155 Amendments of Maria-Manuel LEITÃO-MARQUES related to 2021/0170(COD)
Amendment 168 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation should aim at protecting consumers and their safety as one of the fundamental principle of the EU legal framework, enshrined in the EU Charter of fundamental rights. Dangerous products can have very negative consequences on consumers and citizens. All consumers, including the most vulnerable, such as children, older persons or, persons with disabilities, or those consumers in a state of transitory vulnerability, have the right to safe products. Consumers should have at their disposal sufficient means to enforce such rights, and Member States adequate instruments and measures at their disposal to enforce this Regulation.
Amendment 170 #
Proposal for a regulation
Recital 6
Recital 6
(6) Despite the development of sector- specific Union harmonisation legislation that addresses safety aspects of specific products or categories of products, it is practically impossible to adopt Union legislation for all consumer products that exist or may be developed. There is therefore still a need for a broad based legislative framework of a horizontal nature to fill gaps and, in particular pending revision of the existing specific legislation, and to complement provisions in existing or forthcoming specific legislation to ensure consumer protection not otherwise ensured, in particular with a view to achieving a high level of protection of safety and health of consumers, as required by Article 114 and Article 169 of the Treaty.
Amendment 172 #
Proposal for a regulation
Recital 8
Recital 8
(8) Whilst some of the provisions such as those concerning most of the obligations of economic operators should not apply to products covered by Union harmonisation legislation since already covered in such legislation, a certain number of other provisions should apply in order to complement Union harmonisation legislation. In particular the general product safety requirement and related provisions should be applicable to consumer products covered by Union harmonisation legislation when certain types of risks are not coverspecifically regulated by that legislation. The provisions of this Regulation concerning the obligations of online marketplaces, the obligations of economic operators in case of accidents, the right of information for consumers as well as the recalls of consumer products should apply to products covered by Union harmonisation legislation when there are not specific provisions with the same objective in such legislation. Likewise RAPEX is already used for the purposes of Union harmonisation legislation, as referred to in Article 20 of Regulation (EU) 2019/1020 of the European Parliament and of the Council25 , therefore the provisions regulating the Safety Gate and its functioning contained in this Regulation should be applicable to Union harmonisation legislation. __________________ 25 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).
Amendment 181 #
Proposal for a regulation
Recital 13
Recital 13
(13) Union legislation on food, feed and related areas sets up a specific system ensuring the safety of the products covered by it. Therefore, food and feed should be excluded from the scope of this Regulation with the excep. The regulation of materials and articles intended to come into contact with food insofar as risks covered by the GPSR where aspects are concerned that are not already covered by Regulation (EC) No 1935/2004 of the European Parliament and of the Council27 or by other food specific legislation which only covers chemical and biological food- related risks. __________________ 27 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Amendment 188 #
Proposal for a regulation
Recital 20
Recital 20
(20) New technologies also cause new risks to consumers’ health and safety or change the way the existing risks could materialise, such as an external intervention hacking the product or, changing its characteristics or causing software errors in programs. New technologies, such as through software updates, may substantially modify the original product, which should then be submitted to a new risk assessment.
Amendment 189 #
Proposal for a regulation
Recital 20
Recital 20
(20) New technologies also cause new risks to consumers’ health and safety or change the way the existing risks could materialise, such as an external intervention hacking the product or changing its characteristics. Dynamic products, such as those which learn from their interaction with the surrounding environment and change and adapt their behaviour, also should be taken into consideration.
Amendment 195 #
Proposal for a regulation
Recital 21
Recital 21
(21) The World Health Organisation defines ‘health’ as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. This definition supports the fact that the development of new technologies might bring new health risks to consumers, such as psychological risk, development risks, in particular for children, mental risks, depression, loss of sleep, or altered brain function. Therefore, these aspects need to be included in manufacturer’s and market surveillance authorities’ risk assessments where this is relevant.
Amendment 198 #
Proposal for a regulation
Recital 23
Recital 23
(23) The safety of products should be assessed taking into account all the relevant aspects, notably their characteristics and presentation as well as the specific needs and risks for categories of consumers who are likely to use the products, in particular children, older persons and persons with disabilities as well as gender specificities. Economic operators should avoid bias when assessing the safety of a product in order to reach a high level of safety for all consumer groups. This is why testing should be carried out with an equal involvement of all genders. Therefore, if specific information is necessary to make products safe toward a given category of persons, the assessment of the safety of the products should take into consideration also the presence of this information and its accessibility. The safety of products should be assessed taking into consideration the need for the product to be safe over its entire lifespan.
Amendment 211 #
Proposal for a regulation
Recital 26
Recital 26
(26) Online marketplaces play a crucial role in the supply chain - allowing economic operators to reach an indefinite number of consumers - and therefore also in the product safety system. They do not only facilitate transactions neutrally. Online marketplaces offer the placement of advertisements, comparison, advisory or reputational services. They act as a gateway: consumers would not have access to such products, services or traders without online marketplaces. For this reason, they must be given greater responsibility for the safety of products and consumers, including cases where other economic actors in the supply chain do not act. Depending on the concrete action they can act as manufacturer, authorized representative, importer, distributor or fulfilment service provider.
Amendment 216 #
Proposal for a regulation
Recital 27
Recital 27
(27) Given the important role played by online marketplaces when intermediatenabling the sale and/or the promotion of products between traders and consumers, such actors should have more responsibilities in tackling the sale of dangerous products online. Directive 2000/31/EC of the European Parliament and of the Council29 provides the general framework for e- commerce and lays down certain obligations for online platforms. Regulation […/…] on a Single Market for Digital Services (Digital Services Act) and amending Directive 2000/31/EC30 regulates the responsibility and accountability of providers of intermediary services online with regard to illegal contents, including unsafe products. That Regulation applies without prejudice to the rules laid down by Union law on consumer protection and product safety. Accordingly, building on the horizontal legal framework provided by that Regulation, specific requirements essential to effectively tackle the sale of dangerous products online should be introduced, in line with Article [1(5), point (h)] of that Regulation. __________________ 29 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') - OJ L 178, 17.7.2000, p. 1–16. 30 Regulation […/…] on a Single Market for Digital Services (Digital Services Act) and amending Directive 2000/31/EC.
Amendment 220 #
Proposal for a regulation
Recital 28
Recital 28
(28) The Product Safety Pledge, signed in 2018 and joined by a number of marketplaces since then, provides for a number of voluntary commitments on product safety. The Product Safety Pledge has proved its rationale in enhancingn insufficient for the protection of consumers against dangerous products sold online. Nonetheless, iIts voluntary nature and the voluntary participation by a limited number of online marketplaces reduces its effectiveness and cannot ensure a level- playing field..
