Member states, operational rules, including regarding human and financial resources, expertise and procedures, for the Member States to set up effective liaison offices. Member States shall ensure accordingly that their market surveillance authorities and single liaison office have the necessary resources,
Amendment 116 #
Proposal for a regulation Article 12 – paragraph 1 – point a (a) the effective surveillance of the market within their territory with respect to a
Amendment 117 #
Proposal for a regulation Article 12 – paragraph 1 – point a (a) the effective surveillance of the market within their territory with respect to any products; th
Amendment 118 #
Proposal for a regulation Article 12 – paragraph 1 – point a (a) the effective surveillance of the market within their territory with respect to
Amendment 119 #
Proposal for a regulation Article 12 – paragraph 1 – point b (b) the taking by them of appropriate and proportionate temporary measures and the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation and based on common Union rules.
Amendment 120 #
2. Market surveillance authorities shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach and in accordance with the precautionary principle, taking into account, as a minimum, the following factors:
Amendment 121 #
Proposal for a regulation Article 12 – paragraph 2 – introductory part 2. Market surveillance authorities shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach, taking into account the precautionary principle and, as a minimum, the following factors:
Amendment 122 #
Proposal for a regulation Article 12 – paragraph 2 – introductory part 2. Market surveillance authorities shall perform controls as part of their activities set out in paragraph 1, on a risk- based approach, taking into account the precautionary principle and, as a minimum, the following factors:
Amendment 123 #
Proposal for a regulation Article 12 – paragraph 2 – point a – introductory part (a) the identified and potential risks associated with:
Amendment 124 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point a (a) the product is liable, or is suspected of being able, to compromise the health, security or safety of end-users;
Amendment 125 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point a (a) the product is liable to compromise the health or safety or security of end- users;
Amendment 126 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point a (a) the product is liable to compromise the health
Amendment 127 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point a a (new) (a a) the product is liable to pollute or endanger the environment;
Amendment 128 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 1 – point b (b) the product does not conform to applicable requirements under Union harmonisation legislation or under Directive 2001/95/EC.
Amendment 129 #
Proposal for a regulation Article 12 – paragraph 3 – subparagraph 2 Where the products are withdrawn, recalled, prohibited or restricted, the market surveillance authority shall ensure that the Commission through the Network established under Article 31, the Union testing facilities, other Member States and end-users are informed accordingly.
Amendment 130 #
Proposal for a regulation Article 12 – paragraph 5 a (new) 5 a. To settle any disputes arising out of a divergent risk assessment among the authorities of the Member States, the economic operators and the conformity assessment bodies the Commission may, of its own initiative or at the request of a surveillance authority, have a risk assessment carried out by a reference laboratory of the European Union referred to in Article 28, which shall be binding on all of the stakeholders.
Amendment 131 #
Proposal for a regulation Article 12 – paragraph 5 a (new) 5 a. To settle any disputes arising out of a divergent risk assessment among the authorities of the Member States, the economic operators and the conformity assessment bodies the Commission may, of its own initiative or at the request of a surveillance authority, have a risk assessment carried out by a reference laboratory of the European Union referred to in Article 28,which shall be binding on all of the stakeholders.
Amendment 132 #
Proposal for a regulation Article 13 – paragraph 1 1. Each Member State shall draw up a national market surveillance strategy, as a minimum, every 3 years. The strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and enforcement of Union harmonisation legislation within the territory of the Member State and shall include all sectors and stages of the product supply chain, including imports and digital supply chains. In establishing their national market surveillance strategies, the Member States shall consult stakeholders and make their comments available to the general public.
Amendment 133 #
Proposal for a regulation Article 13 – paragraph 1 1. Each Member State shall draw up a national market surveillance strategy, as a minimum, every 3 years, in view of the rapid market evolutions and new emerging risks. The strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and enforcement of Union
Amendment 134 #
Proposal for a regulation Article 13 – paragraph 1 1. Each Member State shall draw up a national market surveillance strategy, as a minimum, every 3 years to follow the fast development of markets. The strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and enforcement of Union harmonisation
Amendment 135 #
Proposal for a regulation Article 13 – paragraph 2 – point b (b) the areas identified as a priority for the enforcement of Union harmonisation legislation
Amendment 136 #
Proposal for a regulation Article 13 – paragraph 2 – point b (b) the areas identified as a priority for the enforcement of Union harmonisation legislation; Member States shall consider products that are or have been subject to an emergency decision based on Article 13 of Directive2001/95/EC as priority areas;
Amendment 137 #
Proposal for a regulation Article 13 – paragraph 2 – point f a (new) (f a) an assessment of new risks for consumers related to products which can connect to the internet and endanger consumers security;
Amendment 138 #
Proposal for a regulation Article 13 – paragraph 3 3. Member States shall communicate their national market surveillance strategy through the system referred to under Article 34, and shall make it available to the general public.
