118 Amendments of Maria-Manuel LEITÃO-MARQUES related to 2023/0290(COD)
Amendment 78 #
Proposal for a regulation
Recital 2
Recital 2
(2) Children are a particularly vulnerable group. It isThe UN Convention on the Rights of the Child recognises the right of all children to have the best possible start in life, to grow up healthy, and to develop to their full potential. Such a right should be enjoyed by all children, without the risk of being exposed to harmful substances while using toys. It is therefore 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 particularsuch as those stemming from the chemical substances that toys may contain. At the same time, compliant toys should be able to move freely across the internal market without additional requirements.
Amendment 84 #
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 94 #
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 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 misuse, 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 100 #
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 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 and Regulation [insert serial number for Regulation on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020]. Toys which include artificial intelligence as a safety component 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 and insert the number, date, title and OJ reference of that Regulation in the footnote.
Amendment 106 #
Proposal for a regulation
Recital 15
Recital 15
(15) Toys should comply with physical and mechanical requirements that prevent children from getting physically injured when playing with toys and should not pose a risk of choking or suffocation to children. In order to protect children from the risk of impaired hearing, maximum values should be set out for both impulse noise and continuous noise emitted by toys. Toys or their parts and their packaging which can be reasonably expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use and misuse are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council32 . In addition, it is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys in food, since the association of a toy and food could cause a risk of choking which is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measure at Union level. Toys should also ensure sufficient protection as regards flammability or electric properties, in particular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene standards to avoid microbiological risks or other risks of infection or contamination. _________________ 32 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Amendment 109 #
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 allowed. Other substances that are necessary to transmit electric current should be permitted in toys to allow for the making available of electric toys only if such substances are completely inaccessible for a child playing with the toy and therefore do not present aare presumed as not presenting a substantial risk.
Amendment 111 #
Proposal for a regulation
Recital 21
Recital 21
(21) Existing limit values for certain chemical substances and their corresponding test methods have proven to be appropriate for the protection of children as regards those substances and should be maintained. In order to adapt to new scientific knowledge, the Commission should be empowered to revise those limit values where necessary. Limit values for arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic and which should therefore not be intentionally used in toys, should be set out at half the values that are considered safe by the relevant scientific body, in order to ensure that only traces that are compatible with good manufacturing practice and with the health and safety of the child throughout his or her development are present in the toy.
Amendment 114 #
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 visibleclearly intelligible, legible and visible. Minimum requirements on important parameters such as font size, distance and contrast should therefore be laid down.
Amendment 116 #
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 clearly intelligible, legible and visible.
Amendment 119 #
Proposal for a regulation
Recital 31
Recital 31
(31) To facilitate compliance of the manufacturers with their obligations under this Regulation, manufacturers should be allowed to appoint an authorised representativ and to make sure they are always traceable, manufacturers established outside the Union should always appoint an authorised representative, and manufacturers established in the Union should be allowed to appoint one to carry out specific tasks on their behalf. Moreover, to ensure a clear and proportionate distribution of tasks between the manufacturer and the authorised representative, it is necessary to set out a list of tasks that manufacturers should be allowed to entrust the authorised representative with. Further, to ensure the enforceability and compliance with this Regulation, where a manufacturer established outside the Union appoints an authorised representative, the mandate should include the tasks set out in Article 4 of Regulation (EU) 2019/1020.
Amendment 120 #
Proposal for a regulation
Recital 32
Recital 32
(32) Economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that the toys they place on the market do not jeopardisepose risks to the safety and health of children under normal and reasonably foreseeable conditions of use and misuse, and that they make available on the market only toys which comply with the relevant Union legislation.
Amendment 122 #
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 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 productCE marking and technical documentation drawn up by manufacturers are available for inspection by the competent market surveillance authorities.
Amendment 123 #
Proposal for a regulation
Recital 34 a (new)
Recital 34 a (new)
(34 a) With regard to distance and online sales, this Regulation complements Regulation (EU) 2023/988 and Regulation (EU) No 2019/1020. Where there is no economic operator in the Union within the meaning of Article 4(1) of Regulation (EU) No 2019/1020, the online marketplace shall be considered to be the importer responsible for the conformity of the toys sold to consumers located in the Union, and thereby take on the importer’s responsibilities for the purposes of this Regulation.
Amendment 125 #
Proposal for a regulation
Recital 35
Recital 35
(35) As the distributor makes a toy available on the market after the toy has been placed on the market by the manufacturer or the importer, the distributor should act with due care to ensure that the handling of the toy does not adversely affect the compliance of that toy with this Regulation.
