113 Amendments of Malte GALLÉE related to 2023/0290(COD)
Amendment 93 #
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 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 98 #
Proposal for a regulation
Recital 14
Recital 14
(14) Relying on digital technologies has led to new hazards in toys. Radio toys are to comply with essential requirements, including on cybersecurity, for the protection of privacy and internet- connected toys 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 . 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 andorizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020]. However, internet-connected toys might pose specific health and safety risks which can only be provoked by a cyberattack. Internet-connected toys attacked by malicious third parties may pose specific risks that, depending on their intended use or reasonably foreseen misuse, can impact the health and safety of its users. In this respect, health and safety risks in connection with the cybersecurity functions of instert the number, danet-connecte,d title and OJ referencoys shall fall within the scope of thatis Regulation in the footnote.
Amendment 102 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) 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]. As this Regulation focuses mainly on “high-risks AI systems" and does not specifically address toys, particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should be set out.
Amendment 103 #
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14 b) 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.
Amendment 107 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to provide for flexibility where the safety of children is not compromised and where it is necessary for making certain toys available on the market, it should be possible to derogate from the generic prohibitions of chemical substances in toys. Derogations to generic prohibitions permitting the use of prohibited substances should be of general application and should only be possible where the use of the relevant substance is considered safe for children, where there are no commercially viable alternatives for the substanceelimination or substitution of such prohibited substances via design changes or other materials or components is not technically possible, where there are no technically viable alternatives for the substance, where a substitution plan has been submitted and where the use of the substance is not prohibited in consumer articles under Regulation (EC) No 1907/2006. The assessment of the safety of the substance in toys should be carried out by the relevant scientific committees in the European Chemicals Agency (ECHA) in order to ensure consistency and efficient use of resources in the assessment of chemical substances in the Union.
Amendment 108 #
Proposal for a regulation
Recital 19
Recital 19
(19) The use of nickel in stainless steel and in components that transmit electric current has been considered safe in toys by the Scientific Committee on Health, Environment and Emerging risks and should be allow. However, since children should also be adequately protected from allergenic substances and certain metals its use should be limited. Other substances that are necessary to transmit electric current should be permitted in toys to allow for the making available of electric toys if such substances are completely inaccessible for a child playing with the toy and therefore do not present a risk.
Amendment 112 #
Proposal for a regulation
Recital 22
Recital 22
(22) Directive 2009/48/EC includes limit values for certain substances in toys intended for children under 36 months or intended to be put in the mouth. In a family with more than one child, children under 36 months are likely to be attracted by the toys of their siblings that are older than 36 months, making it in practice impossible to completely shield children below 36 months from the toys of their elder siblings. Those substances have shown to also pose a risk to older children, as they could be equally exposed to such chemicals via skin contact or inhalation. These limit values should therefore apply to all toys. Since the adoption of the limit values for bisphenol A in Directive 2009/48/EC, new scientific data has emerged. The European Food Safety Authority (EFSA) re-evaluated the risks to public health from dietary exposure to bisphenol A in April 2023 concluding that exposure to bisphenol A is a health concern for consumers across all age groups. EFSA has established a new tolerable daily intake of bisphenol A which is significantly lower than the previous one. In view of this scientific evidence, bisphenol A should fall under the generic prohibition for CMR substances in toye structural similarities between different bisphenols leading to comparable risks for children, and to avoid regrettable substitution, toys should not contain any bisphenols.
Amendment 115 #
Proposal for a regulation
Recital 25
Recital 25
(25) To prevent misuse of warnings to circumvent the applicable safety requirements, the warnings provided for certain categories of toy should not be allowed if they conflict with the intended use of the toy. To ensure that supervisors are aware of any risks associated with the toy, it is necessary to ensure that the warnings are legible and visible. Minimum requirements on important parameters such as font size, distance and contrast should therefore be laid down.
Amendment 128 #
Proposal for a regulation
Recital 37
Recital 37
(37) Economic operatorsAny natural or legal person that either places a toy on the market under their own name or trademark or substantially modifyies a toy in such a way that compliancenformity with applicable requirements of this Regulation mayight be affected, should be considered to be the manufacturers and should assume the obligations of the manufacturers.