Amendment 139 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to take temporary
Amendment 140 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to take temporary and final measures, where there are no other effective means available to prevent a serious risk, including in particular temporary measures requiring hosting service providers to remove, disable or restrict access to content or to suspend or restrict access to a website, service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time;
Amendment 141 #
Proposal for a regulation Article 14 – paragraph 3 – point h (h) the power to take temporary and final measures, where there are no other effective means available to prevent a serious risk, including in particular temporary measures requiring hosting service providers to remove, disable or restrict access to content or to suspend or restrict access to a website, service or account or requiring domain registries or registrars to put a fully qualified domain name on hold for a specific period of time;
Amendment 142 #
Proposal for a regulation Article 14 – paragraph 3 – point i (i) the power to start investigations or proceedings on their own initiative in order to bring an instance of non-compliance within the territory of the Member State concerned to an end and, where appropriate, to publish information about the investigation through the system referred to in Article 34, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy;
Amendment 143 #
Proposal for a regulation Article 14 – paragraph 3 – point m Amendment 144 #
Proposal for a regulation Article 14 – paragraph 3 – point m (m) the power to order the restitution of profits obtained as a result of an instance of non-compliance and demand companies to refund affected consumers;
Amendment 145 #
Proposal for a regulation Article 14 – paragraph 3 – point n (n) the power to publish any final decisions, final measures, commitments given by the economic operator or decisions taken or made pursuant to this Regulation, including the publication of the identity of the economic operator who was responsible for the non-compliance and the terms stating how the economic operator will have to compensate the loss or damage endured by consumers.
Amendment 146 #
Proposal for a regulation Article 14 – paragraph 3 – point n (n) the power to publish any final decisions, final measures, commitments given by the economic operator or decisions taken or made pursuant to this Regulation, including the publication of the identity of the economic operator who was responsible for the non-compliance, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy.
Amendment 147 #
Proposal for a regulation Article 14 – paragraph 4 4. Market surveillance authorities shall publish any commitments given to them by economic operators, details of any corrective action taken by economic operators in their territory, and details of any temporary measures taken by the relevant market surveillance authority pursuant to this Regulation, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy.
Amendment 148 #
Proposal for a regulation Article 14 – paragraph 5 5. Market surveillance authorities shall exercise their powers in accordance with the pr
Amendment 149 #
Proposal for a regulation Article 14 – paragraph 5 5. Market surveillance authorities shall exercise their powers in accordance with the precautionary principle and the principle of proportionality.
Amendment 150 #
Proposal for a regulation Article 14 – paragraph 5 5. Market surveillance authorities shall exercise their powers in accordance with the precautionary principle and the principle of proportionality.
Amendment 151 #
Proposal for a regulation Article 15 – paragraph 1 – subparagraph 1 Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, with a minimum of 20% checks performed on products placed on the market, in accordance with the priorities determined by the compliance network and the common methodology defined by the Commission, by means of documentary checks and, where appropriate, physical and laboratory controls on the basis of a representative sample.
Amendment 152 #
Proposal for a regulation Article 16 – paragraph 1 Market surveillance authorities shall
Amendment 153 #
Proposal for a regulation Article 18 – paragraph 2 2. The decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard
Amendment 154 #
Proposal for a regulation Article 20 – paragraph 3 3.
Amendment 155 #
(e a) act as a knowledge centre in respect of risks and emerging risks, for example in relation to chemicals that are classified as carcinogenic, mutagenic and toxic for reproduction or other substances of concern in consumer products such as endocrine disrupters and sensitizers. Union testing facilities shall also assist the Commission and Member States to develop joint state of the art testing methodologies related to chemicals in consumer products. Close relationships shall be established between the European Chemicals Agency and the knowledge centre of the Union testing facilities to avoid overlaps and ensure optimal support for the Member States market surveillance and enforcement activities.
