58 Amendments of Maria da Graça CARVALHO related to 2021/0170(COD)
Amendment 176 #
Proposal for a regulation
Recital 10
Recital 10
(10) The precautionary principle is a fundamental principle for ensuring the safety of products and consumers and should therefore be taken into due account by all relevant actors when applying this RegulationSince the cooperation between market surveillance authorities and custom authorities is key in order to avoid unsafe products entering the single market, more financial and human resources for these authorities are needed in order to properly fulfil their tasks.
Amendment 177 #
Proposal for a regulation
Recital 11
Recital 11
(11) Considering also the broad scope given to the concept of health26 , the environmental risk posed by a productsafety, hazards associated with the product, like physical and mechanical resistance, flammability, chemical, electrical or biological properties, hygiene and radioactivity, should be taken into consideration in the application of this Regulation in as much as it cansuch hazards also ultimately result in a risk to the health and safety of consumers. __________________ 26 European Environment Agency, ‘Healthy environment, healthy lives: how the environment influences health and well-being in Europe’, EEA report No 21/2019, 8 September 2020.
Amendment 182 #
Proposal for a regulation
Recital 16
Recital 16
(16) The requirements laid down in this Regulation should apply to second hand products or products that are repaired, refurbished or recycled that re-enter the supply chain in the course of a commercial activity, except for those products for which the consumer cannot reasonably expect that they fulfil state-of-the art safety standards, such as antiques or products which are presented as to be repaired or to be refurbished. Consumer to consumer activities like a garage sale do not fulfil the commercial activity requirement and should therefore be excluded from this legislation;
Amendment 187 #
Proposal for a regulation
Recital 20
Recital 20
(20) New technologies might 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.
Amendment 200 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) Digital items that are linked to a product are also products, even if they are not a tangible item and they should therefore fall under the scope of application of this Regulation.
Amendment 205 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) In order for economic operators that are SMEs and micro-businesses to be able to cope with the new obligations imposed by this Regulation, the Commission should provide them with practical guidelines and tailored guidance, for example, a direct channel to connect to experts in case of questions. The Commission might also consider simplifications in order to limit their administrative burden.
Amendment 206 #
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24 b) The obligations of economic operators should be as less of an administrative burden as possible and some of the obligations should be limited to products with a potential serious risk. If digital consumer information tools are available, the economic operators should be allowed to make use of them to ensure a sustainable way of information. However, upon request of the consumer, the relevant information should also be provided free of charge on paper.
Amendment 214 #
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 could also be considered as economic operators if they are the manufacturer, importer, distributor or a fulfilment service provider of the respective product.
Amendment 215 #
Proposal for a regulation
Recital 27
Recital 27
(27) Given the important role played by online marketplaces when intermediating the sale 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 accountabilityduties of providers of intermediary services online with regard to illegal contents, including unsafe products. That. Lex specialis Article 20 of this 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.in the Digital Services Act in order to effectively tackle the sale of dangerous products online __________________ 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 221 #
Proposal for a regulation
Recital 29
Recital 29
(29) Online marketplaces should act with due care in relation to the content hostsafety of products placed on their online interfaces that concerns safety of products, in accordance with the specific obligations laid down in this Regulation. Accordingly, due diligence obligations for all online marketplaces should be established in relation to the content hosted on their online interfaces that concerns safety of products and at the same time administrative burden should be kept to a minimum in order to allow for a level- playing field.
Amendment 227 #
Proposal for a regulation
Recital 32
Recital 32
(32) TAs specific monitoring obligations, the obligations imposed by this Regulation on online marketplaces shwould neithernot amount to a general obligation to monitor the information whichen 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, expeditiously products are checked with "Safety Gate" before placing them on their website. Online marketplaces should also avoid the reappearing of unsafe products on their interfaces and 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 229 #
Proposal for a regulation
Recital 34
Recital 34
(34) Even where tThe Safety Gate should be modernised and updated in order to make it easier for the economic operators and online marketplaces to detect unsafe products. The information from the Safety Gate does notshould contain an exact uniform resource locator (URL) and, where necessary, additional information enabling the identification of the illegal content concernedunsafe product. Additionally, online marketplaces should nevertheless take into account the transmitted information, such as product identifiers, when available, and other traceability information, in the context of any measures adopted by online marketplaces on their own initiative aiming at detecting, identifying, removing or disabling access to dangerous products offered on their marketplace, where applicable.
Amendment 231 #
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 particular consumer organisations and associations representing consumers’ interest and other relevant stakeholders, upon their request, as trusted flaggers, provided that the conditions set out in that article have been met.
Amendment 243 #
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47 a) Market surveillance authorities should carry out mystery shopping on a regular basis, at least once a year, including on online marketplaces and in particular on products that have been mostly listed on the Safety Gate.
Amendment 244 #
Proposal for a regulation
Recital 50
Recital 50
(50) The Union rapid information system (RAPEX) has proved its effectiveness and efficiency. It enablesneeds to be updated and modernised in order to enable more efficient 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 (Safety Business Gateway). Additionally it has to provide an interoperable interface to enable online marketplaces to check the products on their website with the products listed on Safety Gate in an easy, quick and reliable way.