Amendment 129 #
Proposal for a regulation
Recital 38
Recital 38
(38) Toys are to comply with traceability requirements in accordance with Regulation (EU) 2023/988. Ensuring traceability of a toy throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non- compliant toys available on the market.
Amendment 136 #
Proposal for a regulation
Recital 52
Recital 52
(52) It is appropriate to provide for the publication of a notice in the Official Journal of the European Union indicating the date when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products] becomes operational in order to facilitate public access to that information. Similar publication should be provided should further customs IT systems become operational.
Amendment 138 #
Proposal for a regulation
Recital 58
Recital 58
(58) If a conformity assessment body demonstrates conformity of the toy with the criteria laid down in harmonised standards, ithe toy should be presumed to comply with the corresponding requirements set out in this Regulation.
Amendment 141 #
Proposal for a regulation
Recital 68
Recital 68
(68) In order to take into account technical and scientific progress or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Regulation by adapting the specific warnings to be affixed on toys, adopting specific requirements concerning chemical substances and limit values in toys and granting derogations to include specific uses allowed in toys of substances subject to generic prohibitions.
Amendment 145 #
Proposal for a regulation
Article 1 – title
Article 1 – title
Amendment 148 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down rules on the safety of toys,e objective of this Regulation is to ensuringe a high level of protection of health and safety of children and other persons, and on the free movement of toys in the Union.
Amendment 149 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
This Regulation lays down rules on the safety of toys placed or made available on the market that are underpinned by the precautionary principle. Economic operators shall place or make available on the market only toys that do not adversely affect the health and safety of children and other persons.
Amendment 157 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that person’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;
Amendment 159 #
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 or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with this Regulation;
Amendment 162 #
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
(9) ‘online marketplace’ means online marketplace as defined in Article 3, point (14), of Regulation (EU) 2023/98819/2161;
Amendment 164 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
(12 a) ‘toy’ means a product designed or intended, whether or not exclusively, for use in play by children under 14 years of age, whether or not having digital elements which allow for a direct or indirect connection to a device or network.
Amendment 172 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28
Article 3 – paragraph 1 – point 28
(28) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020 as responsible for organising and carrying out market surveillance in the territory of that Member State;
Amendment 173 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28 a (new)
Article 3 – paragraph 1 – point 28 a (new)
(28 a) ‘notifying authority' means an authority designated by a Member State under Article 25 and 26 as responsible for the assessment and notification of conformity assessment bodies in the territory of that Member State;
Amendment 190 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Where necessary to ensure their safe use and the health and safety of children and other persons, toys shall bear a general warning specifying appropriate user limitations. The user limitations shall include at least the minimum or maximum age of the user and, where appropriate, the required abilities of the user, the maximum or minimum weight of the user and the need to ensure that the toy is used only under adult supervision.
Amendment 195 #
Proposal for a regulation
Article 6 – paragraph 3 – subparagraph 1
Article 6 – paragraph 3 – subparagraph 1
The manufacturer shall mark warnings in a clearly visible, easily legible, accessible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys which are sold without packaging shall have appropriate warnings affixed to them.
Amendment 198 #
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. In particular, warnings shall have the characteristics set out in Annex III.
Amendment 202 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
Before placing toys on the market, manufacturers shall carry out an internal risk analysis and draw up the required technical documentation in accordance with Article 23 and carry out the applicable conformity assessment procedure in accordance with Article 22 or have it carried out.
Amendment 204 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Manufacturers shall keep up to date the technical documentation and the product passport for a period of at least 10 years after the last model of the toy covered by that documentation and product passport has been placed on the market.
Amendment 207 #
Proposal for a regulation
Article 7 – paragraph 4 – subparagraph 2
Article 7 – paragraph 4 – subparagraph 2
When manufacturers,deemed 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 209 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Manufacturers shall ensure that toys bear a type, batch, serial or model number or other element allowing their identification and which is easily visible and legible for consumers, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
Amendment 214 #
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers and other end-users, including persons with disabilities, as determined by the Member State concerned. Such instructions and information shall be clear, understandable and legible.