Amendment 127 #
Proposal for a regulation
Recital 37
Recital 37
(37) Economic operators that either place a toy on the market under their own name or trademark or modify a toy in such a way that compliance with applicable requirements of this Regulation may be affected, should be considered to be manufacturers for the purposes of this Regulation and should assume the obligations of manufacturers.
Amendment 130 #
Proposal for a regulation
Recital 39
Recital 39
(39) In order to facilitate the assessment of conformity with the requirements of this Regulation it is necessary to provide for a presumption of conformity for toys which are in conformity with the applicable harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council36 and published in the Official Journal of the European Union. _________________ 36 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
Amendment 131 #
Proposal for a regulation
Recital 40
Recital 40
(40) In the absence of relevant harmonised standards, the Commission should be empowered to adopt implementing acts setting out common specifications for the essential requirements of this Regulation, provided that in doing so it duly respects the standardisation organisations’ role and functions, as an exceptional fall back solution to facilitate the manufacturer’s obligation to comply with the essential requirements, when the standardisation process is blocked, when the standards are insufficient or when there are delays in the establishment of appropriate harmonised standards.
Amendment 133 #
Proposal for a regulation
Recital 42
Recital 42
(42) Manufacturers should create a digital product passport to provide information on the compliance of toys with this Regulation and with any other Union legislation applicable to toys. The product passport should replace the EU declaration of conformity under Directive 2009/48/EC and include the elements necessary to assess the conformity of the toy with the applicable requirements and harmonised standards or other specifications. In order to facilitate checks on toys by market surveillance authorities and to allow the actors in the supply chain and consumers to access information on the toy, the information on the product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the toy, its packaging or the accompanying documentation. Market surveillance authorities, customs authorities, economic operators and consumers should have immediate access to the information on the toy through the data carrier.
Amendment 137 #
Proposal for a regulation
Recital 56
Recital 56
(56) To ensure that toys comply with the essential requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Internal production control based on the manufacturer’s own responsibility for the conformity assessment is adequate where it has followed the harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all the particular safety requirements for the toy. In cases where such harmonised standards or common specifications do not exist, the toy should be submitted to third party verification, in this case EU-type examination. The same should apply if one or more such standards has been published with a restriction in the Official Journal of the European Union, or if the manufacturer has not followed such standards or specifications completely, or only in part. TIn addition, the manufacturer should submit the toy to EU-type examination in cases where it considers that the nature, design, construction or purpose of the toy necessitates third party verification.
Amendment 139 #
Proposal for a regulation
Recital 60
Recital 60
(60) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for toys to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries. In particular, Member States should take appropriate corrective measures as provided for in Regulation (EC) No 765/2008 in cases where a conformity assessment body would have excessive recourse to subsidiaries and subcontractors, in a manner that would call into question the competence of the notified body or its supervision by the notifying authority should be avoided.
Amendment 142 #
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 in toys and granting or removing derogations to include specific uses allowed in toys of substances subject to generic prohibitions.
Amendment 143 #
Proposal for a regulation
Recital 71
Recital 71
(71) When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert and stakeholder level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making40 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 40 OJ L 123, 12.5.2016, p. 1.
Amendment 144 #
Proposal for a regulation
Recital 72
Recital 72
(72) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish the detailed technical requirements for the product passport for toys, and to determine whether a specific product or group of products is to be considered a toy for the purposes of this Regulation. In exceptional cases where it is necessary in order to address new emerging risks that are not appropriately addressed by the particular safety requirements, the Commission should be empowered to adopt implementingdelegated acts setting out specific measures against toys or categories of toys made available on the market which present a risk for children. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council41 . _________________ 41 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 151 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
This Regulation shall be applied taking due account of the precautionary principle.
Amendment 156 #
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt implementingdelegated acts determining whether or not specific products or categories of products fulfil the criteria set out in paragraph 1 of this Article and therefore can or cannot be considered toys within the meaning of this Regulation. Those implementingdelegated acts shall be adopted in accordance with the procedure set out in Article 50(2)47.