Amendment 225 #
Proposal for a regulation
Recital 32
Recital 32
(32) The obligations imposed by this Regulation on online marketplaces, including App stores, should neitherot amount to a general obligation to monitor the information which they transmit or store, nor to actively seek facts or circumstances indicating illegal activity, such as the sale of dangerous products online. Online marketplaces should, nonetheless,. Online marketplaces, should, nonetheless, be required to comply with specific obligations to effectively prevent the sale of dangerous products online. This includes an obligation to expeditiously remove content referring to dangerous products from their online interfaces, upon obtaining actual knowledge or, in the case of claims for damages, awareness of the illegal content, in particular in cases where the online marketplace has been made aware of facts or circumstances on the basis of which a diligent economic operator should have identified the illegality in question, in order to benefit from the exemption from liability for hosting services under the 'Directive on electronic commerce' and the [Digital Services Act]. Online marketplaces should process notices concerning content referring to unsafe products, received in accordance with [Article 14] of Regulation (EU) …/…[the Digital Services Act], within the additional timeframes established by this Regulation.
Amendment 230 #
Proposal for a regulation
Recital 35
Recital 35
(35) For the purposes of [Article 19] of Regulation (EU) …/…[the Digital Services Act], and concerning the safety of products sold online, the Digital Services Coordinator should consider in particularensure cooperation with consumer organisations and associations representing consumers’ interest, upon their request, as trusted flaggers, provided that the conditions set out in that article have been m on product safety.
Amendment 235 #
Proposal for a regulation
Recital 36
Recital 36
(36) Product traceability is fundamental for effective market surveillance of dangerous products and corrective measures. Consumers should also be protected against dangerous products as well as against advertisement and promotions for unsafe products in the same way in the offline and online sales channels, including when purchasing products on online marketplaces. Building on the provisions of Regulation (EU) …/…[the Digital Services Act]concerning the traceability of traders and products, online marketplaces should not allow listings on their platforms unless the trader provided all information related to product safety and traceability as detailed in this Regulation. Additionally, online marketplaces shall verify the completeness and reliability of such information as detailed in this Regulation. Such information should be displayed together with the product listing so that consumers can benefit from the same information made available online and offline. However, the online marketplace should not be responsible for verifying the completeness, correctness and the accuracy of the information itself, as the obligation to ensure the traceability of products remains with the trader.
Amendment 245 #
Proposal for a regulation
Recital 50
Recital 50
(50) The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. It enables corrective measures to be taken across the Union in relation to products that present a risk beyond the territory of a single Member State. It is opportune, though, to change the used abbreviated name from RAPEX to Safety Gate for greater clarity and better outreach to consumers. Safety Gate comprises a rapid alert system on dangerous non-food products whereby national authorities and the Commission can exchange information on such products, a web portal to inform the public (Safety Gate portal) and an interface to enable businesses to comply with their obligation to inform authorities and consumers of dangerous products and of injuries and accidents caused by them (Safety Business Gateway).
Amendment 248 #
Proposal for a regulation
Recital 52
Recital 52
(52) Under Article 34 of Regulation (EU) No 2019/1020, Member States authorities are to notify measures adopted against products covered by that Regulation, presenting a less than serious risk, through the information and communication system referred to in the same article, while corrective measures adopted against products covered by this Regulation presenting a less than serious risk should be notified in the Safety Gate. Member States and the Commission should make available to the public information relating to risks to the health and safety of consumers posed by products. It is opportune for consumers and businesses that all information on corrective measures adopted against products posing a risk are contained in the Safety Gate, allowing relevant information on dangerous products to be made available to the public through the Safety Gate portal. Member States areshould therefore encouraged to notify in the Safety Gate all corrective measures on products posing a risk to the health and safety of consumers.
Amendment 251 #
Proposal for a regulation
Recital 52
Recital 52
(52) Under Article 34 of Regulation (EU) No 2019/1020, Member States authorities are to notify measures adopted against products covered by that Regulation, presenting a less than serious risk, through the information and communication system referred to in the same article, while corrective measures adopted against products covered by this Regulation presenting a less than serious risk should be notified in the Safety Gate. Member States and the Commission should make available to the public information relating to risks to the health and safety of consumers posed by products. It is opportune for consumers and businesses that all information on corrective measures adopted against products posing a risk are contained in the Safety Gate, allowing relevant information on dangerous products to be made available to the public through the Safety Gate portal. Member States are therefore encouraged to notify in the Safety Gate all corrective measures on products posing a risk to the health and safety of consumers. The database and website of the Safety Gate should be accessible for persons with disabilities.
Amendment 252 #
Proposal for a regulation
Recital 53
Recital 53
(53) In case the information has to be notified in the information and communication system according to Regulation (EU) 2019/1020, there is the possibility, for such notifications, to be submitted directly in the Safety Gate or, to be generated from within the information and communication system for market surveillance provided for in Article 34 of Regulation (EU) 2019/1020. For this purpose, the Commission should maintain and further develop the interface that has been set up for the transfer of information between the information and communication system and the Safety Gate, in order to avoid double data entry and facilitate such transfer. Interoperability between the two systems should be ensured as much as possible.
Amendment 253 #
Proposal for a regulation
Recital 53 a (new)
Recital 53 a (new)
(53 a) Member States should design and update their information systems for product safety activities in such a way that interoperability between such systems and the systems developed by the Commission, i.e. Safety Gate, Safety Business Gateway, ICSMS, Safety Gate for Injuries and Accidents, is as good as technically feasible.
Amendment 255 #
Proposal for a regulation
Recital 54 a (new)
Recital 54 a (new)
(54 a) The Safety Business Gateway and the Safety Gate portal should enable economic operators and consumers to authenticate via the use of national e-ID solutions and, in the case of economic operators, existing authentication tools for other, related Union electronic systems that are already in place.
Amendment 256 #
Proposal for a regulation
Recital 54 b (new)
Recital 54 b (new)
(54 b) Current data sources on product safety may be expanded in the future, with an increased integration of data retrieved from health records, civil protection authorities, media monitoring, or trends on online platforms, among others. New technologies, such as artificial intelligence, may be useful to collect and process data and extract knowledge to be fed into product safety information databases. Such use of technology should have due regard to data protection legislation in place, namely Regulation 2016/679.
Amendment 257 #
Proposal for a regulation
Recital 54 c (new)
Recital 54 c (new)
(54 c) The market surveillance authorities of Member States should register the information received pursuant to Article 25(1) in a pan-European database, named Safety Gate for Injuries and Accidents, with due respect to Union and national rules on data protection. This pan-European database should be a part of the Safety Gate system. Inputs from consumers in the Safety Gate portal should be added to this database upon confirmation by the relevant authorities. Additional sources of information, such as hospital records, civil protection authorities, or online platforms, or others that may arise in the future deemed relevant by the market surveillance authorities, should also feed information to this database. Only duly verified information by the Commission or the market surveillance authorities should be added to this database.