Amendment 216 #
Proposal for a regulation
Article 7 – paragraph 8 – subparagraph 1
Article 7 – paragraph 8 – subparagraph 1
Where manufacturers consider, or have reason to believe, that a toy which they have placed on the market is not in conformity with this Regue relevant Union harmonisation legislation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate.
Amendment 219 #
Proposal for a regulation
Article 7 – paragraph 8 – subparagraph 2 – point a
Article 7 – paragraph 8 – subparagraph 2 – point a
(a) the market surveillance authorities of the Member States in which they have made the toy available, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988, giving details, in particular, of any non- compliance and of any corrective measures takenthe risks to the health and safety to consumers and of any corrective measures taken and if available, of the quantity, by Member State, of the toys still circulating in the market; and
Amendment 221 #
Proposal for a regulation
Article 7 – paragraph 10
Article 7 – paragraph 10
10. Manufacturers shall ensure that other economic operators, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020, and providers of online marketplaces, in the supply chain concerned, are kept informed in a timely manner of any non-conformity that the manufacturers have identifiedor risk to the health or the environment that the manufacturers have identified and of any corrective action, recall or withdrawal.
Amendment 226 #
Proposal for a regulation
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) keep the technical documentation at the disposal of national surveillance authorities and ensure that the product passport is available, in accordance with Article 17(2), for a period of at least 10 years after the last model of the toy covered by those documents has been placed on the market;
Amendment 229 #
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy in an official language that can be understood by the authority;
Amendment 232 #
Proposal for a regulation
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by toys covered by the mandate.
Amendment 234 #
Proposal for a regulation
Article 8 – paragraph 3 – point c a (new)
Article 8 – paragraph 3 – point c a (new)
(c a) immediately terminate the mandate if the manufacturer does not comply with the obligations of the manufacturer under this Regulation and immediately inform the market surveillance authority of the Member State in which is established;
Amendment 235 #
Proposal for a regulation
Article 8 – paragraph 3 – point c b (new)
Article 8 – paragraph 3 – point c b (new)
(c b) where the authorised representative considers or has reason to believe that a toy is a dangerous product, inform the manufacturer thereof;
Amendment 236 #
Proposal for a regulation
Article 8 – paragraph 3 – point c c (new)
Article 8 – paragraph 3 – point c c (new)
(c c) inform the competent national authorities about any action taken to eliminate the risks posed by toys covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer;
Amendment 237 #
Proposal for a regulation
Article 8 – paragraph 3 – point c d (new)
Article 8 – paragraph 3 – point c d (new)
(c d) in case of change of authorised representative, the detailed arrangements for the change shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative, as well as the transfer of documents, including confidentiality aspects and property rights.
Amendment 239 #
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – point e
Article 9 – paragraph 2 – subparagraph 1 – point e
(e) the relevant information in the product passport has been included in the product passport registry in accordance with Article 17(2) and Article 19(1);
Amendment 243 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy. Importers shall ensure that any additional label does not obscure any information required by Union law on the label provided by the manufacturer.
Amendment 246 #
Proposal for a regulation
Article 9 – paragraph 6 – subparagraph 2
Article 9 – paragraph 6 – subparagraph 2
Where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk to health and safety of consumers and other end-users, they shall immediately inform the manufacturer, the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non- compliance, or risk to the health and safety of consumers, and of any corrective measures taken.
Amendment 250 #
Proposal for a regulation
Article 9 – paragraph 8 a (new)
Article 9 – paragraph 8 a (new)
8 a. Importers shall ensure that all relevant economic operators and providers of online marketplaces in the supply chain concerned are kept informed in a timely manner of any non-conformity or risk to the health or the environment that they have identified, and of any corrective action, recall or withdrawal.