Amendment 262 #
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 situations which might distort competition or affect the objectivity, independence and impartiality of the parties.
Amendment 265 #
Proposal for a regulation
Recital 59
Recital 59
(59) Simultaneous coordinated control actions (‘sweeps’) are specific enforcement actions that can further enhance product safety. In particular and therefore should be conducted on a regular basis to detect online and offline infringements to this Regulation. Additionally, sweeps should be conducted where market trends, consumer complaints or other indications suggest that certain product categories are often found to present a serious risk.
Amendment 297 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) equipment on which consumers ride or travel which is not driven by the consumers themselves but operated by a service provider within the context of a service provided to consumers;
Amendment 299 #
Proposal for a regulation
Article 2 – paragraph 5
Article 2 – paragraph 5
Amendment 306 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
1. ‘product’ means any tangible or intangible item, 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 314 #
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;
Amendment 356 #
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 56 does not apply, the following aspects shall be taken into account in particular when assessing whether a product is safe:
Amendment 364 #
Proposal for a regulation
Article 7 – paragraph 1 – point d
Article 7 – paragraph 1 – point d
(d) the presentation of the product, the labelling, including the age labelling of products regarding their suitability of legality for children, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product;
Amendment 367 #
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, including the impact of digital and connected products on their mental health, and older people and persons with disabilities;
Amendment 368 #
Proposal for a regulation
Article 7 – paragraph 1 – point f
Article 7 – paragraph 1 – point f
(f) the appearance of the product and in particular where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and may therefore be placed in the mouth, sucked or ingested by the consumer, especially by children, and which might cause, for example, suffocation, poisoning, the perforation or obstruction of the digestive tract;
Amendment 393 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1 a. For digital connected products likely to impact children, manufacturers shall conduct a child risk assessment ensuring their products meet the highest standards of safety, security and privacy by design.
Amendment 397 #
Proposal for a regulation
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. Manufacturers shall investigate the complaints received 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 402 #
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 or dedicated section of their website, like a customer service, allowing the consumers to file complaints and to inform them of any accident or safety issue they have experienced with the product.
Amendment 413 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Manufacturers shall keepinform distributors, importers and, online marketplaces in the concerned supply chain informed of any safety issueand fulfilment service providers in the concerned supply chain without undue delay of any dangerous product that they have identified.
Amendment 418 #
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 that might present a serious risk. The technical documentation shall contain, as appropriate:
Amendment 427 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Manufacturers shall keep the technical documentation according to paragraph 4, for a period of ten years after the product has been placed on the market and make it available to the market surveillance authorities, upon request.
Amendment 428 #
Proposal for a regulation
Article 8 – paragraph 6
Article 8 – paragraph 6
6. 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 for consumers, 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 digital document accompanying the product. Upon request of the consumer, it should be made available on paper and free of charge.
Amendment 463 #
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 riskis not safe, inform the manufacturer and additionally, if necessary, the importer, the distributor and the fulfilment service provider without undue delay;
Amendment 473 #
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where an importer considers or has reason to believe that a product is not in conformity with Article 5 and Article 8(4), (6) and (7), he or she shall not place the product on the market until it has been brought into conformity. Furthermore, where the product is not safe, the importer shall inform the manufacturer and ensure that the market surveillance authorities are informedwithout undue delay.
Amendment 494 #
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 Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable.
Amendment 498 #
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 and shall immediately inform the manufacturer or 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 513 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Economic operators shall be established in the EU or have a representative person in the EU in order to place a product covered by this Regulation on the single market, therefore the Article 4(1), (2) and (3) of Regulation (EU) 2019/1020 applicable to harmonised products shall also apply to products covered by this Regulation. For the purposes of this Regulation, references to “Union harmonisation legislation” in Article 4(1), (2) and (3) of Regulation (EU) 2019/1020 shall be read as “Regulation […]”.
Amendment 530 #
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Article 15 a Small, medium and micro-enterprises 1. In order for economic operators that are SMEs and micro-businesses to be able to fulfil the new obligations according to Art. 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20 of this Regulation, the Commission shall provide them with practical guidelines and tailored guidance which include practical simplifications from the new obligations, where possible, in order to limit their administrative burden. At the same time financial support shall be provided. 2. The Commission is empowered to adopt delegated acts in accordance with Article 41 in order to guarantee support for SMEs and micro-enterprises according to paragraph 1.
Amendment 539 #
Proposal for a regulation
Article 17 – paragraph 3 – introductory part
Article 17 – paragraph 3 – introductory part
3. TIn cooperation with relevant stakeholders, the Commission is empowered to adopt delegated acts in accordance with Article 41 six months after the entry into force of this Regulation at the latest to supplement this Regulation by:
Amendment 549 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) information to identify the product, including its type and, when available, batch or serial number and any other product identifier;
Amendment 554 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The manufacturer shall ensure that, through the Safety Business Gateway referred to in Article 25, an accident caused by aresulting in severe injuries or serious danger to life which was caused by a defect of the product placed or made available on the market is notified, within two working dout undue delays from the moment it knows about the facts of 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 559 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The importers and the distributors which have knowledge of an accident according to paragraph 1 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 notification, without undue delay.