Amendment 156 #
Proposal for a regulation Article 20 – paragraph 4 – point e a (new) (e a) act as a knowledge hub on risks and emerging risks for consumers and the environment stemming from harmful chemicals;
Amendment 157 #
Proposal for a regulation Article 20 – paragraph 4 – point e b (new) (e b) act as a knowledge hub on new risks for consumers related to products which can connect to the internet;
Amendment 158 #
Proposal for a regulation Article 20 – paragraph 4 – point e a (new) (e a) act as a knowledge hub on risks for consumers stemming from harmful chemicals.
Amendment 159 #
Proposal for a regulation Article 20 – paragraph 4 – point e b (new) Amendment 160 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4a. The market surveillance authorities shall take due account of the results of tests carried out by Union testing facilities when adopting appropriate market surveillance measures.
Amendment 161 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4 a. Market surveillance authorities shall take due account of the test, results, analysis and conclusions of the Union testing facilities to adopt appropriate market surveillance measures.
Amendment 162 #
Proposal for a regulation Article 21 – paragraph 2 2. Market surveillance authorities
Amendment 163 #
Proposal for a regulation Article 23 – paragraph 1 1. At the request of an applicant authority or the Commission or any other stakeholders bringing due evidence of non-compliance, the requested authority shall without delay take all necessary enforcement measures using the powers conferred on it under this Regulation in order to bring an instance of non- compliance to an end. In case the requested authority would not take action, the Commission could itself take all necessary enforcement measures.
Amendment 164 #
Proposal for a regulation Article 25 – paragraph 3 3. Products deemed
Amendment 165 #
Proposal for a regulation Article 25 – paragraph 3 3. Products deemed to be
Amendment 166 #
Proposal for a regulation Article 29 – paragraph 1 1. Market surveillance authorities shall treat
Amendment 167 #
Proposal for a regulation Article 33 – paragraph 1 – point a a (new) (a a) to monitor the activities of market surveillance and customs authorities in order to ensure that there is an equal and stringent level of controls of harmonised and non-harmonised products in the different Member States;
Amendment 168 #
Proposal for a regulation Article 33 – paragraph 1 – point a b (new) (a b) to define a common testing methodology in order to ensure there is uniformity in the controls carried out by Member States;
Amendment 169 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) to organise cooperation and facilitate the effective and regular exchange of information and best practices between
Amendment 170 #
Proposal for a regulation Article 33 – paragraph 1 – point m a (new) (m a) to set up procedures for the provision of a pan-European database for the collection of data regarding accidents, harm or damages caused to the health, safety and/or security of end-users or to the environment, and to make the information provided in that database readily accessible to all relevant stakeholders;
Amendment 172 #
Proposal for a regulation Article 35 – paragraph 1 1. The Commission may exchange confidential market surveillance related information with regulatory authorities of third countries or international organisations
Amendment 173 #
Proposal for a regulation Article 61 – paragraph 1 – subparagraph 1 The Commission, together with Member States, shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation that impose obligations on
Amendment 174 #
Proposal for a regulation Article 61 – paragraph 2 – point a Amendment 175 #
Proposal for a regulation Article 61 – paragraph 2 – point b (b) the nature, gravity and duration of the non-compliance taking into account the harm caused to end-users, to the environment, to social and economic interests;
Amendment 176 #
Proposal for a regulation Article 61 – paragraph 2 – point e a (new) (e a) the financial situation of small and medium-sized enterprises;
Amendment 37 #
Proposal for a regulation Title 1 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and Member States’ legislation on products, and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council (Text with EEA relevance) (This amendment applies throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 38 #
Proposal for a regulation Recital 2 (2) Strengthening the Single Market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the Commission ‘Upgrading the Single Market: more opportunities for people and businesses’24 . This should be achieved by, amongst others, strengthening market surveillance, providing the right incentives to economic operators, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including through cooperation with customs authorities. _________________ 24 COM(2015) 550 final of 28 October 2015.