Amendment 259 #
Proposal for a regulation
Recital 56
Recital 56
(56) The determination of the risk concerning a product and its level is based on a risk assessment performed by the relevant actors. Member States, in performing risk assessment, might reach different results as far as the presence of a risk or its level is concerned. This could jeopardise the correct functioning of the single market and the level playing field for both consumers and economic operators. An arbitration mechanism should therefore be made available to Member States, on a voluntary basiIn cases where differences in risk assessment remain, an arbitration mechanism should used by Member States, which would allow the Commission, to provide an opinion on the issue in dispute.
Amendment 260 #
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56 a) The Commission should produce a periodic report on the decisions of the arbitration mechanism for risk assessments, which should be presented to the Consumer Safety Network. The report should identify the main divergent criteria for risk assessment and its impact on the internal market and on an equal level of consumer protection, enabling Member States and the Commission to harmonize the approaches and criteria for risk assessment.
Amendment 261 #
Proposal for a regulation
Recital 57
Recital 57
(57) The Consumer Safety Network enhances the cooperation on product safety enforcement between Member States. In particular, it facilitates the activities of exchange of information, the organisation of joint market surveillance activities, the exchange of expertise and best practices. It should also contribute to the standardization of data on product safety and the harmonization of data collection, storage and exchange, as well as to an increase in the interoperability between regional, sectorial, national and European information systems for product safety. The Consumer Safety Network should be duly represented and participate in the coordination and cooperation activities of the Union Product Compliance Network provided for in Regulation (EU) 2019/1020 whenever coordination of activities falling under the scope of application of both Regulations is necessary to ensure their effectiveness.
Amendment 263 #
Proposal for a regulation
Recital 58
Recital 58
(58) Market surveillance authorities mightshould carry out joint activities with other authorities or organisations representing economic operators or end users, with a view to promoting safety of products and identifying dangerous products, including those that are offered for sale online. In doing so the market surveillance authorities and the Commission, as appropriate, should ensure that the choice of products and producers as well as the activities performed does not create situation which might distort competition or affect the objectivity, independence and impartiality of the parties.
Amendment 264 #
Proposal for a regulation
Recital 58 a (new)
Recital 58 a (new)
(58 a) The Commission should create product safety teams within its structure, staffed with personnel from DG JUST, DG TAXUD, DG GROW and OLAF, with the aim of assisting and reinforcing the activities of Member States' market surveillance authorities, or to conduct their own market surveillance work in cases where products, for reasons such as their prevalence in several Member States, cause a clear risk to the Union and its internal market. The Commission should appropriately staff and capacitate its product safety teams.
Amendment 269 #
Proposal for a regulation
Recital 61
Recital 61
(61) IPublic access to the information available to the authorities on product safety should be ensured. When making available information on product safety to the public, professional secrecy, as referred to in Article 339 of the Treaty, should be protected in a way which is compatible with the need to ensure the effectiveness of market surveillance activities and of protection measures.
Amendment 274 #
Proposal for a regulation
Recital 69 a (new)
Recital 69 a (new)
(69 a) ‘Directive 2020/1828/EU on Representative Actions for the Protection of the Collective Interests of Consumers underlines that globalisation and digitalisation have increased the risk of a large number of consumers being harmed by the same unlawful practice and that infringements of Union law can cause consumer detriment. Without effective means to bring unlawful practices to an end and to obtain redress for consumers, consumer confidence in the internal market is reduced. As consumers’ interests are heavily affected by unsafe products which are circulating in the internal market it is justified to include the GPSR to annex I of Directive2020/1828/EC.’
Amendment 276 #
Proposal for a regulation
Recital 71
Recital 71
(71) In order to play a significant deterrent effect for economic operators and online marketplaces to prevent the placing of dangerous products on the market, penalties should be adequate to the type of infringement, to the possible advantage for the economic operator or online marketplace and to the type and gravity of the injury suffered by the consumer. Furthermore an homogenous level of penalties is important to ensure a level playing field, avoiding that economic operators or online marketplaces concentrate their activities in territories where the level of penalties is lower.
Amendment 280 #
Proposal for a regulation
Recital 80
Recital 80
(80) Any processing of personal data for the purpose of this Regulation should be in compliance with Regulations (EU) 2016/679 and ,(EU) 2018/1725 and Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector. When consumers report a product in the Safety Gate, only those personal data will be stored that are necessary to report the dangerous product and for a period not exceeding five years after such data have been encoded. Manufacturers and importers should hold the register of consumer complaints only as long as it is necessary for the purpose of this Regulation. Manufacturers and importers, when they are natural persons should disclose their names to ensure that the consumer is able to identify the product for purpose of traceability.
Amendment 286 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down essential rules on the safety of consumer products placed or made available on the market in order to ensure that they are safe.
Amendment 288 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1
Article 2 – paragraph 1 – subparagraph 1
Where products are subject to specific safety requirements imposed by Union legislation, this Regulation shall apply only to the aspects and risks or categories of risks not covered by those requirements thereby posing a threat to consumers health and safety or other relevant public interests.
Amendment 292 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 2 – point a
Article 2 – paragraph 1 – subparagraph 2 – point a
(a) Chapter II shall not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned;. When assessing if the risks are adequately covered, the aspects for assessing the safety of products outlined in Article 7 shall be considered.
Amendment 305 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
1. ‘product’ means any item, including software embedded or not, interconnected or not to other items, supplied or made available, whether for consideration or not, in the course of a commercial activity including in the context of providing a service – which is intended for consumers or can, under reasonably foreseeable conditions, be used by consumers even if not intended for them;
Amendment 309 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
2. ‘safe product’ means any product which, under normal or reasonably foreseeable conditions of use or misuse, including the actual duration of use and its foreseeable accidental or intentional corruption, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of consumers;
Amendment 311 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
2. ‘safe product’ means any product which, under normal or reasonably foreseeable conditions of use or misuse, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of consumers and in compliance with the precautionary principle;
Amendment 322 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
12 a. 'online marketplace’ means an online platform that allows consumers to conclude distance contracts with other traders or consumers on the platform;
Amendment 325 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
13. ‘economic operator’ means the manufacturer, the authorized representative, the importer, the distributor, the fulfilment service provider, the online marketplace or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market in accordance with this Regulation;
Amendment 326 #
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
Amendment 334 #
Proposal for a regulation
Article 3 – paragraph 1 – point 23
Article 3 – paragraph 1 – point 23
23. ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the consumend user;
Amendment 339 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Presumption of safetyconformity with safety requirements
Amendment 345 #
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) in the absence of European standards referred to in point (a), as regards the risks covered by health and safety requirements laid down in the law of the Member State where the product is made available on the market, if it conforms to such national requirementsstandards being established in accordance with European law.
