2013/0048(COD) | [ParlTrack]

Proposal for a regulation
Citation 1

Having regard to the Treaty on the Functioning of the European Union, ~~and~~ in particular Articles 33, 114, 169 and 207 thereof,

Amendment 24 #

Proposal for a regulation
Recital 1

(1) In order to guarantee the ~~free movement of products~~rights of workers and consumers in the EU and in third countries trading within the EU~~nion~~, it is necessary to ensure that ~~they~~products entering the EU market 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 and workers and their basic rights, 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 goods market can thrive~~. Rules are therefore necessary on market surveillance and on controls of products entering the Union from third countries.

Amendment 25 #

Proposal for a regulation
Recital 1

(1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, fair trading practices, protection of consumers, protection of the environment, protection of intellectual property right and public security. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union goods market, online and offline, can thrive. Rules are therefore necessary on market surveillance, online and offline, and on controls of products entering the Union from third countries.

Amendment 26 #

Proposal for a regulation
Recital 1

(1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, protection of intellectual property, protection of the environment and public security. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union goods market can thrive. Rules are therefore necessary on market surveillance and on controls of products entering the Union from third countries.

Amendment 27 #

Proposal for a regulation
Recital 3 a (new)

(3a) Given the EU´s importance as a global trading bloc, it is necessary to use this position to enhance the protection of public interests such as health and safety, the protection of workers' rights and the environment in the countries the EU is trading with.

Amendment 28 #

Proposal for a regulation
Recital 8

(8) This Regulation should therefore integrate the provisions of Regulation 765/2008, Directive 2001/95/EC and several sector-specific acts of Union harmonisation legislation relating to market surveillance into a single regulation which covers products in both the harmonised and non-harmonised areas of the Union legislation, regardless whether they are traded online or offline, intended for use, or are likely to be used, by consumers or professionals.

Amendment 29 #

Proposal for a regulation
Recital 15

(15) Market surveillance should be based on the assessment of the risk presented by a product taking all relevant data into account, and on a duty of care for all relevant economic operators, especially intermediaries, regardless of whether the products are traded online or offline. A product that is subject to Union harmonisation legislation which lays down essential requirements relating to protection of certain public interests should be presumed not to present a risk to those public interests if it complies with those essential requirements.

Amendment 30 #

Proposal for a regulation
Recital 17 a (new)

(17a) In the case of non-harmonised products, market surveillance authorities should take into account documentation provided by economic operators as per (EU) No [.../...] [on consumer product safety].

Amendment 31 #

Proposal for a regulation
Recital 18

(18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector- specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled. Market surveillance authorities shall continue to apply the precautionary principle in cases where scientific evidence does not give certainty of the safety of a product.

Amendment 32 #

Proposal for a regulation
Recital 18

(18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector- specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned, applying a duty of care, to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled.

Amendment 33 #

Proposal for a regulation
Recital 20

(20) Obliging the authorities responsible for the control of products entering the Union market to carry out checks on an adequate scale therefore contributes to a safer Union market for products. In order to increase the effectiveness of such checks, cooperation and exchange of information between those authorities and market surveillance authorities concerning products presenting a risk should be enhanced. Given the increasing importance of imports into the EU and worries expressed by stakeholders about insufficient border controls, the Commission will monitor and assess the overall functioning of external border controls and will address recommendations to Member States in case of relevant shortcoming.

Amendment 34 #

Proposal for a regulation
Recital 21

(21) Market surveillance authorities should be given the power to destroy products, render inoperable or order their destruction or withdrawal by the relevant economic operator, operating online or offline, if they deem it necessary and proportionate to ensure that such goods cannot pose any further threats. or to avoid making illicit products available on the market.

Amendment 35 #

Proposal for a regulation
Recital 25 a (new)

(25a) The Commission should ensure the multi-annual action plan for market surveillance covering the period 2013- 2015 "20 actions for safe and compliant products for Europe: a multi-annual action plan for the surveillance of products in the EU" is effectively implemented. By the end of 2015, the Commission should report on the results achieved through the foreseen 20 actions and examine the need for legislative and non-legislative actions to reduce the number of unsafe or non-compliant products and ensure effectiveness of the surveillance of products both within the Union and on entry into the Union.

Amendment 36 #

Proposal for a regulation
Recital 30

(30) This Regulation should strike a balance between transparency through the release of the maximum possible amount of information to the public and maintaining confidentiality, for example for reasons of personal data protection~~, commercial secrecy~~ or the protection of investigations, in accordance with rules on confidentiality pursuant to applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data apply in the context of this Regulation.

Amendment 37 #

Proposal for a regulation
Recital 31

(31) Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional secrecy and be handled in a way that investigations are not compromised ~~and that the reputations of economic operators are not prejudiced~~.

Amendment 38 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive, in order to discourage the rogue traders to deliberately introduce dangerous or non- compliant products on the internal market.

Amendment 39 #

Proposal for a regulation
Recital 33 a (new)

(33a) In order for the penalties imposed on economic operators by the Member States to be effective, they should be introduced in a coordinated manner.

Amendment 40 #

Proposal for a regulation
Recital 34

(34) Market surveillance should be financed at least in part by fees charged to economic operators where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves. Those fees should not be borne by the consumer and therefore should have no bearing on the retail price of a product.

Amendment 41 #

Proposal for a regulation
Recital 34 a (new)

(34a) The revenues collected from the infringement of this regulation should be earmarked for market surveillance activities.

Amendment 42 #

Proposal for a regulation
Recital 41

(41) Since the objective of this Regulation, namely to ensure that products on the market, online and offline, covered by Union legislation fulfil the requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market, both online and offline, by providing a framework for coherent market surveillance in the Union, cannot be sufficiently achieved by the Member States as the attainment of this objective requires a very high degree of cooperation, interaction and uniformity of operation among all of the competent authorities of all Member States, and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

Amendment 43 #

Proposal for a regulation
Recital 42

(42) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. in particular this Regulation seeks to ensure full respect for obligation to ensure a high level of human health protection a~~nd consumer protection as well as full respect of the freedom to conduct a business and the right to property~~s well as full respect for consumers' and workers' rights,

Amendment 44 #

Proposal for a regulation
Recital 42

(42) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. in particular this Regulation seeks to ensure full respect for obligation to ensure a high level of human health protection ~~and~~, consumer protection and protection of intellectual property rights, as well as full respect of the freedom to conduct a business and the right to property,

Amendment 45 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products available online or offline meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, fair trading practices, consumer protection, the environment, the protection of intellectual property right, the protection of public security and other public interests.

Amendment 46 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, ~~consumer~~the protection of workers' and consumer rights, the environment, public security and other public interests.

Amendment 47 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, protection of intellectual property rights, the environment, public security and other public interests.

Amendment 48 #

Proposal for a regulation
Article 2 – paragraph 1

1. Chapters I, II, III, V and VI of this Regulation shall apply to all products that are subject to Regulation (EU) No [… on Consumer Product Safety] or Union harmonisation legislation, including to products assembled or manufactured for the manufacturer's own exclusive use, and to the extent that Union harmonisation legislation does not contain a specific provision with the same objective.

Amendment 49 #

Proposal for a regulation
Article 3 – paragraph 1 – point 2

(2) ‘making available on the market’ means any supply or presentation of a product for distribution, consumption or use on the Union market, online or offline, in the course of a commercial activity, whether in return for payment or free of charge;

Amendment 50 #

Proposal for a regulation
Article 3 – paragraph 1 – point 3

(3) ‘placing on the market’ means the first making available of a product on the Union market, either online or offline;

Amendment 51 #

Proposal for a regulation
Article 3 – paragraph 1 – point 11

(11) ‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products available either online or offline do not endanger health, safety or any other aspect of public interest protection and, in the case of products falling within the scope of Union harmonisation legislation, that they comply with the requirements set out in that legislation;

Amendment 52 #

Proposal for a regulation
Article 3 – paragraph 1 – point 12

(12) ‘market surveillance authority’ means an authority of a Member State responsible for carrying out market surveillance, either online or offline, on its territory;

Amendment 53 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, protection of intellectual property rights and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 54 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13) ‘product presenting a risk’ means a product ~~having~~which has 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 as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 55 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, ~~health and safety in the workplace, consumer protection, the environment and public security~~including those involved in the manufacturing process, health and safety in the workplace, workers' rights through non- compliance with fundamental ILO conventions, consumer protection, the environment and public security, including in the country where the product was produced and/or processed, as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 56 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13 a (new)

(13a) ‘product presenting a regulatory risk’ means a product which fails to comply with applicable Union legislation;

Amendment 57 #

Proposal for a regulation
Article 3 – paragraph 1 – point 18

(18) ‘Union harmonisation legislation’ means Union legislation harmonising the conditions ~~for~~to make products available on the market both onlinge o~~f products~~r offline;

Amendment 58 #

Proposal for a regulation
Article 4 – paragraph 2

2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products presenting a risk are not placed or made available on the Union market and, where such products have been made available, effective measures are taken to remove the risk presented by the product.

Amendment 59 #

Proposal for a regulation
Article 4 – paragraph 2

2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products presenting a risk, and products that are not compliant with the applicable Union legislation are not made available on the Union market and, where such products have been made available, effective measures are taken to remove the risk presented by the product.

Amendment 60 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls carried out ~~and~~, explanations of how checks and risk evaluations have been carried out and available resources. This information shall be communicated toby all Member States. Member States may make a summary of the results accessible to the public.

Amendment 61 #

Proposal for a regulation
Article 5 – paragraph 2

2. Market surveillance authorities shall be given the powers and entrusted with the resources and means necessary for the proper performance of their tasks. Member States will inform the Commission annually about the resources allocated to market surveillance authorities. On this basis the Commission will evaluate the appropriateness of resource endowment and will send recommendations to the Member States in case of insufficient resources.

Amendment 62 #

Proposal for a regulation
Article 5 – paragraph 5 a (new)

5a. The market surveillance authorities shall undertake to fast-track the harmonisation of customs control systems, with the support of the national authorities.

Amendment 63 #

Daniel CASPARY

Proposal for a regulation
Article 5 – paragraph 5 a (new)

5a. Market surveillance authorities must fully contribute to stepping up the harmonisation of customs control systems in cooperation with the national authorities.

Amendment 64 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

~~Where appropriate~~In case of known or emerging risk pursuant to Article 6(1), market surveillance authorities shall alert users in their territories within an adequate timeframe of products that those authorities have identified as presenting a risk.

Amendment 65 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2

They shall cooperate with economic operators and trade unions to prevent or reduce risks caused by products made available by those ~~operators. For this purpose, they shall encourage and promote voluntary action by economic operators including, where applicable, through the development~~economic operators and develop guidelines of and adherence to codes of good practice.

Amendment 66 #

Proposal for a regulation
Article 6 – paragraph 5 – point a

(a) provide consumers and other interested parties, including trade unions, with the opportunity to submit complaints on issues relating to product safety, market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate;

Amendment 67 #

Proposal for a regulation
Article 8 – title

General obligations of ~~economic operato~~manufacturers and importers

Amendment 68 #

Proposal for a regulation
Article 8 – paragraph 1

1. On request, ~~economic operato~~manufacturers, importers and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them.

Amendment 69 #

Proposal for a regulation
Article 8 – paragraph 1 a (new)

1a. Manufacturers and importers shall ensure that their products are placed on the market and approved in accordance with the requirements set pout in the EU legislation that fall in the scope of this Regulation and safe for use

Amendment 70 #

Proposal for a regulation
Article 8 – paragraph 1 b (new)

1b. Manufacturers and importers established outside the Union shall appoint a single representative established within the Union for the purposes of market surveillance.

Amendment 71 #

Proposal for a regulation
Article 8 – paragraph 1 c (new)

1c. Manufacturers and importers shall indicate their name, registered trade name or registered trade mark and the address in the Union at which they can be contacted on or with the product that is placed in the market.

Amendment 72 #

Proposal for a regulation
Article 8 – paragraph 2

2. ~~Economic operato~~Manufacturers and importers shall provide all necessary information to market surveillance authorities including information that enables the precise identification of the product and facilitates the tracing of the product.

Amendment 73 #

Proposal for a regulation
Article 8 – paragraph 2 a (new)

2a. Manufacturers established outside the Union shall appoint a single authorised representative established within the Union for the purposes of market surveillance

Amendment 74 #

Proposal for a regulation
Article 8 – paragraph 2 b (new)

2b. Importers shall have the authorisation of the manufacturer established outside the EU to act as an authorised representative of the manufacturer for the purposes of market surveillance.

Amendment 75 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 a (new)

In the case of products that are not subject to Union harmonisation legislation, market surveillance authorities will take in due consideration protocols, checklists and other relevant documents that economic operators will have provided with regard the to risk assessment of products as per Directive [...] on consumer products safety.

Amendment 76 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – point a a (new)

(aa) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin.

Amendment 77 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2

The economic operator, applying a duty of care, shall ensure that all necessary corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.

Amendment 78 #

Proposal for a regulation
Article 10 – paragraph 1

1. Where the identity of the relevant economic operator cannot be ascertained by the market surveillance authorities or where an economic operator failed in its duty of care or has not taken the necessary corrective action pursuant to Article 9(3) within the period specified, market surveillance authorities shall take all necessary measures to deal with the risk presented by the product.