Amendment 576 #
Proposal for a regulation
Article 20 – paragraph 2 – introductory part
Article 20 – paragraph 2 – introductory part
2. As far as powers conferred by Member States in accordance to Article 14 of Regulation (EU) 2019/1020 are concerned, Member States shall confer on their market surveillance authorities the power, for all products covered by this Regulation, to order an online marketplace to remove specific illegal content referring to a dangerous product from its online interface, to disable access to it or to display an explicit warning to end users when they access it and to avoid its reappearance. Such orders shall contain a clear statement of reasons and specify one or more exact uniform resource locators and, where necessary, all available additional information enabling the identification of the illegal content concerneddangerous product concerned ideally without further research. They may be transmitted by means of the Safety Gate portal.
Amendment 584 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. Online marketplaces shall take into account 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 Gatecreate a connection to the Safety Gate, through for example an application programme interface, that enables them to quickly and efficiently check the Safety Gate before placing products on their websites and to receive alerts that a product has been notified in the system and therefore ensures that products offered for sale are safe. They shall inform the authority of any action taken by using the contacts of the market surveillance authority published in the Safety Gate.
Amendment 615 #
Proposal for a regulation
Article 20 – paragraph 6 – point a
Article 20 – paragraph 6 – point a
(a) cooperating to ensure effective product recalls, including by abstaining from putting obstacles to product recalls and publishing the recall notice on their website;
Amendment 620 #
Proposal for a regulation
Article 20 – paragraph 6 – point d
Article 20 – paragraph 6 – point d
(d) allowing access to their interfaces for the online tools operated by market surveillance authorities to identify dangerous products while respecting sensitive business information;
Amendment 641 #
Proposal for a regulation
Article 21 – paragraph 4 a (new)
Article 21 – paragraph 4 a (new)
4 a. Market surveillance authorities shall carry out mystery shopping including on online shopping marketplaces, on a regular basis in order to particularly check the safety of product categories that are most frequently flagged on the Safety Gate;
Amendment 646 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. The Commission shall further develop and maintain aodernise the rapid alert system for the exchange of information on corrective measures concerning dangerous products (‘the Safety Gate’)., as well as enhance its efficiency, in particular by providing a interoperable interface for online marketplaces to link their website with the Safety Gate, so that they can easily, quickly and reliably check products and product categories;
Amendment 647 #
Proposal for a regulation
Article 23 – paragraph 2 a (new)
Article 23 – paragraph 2 a (new)
2 a. The Commission shall adopt implementing acts specifying the interoperable interface on the Safety Gate according to Art. 23 para. 1, in particular concerning the access to the system and its operation. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3);
Amendment 653 #
Proposal for a regulation
Article 24 – paragraph 2 – subparagraph 1
Article 24 – paragraph 2 – subparagraph 1
The notification shall be submitted in the Safety Gate within twofour working days from the adoption of the corrective measure.
Amendment 664 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
1. The Commission shall maintain an easy-accessible 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.
Amendment 701 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. Market surveillance authorities may decide toshall conduct simultaneous coordinated control actions (“sweeps”) of particular product categories ton a regular basis, at least once a year, in which they check compliance with or to detect online and offline infringements to this Regulation.
Amendment 721 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Commission, by means of an implementing act, shall adopt the modalities for the sending of information by consumers in accordance with paragraph 2, as well as for the transmission of such information to the concerned national authorities for possible follow up. The Commission shall make sure that the information made by the consumer cannot be published before its accuracy has been verified. This implementing act shall be adopted in accordance with the examination procedure referred to in Article 42(3).
Amendment 722 #
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. In case of a recall or where certain information has to be brought to the attention of consumers to ensure the safe use of a product (‘safety warning’), economic operators, in accordance with their respective obligations as provided for in Articles 8, 9, 10 and 11, shall directly notify all affected consumers that they can identify. Economic operators who collect their customers’ personal data shall make use of this information for recalls and safety warnings. Taking due account of data protection, online marketplaces shall help economic operators in case they have sold the respective product on their marketplace to obtain the specific customer data needed in order to perform an efficient recall.
Amendment 733 #
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. If not all affected consumers can be contacted directly even not with the help of the online marketplaces according to paragraph 1 of this Article, economic 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.
Amendment 775 #
Proposal for a regulation
Article 40 – paragraph 5 – point e
Article 40 – paragraph 5 – point e
(e) to allow market surveillance authorities to perform data scraping of online interfaces. that respect sensitive business information.
Amendment 778 #
Proposal for a regulation
Article 40 – paragraph 8 a (new)
Article 40 – paragraph 8 a (new)
8 a. where the penalties cover only a low amount;
Amendment 786 #
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
It shall apply from [612 months after the entry into force of this Regulation].