39 Amendments of Anne-Sophie PELLETIER related to 2023/0290(COD)
Amendment 79 #
Proposal for a regulation
Recital 2
Recital 2
(2) Children are a particularly vulnerable group. It is essential to ensure a high level of safety of children when playing with toys. Children should be adequately protected from possible risks stemming from toys, in particular from the chemical substances or digital components, functions and features that toys may contain. At the same time, compliant toys should be able to move freely across the internal market without additional requirements.
Amendment 83 #
Proposal for a regulation
Recital 6
Recital 6
(6) Toys are also subject to Regulation (EU) 2023/988 on general product safety25 , which applies in a complementary manner in matters not covered by specific sectoral legislation on consumer products. In particular, Section 2 of Chapter III and Chapter IV in relation to online sales, Chapter VI on the Safety Gate Rapid Alert System and Safety Business Gateway and Chapter VIII on the right of information and remedy also apply to toys. Therefore, this Regulation does not include specific provisions on distance and online sales, accident reporting by economic operators and the right of information and remedy but rather requires economic operators providing information on safety issues concerning toys to inform authorities and consumers in accordance with the procedures set out in Regulation (EU) 2023/988. _________________ 25 OJ L 11, 15.1.2002, p. 4.
Amendment 92 #
Proposal for a regulation
Recital 13
Recital 13
(13) Essential safety requirements for toys should ensure protection from all relevant health and safety hazards posed by toys, for users or third parties. Particular safety requirements should cover the physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene, cybersecurity, privacy and radioactivity to ensure that the safety of children is adequately protected against those specific hazards. Since it is possible that toys which present hazards that are not covered by a particular safety requirement might exist or be developed, it is necessary to maintain a general requirement of safety to ensure protection of children in respect of such toys. The safety of toys should be determined by reference to the intended use, while taking into account also the foreseeable use, and bearing in mind the behaviour of children, who do not generally show the same degree of care as the average adult user. Together, the general safety requirement and the particular safety requirements should form the essential safety requirements for toys.
Amendment 95 #
Proposal for a regulation
Recital 14
Recital 14
(14) Relying on digital technologies has led to new hazards in toys. Radio toyHaving regard to the United Nations Convention on the Rights of the Child as elaborated in its General Comment No. 25 as regards the digital environment, connected toys, smart toys and online games are to comply with essential requirements for the protection of privacy and internet- connected toys, safety and security of children, by design and by default and are to incorporate safeguards towards cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council30 . Toys which include artificial intelligence are to comply with Regulation (EU) …/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial intelligence]31 . However, this legislation does not cover specifically smart or connected toys, which might pose specific health and safety risks which can be provoked by a cyberattack or related to the interaction of children with AI systems. Health and safety risks in connection with the cybersecurity or AI- powered functions of toys should fall within the scope of this Regulation. Therefore, particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should not be set out. However, protecting the health of children should not merely ensure the absence of disease or infirmity and relying on digital technologies may pose risks to children which go beyond their physical health. To ensure that children are protected from any risk coming from the use of digital technologies in toys, the general safety requirement should ensure the psychological and mental health, as well as the well-being and cognitive development, of children. _________________ 30 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 31 PO: Please insert in the text the number of the Regulation and insert the number, date, title and OJ reference of that Regulation in the footnote.
Amendment 118 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) Given the important role played by providers of online marketplaces when intermediating the sale or promotion of toys between traders and consumers, they should be recognised as economic operators. Additional requirements for providers of online marketplaces should be set and they should be held ultimately liable for safety issues.
Amendment 121 #
Proposal for a regulation
Recital 33
Recital 33
(33) It is necessary to ensure that toys from third countries entering the Union market comply with all applicable Union requirements, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those toys. Importers and providers of online marketplaces should therefore ensure that the toys they place on the market comply with the applicable requirements, that conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers are available for inspection by the competent market surveillance authorities.
Amendment 146 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down rules on the safety of toys, ensuring a high level of protection of health and safety of children and other persons, and on the free movement of toys in the Union. The provisions of this Regulation are underpinned by the precautionary principle as it rests on the principle that manufacturers, importers and other economic operators including providers of online marketplaces must manufacture, place and make available on the market only toys that do not adversely affect the health and safety of children and other persons.