Amendment 79 #

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

Risk assessment shall be based on available scientific or technical evidence and, when there is a suspected risk of causing harm to public health in spite of lack of scientific consensus, the precautionary principle shall be invoked.

Amendment 80 #

Proposal for a regulation
Article 13 – paragraph 2 – point c a (new)

(ca) any ILO conventions signed and ratified by the countries involved in the manufacturing and/or processing of the product;

Amendment 81 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 a (new)

In the case of products that are not subject to Union harmonisation legislation, authorities in charge of external border controls will take in due consideration protocols, checklists and other relevant documents that economic operators will have provided with regard the to risk assessment of products as per Directive (EU) No [.../...] [on consumer products safety], and which market surveillance authorities will have made available to them, in order to assess product risks.

Amendment 82 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – point b a (new)

(ba) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin.

Amendment 83 #

Proposal for a regulation
Article 14 – paragraph 6 a (new)

6a. The Commission should ensure that authorities in charge of the control of products at external borders carry out checks in a uniform manner across the EU. The Commission should also evaluate whether authorities dispose of the necessary resources to execute their function effectively. To this purpose, Member States should send annually to the Commission a report explaining how national authorities have carried out checks and risk evaluations, reporting about available resources and including statistics regarding the number of controls carried out. On the basis of this reporting mechanism, the Commission may send recommendations to the Member States in case of important discrepancies and shortcomings.

Amendment 84 #

Proposal for a regulation
Article 15 – paragraph 1

1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 14 shall be released if, within ~~thre~~five working days of the suspension of release, those authorities have not been requested by the market surveillance authorities to continue the suspension or they have been informed by the market surveillance authorities that the product does not present a risk, and provided that all the other requirements and formalities pertaining to such release have been fulfilled.

Amendment 85 #

Proposal for a regulation
Article 23 – paragraph 1

1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, among the different authorities within each Member State and between market surveillance authorities and the Commission and the relevant Union agencies regarding market surveillance programmes and all issues relating to products presenting a risk, whether it be connected to the product's origin or its components. The Member States shall ensure that these procedures are fully consistent with the Union's external border management.

Amendment 86 #

Daniel CASPARY

Proposal for a regulation
Article 23 – paragraph 1

1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, among the different authorities within each Member States and between market surveillance authorities and the Commission and the relevant Union agencies regarding market surveillance programmes and all issues relating to products presenting a risk, also in view of ensuring a full consistency in the management of the EU external borders.

Amendment 87 #

Proposal for a regulation
Article 24 – paragraph 1

1. MWhere necessary, market surveillance authorities ~~may~~shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to Union information exchange systems including the RAPEX system in accordance with Article 19(4), and promoting activities relating to conformity assessment and market surveillance.

Amendment 88 #

Daniel CASPARY

Proposal for a regulation
Article 24 – paragraph 1

1. MWhen appropriate market surveillance authorities mayust cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to Union information exchange systems including the RAPEX system in accordance with Article 19(4), and promoting activities relating to conformity assessment and market surveillance.

Amendment 89 #

Proposal for a regulation
Article 31 – paragraph 1

The Member States ~~shall lay down the rules on~~determine the penalties applicable to infringements of the provisions of this Regulation that impose obligations on economic operators and to infringements of provisions of any Union harmonisation legislation on products covered by this Regulation that impose obligations on economic operators where that legislation does not provide for penalties, and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [insert date - 3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.

Amendment 90 #

Proposal for a regulation
Article 31 – paragraph 2

The penalties referred to in the first subparagraph shall have regard to the size of the undertakings and in particular to the situation of small and medium-sized enterprises. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements.deleted

Amendment 91 #

Proposal for a regulation
Article 31 – paragraph 2 a (new)

The Commission shall establish the minimum penalties amounts as well as the conditions for collection of these penalties, including special provisions for small and medium-sized enterprises.

Amendment 92 #

Proposal for a regulation
Article 31 – paragraph 2 a (new)

The penalties shall be earmarked for market surveillance activities in the Member States concerned.

Amendment 93 #

Proposal for a regulation
Article 31 – paragraph 2 b (new)

The types of infringements which are subject to a penalty shall include at least the following: (a) products presenting a risk according to Article 9(2) until indent (d) or non compliant with the criteria referred to in points (a), (b) and (c) of Article 13(2); (b)making false declaration during approval procedures leading to a recall; (c) falsifying test results for type- approval; (d) refusal to provide access to information

source: PE-514.716

2013/09/11 IMCO 327 amendments...

Amendment 100 #

Proposal for a regulation
Article 3 – paragraph 1 – point 2

(2) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union’s physical and digital markets in the course of a commercial activity, whether in return for payment or free of charge;

Amendment 101 #

Proposal for a regulation
Article 3 – paragraph 1 – point 3

(3) ‘placing on the market’ means the first making available of a product on the Union’s physical and digital markets;

Amendment 102 #

Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)

(7a) 'intermediary service providers' means any natural or legal person who enables the placing or making available on the market of a product via electronic means, such as by operating e-commerce platforms or hosting websites;

Amendment 103 #

Proposal for a regulation
Article 3 – paragraph 1 – point 8

(8) ‘'economic operators’' means the manufacturer, the authorised representative, the importer ~~and the distributo~~, the distributor and the intermediary service provider;

Amendment 104 #

Proposal for a regulation
Article 3 – paragraph 1 – point 11

(11) ‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products available online or offline do not endanger health, safety or any other aspect of public interest protection and, in the case of products falling within the scope of Union harmonisation legislation, that they comply with the requirements set out in that legislation;

Amendment 105 #

Proposal for a regulation
Article 3 – paragraph 1 – point 12

(12) ‘market surveillance authority’ means an authority of a Member State responsible for carrying out physical and digital market surveillance on its territory;

Amendment 106 #

Proposal for a regulation
Article 3 – paragraph 1 – point 12

(12) ‘market surveillance authority’ means an authority of a Member State ~~responsible for carrying out market surveillance on its territory~~competent for exercising the regulated powers under by this Regulation;

Amendment 107 #

Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)

(12a) 'Non-compliant product' means a product which is not in conformity with the requirements laid down in Union harmonisation legislation that applies to it;

Amendment 108 #

Proposal for a regulation
Article 3 – paragraph 1 – point 12 b (new)

(12b) "non-compliant product" means a product which fails to meet the requirements of Union legislation

Amendment 109 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13) ‘product presenting a safety risk’ means a product ~~having~~which has 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 as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 110 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13) ‘product presenting a safety risk’' means a product ~~having~~which has 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 as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 111 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13~~) ‘~~ 'product presenting a safety risk’' means a product ~~having~~which has 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 as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 112 #

Jürgen CREUTZMANN

Proposal for a regulation
Article 3 – paragraph 1 – point 13

(13) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security ~~as well as other public interests~~ to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;

Amendment 113 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13 a

(13a) 'product presenting a regulatory risk' means a product which fails to comply with applicable Union legislation;

Amendment 114 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13 b (new)

(13b) 'product presenting a regulatory risk' means a product which fails to comply with applicable Union legislation;

Amendment 115 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13 c (new)

(13c) 'product presenting a regulatory risk' means a product which fails to comply with applicable Union legislation;

Amendment 116 #

Proposal for a regulation
Article 3 – paragraph 1 – point 13 d (new)

(13d) 'product presenting an emerging risk' means a product which is not subject to EU harmonised legislation and on which there is solid scientific evidence that it presents a newly developing risk or a known risk if it is sold for use in new or unfamiliar conditions not foreseen by the manufacturer.

Amendment 117 #

Proposal for a regulation
Article 3 – paragraph 1 – point 14

(14) ‘'product presenting a serious risk’' means a product presenting a risk requiring rapid intervention and follow-up, including cases where the effects may not be immediate; any product that does not meet an essential requirement defined in the Union harmonisation legislation, as well as any product that does not meet the general safety requirement as defined in the mandate given by the Commission to the standardisation organisation shall be considered as presenting a serious risk;

Amendment 118 #

Proposal for a regulation
Article 3 – paragraph 1 – point 14

Amendment 119 #

Proposal for a regulation
Article 3 – paragraph 1 – point 14 a (new)

(14a) 'product models' means products that are considered to be distinct as presenting identical or similar essential characteristics, with differences, if any, having no impact on their safety level, unless otherwise proven by the manufacturer and or the importer.

Amendment 120 #

Proposal for a regulation
Article 3 – paragraph 1 – point 14 b (new)

(14b) 'product models' means products that are considered to be distinct as presenting identical or similar essential characteristics, with differences, if any, having no impact on their safety level, unless otherwise proven by the manufacturer and or the importer.

Amendment 121 #

Proposal for a regulation
Article 3 – paragraph 1 – point 14 c (new)

(14c) 'product model' means a product that is to be considered as representative of a distinct group of products presenting similar essential characteristics, with differences, if any, having no impact on their safety level;

Amendment 122 #

Proposal for a regulation
Article 3 – paragraph 1 – point 18

(18) ‘Union harmonisation legislation’ means Union legislation harmonising the conditions for the marketing of products; it defines the essential requirements which products must comply with in order to be placed on the Union market;

Amendment 123 #

Proposal for a regulation
Article 3 – paragraph 1 – point 18

(18) ‘Union harmonisation legislation’ means Union legislation harmonising the conditions for ~~the marketing of produc~~making products available on the online and offline markets;

Amendment 124 #

Proposal for a regulation
Article 4 – paragraph 2

2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products that are not compliant with the applicable Union legislation and which present~~ing~~ a risk are not made available on the Union market and, where such products have been made available, effective and proportionate measures are taken to remove the risk presented by the product or to put an end to its non-compliance.

Amendment 125 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 126 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 127 #

Proposal for a regulation
Article 4 – paragraph 2

2. Market surveillance shall be organised and carried out in accordance with this Regulation with a view to ensuring that products presenting a risk and, more generally, products that are not compliant with the applicable Union legislation, are not made available on the Union market and, where such products have been made available, effective measures are taken to remove the risk presented by the product. and to put an end to its non-compliance.

Amendment 128 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 129 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls carried out and shall be communicated to all Member States. Member States may make a summary of the results accessible to the public.deleted

Amendment 130 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls carried out, the number of products queried in relation to those controls, and the number and type of remedial actions subsequently put in hand, and shall be communicated to all Member States. Member States ~~may~~shall make a summary of the results and statistics accessible to the public.

Amendment 131 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every three years. The ~~information reported shall include statistics regarding the number of controls carried out and shall be communicated to all Member States. Member States may make a summary of the results accessi~~Commission shall communicate this information to all Member States. A summary of this information may be made available to the public.

Amendment 132 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls ~~carried out and shall be communicated to all Member States. Member States may make a summary of the results~~of each type carried and their results. These statistics shall be communicated to all Member States and shall be made accessible to the public.

Amendment 133 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number ~~of controls carried out and shall be communicated to all Member States. Member States may make a summary of the results accessi~~and results of controls of each type carried out. These statistics shall be communicated to all Member States and shall be made available to the public.

Amendment 134 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report on these activities and controls to the Commission every year. The information reported shall include statistics regarding the number of controls carried out and shall be communicated to all Member States~~. Member States may make a summary of the results accessible to the public~~ via the Commission.

Amendment 135 #

Proposal for a regulation
Article 4 – paragraph 3

3. The implementation of market surveillance activities and external border controls shall be monitored by the Member States which shall report to the Commission every year on these activities and controls ~~to the Commission every year~~and on the control methods used. The information reported shall include statistics regarding the number of controls carried out and shall be communicated to all Member States. Member States may make a summary of the results accessible to the public.

Amendment 136 #

Proposal for a regulation
Article 4 – paragraph 4

Amendment 137 #

Proposal for a regulation
Article 4 – paragraph 4

4. The results of the monitoring and assessment of market surveillance activities carried out pursuant to paragraph 3 shall be made available to the public, electronically and, where appropriate, by other means. This shall take place within three months after they have been communicated to the other Member States.

Amendment 138 #

Proposal for a regulation
Article 4 – paragraph 4

4. The Member States shall make a summary of the results of the monitoring and assessment of market surveillance activities carried out pursuant to paragraph 3 ~~shall be made~~ available to the public, electronically and, where appropriate, by other means.

Amendment 139 #

Proposal for a regulation
Article 5 – paragraph 1

1. Each Member State shall establish or designate market surveillance authorities ~~and define their duties, powers and organisation~~.

Amendment 140 #

Proposal for a regulation
Article 5 – paragraph 2

2. Market surveillance authorities shall be given the powers and entrusted with the resources and means ~~necessary~~ for the proper and comprehensive performance of their tasks.

Amendment 141 #

Proposal for a regulation
Article 5 – paragraph 3

3. Each Member State shall establish ~~appropriat~~sufficient and comprehensive mechanisms to ensure that the market surveillance authorities that it has established or designated exchange information, cooperate and coordinate their activities both among themselves and with the authorities in charge of controls of products at the external borders of the Union.

Amendment 142 #

Proposal for a regulation
Article 5 – paragraph 5

5. Member States shall inform the public of the existence, responsibilities, powers, available resources, cooperation mechanisms and identity of national market surveillance authorities and how those authorities may be contacted.