Amendment 251 #
Proposal for a regulation
Article 9 – paragraph 10 – subparagraph 2
Article 9 – paragraph 10 – subparagraph 2
Importers shall keep the manufacturer, distributors and, where relevant, providers of online marketplaces informed in a timely manner of the investigation performed and of the results of the investigation.
Amendment 256 #
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 tocomply with the requirements of this Regulation.
Amendment 260 #
Proposal for a regulation
Article 10 – paragraph 4 – subparagraph 2
Article 10 – paragraph 4 – subparagraph 2
Where distributors consider, or have reason to believe, that a toy that they have made available on the market presents a risk, they shall immediately inform the manufacturer or the importer, as applicable, the market surveillance authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non- compliance or risk to health and safety of consumers, and of any corrective measures taken.
Amendment 263 #
Proposal for a regulation
Article 11 – title
Article 11 – title
Cases in which obligations of manufacturers apply to importers and distributorother persons
Amendment 266 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
An importer or a distributor natural or legal person 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 distributornatural or legal person 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 268 #
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
A natural or legal person, other than the manufacturer, that substantially modifies the product within the meaning of Article 13 (3) of Regulation (EU) 2023/988, shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 7 for the part of the product affected by the modification or for the entire product if the substantial modification has an impact on its safety.
Amendment 270 #
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article11a Providers of online marketplaces 1. Without prejudice to the prohibition to conduct general monitoring as established under Regulation (EU) 2022/2065, providers of online marketplaces shall, before and after allowing the offering of the toy by the trader, make reasonable efforts to conduct simple random samples to check whether the toys offered on their interface have been identified as dangerous in the Safety Gate Portal. 2. Providers of online marketplaces are subject to specific obligations in accordance with Regulation (EU) 2023/988 concerning the removal of content referring to an offer of a dangerous toy from their online interfaces and regarding the cooperation with market surveillance authorities and relevant economic operators 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. 3. Notwithstanding the requirement that an economic operator shall be established in the Union pursuant to Article 4 (1) of Regulation (EU) No 2019/1020, where a manufacturer of a toy cannot be identified or, where the manufacturer is established outside the Union, and where an importer, an authorised representative and a fulfilment service provider cannot be identified, any provider of online marketplaces that allows consumers to conclude distance contracts with traders and that is not a manufacturer, importer or distributor, provided that the conditions of Article 6(3) set out in Regulation (EU) 2022/2065 are fulfilled, shall be required by market surveillance authorities to provide adequate and proportionate remedies to consumers where: (a) a market surveillance authority, upon a reasoned request, asks that provider of online marketplace to identify the economic operator or the person who supplied the provider of online marketplace with the toy; and (b) the provider of online marketplace fails to identify the economic operator or the person who supplied the provider of online marketplace with the product within 1 month of receiving the request. 4. Notwithstanding the requirement that an economic operator shall be established in the Union pursuant to Article 4 (1) of Regulation (EU) No 2019/1020, where a manufacturer of a toy cannot be identified or, where the manufacturer is established outside the Union, and where an importer, an authorised representative and a fulfilment service provider cannot be identified, providers of online marketplaces that allow consumers to conclude distance contracts with traders and that are not manufacturers, importers or distributors, shall be required by market surveillance authorities to provide adequate and proportionate remedies to consumers where such providers fail to comply with Article 30 of Regulation (EU) 2022/2065.