Amendment 158 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and 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 toys or making them available on the market in accordance with this Regulation
Amendment 161 #
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
(9) ‘online marketplace’ means online marketplace as defined ina service using software, including a website, part of a website or an application, operated by or on behalf of a trader which allows consumers to conclude distance contracts with other traders or consumers according to Article 32, point (147), of RegulationDirectice (EU) 2023/98811/83;
Amendment 165 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
(12 a) ‘toy’ means products which are designed or intended, whether or not exclusively, for use in play by children, whether or not having digital elements which allow for a direct or indirect connection to a device or network.
Amendment 183 #
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
At trade fairs, exhibitions and demonstrations or similar events, Member States shall not preventmay allow the display of a toy which does not comply with this Regulation, provided that a visible sign clearly indicates that the toy does not comply with this Regulation and will not be available on the market until it has been brought into conformity.
Amendment 197 #
Proposal for a regulation
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
Warnings shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made through distance sales. Warnings shall be of sufficient size to ensure their visibility and legibility. The Commission shall adopt implementing acts determining criteria related to the visibility and legibility of warnings following 12 months after the date of entry into force of this Regulation.
Amendment 208 #
Proposal for a regulation
Article 7 – paragraph 4 – subparagraph 2
Article 7 – paragraph 4 – subparagraph 2
When manufacturersdeemed appropriate, with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers, manufacturers shall, carry out sample testing of marketed toys.
Amendment 254 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. When making a toy available on the market, distributors shall act with due care in relation to the requirements ofDistributors shall only make available on the market toys complying with this Regulation.
Amendment 264 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
An importer or a distributor or a provider of an online marketplace shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 7, where such importer or, distributor or a provider of an online marketplace places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected.
Amendment 271 #
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article11a Providers of online marketplaces 1. Providers of online marketplaces shall, before allowing to publish an offer for a toy, devote best efforts to verify whether such toy is identified as being subject to corrective measures published on the Safety Gate Portal or any other freely accessible database or online interface whose reference must be established by the European Commission by means of implementing acts following 12 months after the date of entry into force of this Regulation. 2. When providers of online marketplaces obtain information on measures taken against dangerous toys through the Safety Gate Portal, they shall devote best efforts to swiftly prevent the publication of the offer, remove or otherwise disable access to it if the offer has been published already. Providers of online marketplaces shall inform authorities of the listings and the actions undertaken. 3. When cooperating with national authorities, consumer associations or other civil society organisations, with relevant economic operators and traders to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a toy that is or was offered online through their services, providers of online marketplaces shall ensure that appropriate and timely corrective measures, including product recalls, are put in place by the relevant economic operators or, if these economic operators fail to do so by themselves or by third party operators under their responsibility. 4. Providers of online marketplaces responsible for the product safety recall shall offer the consumer an effective, cost-free and timely remedy pursuant to article 37 of Regulation (EU) 2023/988.
Amendment 271 #
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article11a Providers of online marketplaces 1. Providers of online marketplaces shall, before allowing to publish an offer for a toy, devote best efforts to verify whether such toy is identified as being subject to corrective measures published on the Safety Gate Portal or any other freely accessible database or online interface whose reference must be established by the European Commission by means of implementing acts following 12 months after the date of entry into force of this Regulation. 2. When providers of online marketplaces obtain information on measures taken against dangerous toys through the Safety Gate Portal, they shall devote best efforts to swiftly prevent the publication of the offer, remove or otherwise disable access to it if the offer has been published already. Providers of online marketplaces shall inform authorities of the listings and the actions undertaken. 3. When cooperating with national authorities, consumer associations or other civil society organisations, with relevant economic operators and traders to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a toy that is or was offered online through their services, providers of online marketplaces shall ensure that appropriate and timely corrective measures, including product recalls, are put in place by the relevant economic operators or, if these economic operators fail to do so by themselves or by third party operators under their responsibility. 4. Providers of online marketplaces responsible for the product safety recall shall offer the consumer an effective, cost-free and timely remedy pursuant to article 37 of Regulation (EU) 2023/988.