Amendment 143 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall organise their activities in such a way that maximum effectiveness can be achieved. They shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. Where appropriate, along with these traditional market sampling mechanisms, the market surveillance authorities shall move to pro- active auditing of supply chain processes at entities involved in the manufacturing, importing, trading, branding and retailing of consumer products. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

Amendment 144 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products, irrespective of the distribution channels and selling techniques, on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. For the sample checks, they shall use 2 % of all products placed on the market per year as an indicative target for each Member State. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

Amendment 145 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products, irrespective of the distribution channels and selling techniques, on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

Amendment 146 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products, irrespective of the distribution channels and selling techniques, on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

Amendment 147 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products, irrespective of the distribution channels and selling techniques, on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

Amendment 148 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall perform appropriate checks on the characteristics of safety- or health-related products on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.

Amendment 149 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1

1. Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21, by precisely identifying the product, referring to its type, model, batch or serial number.

Amendment 150 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 a (new)

The market surveillance authorities shall identify risks arising in connection with products covered by this Regulation and the characteristics of such risks by complying with any possible indications and instructions that may be given by the Commission. They shall record this information in the information and communication system for market surveillance referred to in Article 21. The Commission shall systematically analyse such information and, in case it has information that leads it to suspect a risk, or in case of divergent risk identification among the authorities of Member States, may request additional information from the national market surveillance authorities and, of its own initiative or at the request of a national market surveillance authority, proceed to carry out an identification of the risk itself. The Commission shall transmit its identification of the risk to the national market surveillance authorities.

Amendment 151 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2

In cases of known or emerging risk related to the objectives set out in Article 1 of this Regulation and concerning 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 one or several 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. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2).deleted

Amendment 152 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2

Amendment 153 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

2. ~~Where appropriate, m~~Market surveillance authorities shall without delay alert users in their territories ~~within an adequate timeframe~~ of products that those authorities have identified as presenting a risk. Where available, this information shall also include data on manufacturer, retail channel, pricing, and period of sales.

Amendment 154 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

2. WThe~~re appropriate,~~ competent market surveillance authorities ~~shall alert users in their territories within an adequate timeframe of~~and, where appropriate, economic operators shall alert users as quickly as possible to products ~~that~~which those authorities or operators have identified as presenting a risk. ;

Amendment 155 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

2. Where appropriate, market surveillance authorities shall alert users in their territories with~~in an adequate timeframe~~out delay of the identity of products that those authorities have identified as presenting a risk.

Amendment 156 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

Amendment 157 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2

~~They~~Market surveillance authorities shall cooperate with economic operators and other competent national authorities to prevent or reduce risks caused by products made available by those economic operators. For this purpose, they shall encourage and promote voluntary action by economic operators including, where applicable, through the development of and adherence to codes of good practice.

Amendment 158 #

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2

The~~y shall cooperate with economic operators to prevent or reduce risks caused by products made available by those operators. For this purpose, they~~ market surveillance authorities shall encourage and promote voluntary action by economic operators including, where applicable, through the development of and adherence to codes of good practice.

Amendment 159 #

Proposal for a regulation
Article 6 – paragraph 3

3. Market surveillance authorities shall carry out their duties independently, impartially and without bias and shall fulfil their obligations under this Regulation; they shall exercise their powers in relation to economic operators in accordance with the principle of proportionality and with due regard to the precautionary principle as laid down in Article 191(2) of the Treaty (TFEU).

Amendment 160 #

Proposal for a regulation
Article 6 – paragraph 3 a (new)

3a. Market surveillance authorities shall take duly into account the seriousness of the risk and the precautionary principle. They shall accordingly carry out sample checks on sufficient numbers of products enabling conformity and the real risk posed to be assessed.

Amendment 161 #

Proposal for a regulation
Article 6 – paragraph 3 b (new)

3b. Market surveillance authorities shall take duly into account the seriousness of the risk and the precautionary principle. They shall accordingly carry out sample checks on sufficient numbers of products enabling conformity and the real risk posed to be assessed.

Amendment 162 #

Proposal for a regulation
Article 6 – paragraph 3 c (new)

3c. Market surveillance authorities shall act taking due account of the seriousness of the risk and of the precautionary principle.

Amendment 163 #

Bernadette VERGNAUD

Proposal for a regulation
Article 6 – paragraph 4

4. Where it is necessary and justified for carrying out their duties, market surveillance authorities may enter the premises of economic operators without prior warning, examine, seize or take copies of any and all documents, gain access to IT systems and take any necessary samples of products.

Amendment 164 #

Proposal for a regulation
Article 6 – paragraph 4

4. Where it is necessary and justified for carrying out their duties, market surveillance authorities may enter the premises of economic operators, carry out appropriate documentary checks, make copies of relevant documents and take any necessary samples of products.

Amendment 165 #

Proposal for a regulation
Article 6 – paragraph 4

Amendment 166 #

Proposal for a regulation
Article 6 – paragraph 5 – point a

(a) provide consumers and other interested parties with the opportunity to submit complaints on issues relating to product safety, market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate and within a reasonable time frame;

Amendment 167 #

Proposal for a regulation
Article 6 – paragraph 5 – point c

(c) follow and keep up to date with developments in scientific and technical knowledge concerning the safety ~~of products~~and compliance of products with Union harmonised legislation.

Amendment 168 #

Proposal for a regulation
Article 6 – paragraph 5 – point c a (new)

(ca) monitor accidents and harm to health which are suspected to have been caused by those products.

Amendment 169 #

Anna HEDH

Proposal for a regulation
Article 6 – paragraph 5 – point c b (new)

(cb) monitor accidents and harm to health which are related to those products;

Amendment 170 #

Proposal for a regulation
Article 6 – paragraph 5 – point c c (new)

(cc) Verify the compliance of products with the applicable Union legislation.

Amendment 171 #

Proposal for a regulation
Article 6 – paragraph 5 – point c d (new)

(cd) be encouraged to participate in national standardisation activities aimed at the development or revision of standards requested by the Commission in accordance with Article 10 of Regulation (EU) No 1025/2012.

Amendment 172 #

Proposal for a regulation
Article 6 – paragraph 5 – point c e (new)

(ce) participate, where possible and relevant, in activities of standardisation organisations for the purposes of the development or revision of standards in accordance with Regulation (EU) No. 1025/2010.

Amendment 173 #

Anna HEDH

Proposal for a regulation
Article 6 – paragraph 6

6. Adequate procedures shall be established and made known to the public to enable market surveillance authorities to fulfil these obligations. In particular, market surveillance authorities shall make available to the public on request: (a) the identity of those products about which safety complaints have been received under point a of Article 6(5); (b) the nature of the safety defect and risk perceived in the product by the complainant and any hazardous incident or injury reported; (c) any comments on the complaint made by the economic operators; (d) what follow up action the market surveillance authority has determined to be appropriate.

Amendment 174 #

Proposal for a regulation
Article 6 – paragraph 8

8. ~~The protection of c~~Confidentiality shall not prevent the dissemination to the market surveillance authorities of information ~~necessary to ensur~~relevant for ensuring the effectiveness of market surveillance activities.

Amendment 175 #

Proposal for a regulation
Article 7 – paragraph 1 – introductory part

1. Each Member State shall draw up a general market surveillance programme and shall review that programme, and update it if necessary, at least every four years. The programme shall cover market surveillance organisation and related activities and take into account the specific needs of business generally, and SMEs in particular, when implementing Union harmonisation legislation and Regulation (EU) No […/…] [on consumer product safety], and provide for guidance and assistance. It shall include the following:.

Amendment 176 #

Proposal for a regulation
Article 7 – paragraph 1 – introductory part

1. Each Member State shall draw up a general market surveillance programme and shall review that programme, and update it if necessary, at least every four years. The programme shall cover market surveillance organisation and related activities and take into account the specific needs of ~~business generally, and SMEs in particular,~~consumers when implementing Union harmonisation legislation and Regulation (EU) No […/…] [on consumer product safety], and provide for guidance and assistance for relevant operators. It shall include the following:

Amendment 177 #

Proposal for a regulation
Article 7 – paragraph 1 – introductory part

1. Each Member State shall draw up a general market surveillance programme and shall review that programme, and update it if necessary, at least every four years. The programme shall cover market surveillance organisation and related activities and take into account the specific needs of business ~~generally, and SMEs in particular,~~and consumers when implementing Union harmonisation legislation and Regulation (EU) No […/…] [on consumer product safety], and provide for guidance and assistance. It shall include the following:

Amendment 178 #

Proposal for a regulation
Article 7 – paragraph 1 – point b

~~(b) the financial resources, staff, technical and other means attributed to the authorities;~~deleted

Amendment 179 #

Proposal for a regulation
Article 7 – paragraph 1 – point b

~~(b) the financial resources, staff, technical and other means attributed to the authorities;~~deleted

Amendment 180 #

Proposal for a regulation
Article 7 – paragraph 1 – point b a (new)

(ba) the levels and modalities of calculation of fees applicable to economic operators pursuant to Articles 10 and 16 of this Regulation;

Amendment 181 #

Proposal for a regulation
Article 7 – paragraph 1 – point d a (new)

(da) testing laboratories specialised in the commodity categories to which products to be tested belong, in accordance with the criteria set out in Article 28;

Amendment 182 #

Proposal for a regulation
Article 7 – paragraph 3

3. The general and sector-specific programmes and their updates shall be drawn up after consultation with relevant stakeholders and shall be communicated to the other Member States and the Commission ~~and, s~~. Subject to Article 6(6), they shall be made accessible to the public electronically and, where appropriate, by other means.

Amendment 183 #

Proposal for a regulation
Article 7 – paragraph 3

3. The general and sector-specific programmes and their updates shall be communicated to the other Member States ~~and~~via the Commission and, subject to Article 6(6), shall be made accessible to the public electronically and, where appropriate, by other means.

Amendment 184 #

Andreas SCHWAB, Birgit COLLIN-LANGEN, Sabine VERHEYEN

Proposal for a regulation
Article 8 – paragraph 1

1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them.deleted

Amendment 185 #

Proposal for a regulation
Article 8 – paragraph 1

1. OnFollowing a reasoned request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities~~, in a language which can be easily understood by them~~. Where an economic operator has previously received the documentation and information concerned from another economic operator, and where it is classified as confidential under EU and Member State trade secrecy rules, confidentiality shall be ensured when that documentation and information is made available.

Amendment 186 #

Proposal for a regulation
Article 8 – paragraph 1

1. OnFurther to a reasoned request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities anyll the documentation and information that those authorities require for the purpose of carrying out their activities, in electronic or physical format and in a language which can be easily understood by them. Such information shall include information that enables the precise identification of the product and facilitates the tracing of the product, as appropriate.

Amendment 187 #

Proposal for a regulation
Article 8 – paragraph 1

1. On request, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any necessary documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by ~~them.~~ end users as determined by the Member State concerned.

Amendment 188 #

Proposal for a regulation
Article 8 – paragraph 1

1. On request and without prejudice to Articles R2(9), R4(9) and R5(5) of Annex I of Decision 768/2008/EC, economic operators and, where applicable, conformity assessment bodies, shall make available to market surveillance authorities any documentation and information that those authorities require for the purpose of carrying out their activities, in a language which can be easily understood by them.

Amendment 189 #

Proposal for a regulation
Article 8 – paragraph 2

2. Economic operators shall ~~provide all necessary information to market surveillance authorities including information that enables the precise identification of the product and facilitates the tracing~~cooperate with market surveillance authorities at their request, on any action taken to eliminate the risks presented by products that they have placed or made available ofn the ~~produc~~market.

Amendment 190 #

Proposal for a regulation
Article 8 – paragraph 2 a (new)

2a. Manufacturers and importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or on its packaging or in a document accompanying the product. The address shall indicate a single point at which the manufacturer or the importer can be contacted.

Amendment 191 #

Proposal for a regulation
Article 8 – paragraph 2 b (new)

2b. Manufacturers and importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or on its packaging or in a document accompanying the product. The address shall indicate a single point at which the manufacturer or the importer can be contacted.

Amendment 192 #

Proposal for a regulation
Article 8 – paragraph 2 c (new)

2c. All information supplied or made available to market surveillance authorities under this article shall be presented in a clear and legible manner.

Amendment 193 #

Proposal for a regulation
Article 8 a (new)

Article 8a General obligations of manufacturers 1. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with relevant EU legislation. 2. Manufacturers shall draw up the required technical documentation in accordance with their relevant EU harmonised legislation. 3. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the relevant EU harmonised legislation shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk for the health and safety of the consumer, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measure taken. 4. Manufacturers established outside the Union shall appoint a single authorised representative established within the Union for the purposes of market surveillance

Amendment 194 #

Proposal for a regulation
Article 8 b (new)

Article 8b Obligations of manufacturers 1. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with relevant Union legislation. 2. Proportionate to the possible risks of a product, manufacturers shall have in place adequate quality management systems to ensure the compliance and safety of their products. They shall carry out sample testing of products made available on the market, investigate complaints and keep a register of complaints, nonconforming products and product recalls, and shall keep distributors informed of any such monitoring. 3. Manufacturers shall draw up the required technical documentation in accordance with the relevant Union harmonisation legislation. 4. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon reasoned request. 5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. 6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. 7. Manufacturers who consider or have reason to believe that a product which they have placed on the market presents a risk, including non-compliance with the relevant Union harmonisation legislation, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a serious risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk and of any corrective measure taken.