Amendment 39 #
Proposal for a regulation Recital 2 a (new) (2 a) Union legislation on packaging and packaging waste, as for example Directive 94/62/EC1a, as recently amended, should be taken into account as regards the rules and procedures for compliance on products laid down in this Regulation. _________________ 1aEuropean Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste(OJ L 365 31.12.1994, p. 10).
Amendment 40 #
Proposal for a regulation Recital 5 (5) This Regulation should cover all products that are subject to the Union harmonisation legislation
Amendment 41 #
Proposal for a regulation Recital 5 (5) This Regulation should cover products that are subject to Directive 2001/95/EC or the Union harmonisation legislation listed in the Annex. The legislation listed in the Annex should cover all Union harmonisation legislation concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level. Several instruments of Union harmonisation legislation on products need to be amended in consequence, in particular to remove references to certain provisions of Regulation (EC) No 765/2008. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to provide whether this Regulation is also to apply to that legislation.
Amendment 42 #
Proposal for a regulation Recital 5 (5) This Regulation should cover products that are subject to the Directive 2001/95/EC or the Union harmonisation legislation listed in the Annex. The legislation listed in the Annex should cover all Union harmonisation legislation concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level. Several instruments of Union harmonisation legislation on products need to be amended in consequence, in particular to remove references to certain provisions of Regulation (EC) No 765/2008. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to provide whether this Regulation is also to apply to that legislation.
Amendment 43 #
Proposal for a regulation Recital 7 (7) Safety of consumers largely depends on the active enforcement of Union
Amendment 44 #
Proposal for a regulation Recital 7 a (new) (7 a) Special attention should be given to Internet of Things (IoT) and the increasing number of Artificial Intelligence (AI) enabled devices, taking into account that consumers are increasingly using connected devices in their daily lives without knowing the security threats these devices can represent and the remote risks that exist. The Union regulatory framework should therefore address these issues to ensure a better protection of consumers.
Amendment 45 #
Proposal for a regulation Recital 14 (14) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this purpose, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers, wholesalers, retailers and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product. It is important that there should be a contact person established in the Union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with Union harmonisation legislation. The person responsible for providing such compliance information should be the manufacturer, or the
Amendment 46 #
Proposal for a regulation Recital 14 (14) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this purpose, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers, distributors and the market surveillance authorities is a key element allowing immediate intervention and corrective action in relation to the product. It is important that there should be a contact person established in the Union so that market surveillance authorities have someone to whom questions can be addressed regarding a product’s compliance with Union harmonisation legislation. The person responsible for providing such compliance information should be the manufacturer
Amendment 47 #
Proposal for a regulation Recital 14 (14) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this purpose, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers, distributors and the market surveillance authorities is a key element allowing immediate intervention and corrective
Amendment 48 #
Proposal for a regulation Recital 18 (18) Market surveillance activities
Amendment 49 #
Proposal for a regulation Recital 18 (18) Market surveillance activities should be thorough and effective, to ensure that Union harmonisation legislation on products is applied correctly. Given that controls may represent a burden for economic operators, market surveillance authorities should organise and conduct inspection activities
Amendment 50 #
Proposal for a regulation Recital 23 a (new) (23 a) Market surveillance authorities should be able to advise on packaging and order changes in practice where they find situations in conflict with Union legislation.
Amendment 51 #
Proposal for a regulation Recital 24 (24) Market surveillance authorities should be able to require any representative or m
Amendment 52 #
Proposal for a regulation Recital 30 (30) This Regulation should be without prejudice to the safeguard clause procedure provided for by sectoral Union harmonisation legislation, pursuant to Article 114(10) of the Treaty. With a view to ensuring an equivalent level of protection throughout the Union, Member States should be authorised to take restrictive measures in relation to products presenting a risk to health and safety, or other aspects of public interest protection. They should also be required to notify those measures to other Member States and the Commission
Amendment 53 #
Proposal for a regulation Recital 31 (31) Information exchanged between market surveillance authorities, and the use of evidence and investigation findings should be subject to the strictest guarantees of confidentiality and of professional and commercial secrecy. Information should be handled according to applicable national
Amendment 54 #
Proposal for a regulation Recital 33 (33) To ensure the reliability and consistency of testing across the Union in the market surveillance framework, the Commission should designate Union testing facilities. Furthermore, a more comprehensive information system should be developed for sharing test results within the Union in order to avoid unnecessary duplication and to ensure greater consistency at Union level. Union testing facilities competence centres should act as knowledge centres in respect of known and emerging risks and also assist the Union and Member States to develop joint state of the art testing methodologies related to chemicals in consumer products.