Amendment 160 #
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 and the online marketplace;
Amendment 171 #
Proposal for a regulation
Article 3 – paragraph 1 – point 23 a (new)
Article 3 – paragraph 1 – point 23 a (new)
(23 a) ‘harm’ means physical injury or any other damage to health, including mental health or long-term health effects;
Amendment 175 #
Proposal for a regulation
Article 3 – paragraph 1 – point 32
Article 3 – paragraph 1 – point 32
(32) ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult;
Amendment 180 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 181 #
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
Amendment 184 #
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 2
Article 4 – paragraph 2 – subparagraph 2
Amendment 196 #
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 following characteristics: a) they shall stand out clearly from the background; b) a single font shall be used that is easily legible and without serifs; c) the x-height of the font size shall be equal to or greater than 1,4 mm; d) the distance between two lines shall be appropriate for the selected font size to be easily legible; e) the letter spacing shall be appropriate for the selected font to be easily legible.
Amendment 205 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Manufacturers shall keep the technical documentation and the product passport for a period of at least 10 years after the last model of toy covered by that documentation and product passport has been placed on the market.
Amendment 206 #
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 210 #
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 217 #
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 applicable 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 220 #
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- compliancethe risks to the health and safety to consumers and of any corrective measures taken; and
Amendment 223 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. A manufacturer may appoint an authorised representative by written mandatPrior to making a toy available on the Union market, manufacturers established outside the Union shall appoint an authorised representative by written mandate. A manufacturer established in the Union may also appoint one.
Amendment 225 #
Proposal for a regulation
Article 8 – paragraph 3 – point -a (new)
Article 8 – paragraph 3 – point -a (new)
(-a) verify that the product passport and the technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the manufacturer;
Amendment 227 #
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 228 #
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 which can be easily understood by that authority;
Amendment 230 #
Proposal for a regulation
Article 8 – paragraph 3 – point b a (new)
Article 8 – paragraph 3 – point b a (new)
(b a) where the authorised representative considers or has reason to believe that a toy poses risks to the health and safety or is otherwise non-compliant with this Regulation, inform the manufacturer thereof;
Amendment 242 #
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
Where importers consider, or have reason to believe, that a toy is not in conformity with the essential safety requirements, they shall notinform the manufacturer and refrain from placeing the toy on the market until it has been brought into conformity by the manufacturer.
Amendment 247 #
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, the online matrkeplace, giving details, in particular, of the non-compliancerisk to health and safety of consumers and of any corrective measures taken.
Amendment 248 #
Proposal for a regulation
Article 9 – paragraph 7
Article 9 – paragraph 7
7. Importers shall, for a period of at least 10 years after the last model of the toy has been placed on the market, keep the unique product identifier of the toy at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Article 23 can be made available to those authorities, upon request.
Amendment 252 #
Proposal for a regulation
Article 9 – paragraph 11 a (new)
Article 9 – paragraph 11 a (new)
11 a. Where no importer, distributor or authorised representative can be identified and the toy is made available through an online marketplace, the provider of that online marketplace shall be considered the importer for the purposes of this Regulation and therefore be subject to the same obligations as the importer as set out in this article.
Amendment 253 #
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 258 #
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2
Article 10 – paragraph 2 – subparagraph 2
Where distributors consider, or have reason to believe, that a toy is not in conformity with the essential safety requirements, they shall not makeinform the manufacturer and refrain from making the toy available on the market until it has been brought into conformity by the manufacturer.
Amendment 262 #
Proposal for a regulation
Article 11 – title
Article 11 – title
Cases in which obligations of manufacturers apply to importers and distribuother economic operators
Amendment 265 #
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 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 286 #
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 this Regulation and, in particular, the essential safety requirements, has been demonstrated;
Amendment 286 #
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 this Regulation and, in particular, the essential safety requirements, has been demonstrated;
Amendment 288 #
Proposal for a regulation
Article 17 – paragraph 2 – point d
Article 17 – paragraph 2 – point d
(d) be kept up to date;
Amendment 288 #
Proposal for a regulation
Article 17 – paragraph 2 – point d
Article 17 – paragraph 2 – point d
(d) be kept up to date;
Amendment 292 #
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 10 years after the toylast toy model is placed on the market, 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 292 #
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 10 years after the toylast toy model is placed on the market, 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 298 #
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 alternativelyshall 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. It shall also be accompanied by the statement “More information on the product is available on the website of the manufacturer” or by a similar statement.
Amendment 298 #
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 alternativelyshall 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. It shall also be accompanied by the statement “More information on the product is available on the website of the manufacturer” or by a similar statement.
Amendment 311 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. All information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable. The product passport shall be designed and operated in an accessible manner, and incorporate the principle of security and privacy by design.