Amendment 320 #
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Economic operators mayshall not track, analyse or use any usage information for purposes other than what is absolutely and strictly necessary for providing the information on the product passport online.
Amendment 320 #
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Economic operators mayshall not track, analyse or use any usage information for purposes other than what is absolutely and strictly necessary for providing the information on the product passport online.
Amendment 328 #
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point a
Article 21 – paragraph 2 – subparagraph 1 – point a
(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene, cybersecurity, privacy and radioactivity hazards and the potential exposure to such hazards;
Amendment 328 #
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point a
Article 21 – paragraph 2 – subparagraph 1 – point a
(a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene, cybersecurity, privacy and radioactivity hazards and the potential exposure to such hazards;
Amendment 331 #
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
(c a) assess the risks, including to mental and physical health, that may arise when the smart or connected toy or game is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse.
Amendment 331 #
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
(c a) assess the risks, including to mental and physical health, that may arise when the smart or connected toy or game is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse.
Amendment 340 #
Proposal for a regulation
Article 22 – paragraph 4 a (new)
Article 22 – paragraph 4 a (new)
4 a. Manufacturers shall use either the EU-type examination procedure set out in Part II of Annex IV together with the conformity to type procedure set out in Part III of that Annex or, where applicable, a European cybersecurity certification scheme at assurance level ‘substantial’ or ‘high’ pursuant to Regulation (EU) 2019/881, for toys for children under 36 months, toys that are connected or powered with AI, toys which are chemical mixtures, toys which for functional reasons cannot be designed to eliminate all risks and toys which in case of a failure can lead to severe health impacts of a child. The Commission is empowered to adopt delegated acts in accordance to article [xxx] to amend this list, after consulting the stakeholders concerned, in the light of technical progress, advances in knowledge or new scientific evidence by adding to the list of toys a new category of toys, withdrawing an existing category of toy from this list.
Amendment 340 #
Proposal for a regulation
Article 22 – paragraph 4 a (new)
Article 22 – paragraph 4 a (new)
4 a. Manufacturers shall use either the EU-type examination procedure set out in Part II of Annex IV together with the conformity to type procedure set out in Part III of that Annex or, where applicable, a European cybersecurity certification scheme at assurance level ‘substantial’ or ‘high’ pursuant to Regulation (EU) 2019/881, for toys for children under 36 months, toys that are connected or powered with AI, toys which are chemical mixtures, toys which for functional reasons cannot be designed to eliminate all risks and toys which in case of a failure can lead to severe health impacts of a child. The Commission is empowered to adopt delegated acts in accordance to article [xxx] to amend this list, after consulting the stakeholders concerned, in the light of technical progress, advances in knowledge or new scientific evidence by adding to the list of toys a new category of toys, withdrawing an existing category of toy from this list.
Amendment 366 #
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Where, having carried out an evaluation under Article 41(1), a market surveillance authority finds that, although a toy made available on the market is in compliance with the particular safety requirements it poses a risk to the health and safety of persons, it shall require the relevant economic operators, including providers of online marketplaces, to take all appropriate measures, within a reasonable period of time prescribed by the market surveillance authority taking into account the nature of the risk to ensure that the toy, when made available on the market, no longer presents that risk, to withdraw the toy from the market or to recall it.
Amendment 366 #
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Where, having carried out an evaluation under Article 41(1), a market surveillance authority finds that, although a toy made available on the market is in compliance with the particular safety requirements it poses a risk to the health and safety of persons, it shall require the relevant economic operators, including providers of online marketplaces, to take all appropriate measures, within a reasonable period of time prescribed by the market surveillance authority taking into account the nature of the risk to ensure that the toy, when made available on the market, no longer presents that risk, to withdraw the toy from the market or to recall it.