Amendment 348 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The Commission shall adopt implementing acts determining the specific safety requirements necessary to ensure that products which conform to the European standards satisfy the general safety requirement laid down in Article 5 and are in compliance with the aspects for assessing the safety of products of Article 7. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).
Amendment 352 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. However, presumption of safetyconformity with the safety requirements under paragraph 1 shall not prevent market surveillance authorities from taking action under this Regulation where there is evidence that, despite such conformity, the product is dangerous.
Amendment 355 #
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. Where the presumption of safety laid down in Article 5 does not apply, the following aspects shall be taken into account in particular when assessIn particular the following aspects shall be assessed when determining whether a product is safe:
Amendment 359 #
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) the characteristics of the product, including its design, technical features, composition and chemical constituents, packaging, instructions for assembly and, where applicable, for installation, use and maintenance;
Amendment 360 #
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) the effect on other products, where it is reasonably foreseeable that it will be used with other products, including the interconnection of products among them as well as the possible loss of interconnection;
Amendment 366 #
Proposal for a regulation
Article 7 – paragraph 1 – point e
Article 7 – paragraph 1 – point e
(e) the categories of consumers at risk when using the product, in particular vulnerable consumers such as children, older people and persons with disabilities but as well as gender specificities and appropriate age labelling of products regarding their suitability for children;
Amendment 372 #
Proposal for a regulation
Article 7 – paragraph 1 – point g a (new)
Article 7 – paragraph 1 – point g a (new)
(g a) the appropriate security features necessary to address the loss of connectivity of a product when such a loss of connectivity may have an impact on the safety of the product;
Amendment 377 #
Proposal for a regulation
Article 7 – paragraph 1 – point h
Article 7 – paragraph 1 – point h
(h) the appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, when such an influence mightay have an impact on the safety of the product;
Amendment 381 #
Proposal for a regulation
Article 7 – paragraph 1 – point i a (new)
Article 7 – paragraph 1 – point i a (new)
(i a) the appropriate safeguards to address faulty data that may have an impact on the safety of the product;
Amendment 382 #
Proposal for a regulation
Article 7 – paragraph 1 – point i b (new)
Article 7 – paragraph 1 – point i b (new)
(i b) the physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the product may present to the health and safety of consumers;
Amendment 383 #
Proposal for a regulation
Article 7 – paragraph 1 – point i c (new)
Article 7 – paragraph 1 – point i c (new)
(i c) The health risk posed by digital or connected products, including its accumulative and long term health effects;
Amendment 384 #
Proposal for a regulation
Article 7 – paragraph 1 – point i d (new)
Article 7 – paragraph 1 – point i d (new)
Amendment 385 #
Proposal for a regulation
Article 7 – paragraph 1 – point i e (new)
Article 7 – paragraph 1 – point i e (new)
(i e) the environmental risk posed by a product inasmuch it is likely to result in a risk to the health and safety of consumers;
Amendment 386 #
Proposal for a regulation
Article 7 – paragraph 3 – point d
Article 7 – paragraph 3 – point d
(d) voluntary certification schemes or similar third-party conformity assessment frameworks, in particular thoswhen those are conceived to support Union legislation;
Amendment 387 #
Proposal for a regulation
Article 7 – paragraph 3 – point j a (new)
Article 7 – paragraph 3 – point j a (new)
(j a) if the product, categories or groups of products, have caused injuries notified in the Safety Gate for Accidents as established in Article 25.a of this regulation;
Amendment 388 #
Proposal for a regulation
Article 7 – paragraph 3 – point j a (new)
Article 7 – paragraph 3 – point j a (new)
(j a) information available on Safety Gate and Safety Gate for Injuries and Accidents;
Amendment 391 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. When placing their products on the market, manufacturers shall ensure that these products have been designed and manufactured in accordance with the general safety requirement laid down in Article 5. As well, manufacturers shall provide appropriate safeguards in order to prevent the upload of software that may jeopardize the safety of products during their lifetime.
Amendment 396 #
Proposal for a regulation
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. Manufacturers shall investigate the complaints received and available empiric injury data that concern products they made available on the market, and which have been identified as dangerous by the complainant, and shall keep a register of these complaints as well as of product recalls.
Amendment 403 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1
Manufacturers shall make publicly available to consumers, communication channels such as telephone number, electronic address orand dedicated sections of their website, allowing the consumers to file complaints in an accessible way and to inform them of any accident or safety issue they have experienced with the product.
Amendment 417 #
Proposal for a regulation
Article 8 – paragraph 4 – introductory part
Article 8 – paragraph 4 – introductory part
4. Manufacturers shall draw up technical documentation of the product before placing it on the market and ensure that the documentation is kept up to date. The technical documentation shall contain, as appropriate:
Amendment 421 #
Proposal for a regulation
Article 8 – paragraph 4 – point c
Article 8 – paragraph 4 – point c
(c) the list of the European standards referred to in Article 6(1) point a, or the other elements referred to in Articles 6.1(b), 6.2, 7(1) and 7(3), applied to meet the general safety requirement laid down in Article 5.
Amendment 422 #
Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 1
Article 8 – paragraph 4 – subparagraph 1
Where any of the European standards, health and safety requirements or elements referred to in Articles 6, 7(1) and 7(3) have been only partly applied, the parts which have been applied shall be identified.
Amendment 426 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Manufacturers shall keep the technical documentation, for a period ofthe lifespan of a product, at least ten years after the product has been placedmade available on the market and make it available to the market surveillance authorities, upon request.
Amendment 434 #
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal and, electronic address and a phone number 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 shall indicate a single contact point at which the manufacturer can be contacted.
Amendment 438 #
Proposal for a regulation
Article 8 – paragraph 8
Article 8 – paragraph 8
8. Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available, and by a non-removable QR code which shall direct consumers to a digital version of such documents, which shall be maintained for at least 10 years. This requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Amendment 440 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the general safety requirement laid down in Article 5 and respect Articles 6 and 7.
Amendment 444 #
Proposal for a regulation
Article 8 – paragraph 9 a (new)
Article 8 – paragraph 9 a (new)
9 a. For connected products, manufacturers shall establish a safety risk-management system to ensure the continued safe functioning of products over their entire life time.