Amendment 311 #
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. All information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable. The product passport shall be designed and operated in an accessible manner, and incorporate the principle of security and privacy by design.
Amendment 313 #
Proposal for a regulation
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3 a. Consumers shall not be requested to register, download, 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 313 #
Proposal for a regulation
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3 a. Consumers shall not be requested to register, download, 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 319 #
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. End-users shall not be required to install any software, register or otherwise process personal data to access the digital product passport online.
Amendment 319 #
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. End-users shall not be required to install any software, register or otherwise process personal data to access the digital product passport online.
Amendment 333 #
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 under conditions of reasonably foreseeable misuse.
Amendment 333 #
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 under conditions of reasonably foreseeable misuse.
Amendment 337 #
Proposal for a regulation
Article 22 – paragraph 3 – point d a (new)
Article 22 – paragraph 3 – point d a (new)
(d a) toys for children under 36 months which contain chemical mixtures;
Amendment 337 #
Proposal for a regulation
Article 22 – paragraph 3 – point d a (new)
Article 22 – paragraph 3 – point d a (new)
(d a) toys for children under 36 months which contain chemical mixtures;
Amendment 338 #
Proposal for a regulation
Article 22 – paragraph 3 – point d b (new)
Article 22 – paragraph 3 – point d b (new)
(d b) connected toys or toys that make use of artificial intelligence systems as defined in Regulation xxx.
Amendment 338 #
Proposal for a regulation
Article 22 – paragraph 3 – point d b (new)
Article 22 – paragraph 3 – point d b (new)
(d b) connected toys or toys that make use of artificial intelligence systems as defined in Regulation xxx.
Amendment 352 #
Proposal for a regulation
Article 41 – paragraph -1 (new)
Article 41 – paragraph -1 (new)
-1. Market surveillance authorities of the Member States shall perform their activities taking due account of the precautionary principle.
Amendment 352 #
Proposal for a regulation
Article 41 – paragraph -1 (new)
Article 41 – paragraph -1 (new)
-1. Market surveillance authorities of the Member States shall perform their activities taking due account of the precautionary principle.
Amendment 372 #
Proposal for a regulation
Article 46 – paragraph 5
Article 46 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex I and III in order to adapt it to technical and scientific progress.
Amendment 372 #
Proposal for a regulation
Article 46 – paragraph 5
Article 46 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex I and III in order to adapt it to technical and scientific progress.
Amendment 378 #
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for an indeterminatefive years from … [the date of entry into force of the Regulation].The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of timean identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 378 #
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for an indeterminatefive years from … [the date of entry into force of the Regulation].The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of timean identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 380 #
Proposal for a regulation
Article 47 – paragraph 6
Article 47 – paragraph 6
6. Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of twohree months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by twohree months at the initiative of the European Parliament or of the Council.
Amendment 380 #
Proposal for a regulation
Article 47 – paragraph 6
Article 47 – paragraph 6
6. Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of twohree months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by twohree months at the initiative of the European Parliament or of the Council.
Amendment 382 #
Proposal for a regulation
Article 51 – paragraph 1 – point b a (new)
Article 51 – paragraph 1 – point b a (new)
(b a) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits;
Amendment 382 #
Proposal for a regulation
Article 51 – paragraph 1 – point b a (new)
Article 51 – paragraph 1 – point b a (new)
(b a) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits;
Amendment 388 #
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 4230 months after the date of entry into force of this Regulation].
Amendment 388 #
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 4230 months after the date of entry into force of this Regulation].
Amendment 390 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Chapter VII and 5.1 of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and 45 of Directive 2009/48/EC to toys which were placed on the market in conformity with that Directive before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation], including toys for which a procedure has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation].
Amendment 390 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Chapter VII and 5.1 of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and 45 of Directive 2009/48/EC to toys which were placed on the market in conformity with that Directive before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation], including toys for which a procedure has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation].
Amendment 394 #
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [PO insert date: the first day of the month following 4230 months after the date of entry into force of this Regulation], unless they expire before that date.
Amendment 394 #
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [PO insert date: the first day of the month following 4230 months after the date of entry into force of this Regulation], unless they expire before that date.
Amendment 396 #
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 360 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 findings.
Amendment 396 #
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 360 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 findings.
Amendment 400 #
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
It shall apply from … [OP please insert the date = the first day of the month following 3024 months after the date of entry into force of this Regulation].
Amendment 400 #
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
It shall apply from … [OP please insert the date = the first day of the month following 3024 months after the date of entry into force of this Regulation].