Amendment 195 #

Proposal for a regulation
Article 8 c (new)

Article 8c General Obligations of the single authorised representatives For the purposes of market surveillance, the single authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The obligations laid down in Article [8a first paragraph – General Obligations of the Manufacturer] and the drawing up of technical documentation shall not form part of the single authorised representative’s mandate. The mandate shall allow the single authorised representative to do at least the following: (a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities. (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product subject to Union harmonisation legislation; (c) cooperate with the competent national authorities at their request, on any action taken to eliminate the risks posed by the products covered by their mandate.

Amendment 196 #

Proposal for a regulation
Article 8 d (new)

Article 8d Authorised representatives 1. A manufacturer established outside the Union shall appoint an authorised representative established within the Union for the purposes of market surveillance 2. For the purpose of market surveillance, the authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (a) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product; (b) cooperate with the market surveillance authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.

Amendment 197 #

Proposal for a regulation
Article 8 e (new)

Article 8e General Obligations of importers 1. Importers shall place on the market only compliant and safe products. 2. Before placing a product on the market, importers shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the required marking and is accompanied by the required documents. 3. Where importers consider or have reason to believe that a product is not in conformity with relevant EU legislation, they shall not place it on the market. Furthermore, where they consider or have reason to believe that the product presents a serious risk, they shall inform the manufacturer and the market surveillance authorities. For type-approved products, they shall also inform the approval authority that has granted the approval to that effect.

Amendment 198 #

Proposal for a regulation
Article 8 f (new)

Article 8f Obligations of importers 1. Before placing a product on the market importers shall ensure that the product is compliant with relevant Union legislation. 2. Where an importer considers or has reason to believe that a product presents a risk, including non-compliance with the relevant Union harmonisation legislation, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a serious risk, the importer shall inform the manufacturer and the market surveillance authorities of the Member State in which he is established to that effect. 3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 4. Proportionate to the possible risks presented by a product, importers shall have in place adequate quality management systems to ensure the compliance and safety of their imported products. They shall carry out sample testing of marketed products, investigate complaints, and keep a register of complaints, of non-conforming products and of product recalls, and shall keep the manufacturer and distributors informed of such monitoring. 5. Importers who consider or have reason to believe that a product which they have placed on the market presents a risk, including non-compliance with the relevant Union harmonisation legislation, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a serious risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk and of any corrective measure taken. 6. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon reasoned request.

Amendment 199 #

Proposal for a regulation
Article 8 g (new)

Article 8g General Obligations of distributors 1. When making a product available on the market, distributors shall act with due care in relation to the requirements set out in the Union legislation. Before making a product available on the market, distributors shall verify that it bears the required statutory marking or type-approval mark, where applicable, and that it is accompanied by the required documents demonstrating compliance, including labelling information where applicable, and by instructions and safety information in the official language or languages of the Member State in which the product is to be made available on the market. 2. Distributors shall provide all necessary information to market surveillance authorities including information that enables the precise identification of the product and facilitates the tracing of the product.

Amendment 200 #

Proposal for a regulation
Article 8 h (new)

Article 8h Obligations of distributors 1. Where a distributor considers or has a reason to believe that a product presents a risk, including non-compliance with the relevant Union harmonisation legislation, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a serious risk, the distributor shall inform the manufacturer or the importer, as applicable, to that effect as well as the market surveillance authority of the Member State in which the distributor is established. 2. Distributors who consider or have reason to believe that a product which they have placed on the market presents a risk, including non-compliance with the relevant Union harmonisation legislation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a serious risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk and of any corrective action taken. 3. Following a request of the technical documentation to the distributor, he shall take steps to either obtain the documentation himself and hand it to the authority or arrange that the documentation is sent directly by the manufacturer to the authority. In the latter case the distributor remains responsible and liable to sanctions in the event the documentation does not reach the authority. The distributor has the possibility, when having received a reasoned request, to contact the importer, manufacturer or authorised representative in order to obtain the documentation or to arrange that it is sent directly to the authority. The obligation for distributors to provide the technical documentation to an authority upon reasoned request does not include an obligation to keep it.

Amendment 201 #

Proposal for a regulation
Article 8 i (new)

Article 8i Formal non-compliance of products 1. Where market surveillance authorities identify one of the following cases of formal non-compliance in relation to a product subject to Union harmonisation legislation, they shall require the relevant economic operator to rectify that formal non-compliance: (a) the CE marking or other markings required by Union harmonisation legislation have not been affixed or have been affixed incorrectly; (b) the EU declaration of conformity, where required, has not been drawn up or has been drawn up incorrectly; (c) the technical documentation is incomplete or unavailable; (d) the required labelling or instructions for use are incomplete or missing. 2. If the economic operator fails to rectify the formal non-compliance referred to in paragraph 1, market surveillance authorities shall ensure that the product is withdrawn or recalled.

Amendment 202 #

Proposal for a regulation
Article 9 – title

Procedures for dealing with non- compliant products or Products presenting a risk

Amendment 203 #

Proposal for a regulation
Article 9 – title

PNon-compliant products and products presenting a risk

Amendment 204 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may be non-compliant or present a risk, they shall carry out a risk assessment in relation to thate product ~~taking account of~~concerned covering the requirements laid down in the applicable Union legislation and, where necessary, the considerations and criteria set out in Article 13.

Amendment 205 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may present a risk or is otherwise not compliant with the applicable Union legislation, they shall carry out a ~~risk assessment~~n evaluation in relation to that product taking account of the considerations and criteria set out in Article 13.

Amendment 206 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may present a risk and may be non-compliant with the applicable Union legislation, they shall carry out a risk assessment in relation to that product taking account of the considerations and criteria set out in Article 13.

Amendment 207 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities learn or have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may present a risk, they shall carry out a risk assessment in relation to that product taking account of the considerations and criteria set out in Article 13.

Amendment 208 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may present a risk, they shall carry out a risk assessment in relation to that product taking account of the considerations and criteria set out in Article 13 of this Regulation and in Article 6 of the Regulation on Consumer Product Safety.

Amendment 209 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1

1. Where, in the course of carrying out the checks referred to in Article 6(1) or as a result of information received, market surveillance authorities have sufficient reason to believe that a product that is placed or made available on the market or is used in the course of the provision of a service may present a risk, they shall carry out a risk assessment in relation to that product taking account of the considerations and criteria set out in Article 13 of this Regulation and in Article 6 of the Regulation on Consumer Product Safety.

Amendment 210 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 a (new)

Without prejudice to Article R31 and in line with Article R34 of Annex I of Decision 768/2008/EC, 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 Article [R11] or of Article [R12] of Decision 768/2008/EC; (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 referred to in paragraph 1 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 211 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2

Market surveillance authorities shall take ~~due~~ consideration of any readily available and comprehensible test result and risk assessment that has already been carried out or issued in relation to the product by an economic operator or any other person or authority including the authorities of other Member States.

Amendment 212 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2

Market surveillance authorities shall take due consideration of any readily available and comprehensible test result and risk assessment that has already been carried out or issued in relation to the product by an economic operator or any other person or authority including the authorities of other Member States.

Amendment 213 #

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2

Market surveillance authorities shall take due consideration of any readily available and objective test result and risk assessment that has already been carried out or issued in relation to the product by an economic operator or any other person or authority including the authorities of other Member States.

Amendment 214 #

Proposal for a regulation
Article 9 – paragraph 2

2. In relation to a product that is subject to Union harmonisation legislation, formal non-compliance with that legislation shall give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases: (a) the CE marking or other markings required by Union harmonisation legislation have not been affixed or have been affixed incorrectly; (b) the EU declaration of conformity, where required, has not been drawn up or has been drawn up incorrectly; (c) the technical documentation is incomplete or unavailable; (d) the required labelling or instructions for use are incomplete or missing. Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled.deleted

Amendment 215 #

Proposal for a regulation
Article 9 – paragraph 2

Amendment 216 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – introductory part

In relation to a product that is subject to Union harmonisation legislation, formal non-compliance with that legislation ~~shall~~may give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases:

Amendment 217 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – introductory part

In relation to a product ~~that is subject to Union harmonisation legislation~~, formal non-compliance with ~~that~~EU legislation shall give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases:

Amendment 218 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – point a a (new)

Amendment 219 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – point b a (new)

(ba) the product or any presentation of the product bears, without authorisation, a trade mark that is identical or similar to the registered trade mark for this product, thereby preventing its authenticity or origin from being firmly established;

Amendment 220 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2

Regardless whether the risk assessment shows that the product in fact presents a risk, ~~market surveillance authorities shall require~~ the economic operator toshall rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities ~~shall~~may ensure that the product is withdrawn or recalled. For minor infringements, a warning may be issued or a penalty payment imposed.

Amendment 221 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2

Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities ~~shall ensure that the product is withdrawn or recall~~may, if appropriate, withdraw or recall the product in question until the non-compliance is rectified.

Amendment 222 #

Othmar KARAS

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2

Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled. Warnings and penalties can be applied in case of infringements.

Amendment 223 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2

Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator responsible for placing the product on the market to rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shall ensure that the product is withdrawn or recalled.

Amendment 224 #

Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2

Amendment 225 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1

Without prejudice to Article 10(4), where market surveillance authorities find that a product does present a risk they shall without delay specify the necessary corrective action to be taken by the relevant economic operator responsible for placing the product on the market to address the risk within a specified period. Market surveillance authorities may recommend or agree with the relevant economic operator responsible for placing the product on the market the corrective action to be taken.

Amendment 226 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1

Without prejudice to Article 10(4), where market surveillance authorities find that a product does present a risk they shall without delay specify the necessary corrective action to be taken by the relevant ~~economic operator~~party responsible for placing the product on the market to address the risk within a specified period. Market surveillance authorities may recommend or agree with the relevant ~~economic operator~~party responsible for placing the product on the market the corrective action to be taken.

Amendment 227 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1

Without prejudice to Article 10(4), where market surveillance authorities find that a product does present a risk they shall without delay specify the necessary corrective action to be taken by the relevant economic operator to address the risk within a specified period~~. Market surveillance authorities may recommend or agree with the relevant economic operator the corrective action to be taken~~ in which he can implement that action and present his case, submitting any relevant statements.

Amendment 228 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2

The ~~economic operator~~party responsible for placing on the market shall ensure that all necessary corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.

Amendment 229 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2

Amendment 230 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 3 – introductory part

The ~~economic operator~~party responsible for placing on the market shall provide all necessary information to market surveillance authorities pursuant to Article 8, and in particular the following information:

Amendment 231 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 3 – introductory part

Amendment 232 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 4

Where ~~possible, market surveillance authorities shall identify the manufacturer or importer of the product and take action in relation to that economic operator in addi~~it is not possible to identify the party responsible for placing the product on the market, market surveillance authorities shall take action in relation to the distributor.

Amendment 233 #

Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 4

Amendment 234 #

Proposal for a regulation
Article 9 – paragraph 4 – introductory part

4. Corrective action to be taken by ~~economic operators~~those responsible for placing on the market in relation to a product presenting a risk may include:

Amendment 235 #

Proposal for a regulation
Article 9 – paragraph 4 – introductory part

4. Corrective action to be taken by ~~economic operators~~those responsible for placing on the market in relation to a product presenting a risk may include:

Amendment 236 #

Proposal for a regulation
Article 9 – paragraph 4 – introductory part

4. Corrective action to be taken ~~by economic operators~~ in relation to a product presenting a risk may include:

Amendment 237 #

Proposal for a regulation
Article 9 – paragraph 4 – point b – introductory part

(b) in the case of a product that is liable to present a risk only in certain conditions or only to certain persons and where such risk is not addressed by requirements of Union ~~harmonisation~~ legislation:

Amendment 238 #

Proposal for a regulation
Article 9 – paragraph 4 – point b – point iii

(iii) alerting the persons at risk to the risk, ~~in good time and in an appropriate form~~without undue delay, including by publication of special warnings;

Amendment 239 #

Proposal for a regulation
Article 9 – paragraph 4 – point b – point iii

(iii) alerting the persons at risk to the risk, i~~n good time~~mmediately and in an appropriate form, including by publication of special warnings;

Amendment 240 #

Proposal for a regulation
Article 9 – paragraph 4 – point b – point iii

(iii) alerting the persons at risk to the risk, i~~n good time~~mmediately and in an appropriate form, including by publication of special warnings;

Amendment 241 #

Proposal for a regulation
Article 9 – paragraph 4 – point d – point i

(i) preventing immediately the product from being placed or made available on the market;

Amendment 242 #

Proposal for a regulation
Article 9 – paragraph 4 – point d – point i

(i) preventing immediately the product from being placed or made available on the market;

Amendment 243 #

Proposal for a regulation
Article 9 – paragraph 4 – point d – point ii

(ii) withdrawing or recalling the product and immediately alerting the public, in an appropriate form, to the risk presented;

Amendment 244 #

Proposal for a regulation
Article 9 – paragraph 5

5. The Commission may adopt implementing acts establishing the modalities for the provision of information in accordance with the third subparagraph of paragraph 3, while ensuring the effectiveness and proper functioning of the system. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2).deleted

Amendment 245 #

Proposal for a regulation
Article 10 – paragraph 1

1. Where the identity of the relevant economic operator cannot be ascertained by the market surveillance authorities or where an economic operator has failed in its duty of care or has not taken the necessary corrective action pursuant to Article 9(3) within the period specified, market surveillance authorities shall take all necessary measures to deal with the risk presented by the product.

Amendment 246 #

Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2

Market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. ~~They may require the relevant economic operator to bear the cost of such action~~All of the expenses incurred by the surveillance authority in the scope of the application of this provision (destruction of products, work performed, etc.) shall be borne by the economic operator unless the surveillance authority considers this decision to be disproportionate, in which case it may decide that the cost shall be borne by the economic operator only partly.