Amendment 285 #
Proposal for a regulation
Article 17 – paragraph 2 – point b
Article 17 – paragraph 2 – point b
(b) state that compliance of the toy with the requirements set out in Union legislation applicable to toys and in particular in this Regulation and, in particular, the essential safety requirements, has been demonstrated;
Amendment 289 #
Proposal for a regulation
Article 17 – paragraph 2 – point f
Article 17 – paragraph 2 – point f
(f) be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, civil society organisations, researchers, trade unions, the Commission and other economic operators;
Amendment 291 #
Proposal for a regulation
Article 17 – paragraph 2 – point g
Article 17 – paragraph 2 – point g
(g) be available for a period of at least the expected lifetime or 10 years after the last model of toy is placed on the market, whichever is longer, also in cases of insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
Amendment 293 #
Proposal for a regulation
Article 17 – paragraph 2 – point g a (new)
Article 17 – paragraph 2 – point g a (new)
(g a) be based on open standards, developed with an inter-operable format and shall be machine-readable, structured, searchable, and shall be transferable through an open interoperable data exchange network without vendor lock-in, in accordance with the essential requirements set out in the Ecodesign Regulation;
Amendment 294 #
Proposal for a regulation
Article 17 – paragraph 2 – point i
Article 17 – paragraph 2 – point i
(i) fulfil the specific and technical requirements laid down pursuant to paragraph 10. in order to facilitate the verification of product compliance by competent national authorities;
Amendment 296 #
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. By creating the product passport, the manufacturer shall assume responsibility for the compliance of the toy with this Regulation and with any other Union legislation applicable to toys.
Amendment 297 #
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. The data carrier shall be physically present on the toy or on a label attached to the toy, in accordance with the implementing act adopted in accordance with paragraph 10. In the case of small toys and toys consisting of small parts, the data carrier may alternatively be affixed to its packaging. It shall be clearly visible to the consumer before any purchase and to market surveillance authorities, including in cases where the toy is made available through distance sales. In addition, the data carrier shall be accompanied by the statement ‘More information on the product is available online’ or by a similar statement.
Amendment 299 #
Proposal for a regulation
Article 17 – paragraph 5 a (new)
Article 17 – paragraph 5 a (new)
5 a. The economic operator placing the toy on the market shall provide other economic operators involved in the distribution of the toy with a digital copy of the data carrier to allow them to make it accessible to consumers and market surveillance authorities where they cannot physically access the product. The economic operator shall provide that digital copy free of charge and within 5 working days of receiving a request.
Amendment 301 #
Proposal for a regulation
Article 17 – paragraph 8
Article 17 – paragraph 8
8. By way of derogation from paragraph 2, point (c), where information requirements relating to substances of concern in toys are established in a delegated act adopted in accordance with Article 4 of Regulation …/… [OP please insert: the Ecodesign for Sustainable Products Regulation], the information referred to in Part I, point (k), of Annex VI to this Regulation is no longer required insofar as the information requirements established in the delegated act are equivalent.
Amendment 306 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 1 – point d
Article 17 – paragraph 10 – subparagraph 1 – point d
(d) the actors that shall have access to information in the product passport and to what information they shall have access and the actors that may introduce or update the information in the product passport, including where needed the creation of a new passport, including manufacturers, importers and distributors, dealers, repairers, refurbishers, remanufacturers, recyclers, notified bodies, competent national authorities, public interest organisations and the Commission, or any organisation acting on their behalf, and the types of information they may introduce or update.
Amendment 307 #
Proposal for a regulation
Article 17 – paragraph 10 – subparagraph 1 – point d a (new)
Article 17 – paragraph 10 – subparagraph 1 – point d a (new)
(d a) the period for which the product passport shall remain available by specifying the minimum period of time during which the actors of the value chain storing the data shall guarantee continuous availability of those data.
Amendment 314 #
Proposal for a regulation
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3 a. Product passports shall be designed and operated so that they are user-friendly and accessible.
Amendment 315 #
Proposal for a regulation
Article 18 – paragraph 3 b (new)
Article 18 – paragraph 3 b (new)
3 b. Consumers shall not be requested to register, download or install applications, or to provide a password to access the product passport. A functionality shall allow consumers to place alerts about toys that present a risk to their health and safety through a separate section of the Safety Gate Portal pursuant to article 34 (3) of Regulation (EU) 2023/988.
Amendment 316 #
Proposal for a regulation
Article 18 – paragraph 3 c (new)
Article 18 – paragraph 3 c (new)
3 c. Manufacturers shall provide, on oral or written demand or when the product passport is temporarily unavailable at the time of purchase of the toy, the information provided in the product passport by alternative means on a durable medium. Manufacturers shall provide that information independently of a purchase and free of charge.