Amendment 404 #
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 404 #
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 405 #
Proposal for a regulation
Annex I – Part II – point 5
Annex I – Part II – point 5
Amendment 405 #
Proposal for a regulation
Annex I – Part II – point 5
Annex I – Part II – point 5
Amendment 408 #
Proposal for a regulation
Annex I – Part II – point 8
Annex I – Part II – point 8
Amendment 408 #
Proposal for a regulation
Annex I – Part II – point 8
Annex I – Part II – point 8
Amendment 411 #
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 mediaand 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 computer and smartphone games;
Amendment 411 #
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 mediaand 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 computer and smartphone games;
Amendment 414 #
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 half of those set in Directive 2003/10/ EEC.
Amendment 414 #
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 half of those set in Directive 2003/10/ EEC.
Amendment 421 #
Proposal for a regulation
Annex II – Part III – point 2
Annex II – Part III – point 2
2. Toys that are themselves substances or mixtures, such as fingerpaint or modeling clay, shall comply also with Regulation (EC) No 1272/2008 as well as with the labelling requirements laid down in Regulation (EC) No 1223/2009.
Amendment 421 #
Proposal for a regulation
Annex II – Part III – point 2
Annex II – Part III – point 2
2. Toys that are themselves substances or mixtures, such as fingerpaint or modeling clay, shall comply also with Regulation (EC) No 1272/2008 as well as with the labelling requirements laid down in Regulation (EC) No 1223/2009.
Amendment 424 #
Proposal for a regulation
Annex II – Part III – point 8
Annex II – Part III – point 8
8. Cosmetic toys, such as play cosmetics for dolls or children, shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the Council43 . _________________ 43 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
Amendment 424 #
Proposal for a regulation
Annex II – Part III – point 8
Annex II – Part III – point 8
8. Cosmetic toys, such as play cosmetics for dolls or children, shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the Council43 . _________________ 43 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
Amendment 427 #
Proposal for a regulation
Annex II – Part V – point 2
Annex II – Part V – point 2
2. A toy intended for use by children under 36 months or intended to be put in the mouth shall be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer’s instructions.
Amendment 427 #
Proposal for a regulation
Annex II – Part V – point 2
Annex II – Part V – point 2
2. A toy intended for use by children under 36 months or intended to be put in the mouth shall be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer’s instructions.
Amendment 432 #
Proposal for a regulation
Annex II – Part A – point 2 a (new)
Annex II – Part A – point 2 a (new)
2 a. Toys shall not contain per- and polyfluorinated alkyl substances (PFASs) and bisphenols, unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material.
Amendment 432 #
Proposal for a regulation
Annex II – Part A – point 2 a (new)
Annex II – Part A – point 2 a (new)
2 a. Toys shall not contain per- and polyfluorinated alkyl substances (PFASs) and bisphenols, unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material.
Amendment 433 #
Proposal for a regulation
Annex II – Part A – point 3 a (new)
Annex II – Part A – point 3 a (new)
3 a. Toys intended for use by children under 36 months or toys intended to be placed in the mouth shall not contain any fragrances.
Amendment 433 #
Proposal for a regulation
Annex II – Part A – point 3 a (new)
Annex II – Part A – point 3 a (new)
3 a. Toys intended for use by children under 36 months or toys intended to be placed in the mouth shall not contain any fragrances.
Amendment 435 #
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/kg:the limit of detection.
Amendment 435 #
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/kg:the limit of detection.
Amendment 437 #
Proposal for a regulation
Annex II – Part B – point 1 – introductory part
Annex II – Part B – point 1 – introductory part
1. The names of the following fragrance allergens shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, as well as in the product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 100 mg/kg:
Amendment 437 #
Proposal for a regulation
Annex II – Part B – point 1 – introductory part
Annex II – Part B – point 1 – introductory part
1. The names of the following fragrance allergens shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, as well as in the product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 100 mg/kg:
Amendment 440 #
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
Annex III – point 1 – paragraph 2 – introductory part
All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram asuch as the followings:
Amendment 440 #
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
Annex III – point 1 – paragraph 2 – introductory part
All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram asuch as the followings:
Amendment 451 #
Proposal for a regulation
Annex V – point 5
Annex V – point 5
(5) Copies of documents that the manufacturer has submitted to any notified body, where relevant;
Amendment 451 #
Proposal for a regulation
Annex V – point 5
Annex V – point 5
(5) Copies of documents that the manufacturer has submitted to any notified body, where relevant;