Amendment 55 #
Proposal for a regulation Recital 33 (33) To ensure the reliability and
Amendment 56 #
Proposal for a regulation Recital 36 a (new) (36 a) The level of penalties applicable to infringements of the provisions of this Regulation that impose obligations on economic operators and to infringements of provisions of any Union and Member States’ legislation on products that impose obligations on economic operators should be stepped up in order to efficiently deter the placement of non-compliant products on the market.
Amendment 57 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation
Amendment 58 #
Proposal for a regulation Article 1 – paragraph 2 Amendment 59 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products
Amendment 60 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products that are subject to the Union harmonisation legislation
Amendment 61 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products
Amendment 62 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies
Amendment 63 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products that are subject to Directive 2001/95/EC or the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
Amendment 64 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation shall appl
Amendment 65 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products that are subject to Directive 2001/95/EC or the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
Amendment 66 #
Proposal for a regulation Article 2 – paragraph 1 1. This Regulation applies to all products that are subject to Directive 2001/95/EC or the Union harmonisation legislation set out in the Annex to this Regulation (‘Union harmonisation legislation’).
Amendment 67 #
Proposal for a regulation Article 2 – paragraph 3 3. The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC. Those authorities are to always act on the basis of the precautionary principle, in particular when it comes to health and the environment.
Amendment 68 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements under Union
Amendment 69 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 (7) ‘non-compliance’ means any failure to comply with any of the requirements under the Union harmonisation legislation or to Member States ‘ legislation applicable to the product in question; (This amendments applies throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 70 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 a (new) Amendment 71 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘serious risk’ means any
Amendment 72 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘serious risk’ means any
Amendment 73 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘
Amendment 74 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘serious risk’ means any serious risk, including a serious risk where the effects are not immediate, requiring rapid intervention by the market surveillance authorities, in accordance with the precautionary principle;
Amendment 75 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 a (new) (22 a) ‘distinct models’ means models of products that are considered to be distinct due to different essential characteristics that may have an impact on their safety.
Amendment 76 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 a (new) (22a) ‘distinct models’ means all products with different characteristics, even when those differences are minor or even non-existent.
Amendment 77 #
Proposal for a regulation Article 4 – paragraph 1 – point a – introductory part (a) the manufacturer, or its
Amendment 78 #
Proposal for a regulation Article 4 – paragraph 1 – point a – introductory part (a) the manufacturer, or its
Amendment 79 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point i (i) an importer, when the manufacturer is not established in the Union and there is no authorised representative;
Amendment 80 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point i (i) (b) an importer, when the manufacturer is not established in the Union and there is no authorised representative;
Amendment 81 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point i a (new) (ia) a distributor;
Amendment 82 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point ii (ii) (c) in case there is no manufacturers or importer established in the Union, a natural or legal person established in the Union who has a written mandate from the manufacturer designating him as a person responsible for compliance and performing the tasks listed in paragraph 3
Amendment 83 #
Proposal for a regulation Article 4 – paragraph 1 – point a – point ii (ii) in case there is no manufacturers or importer established in the Union, a natural or legal person established in the Union who has a written mandate from the manufacturer designating him as a person responsible for performing the tasks listed in paragraph 3 and requiring him to perform those tasks on the manufacturer’s behalf;
Amendment 84 #
Proposal for a regulation Article 4 – paragraph 1 – point b (b) the identity and contact details of the manufacturer, importer, distributor or other person
Amendment 85 #
Proposal for a regulation Article 4 – paragraph 1 – point b (b) (d) the identity and contact details of the manufacturer, importer or other person meeting the requirements of points (a to c) are publicly available in accordance with paragraph 4 and are indicated or identifiable in accordance with paragraph 5.