Amendment 446 #
Proposal for a regulation
Article 8 – paragraph 10
Article 8 – paragraph 10
10. Manufacturers who consider or have reason to believe, on the basis of the information in their possession, that a product which they have placed on the market is not safe, shall immediately take the corrective measures necessary to bring the product into conformity, including adequately and effectively warning end users who are at risk caused by the non- conformity of the product, a withdrawal or recall, as appropriate.
Amendment 450 #
Proposal for a regulation
Article 8 – paragraph 11
Article 8 – paragraph 11
11. Manufacturers shall, via the Safety Business Gateway referred to in Article 25, immediately alert consumers of the risk to theimarket surveillance authorities of the Member States in which a dangerous product has been made available, including on the risk for health and safety presented by athe product they manufacture and immediately inform the market surveillance authorities of the Member States in which the product has been made available to that effect, giving details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken, giving details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken. Manufacturers shall immediately alert consumers of the risk to their health and safety presented by a product they manufacture. In accordance with Article 33, consumers must be alerted immediately through clear and targeted information at least in the official languages of their country of residence, including but not exclusively using digital means.
Amendment 454 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. AWhere a manufacturer mayis established outside of the European Union, it shall, by a written mandate, appoint an authorised representative. Manufacturers established in the EU may appoint an authorised representative.
Amendment 464 #
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) where they have a reason to believe that a product in question presents a risk, inform the manufacturer; and notify the product via the Safety Business Gateway;
Amendment 470 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 5 and that the manufacturer has complied with the requirements set out in Article 6, 7, 8 (4), (6), (7), and (78).
Amendment 478 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its conformity with the general safety requirement laid down in Article 5 and its conformity with Articles 6, 7, 8 (6) and (7).
Amendment 481 #
Proposal for a regulation
Article 10 – paragraph 6 – introductory part
Article 10 – paragraph 6 – introductory part
6. Importers shall investigate complaints related to products they made available on the market and file these complaints, as well as products recalls, in the register referred to in Article 8(2), first subparagraph, or and in their own register. Importers shall keep the manufacturer and distributors informed of the investigation performed and of the results of the investigation.
Amendment 485 #
Proposal for a regulation
Article 10 – paragraph 7
Article 10 – paragraph 7
7. Importers shall cooperate with market surveillance authorities and othe manufacturerr relevant economic operators to ensure that a product is safe.
Amendment 487 #
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. Importers who consider or have reason to believe, on the basis of the information in their possession, that a product which they have placed on the market is not safe shall immediately inform the manufacturer and ensure that the corrective measures necessary to bring the product into conformity are adopted including withdrawal or recall, as appropriate. In case such measures have not been adopted, the importer shall adopt them. Importers shall ensure that, through the Safety Business Gateway referred to in Article 25, consumers are immediately and effectively alerted of the risk where applicable and thaimmediately alert market surveillance authorities of the Member States in which they made the product available to that effect be immediately informed, giving details, in particular, of the risk to health and safety of consumers and of any corrective measure already taken. Additionally, Importers shall immediately alert consumers of the risk to their health and safety presented by a product they made available. In accordance with Article 33, consumers must be alerted immediately through clear and targeted information at least in the official languages of their country of residence, including but not exclusively using digital means.
Amendment 491 #
Proposal for a regulation
Article 10 – paragraph 9
Article 10 – paragraph 9
9. Importers shall keep the technical documentation referred to in Article 8(4) for a period of 10the lifespan of a product, at least ten years after they have placedmade the product available on the market and make it available to the market surveillance authorities, upon request. .
Amendment 493 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Before making a product available on the market, distributors shall verify that the manufacturer and the importer have complied with the requirements set out in Articles 5, 6, 7, 8(6), (7) and (8) and Article 10(3) and (4), as applicable.
Amendment 496 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its conformity with the general safety requirement laid down in Article 5 and its conformity with Article 6, 7, 8(6), (7) and (8) and Article 10(3) and (4), as applicable.
Amendment 499 #
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Distributors who consider or have reason to believe, on the basis of the information in their possession, that a product is not in conformity with the provisions referred to in paragraph 2, shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product is not safe, the distributor shall immediately inform the manufacturer orand the importer, as applicable, to that effect and shall make sure that, through the Safety Business Gateway referred to in Article 25, the market surveillance authorities are informed.
Amendment 501 #
Proposal for a regulation
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Distributors who consider or have reason to believe, on the basis of the information in their possession, that a product which they have made available on the market is not safe or is not in conformity with Article 5, 6, 7, 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall ensure that the corrective measures necessary to bring the product into conformity are adopted, including withdrawal or recall, as appropriate. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer orand the importer, as applicable, to that effect and shall make sure that, through the Safety Business Gateway referred to in Article 25, the market surveillance authorities of the Member State in which they made the product available to that effect are informed giving details, in particular, of the risk to health and safety and of any corrective measure taken.
Amendment 505 #
Proposal for a regulation
Article 12 – paragraph 2 a (new)
Article 12 – paragraph 2 a (new)
2 a. Where a product has been substantially modified in the meaning of this article, that product shall be submitted to a new risk assessment pursuant to Articles 5, 6 and 7 of this Regulation.
Amendment 507 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
The economic operators shall ensure that they have internal processes for product safety in place, allowing them to respect the general safety requirement laid down in Article 5. These internal processes shall be independently audited when necessary. Economic operators shall make publicly available an overview of this audit report.
Amendment 510 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Economic operators shall cooperate with market surveillance authorities and where relevant with other authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators.
Amendment 533 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. For certain products, categories or groups of products, which are susceptible to bear a serious risk to health and safety of consumers, based on accidents registered in the Safety Gate for Accidents, Safety Business Gateway, the Safety Gate statistics, the results of the joint activities on product safety and other relevant indicators or evidence, the Commission mayshall require economic operators who place and make available those products on the market to establish or adhere to a system of traceability or require independent third-party conformity assessment.
Amendment 535 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. For certain products, categories or groups of products, which are susceptible to bear a serious risk to health and safety of consumers, based on accidents registered in the Safety Business Gateway, the Safety Gate statisticGate for Injuries and Accidents, the results of the joint activities on product safety and other relevant indicators or evidence, the Commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability.
Amendment 552 #
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
(e) age restrictions, labelling and marketing consistent with legal requirements and the indications of the manufacturer, including for App stores.
Amendment 558 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The manufacturer shall ensure thatnotify, through the Safety Business Gateway referred to in Article 25, an accident caused by a product placed or made available on the market is notified, within two working day, within 24 hours from the moment it knows about the accident, to the competent authorities of the Member State where the accident has occurred. The notification shall include the type and identification number of the product as well as the circumstances of the accident, if known. The manufacturer shall notify, upon request, to the competent authorities any other relevant information.