Amendment 370 #
Proposal for a regulation
Article 45 a (new)
Article 45 a (new)
Article 45a Pan-European Injury Database 1. A Pan-European Injury Database covering all types of injuries caused by toys shall be set up and coordinated by the European Commission. 2. The relevant market surveillance authorities established by the Member States shall contribute to the establishment of the database and deliver injury data to the database, based on a common methodology, comprehensive and in accordance with European and national laws on data protection. 3. The Commission shall support the co- ordination of the collection of data from Member States and the operation of the database.
Amendment 370 #
Proposal for a regulation
Article 45 a (new)
Article 45 a (new)
Article 45a Pan-European Injury Database 1. A Pan-European Injury Database covering all types of injuries caused by toys shall be set up and coordinated by the European Commission. 2. The relevant market surveillance authorities established by the Member States shall contribute to the establishment of the database and deliver injury data to the database, based on a common methodology, comprehensive and in accordance with European and national laws on data protection. 3. The Commission shall support the co- ordination of the collection of data from Member States and the operation of the database.
Amendment 376 #
Proposal for a regulation
Article 46 – paragraph 9
Article 46 – paragraph 9
9. For the purposes of paragraphs 6, 7 and 7,8 the Commission shall systematically and regularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In those evaluations, the Commission shall take into account reports of market surveillance bodies and scientific evidence presented by Member States and stakeholders.
Amendment 376 #
Proposal for a regulation
Article 46 – paragraph 9
Article 46 – paragraph 9
9. For the purposes of paragraphs 6, 7 and 7,8 the Commission shall systematically and regularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In those evaluations, the Commission shall take into account reports of market surveillance bodies and scientific evidence presented by Member States and stakeholders.
Amendment 387 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation] may continue to be made available on the market until … [OP please insert the date = the first day of the month following 412 months after the date of entry into force of this Regulation].
Amendment 387 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation] may continue to be made available on the market until … [OP please insert the date = the first day of the month following 412 months after the date of entry into force of this Regulation].
Amendment 410 #
Proposal for a regulation
Annex I – Part II – point 15
Annex I – Part II – point 15
15. interactive software, intended for leisure and entertainment, such as computer games, and their storage media; unless the interactive software is either specifically designed for and targeted at children or can be reasonably expected to be played by children, such as computers and smart phones games
Amendment 410 #
Proposal for a regulation
Annex I – Part II – point 15
Annex I – Part II – point 15
15. interactive software, intended for leisure and entertainment, such as computer games, and their storage media; unless the interactive software is either specifically designed for and targeted at children or can be reasonably expected to be played by children, such as computers and smart phones games
Amendment 415 #
Proposal for a regulation
Annex II – Part I – point 9
Annex II – Part I – point 9
9. Toys shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The maximum values shall not exceed those set in Directive 2003/10/EEC.
Amendment 415 #
Proposal for a regulation
Annex II – Part I – point 9
Annex II – Part I – point 9
9. Toys shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The maximum values shall not exceed those set in Directive 2003/10/EEC.
Amendment 426 #
Proposal for a regulation
Annex II – Part IV a (new)
Annex II – Part IV a (new)
IV a Toys shall be designed, developed, produced, manufactured, and updated ensuring an appropriate level of cybersecurity and privacy protection proportionate to the risks they pose to the health and safety of children, taking into account the intended use or reasonably foreseen misuse, any risk of adverse impact to health and safety of children and bearing in mind their behaviour. Toys shall comply with relevant Union legislation relating to cybersecurity, privacy and artificial intelligence systems, notably with the requirements of Annex I of Regulation […] on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020 (Cyber Resilience Act).
Amendment 426 #
Proposal for a regulation
Annex II – Part IV a (new)
Annex II – Part IV a (new)
IV a Toys shall be designed, developed, produced, manufactured, and updated ensuring an appropriate level of cybersecurity and privacy protection proportionate to the risks they pose to the health and safety of children, taking into account the intended use or reasonably foreseen misuse, any risk of adverse impact to health and safety of children and bearing in mind their behaviour. Toys shall comply with relevant Union legislation relating to cybersecurity, privacy and artificial intelligence systems, notably with the requirements of Annex I of Regulation […] on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020 (Cyber Resilience Act).