Amendment 247 #

Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2

Market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. The~~y may require the relevant economic operator to bear the cost of such ac~~ cost of action taken by market surveillance authorities shall be borne by the relevant economic operator unless the market surveillance concerned regards that as disproportionate.

Amendment 248 #

Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2

Market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. TWhe~~y may requi~~re the relevant economic operator tohas been identified, he shall bear the entire cost of such action.

Amendment 249 #

Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2

Market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. The~~y may require the~~ relevant economic operator toshall bear the cost of such action.

Amendment 250 #

Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2

Market surveillance authorities may destroy or otherwise render inoperable a product presenting a risk where they deem it necessary and proportionate. They may require the ~~relevant~~ economic operator responsible for placing that product on the market to bear the cost of such action.

Amendment 251 #

Proposal for a regulation
Article 10 – paragraph 3

3. Prior to taking any measure under paragraph 1 in relation to an economic operator who has failed to take the necessary corrective action, market surveillance authorities shall allow him at least 10 days within which to be heard.deleted

Amendment 252 #

Proposal for a regulation
Article 10 – paragraph 3

3. Prior to taking any measure under paragraph 1 in relation to an economic operator who has failed in his duty of care or has noto taken the necessary corrective action, market surveillance authorities shall allow him at least 10 days within which to be heard.

Amendment 253 #

Proposal for a regulation
Article 10 – paragraph 4

4. Where market surveillance authorities consider that a product presents a serious risk and the economic operator cannot be identified or is unwilling to take the necessary measures, they shall take all necessary measures and may do so without first requiring the economic operator to take corrective action pursuant to Article 9(3) and without giving the operator the opportunity to be heard beforehand. In such cases the economic operator shall be heard as soon as practicable.

Amendment 254 #

Proposal for a regulation
Article 10 – paragraph 5 – subparagraph 1 – point a

(a) be communicated without delay to the economic operator ~~together with information about the remedies available under the law of the Member State concerned~~;

Amendment 255 #

Proposal for a regulation
Article 10 – paragraph 6

6. Market surveillance authorities shall publish information about product identification, the nature of a risk and the measures taken to prevent, reduce or eliminate that risk on a dedicated website to the fullest extent necessary to protect the interests of users of products in the Union. This information shall not be published where it is imperative to observe confidentiality in order to protect commercial secrets, preserve personal data pursuant to national and Union legislation or avoid undermining monitoring and investigation activities.deleted

Amendment 256 #

Proposal for a regulation
Article 10 – paragraph 6

6. Market surveillance authorities shall, without undue delay, publish information about product identification, the nature of a risk and the measures taken to prevent, reduce or eliminate that risk on a dedicated website to the fullest extent necessary to protect the interests of users of products in the Union. This information shall not be published where it is imperative to observe confidentiality in order to ~~protect commercial secrets,~~ preserve personal data pursuant to national and Union legislation or avoid undermining monitoring and investigation activities.

Amendment 257 #

Anna HEDH

Proposal for a regulation
Article 10 – paragraph 6

6. Market surveillance authorities shall publish information about product identification, the nature of a risk and the measures taken to prevent, reduce or eliminate that risk - as referred to in Article 6(6) - on a dedicated website, without delay, to the fullest extent necessary to protect the interests of users of products in the Union. This information shall not be published where it is imperative to observe confidentiality in order to protect commercial secrets, preserve personal data pursuant to national and Union legislation or avoid undermining monitoring and investigation activities.

Amendment 258 #

Proposal for a regulation
Article 10 – paragraph 6

6. Market surveillance authorities shall publish information about product identification, the nature of a risk and the measures taken to prevent, reduce or eliminate that risk on a dedicated website to the fullest extent necessary to protect the interests of users of products in the Union. This information shall not be published where it is imperative to observe confidentiality in order to protect ~~commercial secrets, preserve~~ personal data pursuant to national and Union legislation or avoid undermining monitoring and investigation activities.

Amendment 259 #

Proposal for a regulation
Article 10 – paragraph 6

6. MIn the case of products found to present a risk, market surveillance authorities shall publish information about product identification, the nature of a risk and the measures taken to prevent, reduce or eliminate that risk on a dedicated website to the fullest extent necessary to protect the interests of users of products in the Union. This information shall not be published where it is imperative to observe confidentiality in order to protect commercial secrets, preserve personal data pursuant to national and Union legislation or avoid undermining monitoring and investigation activities.

Amendment 260 #

Proposal for a regulation
Article 10 – paragraph 6

Amendment 261 #

Proposal for a regulation
Article 10 – paragraph 8

8. Market surveillance authorities may charge fees on economic operators which are caught placing or making available non-compliant products and products presenting a risk on the Union market. Such fees should wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraphs 1 or 4.

Amendment 262 #

Proposal for a regulation
Article 10 – paragraph 8

8. Market surveillance authorities may charge fees on economic operators ~~which wholly or~~responsible for placing on the market which partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraphs 1 or 4. The fees shall be calculated on the basis of the actual cost of each market surveillance activity and shall be charged to those economic operators which are responsible for placing on the market and subject to the market surveillance activities in question according to their role within the supply chain, taking into account company size and the situation of SMEs in particular as well as the activity actually performed by the given economic operator in the production process and the ability of that operator to affect product safety. Such fees may not exceed the actual costs of the market surveillance activities carried out and may fully or partially reflect the time spent by market surveillance authority personnel in carrying out the above-mentioned checks.

Amendment 263 #

Proposal for a regulation
Article 10 – paragraph 8 a (new)

8a. Where a product is found to be non- compliant for which an outside body was tasked with carrying out parts of the conformity assessment procedure, the market surveillance authority concerned should act to review and, where necessary, limit or rescind that body's accreditation, licence or appointment.

Amendment 264 #

Proposal for a regulation
Article 10 – paragraph 8 b (new)

8b. Any funds or revenues obtained through such fees shall be earmarked to the financing of the activities of market surveillance authorities.

Amendment 265 #

Proposal for a regulation
Article 11 – paragraph 1

1. Within 6015 days of communication by the Commission to the Member States, pursuant to Article 20(4), of measures taken pursuant to paragraphs 1 or 4 of Article 10 by the original notifying Member State, a Member State may object to those measures where they relate to a product subject to Union harmonisation legislation. The Member State shall state its reasons for objecting, indicate any difference in its assessment of the risk presented by the product and mention any special circumstances and any additional information relating to the product in question.

Amendment 266 #

Proposal for a regulation
Article 11 – paragraph 3

3. Where an objection is raised by a Member State pursuant to paragraph 1 or the Commission considers that the national measures may be contrary to Union legislation, the Commission shall without delay enter into consultation with the notifying Member State and the relevant economic operator(s) and shall evaluate, within 60 days at the most, the national measures, taking account of all available scientific or technical evidence.

Amendment 267 #

Proposal for a regulation
Article 11 – paragraph 3 a (new)

3a. If an objection is raised within 15 days by the Commission or a Member State in accordance with paragraph 1, the Commission shall inform all the Member States through the RAPEX contact points.

Amendment 268 #

Proposal for a regulation
Article 11 – paragraph 3 b (new)

3b. If an objection is raised in accordance with paragraph 1 by the Commission or a Member State, the Commission shall inform all the Member States through the RAPEX contact points.

Amendment 269 #

Proposal for a regulation
Article 11 – paragraph 4

4. On the basis of the results of the evaluation conducted pursuant to paragraph 3, the Commission ~~may~~shall decide by implementing acts within 3 months whether the national measures are justified and similar measures should be taken by all Member States that have not already done so. In this case, it shall address the decision to the Member States concerned and immediately communicate it to all Member States and the relevant economic operator or operators.

Amendment 270 #

Proposal for a regulation
Article 11 – paragraph 4

4. On the basis of the results of the evaluation conducted pursuant to paragraph 3, the Commission ~~may~~shall decide without undue delay by implementing acts whether the national measures are justified and similar measures should be taken by all Member States that have not already done so. In this case, it shall address the decision to the Member States concerned and immediately communicate it to all Member States and the relevant economic operator or operators.

Amendment 271 #

Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1

1. Where it is evident that a product, or a specific category or group of products, when used in accordance with the product's intended purpose or under conditions which can be reasonably foreseeable, presents a serious risk the Commission may, by means of implementing acts, take any appropriate measures depending on the gravity of the situation, including measures prohibiting, suspending or restricting the placing or making available on the market of such products or laying down special conditions for their marketing,. In addition to the measures specifically set forth in this Regulation, the Commission may take any other appropriate emergency measures in order to ensure a high level of protection of the public interest, provided that the risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned or by any other procedure under Union legislation. By those implementing acts, the Commission may lay down the appropriate control and precautionary measures to be taken by Member States to ensure their effective implementation. The market surveillance authorities shall identify risks arising in connection with products covered by this Regulation and the characteristics of such risks by complying with any possible indications and instructions that may be given by the Commission in relation to the actual methods, grids and criteria to be used in performing risk assessment. The market surveillance authorities shall record this information in the information and communication system for market surveillance referred to in Article 21. As appropriate, such implementing acts shall include the definition of the product models on which the tests are to be performed, regardless of those defined by the economic operator, as well as the risk assessment criteria. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 32(2).

Amendment 272 #

Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 2

The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 32(2) and with the recommendations of the committee referred to in Article 19(1), first paragraph, of Regulation (EU) No. ... of the European Parliament and of the Council of ... on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC*. __________________ * OJ: Please insert the number, date and reference details for the Consumer Product Safety Regulation (2013/0049(COD)).

Amendment 273 #

Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 3

On duly justified imperative grounds of urgency ~~relating to the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security and other public interests~~, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 32(3).

Amendment 274 #

Andreas SCHWAB, Birgit COLLIN-LANGEN, Sabine VERHEYEN

Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 3 a (new)

In respect of consumer products presenting health and safety risks, the measures adapted under the previous paragraphs shall be implemented in accordance with Article XXX of the CPSR.

Amendment 275 #

Proposal for a regulation
Article 12 – paragraph 2

2. For products ~~and risks~~ subject to Regulation (EC) No 1907/2006, athe Commission may take a decision, pursuant to paragraph 1 of this Article, only if it has justifiable grounds for believing that urgent action is essential to protect human health or the environment. A decision taken by the Commission pursuant to paragraph 1 of this Article shall be valid for up to two years and may be extended for additional periods of up to two years. Such a decision shall be without prejudice to procedures provided in that Regulation. The Commission shall immediately inform the Member States and the European Chemicals Agency thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based. If the provisional measure adopted by the Commission involves restricting the placing on the market or use of a substance, the Commission shall initiate a Community restrictions procedure by submitting to European Chemicals Agency a dossier, in accordance with Annex XV to Regulation (EC) No 1907/2006, within three months of the date of the Commission decision.

Amendment 276 #

Proposal for a regulation
Article 13 – title

~~Risk~~Safety assessment

Amendment 277 #

Proposal for a regulation
Article 13 – paragraph - 1 (new)

-1. The Commission shall adopt by means of implementing acts a general risk assessment methodology and, where relevant, guidelines for the application of that methodology to specific categories of products. Such implementing acts shall be adopted in accordance with the examination procedure referred to in Article 32(2).

Amendment 278 #

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. Risk assessment shall be based on available scientific or technical evidence. and shall be carried out in accordance with the general risk assessment methodology developed by the Commission in accordance with the previous paragraph and, where relevant, according to the guidelines on the application of thereof to specific categories of products.

Amendment 279 #

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. Risk assessment shall be based on available scientific or technical evidence. Risk assessment shall be carried out in accordance with the general risk assessment methodology established and used by the Commission and, as appropriate, in accordance with the application made by the Commission for a specific category of products.

Amendment 280 #

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. Risk assessment shall be based on available scientific or technical evidence. Risk assessment shall be carried out in accordance with the general risk assessment methodology established by the Commission and, as appropriate, in accordance with the application made by the Commission for a specific category of products.

Amendment 281 #

Nora BERRA

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. Risk assessment shall be based on available scientific or technical evidence. Risk assessment shall be carried out in accordance with the general risk assessment methodology established by the Commission and, as appropriate, in accordance with the application made by the Commission for a specific category of products.

Amendment 282 #

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. Risk assessment shall be based on available scientific or technical evidence. Risk assessment shall be carried out in accordance with the general risk assessment methodology established by the Commission and, as appropriate, in accordance with the application made by the Commission for a specific category of products.

Amendment 283 #

Othmar KARAS

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. Risk assessment shall be based on available scientific or technical evidence. , such as the Risk Assessment Guidelines for Consumer Products from the RAPEX Guidelines (Commission Decision 2010/15/EU). Or. en (Commission Decision 2010/15/EU)

Amendment 284 #

Andreas SCHWAB, Birgit COLLIN-LANGEN, Sabine VERHEYEN

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2

For products subject to Regulation (EC) No 1907/2006, risk assessment shall be carried out as appropriate in accordance with the relevant parts of Article 57 and Annex I to that Regulation.