Amendment 561 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The importers and the distributors which have knowledge of an accident caused by a product that they placed or made available on the market shall inform the manufacturer, which can instruct the importer or one of the distributors to proceed to the notificationnotify this information to the Safety Business Gateway within 24 hours and inform the manufacturer thereof.
Amendment 568 #
Proposal for a regulation
Chapter IV – title
Chapter IV – title
Delete Chapter IV Online marketplaces (The intention is to delete chapter IV on online marketplaces so hat Article 20 falls under Chapter III related to obligations on economic operators. As online marketplaces have previously been defined as economic operators there is no need for a specific chapter and furthermore specific articles on them should, from the drafting point of view, be placed in the chapter related to economic opertors.) Or. en (If this amendment is adopted Article 20 shall fall under chapter III.)
Amendment 570 #
Proposal for a regulation
Article 20 – title
Article 20 – title
Amendment 571 #
Proposal for a regulation
Article 20 – paragraph -1 (new)
Article 20 – paragraph -1 (new)
-1. Online marketplaces shall ensure the identification of the traders and the traceability of the products offered to consumers via their online interfaces
Amendment 573 #
Proposal for a regulation
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
1. Online marketplaces shall establish a single contact point allowing forfor the purpose of ensuring a swift and direct communication with all competent Member States’ authorities, including market surveillance and customs authorities, in relation to product safety issues, in particular for orders concerning offers of dangerous products.
Amendment 575 #
Proposal for a regulation
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
1 a. Online marketplaces shall ensure that all consumers have the possibility to communicate with them in an effective, swift and easily accessible way. For this purpose: (a) Online marketplaces shall disclose their contact details, including their phone numbers, email addresses and the postal address of their establishment within the Union. (b) Online marketplaces shall not exclusively rely on automated tools for the purpose of ensuring communication with consumers. (c) Where online marketplaces proposes electronic contact forms or instant messaging for consumers, online marketplaces shall also allow consumers to store or save on a durable medium any correspondence, including the date and hour of such correspondence. (d) Online marketplaces shall provide consumers with the postal or electronic address and the identity of the trader on whose behalf the online marketplace is acting. f) Online marketplaces shall allocate the necessary human and financial resources to ensure that the communication referred to in Paragraph 14 is performed in a quick, effective and efficient manner.
Amendment 580 #
Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1
Article 20 – paragraph 2 – subparagraph 1
Online marketplaces shall take the necessary measures to receive and process the orders issued in accordance with this paragraph. They shall act upon receipt of the order issued without undue delay, and in any event within two working day24 hours in the Member State where the online marketplace operates, from receipt of the order. They shall inform the issuing market surveillance authority of the effect given to the order by using the contacts of the market surveillance authority published in the Safety Gate.
Amendment 581 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. Online marketplaces shall take into accperiodically carry ount regular information on dangerous products notified by the market surveillance authorities in line with Article 24, received via the Safety Gate portal, for the purpose of applying their voluntary measures aimed at detecting, identifying, removing or disabling access to the illegal content referring to dangerous products offered on their marketplace, where applicable. They shall inform the authority that made the notification to the Safety Gate of any action taken by using the contacts of the market surveillance authority published in the Safety Gatevisual inspections and sample testing of randomly chosen products considering previous reports, databases, reviews and potential risks and harms towards consumers.
Amendment 586 #
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3 a. Where an online marketplace detects and identifies illegal content, referring to dangerous products, it shall be obliged to establish an internal database of those products that had previously been taken down by the online marketplace because they had been found to be illegal. They shall, under the inclusion of elements listed in the Rapid Exchange of Information System (RAPEX) and other relevant public databases, compare the products or product categories offered where they have reason to believe products are illegal to the established database. If this process detects a product that has previously been found to be illegal, the online marketplace shall be obliged to inform the trader and delete the content expeditiously. Online marketplaces shall ensure that any detected or identified illegal content does not reappear on offer to consumers and is not made available on the market. The application of this paragraph shall not lead to any general monitoring obligation and shall be subject to human review.
Amendment 588 #
Proposal for a regulation
Article 20 – paragraph 3 b (new)
Article 20 – paragraph 3 b (new)
3 b. The online marketplace shall inform the issuing competent authority of any follow-up actions they will take to prevent the illegal content, referring to dangerous products, from reappearing on the online interface. The application of this paragraph shall not lead to any general monitoring obligation and shall be subject to human review.
Amendment 591 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Online marketplaces shall give an appropriate answer without undue delay, and in any event within five working day48 hours, in the Member State where the online marketplace operates, to notices related to product safety issues and dangerous products received in accordance with [Article 14] of Regulation (EU) […/…] on a Single Market for Digital Services (Digital Service Act) and amending Directive 2000/31/EC.
Amendment 594 #
Proposal for a regulation
Article 20 – paragraph 5 – introductory part
Article 20 – paragraph 5 – introductory part
5. For the purpose of the requirements of Article 22(7) of Regulation (EU) […/…] on a Single Market for Digital Services (Digital Services Act) and amending Directive 2000/31/EC, online marketplaces shall design and organise their online interface in a way that enables traders to provide the following information for each product offered and ensures that it is displayed or otherwise made easily accessible by consumers on the product listingusing their service to comply with this regulation. Online marketplaces shall ensure that the traders provide the following information for each product offered on the market through the online interface:
Amendment 597 #
Proposal for a regulation
Article 20 – paragraph 5 – point a
Article 20 – paragraph 5 – point a
(a) the name, registered trade name or/and registered trade mark of the manufacturer, as well as the postal or electronic address at which they manufacturer can be contacted;
Amendment 598 #
Proposal for a regulation
Article 20 – paragraph 5 – point b
Article 20 – paragraph 5 – point b
(b) where the manufacturer is not established in the Union, the name, address, telephone number and electronic address of the responsible person within the meaning of Article 15 (1) of this Regulation;
Amendment 600 #
Proposal for a regulation
Article 20 – paragraph 5 – point c
Article 20 – paragraph 5 – point c
(c) the information necessary to identify the product, including its type and, when available, batch or serial number and any other product identifier;
Amendment 603 #
Proposal for a regulation
Article 20 – paragraph 5 – point d
Article 20 – paragraph 5 – point d
(d) any warning or safety information that is toshall be affixed on the product or to accompany it in accordance with this Regulation or the applicable Union harmonisation legislation in a language which can be easily understood by consumers.
Amendment 604 #
Proposal for a regulation
Article 20 – paragraph 5 a (new)
Article 20 – paragraph 5 a (new)
5 a. The information listed under paragraph 5 of this Article shall be displayed alongside the digital product listing in a clear, intelligible and unambiguous language andin a way that is easily accessible and understandable for all consumers.