Amendment 318 #
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Economic operators may not trackand any other relevant natural or legal person shall not track or profile end-users or otherwise process any personal data in line with Regulation (EU) 2016/679, 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. End-users must not be required to install any software, register or otherwise process personal data to access the digital product passport online.
Amendment 321 #
Proposal for a regulation
Article 18 – paragraph 6 a (new)
Article 18 – paragraph 6 a (new)
6 a. The rights to access and to introduce, modify or update information in product passport shall be restricted based on the access rights specified in delegated acts adopted pursuant to paragraph 10 of Article 17.
Amendment 322 #
Proposal for a regulation
Article 18 – paragraph 6 b (new)
Article 18 – paragraph 6 b (new)
6 b. Data authentication, reliability and integrity shall be ensured.
Amendment 323 #
Proposal for a regulation
Article 18 – paragraph 6 c (new)
Article 18 – paragraph 6 c (new)
6 c. The product passport shall be designed and operated so that a high level of security and privacy is ensured and fraud is avoided.
Amendment 325 #
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2 a. To make controls more efficient, the registry should be automatically accessible from other data sharing platforms used by authorities, such as customs IT systems.
Amendment 327 #
Proposal for a regulation
Article 20 – paragraph 5
Article 20 – paragraph 5
5. The verifications referred to in paragraphs 3 and 4 of this Article shall take place electronically and automatically using the interconnection between the registry referred to in Article 19(1) and the EU Customs Single Window Certificates Exchange System referred to in [Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products]] and any future customs IT systems.
Amendment 330 #
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, cybersecurity, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards;
Amendment 334 #
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 health, that may emerge when the toy is used in accordance with its intended purpose and reasonably foreseeable use.
Amendment 335 #
Proposal for a regulation
Article 22 – paragraph 3 – introductory part
Article 22 – paragraph 3 – introductory part
3. In the following cases, the manufacturer shall use 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 and, where applicable, a European cybersecurity certification scheme at assurance level ‘high’ pursuant to Regulation (EU) 2019/881:
Amendment 339 #
Proposal for a regulation
Article 22 – paragraph 4 a (new)
Article 22 – paragraph 4 a (new)
4 a. Manufacturers shall use 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 and, where applicable, a European cybersecurity certification scheme at assurance level ‘high’ pursuant to Regulation (EU) 2019/881, for toys for children under 36 months, toys which include artificial intelligence, internet-connected toys, 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 consequences for children. The Commission should be empowered to adopt delegated acts in accordance with Article 46 (5 a new) to amend this list, also contained in Anne IV, 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 or by withdrawing an existing category of toys from this list.
Amendment 341 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the toy complies with the essential safety requirements. It shall, in particular, contain the documents listed in Annex V. In case the toy or any part of it complies with European standards or common specifications, the list of the relevant European standards and common specifications shall also be indicated.
Amendment 342 #
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The technical documentation shall be drawn up and kept up-to-date by the manufacturer in one of the official languages of the Union.
Amendment 351 #
Proposal for a regulation
Article 41 – paragraph -1 (new)
Article 41 – paragraph -1 (new)
-1. When market surveillance authorities of the Member States take measures as provided for in this Regulation, they shall take due account of the precautionary principle.
Amendment 354 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
Where the market surveillance authorities of one Member State have sufficient reason to believe that a toy covered by this Regulation presents a risk to the health or safety of persons, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. The relevant economic operators and providers of online marketplaces shall cooperate, as necessary, with the market surveillance authorities for that purpose.
Amendment 356 #
Proposal for a regulation
Article 41 – paragraph 5 – point c a (new)
Article 41 – paragraph 5 – point c a (new)
(c a) shortcomings in the EU-type examination procedure referred to in Article 22;
Amendment 358 #
Proposal for a regulation
Article 42 – paragraph -1 (new)
Article 42 – paragraph -1 (new)
-1. On duly justified imperative grounds of urgency relating to the protection of health and safety of children and other persons, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 50.