Amendment 285 #

Proposal for a regulation
Article 13 – paragraph 2 – point a

(a) any requirements laid down in or pursuant to Union harmonisation legislation that apply to the product and relate to the potential risk under consideration, taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body, including assessments drawn up pursuant to Regulation (EC) No 1907/2006, e.g. in connection with registration, authorisation, restrictions or reporting;

Amendment 286 #

Proposal for a regulation
Article 13 – paragraph 2 – point a

(a) any requirements laid down in or pursuant to Union harmonisation legislation that apply to the product and relate to the potential risk under consideration, taking ~~full~~ account of test reports or certificates attesting conformity and issued by a conformity assessment body;

Amendment 287 #

Proposal for a regulation
Article 13 – paragraph 2 a (new)

2a. In the absence of requirements laid down in paragraphs (a), (b) and (c), account must be taken of the provisions of Article 6 of the Regulation on Consumer Product Safety;

Amendment 288 #

Proposal for a regulation
Article 13 – paragraph 3

Amendment 289 #

Proposal for a regulation
Article 13 – paragraph 3

Amendment 290 #

Proposal for a regulation
Article 13 – paragraph 3

Amendment 291 #

Proposal for a regulation
Article 13 – paragraph 3

3. Compliance with the criteria referred to in points (a), (b) and (c) of paragraph 2 shall raise a presumption that the product adequately safeguards the public interests to which those criteria relate. However, this shall not prevent market surveillance authorities from taking action under this Regulation where there is new evidence that, despite such conformity or compliance~~, the product presents a risk~~ with the criteria referred to in points (b) and (c) of paragraph 2, the product presents a serious risk. In that case the market surveillance authorities shall demonstrate that the product presents a serious risk and notify its decision pursuant to Article 19.

Amendment 292 #

Proposal for a regulation
Article 13 – paragraph 3

3. Compliance with any of the criteria referred to in points (a), (b) and (c) of paragraph 2 shall raise a presumption that the product adequately safeguards the public interests to which those criteria relate. However, this shall not prevent market surveillance authorities from taking action under this Regulation where there is new evidence that, despite such conformity or compliance, the product presents a risk.

Amendment 293 #

Proposal for a regulation
Article 13 – paragraph 4

4. The feasibility of obtaining higher levels of protection of the public interest concerned and the availability of other products presenting a lesser risk shall not be asufficient reason to consider that a product presents a risk.

Amendment 294 #

Proposal for a regulation
Article 13 – paragraph 4 a (new)

4a. The Commission may, of its own initiative or at the request of a market surveillance authority, have a risk assessment carried out by a European Union reference laboratory , in accordance with Article 28. Such assessment shall be binding on all stakeholders.

Amendment 295 #

Proposal for a regulation
Article 13 – paragraph 4 b (new)

4b. The Commission may, of its own initiative or at the request of a surveillance authority, have a risk assessment carried out by a European Union reference laboratory , in accordance with Article 28. Such assessment shall be binding on all stakeholders.

Amendment 296 #

Proposal for a regulation
Article 13 – paragraph 4 c (new)

4c. The Commission may, of its own initiative or at the request of a surveillance authority, have a risk assessment carried out by a European Union reference laboratory, in accordance with Article 28. Such assessment shall be binding on all stakeholders.

Amendment 297 #

Proposal for a regulation
Article 13 – paragraph 4 d (new)

4d. In cases where Member State risk assessment practices differ and result in divergent interpretations as to the necessity of measures in respect of similar products, the Commission shall provide guidance on appropriate risk assessment practices. The Commission shall be assisted by the scientific committees established under Commission Decision 2004/210/EC and take into account all available scientific and technical evidence relating to the risks under consideration.

Amendment 298 #

Proposal for a regulation
Article 13 – paragraph 4 e (new)

4e. At the request of a market surveillance authority or on its own initiative, the Commission may have risk assessments carried out by reference laboratories in accordance with Article 28. Those risk assessments shall be binding on all parties.

Amendment 299 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – introductory part

In relation to a product which must comply with Union harmonisation legislation when it is released for free circulation, formal non-compliance with that legislation shall give the authorities of Member States sufficient reason to ~~believe that the product may present a risk~~suspend the release of a product in any of the following cases:

Amendment 300 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – introductory part

In relation to a product which must comply with Union harmonisation legislation when it is released for free circulation, formal non-compliance with that legislation ~~shall~~may give the authorities of Member States sufficient reason to believe that the product may present a risk in any of the following cases:

Amendment 301 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – introductory part

In relation to a product which must comply with Union ~~harmonisation~~ legislation when it is released for free circulation, formal non-compliance with that legislation shall give the authorities of Member States sufficient reason to believe that the product may present a risk in any of the following cases:

Amendment 302 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – point b a (new)

Amendment 303 #

Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – point b b (new)

(bb) the product or any presentation of the product bears without authorisation a trade mark that is identical or similar to a registered trade mark for this product, thereby not allowing to guarantee its authenticity or origin;

Amendment 304 #

Jürgen CREUTZMANN

Proposal for a regulation
Article 14 – paragraph 3 a (new)

3a. Where products are not intended to be placed on the market in the Member State in which they are released for free circulation, the language in which the information set out in points (a), (b) and (c) of paragraph 3 is presented shall not give the authorities in charge of external border controls sufficient reason to believe that the product may present a risk.

Amendment 305 #

Proposal for a regulation
Article 14 – paragraph 3 b (new)

3b. The corrective measures of the market surveillance authorities must be proportionate to the seriousness of the non-compliance.

Amendment 306 #

Proposal for a regulation
Article 14 – paragraph 5

5. In the case of perishable products, the authorities in charge of external border controls shall, as far as possible, ~~seek~~facilitate measures to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products.

Amendment 307 #

Proposal for a regulation
Article 15 – paragraph 2

2. If the market surveillance authorities conclude that a product the release of which was suspended due to formal non- compliance in accordance with the second sub-paragraph of paragraph 3 of Article 14 does not in fact present a risk, the ~~economic operator shall nevertheless rectify the formal~~y shall take measures, on the basis of the proportionality principle, to bring a criminal prosecution for non-compliance before the product is released.

Amendment 308 #

Proposal for a regulation
Article 15 – paragraph 3

3. Compliance with the requirements of any Union harmonisation legislation that apply to the product upon its release which relate to the potential risk under consideration, taking full account of test reports or certificates attesting conformity and issued by a conformity assessment body, shall raise a presumption on the part of market surveillance authorities that the product does not present a risk. However, this shall not prevent those authorities from instructing the authorities in charge of external border controls not to release the product where there is evidence that, despite such compliance, the product does in fact present a risk.

Amendment 309 #

Proposal for a regulation
Article 15 – paragraph 3

3. Compliance with the requirements of any Union harmonisation legislation that apply to the product upon its release which relate to the potential risk under consideration, taking ~~full~~ account of test reports or certificates attesting conformity and issued by a conformity assessment body, shall raise a presumption on the part of market surveillance authorities that the product does not present a risk. However, this shall not prevent those authorities from instructing the authorities in charge of external border controls not to release the product where there is evidence that, despite such compliance, the product does in fact present a risk.

Amendment 310 #

Proposal for a regulation
Article 16 – paragraph 6

6. Market surveillance authorities shall request subcontractors to directly charge the cost of their services to the economic operator concerned unless the market surveillance authority considers this measure to be disproportionate, where they take measures in accordance with paragraph 1. Market surveillance authorities may charge fees which wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, ~~where they take measures in accordance with paragraph 1~~and work performed.

Amendment 311 #

Proposal for a regulation
Article 16 – paragraph 6

Amendment 312 #

Proposal for a regulation
Article 16 – paragraph 6

6. Market surveillance authorities ~~may~~shall charge fees on economic operators declaring the non-compliant products and products presenting a risk for free circulation which wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraph 1.

Amendment 313 #

Proposal for a regulation
Article 16 – paragraph 6

6. Market surveillance authorities may charge fees which wholly or partly cover the costs of their activities, including testing carried out for the risk assessment, where they take measures in accordance with paragraph 1. Subcontractors commissioned by market surveillance authorities to destroy or test products may also charge fees which wholly or partly cover the costs of their activities. The manufacturer or importer examined shall be directly invoiced for fees.

Amendment 314 #

Proposal for a regulation
Article 17

Article 17 Personal imports 1. Where a product enters the Union accompanied by, and in the physical possession of, a natural person and reasonably appears to be destined for the personal use of that person, its release shall not be suspended pursuant to Article 14(3) except where the use of the product can endanger the health and life of persons, animals or plants. 2. A product shall be deemed to be destined for the personal use of a natural person bringing it into the Union if it is of an occasional nature and exclusively intended for use by that person or his family and does not by its nature or quantity indicate any commercial intent.deleted

Amendment 315 #

Proposal for a regulation
Article 18 – paragraph 1

1. Within 6015 days of communication by the Commission to the Member States, pursuant to Article 20(4), of any refusal to release a product for free circulation by the original notifying Member State, a Member State may object to that refusal where it relates to a product subject to Union harmonisation legislation. The Member State shall state its reasons for objecting, indicate any difference in its assessment of the risk presented by the product and mention any special circumstances and any additional information relating to the product in question.

Amendment 316 #

Proposal for a regulation
Article 18 – paragraph 3

3. Where an objection is raised by a Member State under paragraph 1 or the Commission considers that the refusal may be contrary to Union legislation, the Commission shall without delay enter into consultation with the notifying Member State and the relevant economic operator(s) and shall ~~evaluate the refusal,~~ , within a maximum period of 60 days evaluate the national measures, taking account of all available scientific or technical evidence.

Amendment 317 #

Proposal for a regulation
Article 18 – paragraph 3 a (new)

3a. If an objection is entered within 15 days in accordance with paragraph 1 by the Commission or a Member State, the Commission shall inform all the Member States through the RAPEX contact points.

Amendment 318 #

Proposal for a regulation
Article 19 – paragraph 1

1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a ~~risk~~serious risk to the health and safety of consumers in accordance with this Regulation.

Amendment 319 #

Proposal for a regulation
Article 19 – paragraph 1

1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a serious risk in accordance with this Regulation.

Amendment 320 #

Proposal for a regulation
Article 19 – paragraph 1

Amendment 321 #

Proposal for a regulation
Article 19 – paragraph 1

1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a considerable risk in accordance with this Regulation.

Amendment 322 #

Proposal for a regulation
Article 19 – paragraph 4

4. Participation in RAPEX shall be open to applicant countries, third countries or international organisations within the framework of and in accordance with agreements between the Union and those countries or organisations. Any such agreements shall be based on reciprocity and include provisions on confidentiality and personal-data protection corresponding to those applicable in the Union.

Amendment 323 #

Proposal for a regulation
Article 19 – paragraph 4

4. Participation in RAPEX shall be open to applicant countries, third countries or international organisations within the framework of and in accordance with agreements between the Union and those countries or organisations. Any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the Union as well as special provisions on personal data protection, as required by Article 25 of Directive 95/46/EC and Article 9 of Regulation (EC) No 45/2001.

Amendment 324 #

Proposal for a regulation
Article 19 – paragraph 4 a (new)

4a. The Commission shall publish a weekly overview of the products posing a serious risk as reported by the national authorities. The weekly overview shall cover measures taken by national authorities as well as measures taken voluntarily by economic operators.

Amendment 325 #

Proposal for a regulation
Article 20 – title

Notification through RAPEX of products presenting a serious risk

Amendment 326 #

Proposal for a regulation
Article 20 – title

Notification through RAPEX of products presenting a serious risk

Amendment 327 #

Proposal for a regulation
Article 20 – title

Notification through RAPEX of products presenting a serious risk

Amendment 328 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point a

(a) any corrective action taken by economic operators ~~pursuant to Article 9(3)~~;

Amendment 329 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point a

(a) any corrective action taken by economic operators pursuant to points (c) and (d) of Article 9(34);

Amendment 330 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b a (new)

(ba) measures adopted in response to cases of formal non-compliance which have not been rectified and could result in serious risk (Art. 9(2))

Amendment 331 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point b b (new)

(bb) measures notified by economic operators to the market supervisory authorities in accordance with Articles 8(9), 10(7) and 11(5) of the Regulation on Consumer Product Safety (CPSR).

Amendment 332 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)

(ca) the arguments put forward by the relevant economic operator.

Amendment 333 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2

~~The first subparagraph shall not apply where the RAPEX contact point has reason to believe that the effects of the risk presented by a product do not go beyond the territory of its Member State.~~deleted

Amendment 334 #

Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2

The first subparagraph shall not apply where the RAPEX contact point has reason to believe that the effects of the serious risk presented by a product do not go beyond the territory of its Member State.

Amendment 335 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point a

(a) the ndat~~ure and level of the risk, including a summary of the results of the risk assessmen~~a necessary to identify the product;

Amendment 336 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point b

(b) the nature ~~of any non-compliance with Union harmonisation legislation~~and risk level and summary of safety and risk assessment findings;

Amendment 337 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point c

Amendment 338 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point c

Amendment 339 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point d

(d) the ~~origin and the supply chain of the product~~nature of the measure or corrective action taken and whether voluntary or compulsory;

Amendment 340 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point f

(f) the ~~nature of the measure or corrective action taken and whether voluntary, approved, required~~origin and the supply chain of the product;

Amendment 341 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point f a (new)

(fa) website and alternative contact details for consumers;

Amendment 342 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point f b (new)

(fb) whether the product is known to be counterfeit;

Amendment 343 #

Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1 – point g a (new)

(ga) Whether the product is known to be counterfeit

Amendment 344 #

Proposal for a regulation
Article 20 – paragraph 3

3. Where a notification relates to a product found not to comply with Union harmonisation legislation, the information provided shall also indicate whether the non-compliance is due to any of the following: (a) the failure of the product to satisfy the requirements of the applicable legislation; (b) shortcomings in the harmonised standards referred to in that legislation which confer a presumption of conformity with those requirements. Where a measure or corrective action referred to in paragraph 1 relates to a product that has undergone conformity assessment by a notified body, the market surveillance authorities shall ensure that the relevant notified body is informed of the corrective action or measures taken.deleted

Amendment 345 #

Proposal for a regulation
Article 20 – paragraph 4

4. On receiving a notification, the Commission shall communicate it towithout delay to the economic operator and the other Member States. If the notification does not satisfy the requirements set out in paragraphs 1, 2 and 3, the Commission may suspend it.