Amendment 608 #
Proposal for a regulation
Article 20 – paragraph 5 b (new)
Article 20 – paragraph 5 b (new)
5 b. Online marketplaces shall ensure that the information listed in paragraph 5 provided by the trader is complete before products are allowed to be offered on the market through their online interfaces.
Amendment 610 #
Proposal for a regulation
Article 20 – paragraph 5 c (new)
Article 20 – paragraph 5 c (new)
5 c. The Online Marketplace shall, upon receiving the information in paragraph 5 and until the end of the contractual relationship with the trader, make reasonable efforts to assess whether the information referred to in points (a) to (d) of paragraph 5 is reliable and up-to- date through the use of any freely accessible official online database or online interface made available by a Member States or the Union or through requests to the business user to provide supporting documents from reliable sources.
Amendment 611 #
Proposal for a regulation
Article 20 – paragraph 5 d (new)
Article 20 – paragraph 5 d (new)
5 d. Where the online marketplace obtains indications that information under paragraph 5 is inaccurate or incorrect it shall temporarily remove the product directly from its online platform. This online marketplace shall request the trader to correct the information in so far as necessary to ensure that all information is accurate and complete immediately in order to allow the offering of the product on its interface. Where the trader fails to correct or complete that information, the online marketplaces shall suspend the provision of its service to the trader in relation to the offering of products to consumers until the request is fully complied with. Online marketplaces shall report those traders to Member State competent authorities and to the European Commission through the Business Safety Gateway.
Amendment 638 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Where a dangerous product has been identified, the manufacturer shall indicate, upon request by to the market surveillance authorities, upon obtaining knowledge of this identification, which other products, produced with the same procedure, containing the same components or being part of the same production batch, are affected by the same risk.
Amendment 643 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Member States shall communicate to the Commission, once a year, data concerning the implementation of this Regulation. A summary report shall be made available to the public.
Amendment 644 #
Proposal for a regulation
Article 22 a (new)
Article 22 a (new)
Article 22 a Member States shall ensure that any measure taken by the competent authorities involving restrictions on the placing of a product on the market or requiring its withdrawal or recall can be challenged before the competent courts.
Amendment 645 #
Proposal for a regulation
Chapter VI – title
Chapter VI – title
Amendment 649 #
Proposal for a regulation
Article 24 – paragraph 1 – point b
Article 24 – paragraph 1 – point b
(b) on the basis of provisions of Union harmonisation legislation and Regulation (EU) 2019/1020 in relation to products presenting a serious risk, in accordance with Article 20 of Regulation (EU) 2019/1020ny level of risk.
Amendment 651 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
Amendment 662 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
1. The Commission shall maintain a web portal enabling the economic operators to provide market surveillance authorities and consumers with the information referred to in Articles 8(11), 9(2) point c), 10(8), 11(3), 11(4) and Article 19 which must be accessible for consumers with disabilities.
Amendment 667 #
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
Article 25 a Safety Gate for Injuries and Accidents (SGIA) 1. The market surveillance authorities of Member States shall register the information received pursuant to Article 25(1) in a pan-European database with due respect to Union and national rules on data protection. 2. This pan-European database will be part of the Safety Gate system, and the Commission shall support the coordination of data collection from market surveillance authorities and maintain this pan-European database. 3. The inputs from consumers regarding injuries and accidents shall, upon confirmation through an investigation by market surveillance authorities, also be made available in this database 4. Information received from other sources and verified by market surveillance authorities and the Commission shall also be added to this database
Amendment 669 #
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
Amendment 672 #
Proposal for a regulation
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. If the Commission becomes aware of a product, or a specific category or group of products presenting a serious risk to the health and safety of consumers, it may take any appropriate measures, either on its own initiative or upon request of Member States, by means of implementing acts, adapted to the gravity and urgency of the situation if, at one and the same time:
Amendment 674 #
Proposal for a regulation
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
(a) it emerges from prior consultations with the Member States that they differ significantly on the approach adopted or to be adopted to deal with the risk; and;or
Amendment 677 #
Proposal for a regulation
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) the risk cannot be dealt with, in view of the nature of the safety issue posed by the product, category or group of products, in a manner compatible with the degree of gravity or urgency of the case, under other procedures laid down by the specific Union legislation applicable to the products concerned; andor
Amendment 678 #
Proposal for a regulation
Article 26 – paragraph 1 – subparagraph 1
Article 26 – paragraph 1 – subparagraph 1
Those measures may include measures prohibiting, suspending or restricting the placing or making available on the market of such products or laying down special conditions for their conformity assessment, going beyond those for self-assessment and marketing, in order to ensure a high level of consumer safety protection.
Amendment 684 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. Where market surveillance authorities in other Member States reach a different conclusion in terms of identification or level of the risk on the basis of their own investigation and risk assessment, the Member States concerned mayshall request the Commission to arbitrate. In that case, the Commission shall invite all Member States to express a recommendation.
Amendment 686 #
Proposal for a regulation
Article 27 – paragraph 4 a (new)
Article 27 – paragraph 4 a (new)
4 a. The Commission shall produce a periodic report on the decisions of the arbitration mechanism for risk assessments, which should be presented to the Consumer Safety Network.
Amendment 687 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. A European network of the authorities of the Member States competent for product safety (‘Consumer Safety Network’) shall be established. Consumer organisations shall be observers to the Safety Network.
Amendment 691 #
Proposal for a regulation
Article 28 – paragraph 3 – point a
Article 28 – paragraph 3 – point a
(a) the exchange of information on risk assessments, dangerous products, test methods and results, recent scientific developments as well as other aspects relevant for control activities such as consideration of European Standards providing presumption of conformity with this Regulation;
Amendment 693 #
Proposal for a regulation
Article 28 – paragraph 3 – point e a (new)
Article 28 – paragraph 3 – point e a (new)
(e a) Increased standardization of data collected, reported and exchanged on product safety, as well as the interoperability of national and European product safety information systems.
Amendment 695 #
Proposal for a regulation
Article 28 – paragraph 4 a (new)
Article 28 – paragraph 4 a (new)
4 a. Third-country authorities or international organizations may be invited to meetings of the Consumer Safety Network when relevant for the matters under discussion.