Amendment 86 #
Proposal for a regulation Article 4 – paragraph 3 – point b (b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language determined by the Member State concerned and to demonstrate the existence of different essential characteristics between its distinct models as defined in point 22a of Article 3;
Amendment 87 #
Proposal for a regulation Article 4 – paragraph 3 – point b (b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language determined by the Member State concerned; and to demonstrate the existence of different essential characteristics between its between its distinct models as defined in point 22a of Article 3;
Amendment 88 #
Proposal for a regulation Article 4 – paragraph 3 – point b (b) further to a reasoned request from a market surveillance authority, providing that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language determined by the Member State concerned, and to show significant differences in the characteristics of its distinct models as defined in Article 3(22)(a);
Amendment 89 #
Proposal for a regulation Article 4 – paragraph 3 – point c (c) cooperating with the market surveillance authorities, a
Amendment 90 #
Proposal for a regulation Article 4 – paragraph 3 – point c (c) cooperating with the market surveillance authorities
Amendment 91 #
Proposal for a regulation Article 4 – paragraph 3 – point c (c) cooperating with the market surveillance authorities,
Amendment 92 #
Proposal for a regulation Article 4 – paragraph 3 – point c (c) cooperating with the market surveillance authorities,
Amendment 93 #
Proposal for a regulation Article 4 – paragraph 3 – point c a (new) (c a) when considering or having reason to believe that a product in question present a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;
Amendment 94 #
Proposal for a regulation Article 4 – paragraph 3 – point c a (new) (c a) when considering or having reason to believe that a product in question present a risk or is not in conformity with the applicable Union harmonisation legislation or harmonised standard, immediately inform the manufacturer and, where applicable, other economic operators;
Amendment 95 #
Proposal for a regulation Article 4 – paragraph 3 – point c a (new) (ca) immediately inform the manufacturer and all other economic operators concerned when there is enough evidence to believe that a product could present a serious risk or does not comply with the applicable EU harmonisation laws.
Amendment 96 #
Proposal for a regulation Article 4 – paragraph 4 Amendment 97 #
Proposal for a regulation Article 4 – paragraph 5 a (new) 5 a. The manufacturer, importer and any other person meeting the requirements of point (a) of paragraph 1 of this Article, shall make available to the public and to other economic operators by any appropriate means, lists of their product models, accompanied by a picture, in particular for products that are or have been the subject of a decision by the Commission under Article 13 of Directive 2001/95/CE and for products that are the subject of widespread distribution.
Amendment 98 #
Proposal for a regulation Article 4 a (new) Article 4 a Obligations of distributors 1. Before making a product available on the market, distributors shall take all reasonable steps to ensure that the manufacturer and the importer have complied with the requirements set out in the applicable harmonisation legislation, harmonised standards or the Directive 2001/95/EC. 2. Further to a reasoned request from a market surveillance authority, the person responsible for compliance information shall provide that authority with all the information and documentation necessary to demonstrate the conformity of the product in an official Union language determined by the Member State concerned, and to demonstrate the existence of different essential characteristics between its distinct models as defined in point 22a of Article 3.
Amendment 99 #
Proposal for a regulation Article 5 – paragraph 1 Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers shall make the declaration
source: 622.241
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History
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2023-08-03Show (18) Changes | Timetravel
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Amending Directive 2004/42/EC 2002/0301(COD) Amending Directive 2009/48/EC 2008/0018(COD) Amending Regulation (EU) No 305/2011 2008/0098(COD) Amending Regulation (EU) No 528/2012 2009/0076(COD) Amending Directive 2010/35/EU 2009/0131(COD) Amending Directive 2013/53/EU 2011/0197(COD) Amending Directive 2014/28/EU 2011/0349(COD) Amending Directive 2014/29/EU 2011/0350(COD) Amending Directive 2014/30/EU 2011/0351(COD) Amending Directive 2014/31/EU 2011/0352(COD) Amending Directive 2014/32/EU 2011/0353(COD) Amending Directive 2014/33/EU 2011/0354(COD) Amending Directive 2014/34/EU 2011/0356(COD) Amending Directive 2014/35/EU 2011/0357(COD) Amending Directive 2013/29/EU 2011/0358(COD) Amending Directive 2014/53/EU 2012/0283(COD) Amending Directive 2014/90/EU 2012/0358(COD) Amending Directive 2014/68/EU 2013/0221(COD) Amending Regulation (EU) 2016/424 2014/0107(COD) Amending Regulation (EU) 2016/425 2014/0108(COD) Amending Regulation (EU) 2016/426 2014/0136(COD) Amending Regulation (EU) 2017/1369 2015/0149(COD)
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