Amendment 359 #
Proposal for a regulation
Article 42 – paragraph 1 – subparagraph 1
Article 42 – paragraph 1 – subparagraph 1
Where, on completion of the procedure set out in Article 41(3) and (4) and in Article 44 (2) and (2a new), objections are raised against a measure taken by a Member State, or where the Commission has reasons to believe that a national measure could be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.
Amendment 360 #
Proposal for a regulation
Article 43 – paragraph 1 – introductory part
Article 43 – paragraph 1 – introductory part
1. Without prejudice to Article 41, where a market surveillance authority makes, inter alia, one of the following findings with regard to a toy, it shall require the relevant economic operator to put an end to the non-compliance concerned:
Amendment 363 #
Proposal for a regulation
Article 43 – paragraph 1 – point e a (new)
Article 43 – paragraph 1 – point e a (new)
(e a) the toy is not in conformity with the product requirements in accordance with Article 5;
Amendment 364 #
Proposal for a regulation
Article 43 – paragraph 1 – point e b (new)
Article 43 – paragraph 1 – point e b (new)
(e b) the toy does not bear, where appropriate, a general warning in accordance with Article 6;
Amendment 365 #
Proposal for a regulation
Article 43 – paragraph 1 – point e c (new)
Article 43 – paragraph 1 – point e c (new)
(e c) the conformity assessment procedures laid down in Article 22 are not fulfilled;
Amendment 367 #
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 operator, 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 368 #
Proposal for a regulation
Article 44 – paragraph 2 a (new)
Article 44 – paragraph 2 a (new)
2 a. Where the relevant economic operator does not take adequate corrective actions within the period referred to in paragraph 1, the market surveillance authorities shall take appropriate provisional measures to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it.
Amendment 371 #
Proposal for a regulation
Article 45 a (new)
Article 45 a (new)
Article45a 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 373 #
Proposal for a regulation
Article 46 – paragraph 5 a (new)
Article 46 – paragraph 5 a (new)
5 a. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Article 22 (4 a new) by adding to the list of toys that are required to comply with the EU-type examination procedure set out in Annex IV a new category of toys or by withdrawing an existing category of toys from that list.
Amendment 374 #
Proposal for a regulation
Article 46 – paragraph 6
Article 46 – paragraph 6
6. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in order to permit for a specified period of time a certain use in toys of a specific substance or mixture that is prohibited under Part III, point 4, of Annex II, or to limit a certain use that has been permitted.
Amendment 375 #
Proposal for a regulation
Article 46 – paragraph 9
Article 46 – paragraph 9
9. For the purposes of paragraphs 6, 7 and 78, 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 379 #
Proposal for a regulation
Article 47 – paragraph 4
Article 47 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult relevant stakeholders and experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 381 #
Proposal for a regulation
Article 51 – paragraph 1 – introductory part
Article 51 – paragraph 1 – introductory part
1. Competent national authorities, notified bodies, ECHA and the Commission shall respect the confidentiality of the following information and data obtained in carrying out their tasks in accordance with this Regulation:
Amendment 383 #
Proposal for a regulation
Article 52 – paragraph 1
Article 52 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and shall be increased if the relevant economic operator has previously committed infringements of this Regulation .. Member States by … [P.O. insert date: the first day of the month following 30 months after the date of entry into force of this Regulation] notify the Commission of those rules and shall notify it without delay of any subsequent amendment affecting them.
Amendment 386 #
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 3018 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 4230 months after the date of entry into force of this Regulation].
Amendment 395 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. By … [OP please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation] and every 5 years thereafter, the Commission shall carry out an evaluation of this Regulation. The Commission shall submit a report to the European Parliament and to the Council on the main findingsOn request, Member States shall provide the Commission with information necessary for the evaluation of this Regulation. The Commission shall submit a report to the European Parliament and to the Council on the main findings and draw up a summary that is made available to the public. The report shall assess whether this Regulation, and in particular the provisions in Chapter IV achieved the objective of ensuring a high level of protection of health and safety of children and other persons and shall assess the possibility to include adaptive toys in the scope of this Regulation.