Amendment 697 #
Proposal for a regulation
Article 28 a (new)
Article 28 a (new)
Article 28 a Product Safety Action Plans Member States shall draw up and present, every three years, a Product Safety National Action Plan, which shall, at a minimum,: 1. Detail the authorities tasked with product safety and market surveillance roles within their territory; 2. How such national and/or regional authorities cooperate in market surveillance activities; 3. Plan actions to increase product safety nationally; 4. Draft plans for traceability and recall of products and traceability of consumers for product categories that present the highest risk according to information available in Safety Gate. 5. Detail the information systems used by their national competent authorities and their interoperability with information systems designed and maintained by the Commission
Amendment 700 #
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a EU Product Safety Teams The Commission shall create Product Safety Teams (PSTs) within its structure, staffed with personnel from DG JUST, DG TAXUD, DG GROW and OLAF, with the aim of assisting and reinforcing the activities of Member States' market surveillance authorities, or to conduct their own market surveillance work in cases where products, for reasons such as being prevalent in several Member States, cause a clear risk to the Union and its internal market, according to the rules set out in Regulation 2019/1020.
Amendment 702 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. Market surveillance authorities may decide toshall regularly conduct simultaneous coordinated control actions (“sweeps”) of particular product categories to check compliance with or to detect infringements to this Regulation.
Amendment 705 #
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
2. Unless otherwise agreed upon by the market surveillance authorities concerned, sweeps shall be coordinated by the Commission. The coordinator of the sweep may, where appropriate,shall make the aggregated results publicly available.
Amendment 707 #
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
Amendment 708 #
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Information available to the authorities of the Member States or to the Commission relating to measures on products presenting risks to consumer health and safety shall in generaor information that is considered relevant in order to protect the interests of end users shall be made available to the public, in accordance with the requirements of transparency and without prejudice to the restrictions required for monitoring and investigation activities. In particular, the public shall have access to information on product identification, the nature of the risk and the measures taken. This information shall be provided in accessible formats for persons with disabilities.
Amendment 712 #
Proposal for a regulation
Article 31 – paragraph 4
Article 31 – paragraph 4
4. Member States shall give consumers or organisations representing consumers and other interested parties the opportunity to submit complaints to the competent authorities on product safety and on surveillance and control activities and these complaints shall be followed up as appropriate. The authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken, and shall inform the complainant of the right to an effective judicial remedy provided for in Article 35 a (new).
Amendment 716 #
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. For the purpose of Article 31(1) and Article 19, the Commission shall maintain a Safety Gate portal, providing the general public with free access to selected information notified in accordance with Article 24 in an accessible way.
Amendment 717 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Consumers and other interested parties shall have the possibility to inform the Commission of products presenting a risk to consumer health and safety through a separate section of the Safety Gate portal. The Commission shall take in due consideration the information received and ensure follow -up, where appropriate and inform consumers and other interested parties of its decision.
Amendment 726 #
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
Amendment 729 #
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Where economic operators have product registration systems or customer loyalty programs in place for purposes other than contacting their customers with safety information, they shall offer the possibility to their customers to provide separate contact details only for safety purposes. The personal data collected for that purpose shall be limited to the necessary minimum and mayshall only be used to contact consumers in case of a recall or safety warning.
Amendment 734 #
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. If not all affected consumers can be contacted directly, eEconomic operators, in accordance with their respective responsibilities, shall disseminate a recall notice or safety warning through other appropriate channels, ensuring the widest possible reach including, where available: the company’s website, social media channels, newsletters and retail outlets and, as appropriate, announcements in mass media and other communication channels. Information shall be accessible to consumers with disabilities. Consumer organisations shall also be informed to support the dissemination of the information.
Amendment 736 #
Proposal for a regulation
Article 34 – paragraph 2 – point c
Article 34 – paragraph 2 – point c
(c) clear description of the hazard associated with the recalled product, avoidingwithout any elements that may decrease consumers’ perception of risk, including terms and expressions such as “voluntary”, “precautionary”, “discretionary”, “in rare/specific situations” as well as indicating that there have been no reported accidents;
Amendment 739 #
Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Article 35 – paragraph 1 – introductory part
1. Without prejudice to Directive (EU) 2019/771, in the case of a recall, the economic operator responsible for the recall shall offer to the consumer an effective, cost-free and timely remedy. That remedy shall consist of at leastWhile preference shall be given to the most sustainable solution of the repair of the recalled product, except if it is not possible to ensure the safety of the product through this measure. In this case in order to have the goods brought into conformity with this regulation, the consumer may choose between one of the following:
Amendment 744 #
Proposal for a regulation
Article 35 – paragraph 1 – point a
Article 35 – paragraph 1 – point a
Amendment 748 #
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) refund of the value of the initial purchase price of the recalled product.
Amendment 749 #
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) refund of the valuinitial purchase price of the recalled product.
Amendment 751 #
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
Amendment 753 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Repair, disposal or destruction of the product by consumers shall only be considered an effective remedy where it can be carried out easily and safely by the consumer. In such cases, the economic operator responsible for the recall shall provide consumers with the necessary instructions and/or, in the case of self- repair, free replacement parts or software updates including potential risks as well as their consequences.
Amendment 754 #
Proposal for a regulation
Article 35 – paragraph 2 a (new)
Article 35 – paragraph 2 a (new)
2 a. The right to remedy laid down in this paragraph is without prejudice to Directive(EU) 85/374/EEC.
Amendment 756 #
Proposal for a regulation
Article 35 – paragraph 3 a (new)
Article 35 – paragraph 3 a (new)
3 a. Where no economic operator offers a remedy to the consumer, the consumer shall be entitled to submit a complaint to the competent authority in accordance with Article 31(4).
Amendment 758 #
Proposal for a regulation
Article 35 a (new)
Article 35 a (new)
Article 35 a Right to an effective judicial remedy Notwithstanding any administrative or other non-judicial remedies, any affected consumer or organisation representing consumers and other interested parties shall have the right to an effective judicial remedy with regard to the failure of economic operators to comply with their obligations under this Regulation.
Amendment 764 #
Proposal for a regulation
Article 36 a (new)
Article 36 a (new)
Article 36 a Amendments to Directive 2020/1828/EC on Representative Actions for the Protection of the Collective Interests of Consumers The following is added to Annex I of Directive 2020/1828/EC: “(X) Regulation of the European Parliament and of the Council on a General Product Safety Regulation”
Amendment 769 #
Proposal for a regulation
Article 40 – paragraph 3 – point d
Article 40 – paragraph 3 – point d
(d) failure to comply with traceability and information obligations of economic operators referred to in Articles 8, 9, 10, 11 and 18 and 19 and 20;
Amendment 782 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By [insert date five years after the date of entry into force] the Commission shall carry out an evaluation of this Regulation. The Commission shall present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. The report shall in particular assess if this Regulation achieved the objective of enhancing the protection of consumers against dangerous products while taking into account its impact on businesses and in particular on small and medium-sized enterprisin particular with regard to improved traceability, the level and functioning of market surveillance, standardisation work, the functioning of the Safety Gate, challenges posted by new technologies and by online marketplaces.