Amendment 346 #

Andreas SCHWAB, Birgit COLLIN-LANGEN, Sabine VERHEYEN

Proposal for a regulation
Article 20 – paragraph 4

4. On receiving a notification, the Commission shall communicate it to the other Member States. If the notification does not satisfy the administrative requirements set out in paragraphs 1, 2 and 3, the Commission may suspend it.

Amendment 347 #

Proposal for a regulation
Article 20 – paragraph 4

4. On receiving a notification, the Commission shall communicate it to the relevant economic operator and the other Member States. If the notification does not satisfy the requirements set out in paragraphs 1, 2 and 3, the Commission may suspend it.

Amendment 348 #

Proposal for a regulation
Article 20 – paragraph 5

5. The Member States shall ~~immediately~~as soon as possible inform the Commission of the action or measures taken following receipt of a notification and shall provide any supplementary information, including the results of any tests or analyses carried out or possible differences in views. The Commission shall immediately transmit this information to other Member States..

Amendment 349 #

Andreas SCHWAB, Birgit COLLIN-LANGEN, Sabine VERHEYEN

Proposal for a regulation
Article 20 – paragraph 5 a (new)

5a. It shall be possible to update the information related to a product notified to the RAPEX system.

Amendment 350 #

Proposal for a regulation
Article 20 – paragraph 5 b (new)

5b. Where appropriate, information on a product in a RAPEX notification shall be updated.

Amendment 351 #

Proposal for a regulation
Article 21 – paragraph 1 – subparagraph 1 – introductory part

The Commission shall maintain an information and communication system for market surveillance (ICSMS) for the collection and structured storage of information on issues relating to market surveillance,. Member States shall collect and enter in ICSMS in particular the following information:

Amendment 352 #

Proposal for a regulation
Article 21 – paragraph 1 – subparagraph 1 a (new)

The Commission shall provide an interface solution through which ICSMS can be connected to RAPEX for data interchange between these systems, when appropriate.

Amendment 353 #

Proposal for a regulation
Article 21 – paragraph 1 – subparagraph 1 – point e

(e) any non-compliance with Union ~~harmonisation~~ legislation other than measures or corrective action notified under RAPEX in accordance with Article 20;

Amendment 354 #

Proposal for a regulation
Article 21 – paragraph 1 – subparagraph 1 – point f

~~(f) any objection raised by a Member State in accordance with Articles 11(1) or 18(1) and the follow-up.~~deleted

Amendment 355 #

Proposal for a regulation
Article 21 – paragraph 1 – subparagraph 2

ICSMS shall contain a record of references to the notifications of measures or corrective action made under RAPEX in accordance with Article 20. The Commission will develop an interface between ICSMS and RAPEX which will automatically transfer information about serious risk to the RAPEX system.

Amendment 356 #

Christel SCHALDEMOSE, Evelyne GEBHARDT, Anna HEDH

Proposal for a regulation
Article 21 – paragraph 3

3. Market surveillance authorities shall ~~recognise the validity~~as far as possible take into account and make use of test reports prepared by or for their counterparts in other Member States and entered into ICSMS.

Amendment 357 #

Proposal for a regulation
Article 21 a (new)

Article 21a Pan-European Injuries Database 1. A Pan-European Injuries Database (IDB), which would cover all types of injuries, and namely those related to products used at home and for leisure, transportation and work activities, shall be set up and coordinated by the European Commission. 2. The relevant market surveillance authorities established by the Member States shall contribute to the establishment of the database and deliver injury data to the database that is comprehensive and in accordance with European and national laws on data protection. 3. The Commission shall support the co- ordination of the collection of data from Member States and the operation of the database.

Amendment 358 #

Proposal for a regulation
Article 22 – paragraph 1

The Commission and Member States may exchange confidential information, including information exchanged through RAPEX, with regulatory authorities of third countries or international organisations with which the Commission and the Member State or group of Member States have concluded bilateral or multilateral confidentiality arrangements based on reciprocity. Where an exchange of information concerns personal data, Directive 95/46/EC shall apply.

Amendment 359 #

Proposal for a regulation
Article 22 – paragraph 1

The Commission and Member States may exchange confidential information, including information exchanged through RAPEX, with regulatory authorities of third countries or international organisations with which the Commission and the Member State or group of Member States have concluded bilateral or multilateral confidentiality arrangements based on reciprocity. Any such arrangements shall include provisions on confidentiality corresponding to those applicable in the Union as well as special provisions on personal data protection, as required by Article 25 of Directive 95/46/EC and Article 9 of Regulation (EC) No 45/2001.

Amendment 360 #

Proposal for a regulation
Article 22 – paragraph 1

The Commission ~~and~~, together with the Member States may exchange confidential information, including information exchanged through RAPEX, with regulatory authorities of third countries or international organisations with which the Commission and ~~the Member State or group of~~ Member States have concluded bilateral or multilateral confidentiality arrangements based on reciprocity.

Amendment 361 #

Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 1

2. Market surveillance authorities shall, on receipt of a duly motivated request from a market surveillance authority in another Member State, provide a~~ny relevant information or documentation and carry out checks, inspections or investigations and report on them and on any follow-up action taken~~ssistance on an appropriate scale to the requesting authority.

Amendment 362 #

Proposal for a regulation
Article 23 – paragraph 2 – subparagraph 1

2. Market surveillance authorities shall, on receipt of a duly motivated request from a market surveillance authority in another Member State~~, provide any relevant information or documentation and~~ which has exhausted other channels carry out cthe~~cks,~~ inspections ~~or investigations and report on them and~~considered necessary and report on any follow-up action taken to the requesting authority.

Amendment 363 #

Proposal for a regulation
Article 24 – paragraph 1

1. Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to Union information exchange systems in, excluding the RAPEX system, in accordance with Article 19(4), and promoting activities relating to conformity assessment and market surveillance.

Amendment 364 #

Proposal for a regulation
Article 24 – paragraph 2 a (new)

2a. Where, in an exchange of information, personal data are exchanged, Directive 95/46/EC shall apply.

Amendment 365 #

Proposal for a regulation
Article 25 – paragraph 5

5. The EMSF may invite experts and other third parties to attend meetings or provide written contributions. Organisations representing the interests of industry, small and medium-sized enterprises, consumers, laboratories and conformity assessment bodies at Union level may be consulted on the yearly market surveillance programme.

Amendment 366 #

Proposal for a regulation
Article 27 – paragraph 1 – point c

Amendment 367 #

Proposal for a regulation
Article 27 – paragraph 1 – point e

(e) to ~~organise~~facilitate the organisation of training programmes and exchanges of national officials;

Amendment 368 #

Proposal for a regulation
Article 27 – paragraph 1 – point g

(g) to organise information campaigns and joint visit programmes, including controls at borders;

Amendment 369 #

Proposal for a regulation
Article 27 – paragraph 1 – point g

(g) to ~~organise~~facilitate the organisation of information campaigns and joint visit programmes;

Amendment 370 #

Proposal for a regulation
Article 27 – paragraph 1 – point j

(j) to contribute to the development of guidance to ensure the effective and uniform implementation of this Regulation, taking due account of the interests of ~~business, in particular small and medium- sized enterprises,~~consumers and other stakeholders;

Amendment 371 #

Proposal for a regulation
Article 27 – paragraph 1 – point j

(j) to contribute to the development of guidance to ensure the effective and uniform implementation of this Regulation, taking due account of the interests of business, in particular small and medium- sized enterprises, consumer protection, and other stakeholders;

Amendment 372 #

Proposal for a regulation
Article 27 – paragraph 1 – point k

(k) to provide advice and assist the Commission, ~~at its~~Member States and the European Parliament, at their request, in ~~its~~their assessment of any issue relating to the implementation of this Regulation;

Amendment 373 #

Proposal for a regulation
Article 27 – paragraph 1 – point l a (new)

(la) to contribute to the creation of a European network of product safety laboratories.

Amendment 374 #

Proposal for a regulation
Article 27 – paragraph 1 – point l b (new)

(lb) to organise specific and regular market surveillance campaigns on products that are distributed on-line;

Amendment 375 #

Proposal for a regulation
Article 27 – paragraph 1 – point l c (new)

(lc) to ensure adequate involvement of and cooperation with customs authorities;

Amendment 376 #

Proposal for a regulation
Article 27 – paragraph 1 – point l d (new)

(ld) to contribute to a streamlining of administrative and enforcement practices with regard to market surveillance in the Member States;

Amendment 377 #

Proposal for a regulation
Article 28

Article 28 European Union reference laboratories 1. For specific products or a category or group of products or for specific risks related to a category or group of products, the Commission may by means of implementing acts designate Union reference laboratories that satisfy the criteria set out in paragraph 2. 2. Each Union reference laboratory shall satisfy the following criteria: (a) have suitably qualified staff with adequate training in the analytical techniques used in their area of competence and an adequate knowledge of standards and practices; (b) possess the equipment and reference material needed to carry out the tasks assigned to them; (c) act in the public interest in an impartial and independent manner; (d) ensure that the staff respect the confidential nature of certain subjects, results or communications. 3. Within the area of their designation, Union reference laboratories shall where appropriate have the following tasks: (a) carrying out product testing in relation to market surveillance activities and investigations; (b) contributing to the resolution of disputes between the authorities of Member States, economic operators and conformity assessment bodies; (c) providing independent technical or scientific advice to the Commission and the Member States; (d) developing new techniques and methods of analysis; (e) disseminating information and providing training.deleted

Amendment 378 #

Proposal for a regulation
Article 28

Amendment 379 #

Proposal for a regulation
Article 28 – paragraph 2 – introductory part

2. Each Union reference laboratory must be independent and shall satisfy the following criteria:

Amendment 380 #

Proposal for a regulation
Article 28 – paragraph 2 – point -a (new)

(-a) It shall be accredited and inspected by the Commission.

Amendment 381 #

Proposal for a regulation
Article 28 – paragraph 3 a (new)

3a. The independence of Union reference laboratories of commercial interests and conflicts of interest must be ensured through the procedures as stated in Chapter II of Regulation 765/2008 with regard to national accreditation bodies.

Amendment 382 #

Proposal for a regulation
Article 31 – paragraph 1 a (new)

The penalties provided for must be effective, proportionate and dissuasive. Where the infringement has been committed intentionally, these penalties shall include, inter alia, administrative penalties for the relevant economic operator of up to 10 % of its total annual turnover in the preceding business year;

Amendment 383 #

Proposal for a regulation
Article 31 – paragraph 2

Amendment 384 #

Proposal for a regulation
Article 31 – paragraph 2

Amendment 385 #

Proposal for a regulation
Article 31 – paragraph 2

TWhen defining penalties referred to in the first subparagraph shall have regard to the size of the undertakings and in particular to the situation of small and medium-sized enterprises. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringementsauthorities should take into account the revenue that was made in the internal market with the non-compliant product, economic damage caused to other operators selling similar or comparable products in the Union, seriousness of the non-compliance, recurrence of the non-compliance, intentionality of the economic operator placing the product on the market.

Amendment 386 #

Proposal for a regulation
Article 31 – paragraph 2

The level of the penalties referred to in the first subparagraph shall ~~have regard to the size of the undertakings and in particul~~be established as a proportion of the value of sales of the products concerned during the last full year tof the ~~situation of small and medium-size~~infringement, depending on its seriousness, duration and einte~~rprises~~ntional character. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements. In any case, the penalties shall not exceed 10% of the company's total turnover in the preceding business year.

Amendment 387 #

Proposal for a regulation
Article 31 – paragraph 2

The penalties referred to in the first subparagraph shall have regard to the s~~ize of the undertakings and in particular to the situation of small and medium-sized enterprises~~eriousness of the infringement and the amount of undue revenue derived from it. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements.

Amendment 388 #

Proposal for a regulation
Article 31 – paragraph 2

The penalties referred to in the first subparagraph shall have regard to the seriousness of the infringement, the size of the undertakings and in particular to the situation of ~~small and medium-sized enterprises~~SMEs, and to the roles played by individual undertakings within the supply chain, with particular reference to the activity actually performed by the given economic operator in the production process and the ability of that operator to affect product safety. The penalties may be increased if the ~~relevant~~ economic operator responsible for placing on the market has previously committed a similar infringement and may include criminal sanctions for serious infringements.

Amendment 389 #

Proposal for a regulation
Article 33

No later than [five] years after the date of application, the Commission shall assess the application of this Regulation and transmit an evaluation report to the European Parliament and the Council. That report shall assess if this Regulation achieved its objectives, in particular with regard to ensuring more effective and efficient enforcement of product safety rules and Union harmonisation legislation, improving cooperation between market surveillance authorities, strengthening the controls of products entering the Union and better protecting the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests, taking into account its impact on business and in particular on small and medium-sized enterprises. In addition to checks by market surveillance authorities, there should be mandatory checks by independent third parties and, in particular, sampling by such testing bodies of a representative number of products.