Amendment 403 #
Proposal for a regulation
Annex I – Part II – point 3
Annex I – Part II – point 3
3. sports equipment, including roller skates, inline skates, and skateboards, scooters and other means of transport intended for children with a body mass of more than 20 kg;
Amendment 406 #
Proposal for a regulation
Annex I – Part II – point 5
Annex I – Part II – point 5
Amendment 407 #
Proposal for a regulation
Annex I – Part II – point 8
Annex I – Part II – point 8
Amendment 409 #
Proposal for a regulation
Annex I – Part II – point 14
Annex I – Part II – point 14
14. electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals or components, unless the electronic equipment or the associated peripherals are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels;
Amendment 416 #
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 419 #
Proposal for a regulation
Annex II – Part II – point 2 – point a – point 5
Annex II – Part II – point 2 – point a – point 5
(5) hazard classes 3.9, 3.10 and 3.101;
Amendment 420 #
Proposal for a regulation
Annex II – Part II – point 2 – point a – point 6
Annex II – Part II – point 2 – point a – point 6
(6) hazard class 4.1, 4.2, 4.3 and 4.4;
Amendment 428 #
Proposal for a regulation
Annex II – Part VI a (new)
Annex II – Part VI a (new)
VI a Part VIa Cybersecurity 1. Toys shall be designed, developed, and produced and, where applicable, updated, in such a way that they ensure a level of cybersecurity protection proportionate to the risks to health and safety of children that can be caused by a cybersecurity incident. Toys shall be designed and manufactured so as to eliminate cybersecurity incidents or reduce the associated risks by an inherent security, taking into account the intended use or reasonably foreseen misuse, any risk of adverse impact to the health and safety of its users bearing in mind the behaviour of children. 2. Toys shall comply with the relevant Union legislation relating to cybersecurity. In particular, toys shall comply with the specific cybersecurity requirements set out in Annex I of the Regulation XX/XX on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020 (Cyber Resilience Act).
Amendment 431 #
Proposal for a regulation
Annex II – Part A – point 2
Annex II – Part A – point 2
2. Nitrosamines and nitrosable substances are prohibited in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth where the migration of those substances is equal to or higher than. The migration of those substances from toys, components of toys or micro-structurally distinct parts of toys, shall not exceed 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosable substances.
Amendment 434 #
Proposal for a regulation
Annex II – Part A – point 4 – introductory part
Annex II – Part A – point 4 – introductory part
4. Toys shall not contain the following fragrance allergens unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kgthe limit of detection:
Amendment 436 #
Proposal for a regulation
Annex II – Part B – point 1
Annex II – Part B – point 1
Amendment 438 #
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
Annex III – point 1 – paragraph 2 – introductory part
Amendment 444 #
Proposal for a regulation
Annex IV – Part I – point 4 – point 4.2
Annex IV – Part I – point 4 – point 4.2
4.2. The manufacturer shall draw up the product passport for a toy model and ensure that together with the technical documentation, it remains available for at least the expected lifetime of 10 years after the last model of the product has been placed on the market, whichever is longer. The product passport shall identify the toy for which it has been drawn up.
Amendment 446 #
Proposal for a regulation
Annex IV – Part II – point 9
Annex IV – Part II – point 9
9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for at least 10 years after the last model of toy has been placed on the market.
Amendment 447 #
Proposal for a regulation
Annex IV – Part II a (new)
Annex IV – Part II a (new)
II a Part II - Module B (a new): Toys required to undergo the EU-type examination procedure 1. Toys for children under 36 months; 2. Toys which include artificial intelligence; 3. Internet-connected toys; 4. Toys which are chemical mixtures; 5. Toys which for functional reasons cannot be designed to eliminate all risks; 6. Toys which in case of a failure can lead to severe health consequences for children.
Amendment 449 #
Proposal for a regulation
Annex IV – Part III – point 3 – point 3.2
Annex IV – Part III – point 3 – point 3.2
3.2. The manufacturer shall create a product passport for a toy model and ensure that it remains available for at least the expected lifetime or 10 years after the last model of toy has been placed on the market, whichever is longer. The product passport shall identify the toy for which it has been drawn up.