Amendment 390 #

Proposal for a regulation
Article 33

No later than [five] years after the date of application, the Commission shall assess the application of this Regulation and transmit an evaluation report to the European Parliament and the Council. That report shall assess if this Regulation achieved its objectives, in particular with regard to ensuring more effective and efficient enforcement of product safety rules and Union harmonisation legislation, improving cooperation between market surveillance authorities, strengthening the controls of products entering the Union and better protecting the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests, taking into account its impact on business and in particular on small and medium-sized enterprises. In addition, that report shall explore new and innovative, market-based solutions that could effectively complement the market surveillance actions carried out by the market surveillance authorities, and shall include, but not be limited to, exploring the potential of compulsory third party auditing schemes, together with compulsory third party collection and sampling of products tested.

Amendment 391 #

Proposal for a regulation
Article 33

No later than [five] years after the date of application, the Commission shall assess the application of this Regulation and transmit an evaluation report to the European Parliament and the Council. That report shall assess if this Regulation achieved its objectives, in particular with regard to ensuring more effective and efficient enforcement of product safety rules and Union harmonisation legislation, improving cooperation between market surveillance authorities, strengthening the controls of products entering the Union and better protecting the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, energy efficiency, public security and other public interests, taking into account its impact on business and in particular on small and medium-sized enterprises. In addition, that report shall explore new and innovative, market-based solutions that could effectively complement the market surveillance actions carried out by the market surveillance authorities, and shall include, but not be limited to, exploring the potential of compulsory third party auditing schemes, together with compulsory third party collection and sampling of products tested.

Amendment 392 #

Andreas SCHWAB, Birgit COLLIN-LANGEN, Sabine VERHEYEN, Jürgen CREUTZMANN

Proposal for a regulation
Article 34 – paragraph 1 – point q

(q) Articles ~~39,~~ 40, 42 to 45 of Directive 2009/48/EC;

Amendment 66 #

Proposal for a regulation
Recital 1

(1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment, intellectual property rights and public security. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union goods market can thrive. Rules are therefore necessary on market surveillance and on controls of products entering the Union from third countries.

Amendment 67 #

Proposal for a regulation
Recital 1

(1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety in the workplace, fair trading practices, protection of consumers, protection of the environment, protection of intellectual property rights and public security. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union goods market, both offline and online, can thrive. Rules are therefore necessary on physical and digital market surveillance and on controls of products entering the Union from third countries.

Amendment 68 #

Proposal for a regulation
Recital 8

(8) This Regulation should therefore integrate the provisions of Regulation 765/2008, Directive 2001/95/EC and several sector-specific acts of Union harmonisation legislation relating to market surveillance into a single regulation which covers products in both the harmonised and non-harmonised areas of the Union legislation, regardless whether they are intended for use, or are likely to be used, by consumers or professionals and whether they are sold offline or online.

Amendment 69 #

Proposal for a regulation
Recital 8

(8) This Regulation should therefore integrate the provisions of Regulation 765/2008, Directive 2001/95/EC and several sector-specific acts of Union harmonisation legislation relating to market surveillance into a single regulation which covers products in both the harmonised and non-harmonised areas of the Union legislation, regardless whether they are traded online or offline and are intended for use, or are likely to be used, by consumers or professionals.

Amendment 70 #

Proposal for a regulation
Recital 12

(12) This Regulation should establish a comprehensive framework for market surveillance in the Union. It should define the scope of the products covered and those excluded, impose an obligation on Member States to organise and carry out market surveillance, require Member States to appoint market surveillance authorities and to specify their powers and duties, and make Member States responsible for setting up general and sector-specific physical and digital market surveillance programmes.

Amendment 71 #

Proposal for a regulation
Recital 14

(14) In order to make the entire market surveillance process transparent and easy to follow for both market surveillance authorities and economic operators, the Regulation should clearly set out the chronological steps of that process, from the moment when market surveillance authorities identify a product which they believe may present a risk, to the assessment of the risk presented, the corrective action to be taken by the relevant ~~economic operator~~party responsible for placing the product on the market within a specified period and the measures to be taken by market surveillance authorities themselves if ~~economic operators~~those responsible for placing on the market do not comply or in cases of urgency.

Amendment 72 #

Proposal for a regulation
Recital 14

(14) In order to make the entire market surveillance process transparent and easy to follow for both market surveillance authorities and economic operators, the Regulation should clearly set out the chronological steps of that process, from the moment when market surveillance authorities identify a product which they believe may present a risk, to the assessment of the risk presented, the corrective action to be taken by the relevant economic operator in the physical and digital markets within a specified period and the measures to be taken by market surveillance authorities themselves if economic operators do not comply or in cases of urgency.

Amendment 73 #

Proposal for a regulation
Recital 14

Amendment 74 #

Proposal for a regulation
Recital 14 a (new)

(14a) In order to facilitate the work of market surveillance authorities, economic operators should make available all the documentation and information necessary to such authorities for the purpose of carrying out their activities. Market surveillance authorities should only require documentation and information that the relevant economic operator can be expected to possess according to their role in the supply chain.

Amendment 75 #

Proposal for a regulation
Recital 15

(15) Market surveillance should be based on the assessment of the risk presented by a product taking all relevant data into account. The methodology and criteria of assessing risks should be homogeneous in all Member States in order to ensure level playing field for all economic operators. A product that is subject to Union harmonisation legislation which lays down essential requirements relating to protection of certain public interests should be presumed not to present a risk to those public interests if it complies with those essential requirements.

Amendment 76 #

Proposal for a regulation
Recital 15

(15) Market surveillance should be based on the assessment of the risk presented by a product taking all relevant data into account, and on a duty of care for all relevant economic operators, regardless of whether the products are traded online or offline. A product that is subject to Union harmonisation legislation which lays down essential requirements relating to protection of certain public interests should be presumed not to present a risk to those public interests if it complies with those essential requirements.

Amendment 77 #

Proposal for a regulation
Recital 15 a (new)

(15a) Consumers can play an active and important role in contributing to market surveillance, as they are usually in direct contact with products presenting a risk, including products that are not compliant with applicable Union legislation. In that context Member States should raise awareness of the consumers with regard to their rights to submit complaints on issues relating to product safety and market surveillance activities and ensure that the reporting procedure is easily accessible, relatively simple and efficient. The Commission should further explore the opportunities of making the submission of such complaints harmonized throughout the Union, for example through creation of a central database where the complaints filed by the consumers could be stored as well as examine possibilities of making those complaints public, subject to the right of review and reply by the economic operators involved.

Amendment 78 #

Proposal for a regulation
Recital 18

(18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector- specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into special account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled.

Amendment 79 #

Proposal for a regulation
Recital 18

(18) For the purposes of this Regulation risk assessment should be carried out to identify products which have the potential to affect adversely the public interests protected by [Regulation (EU) No xxxx (on consumer product safety)], sector- specific Union harmonisation legislation and other Union legislation on products that are subject to this Regulation. It should include, where available, data on risks that have materialised previously with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned, in keeping with their duty of care, to alleviate the risks. The particular potential vulnerability of consumers, as opposed to professional users, should be taken into account as should the increased vulnerability of certain categories of consumer such as children, the elderly or the disabled.

Amendment 80 #

Proposal for a regulation
Recital 21

(21) Market surveillance authorities should be given the power to destroy products, render them inoperable or order their destruction by the relevant economic operator, regardless of whether that operator trades online or offline, if they deem it necessary and proportionate to ensure that such goods cannot pose any further threats.

Amendment 81 #

Proposal for a regulation
Recital 21

(21) Market surveillance authorities should be given the power to destroy products, render inoperable or order their destruction by the relevant economic operator, if they deem it necessary and proportionate to ensure that such goods cannot pose any further threats. The relevant economic operator should bear all the costs related to those actions.

Amendment 82 #

Proposal for a regulation
Recital 23

(23) There should be effective, speedy and accurate exchange of information among the Member States and between the Member States and the Commission. It is therefore necessary to provide for effective tools for such exchange. The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. RAPEX enables measures to be taken across the Union in relation to products that present a serious risk beyond the territory of a single Member State. To avoid unnecessary duplication, this system should be used for all alert notifications required by this Regulation relating to products presenting a serious risk.

Amendment 83 #

Proposal for a regulation
Recital 23

(23) There should be effective, speedy and accurate exchange of information among the Member States and between the Member States and the Commission. It is therefore necessary to provide for effective tools for such exchange. The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. RAPEX enables measures to be taken across the Union in relation to products that present a risk beyond the territory of a single Member State. To avoid unnecessary duplication, this system should be used for all alert notifications required by this Regulation relating to products presenting a risk. RAPEX should also include notifications related to Food Contact Materials, moved there from the RASFF platform.

Amendment 84 #

Proposal for a regulation
Recital 27

(27) A European Market Surveillance Forum composed of representatives from market surveillance authorities should be established. The Forum should provide a means of involving all stakeholders concerned, including professional organisations and, above all, consumer organisations, in order to take advantage of available information relevant for market surveillance when establishing, implementing and updating market surveillance programmes.

Amendment 85 #

Proposal for a regulation
Recital 30

(30) This Regulation should strike a balance between transparency through the release of the maximum possible amount of information to the public and maintaining confidentiality, for example for reasons of ~~personal data protection,~~ commercial secrecy or the protection of investigations, , in accordance with rules on confidentiality pursuant to applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Moreover, this Regulation should respect data protection principles, such as confidential handling of personal data, requirement to process data fairly and lawfully and for specific purpose, while ensuring their quality and allowing the individuals concerned to exercise their rights. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data apply in the context of this Regulation.

Amendment 86 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive. The level thereof should be set as a proportion of the value of sales of the products concerned during the last full year of the infringement, depending on its seriousness, duration and intentional or recurring character of the infringement. In any case, penalties should not exceed 10% of the company's total turnover in the preceding accounting year. Where possible under national law, Member States should be encouraged to allocate the revenue from such penalties to market surveillance activities.

Amendment 87 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive and include administrative penalties harmonised Union-wide. To that end it is necessary to allow for the seriousness of the infringement, company size and the situation of SMEs in particular, and the roles played by individual businesses within the supply chain, with particular reference to the activity actually performed by the given economic operator in the production process and the ability of that operator to affect product safety. Member States should ensure that the proceeds obtained from such administrative penalties are used for market surveillance activities.

Amendment 88 #

Proposal for a regulation
Recital 34

(34) Market surveillance should be financed ~~at least in part by fees charged to economic operators~~chiefly by Member States and only to a very limited extent by penalties charged to economic operators responsible for placing on the market where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves. In such cases it will, however, be necessary to allow for the seriousness of the infringement, company size and the situation of SMEs in particular, and the roles played by individual businesses within the supply chain, with particular reference to the activity actually performed by the given economic operator in the production process and the ability of that operator to affect product safety.

Amendment 89 #

Proposal for a regulation
Recital 38

(38) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards uniform conditions for the carrying -out of checks by reference to particular product categories or sectors, including the scale of checks to be carried out and the adequacy of samples to be checked. Implementing powers should also be conferred as regards the modalities for the provision of information to market surveillance authorities by economic operators, as regards establishing uniform conditions for determining cases in which such information need not be provided. Economic operators should not, in any event, be called upon to supply information other than that which they are required to know by virtue of their role within the supply chain. Implementing powers should also be conferred as regards the modalities and procedures for the exchange of information through RAPEX and as regards the adoption of temporary or permanent marketing restrictions on products presenting a serious risk, where appropriate, specifying the necessary control measures to be taken by the Member States for their effective implementation where other Union legislation does not provide a specific procedure to address the risks in question. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of its implementing powers.

Amendment 90 #

Proposal for a regulation
Recital 38

Amendment 91 #

Proposal for a regulation
Recital 41

(41) Since the objective of this Regulation, namely to ensure that products on the physical and digital markets covered by Union legislation fulfil the requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the physical and digital internal markets by providing a framework for coherent market surveillance in the Union, cannot be sufficiently achieved by the Member States as the attainment of this objective requires a very high degree of cooperation, interaction and uniformity of operation among all of the competent authorities of all Member States, and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

Amendment 92 #

Proposal for a regulation
Recital 42 a (new)

(42a) This Regulation should comply with the precautionary principle in order to ensure a high level of human health, consumer and environmental protection.

Amendment 93 #

Proposal for a regulation
Recital 42 b (new)

(42b) This Regulation should comply with the precautionary principle in order to ensure a high level of human health, consumer and environmental protection.

Amendment 94 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products available online or offline meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, fair trading practices, consumer protection, the environment, intellectual property rights, public security and other public interests.

Amendment 95 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products available on the market, either online or offline, meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security, the level-playing field among market operators and other public interests.

Amendment 96 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products placed or made available on the market meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security, a level-playing field among market operators and other public interests.

Amendment 97 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests, and ensuring a level-playing field for economic operators.

Amendment 98 #

Proposal for a regulation
Article 1 – paragraph 1

This Regulation lays down a framework for verifying that products meet requirements which safeguard, at a high level, the health and safety of persons in general, health and safety in the workplace, consumer protection, the environment, public security and other public interests, and for general compliance with EU legislation.

Amendment 99 #