Changes from report parliamentary committee draft to plenary report

AddedArticle 14 – paragraph 2 – subparagraph 1 – point b – point 1: deleted

AddedArticle 14 – paragraph 2 – subparagraph 1 – point b – point 2: deleted / (deleted) / (deleted) / (deleted)

AddedArticle 14 – paragraph 2 – subparagraph 2: deleted

AddedArticle 14 – paragraph 2 a (new): 2a. When preparing the delegated act referred to in paragraph 2, the Commission shall take into account the views of the relevant bodies and expert groups.

AddedArticle 14 – paragraph 3: 3. When references of a harmonised standard are published in the Official Journal of the European Union, the Commission shall assess whether the delegated acts referred to in paragraph 2 of this Article which cover the same essential safety requirement need to be repealed or amended.

AddedChapter IV – title: DIGITAL PRODUCT PASSPORT

AddedArticle 17 – title: Digital Product passport

AddedArticle 17 – paragraph 1: 1. Before placing a toy on the market, manufacturers shall draw up a digital product passport for that toy. The digital product passport shall meet the requirements laid down in this Article and Article 18 and other relevant Union harmonised legislation requiring an EU declaration of conformity and it shall replace all EU declarations of conformity required.

AddedArticle 17 – paragraph 2 – introductory part: 2. The digital product passport shall:

AddedArticle 17 – paragraph 2 – point b: (b) state that compliance of the toy with the requirements set out in this Regulation and in other Union harmonised legislation requiring an EU declaration of conformity, in particular, the essential safety requirements, has been demonstrated;

AddedArticle 17 – paragraph 2 – point f: (f) depending on access rights, be accessible to consumers or other end-users, market surveillance authorities, customs authorities, notified bodies, the Commission and other economic operators in accordance with paragraph 2a and taking into account the need to protect confidential business information and trade secrets in accordance with Directive (EU) 2016/943;

AddedArticle 17 – paragraph 2 – point g: (g) be available for a period of 10 years after the last item of the 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 digital product passport;

AddedArticle 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.

AddedArticle 17 – paragraph 2 a (new): 2a. The access rights referred to in paragraph 2, point (f) of this Article shall comprise: / (a) information accessible to consumers or other end-users listed in points (c), (d), (i), (j), (ja), (jb) and (jc) of Part I of Annex VI and, where applicable, points (a) and (b) of Part II of Annex VI; / (b) information accessible only to market surveillance authorities, customs authorities, notified bodies, and the Commission listed in points (a) to (j) of Part I of Annex VI and, where applicable, points (a) and (b) of Part II of Annex VI.

AddedArticle 17 – paragraph 3: 3. In addition to the information referred to in paragraph 2, the digital product passport may contain the information set out in Part II of Annex VI.

AddedArticle 17 – paragraph 4: 4. By creating the digital 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.

AddedArticle 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 shall 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.

AddedArticle 17 – paragraph 7: 7. Where other Union legislation applying to toys requires a digital product passport, a single digital product passport shall be created for toys containing the information required under this Regulation as well as any other information required for the digital product passport by that other Union legislation.

AddedArticle 17 – paragraph 8: deleted

AddedArticle 17 – paragraph 10 – subparagraph 1 – introductory part: The Commission is empowered to adopt delegated acts in accordance with Article 47 to supplement this Regulation by determining the basic technical requirements related to the digital product passport for toys by.....[12 months after the entry into force of this Regulation]. Those requirements shall cover in particular the following:

AddedArticle 17 – paragraph 10 – subparagraph 1 – point d: (d) the actors that may introduce or update the information in the digital product passport, including where needed the creation of a new passport, including manufacturers, notified bodies, competent national authorities, and the Commission, or any organisation acting on their behalf, and the types of information they may introduce or update.

AddedArticle 17 – paragraph 10 – subparagraph 2: Those delegated acts shall be adopted in accordance with the procedure set out in Article 46 (2).

AddedArticle 18 – title: Technical design and operation of the digital product passport

AddedArticle 18 – paragraph 1: 1. The digital product passport shall be fully interoperable with digital product passports required by other Union legislation in relation to the technical, semantic and organisational aspects of end-to-end communication and data exchange.

AddedArticle 18 – paragraph 2: 2. All information included in the digital product passport shall be based on open standards developed with an interoperable format, including for the purpose of transmitting information via the Safety Business Gateway and the Safety Gate Portal referred to in Articles 27 and 34 of Regulation 2023/988. It shall be machine readable, structured and searchable in accordance with the essential requirements set out in Regulation .../... [Ecodesign Regulation for Sustainable Products]. The digital product passport shall be designed and operated in an accessible manner, and incorporate the principle of security and privacy by design.

AddedArticle 18 – paragraph 3: 3. Consumers or other end-users, economic operators and other relevant actors shall have access on the basis of their respective access rights in accordance with Union legislation to the digital product passport free of charge.

AddedArticle 18 – paragraph 3 a (new): 3a. Consumers shall not be requested to download and install any software, register, or to provide a password to access the digital product passport.

AddedArticle 18 – paragraph 4: 4. The data included in the digital product passport shall be stored by the economic operator responsible for its creation or by operators authorised to act on their behalf.

AddedArticle 18 – paragraph 5: 5. Where the data included in the digital product passport is stored or otherwise processed by an operator authorised to act on behalf of the economic operators placing the toy on the market, that other operator shall not be allowed to sell, re-use or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services.

AddedArticle 18 – paragraph 6: 6. Economic operators shall not track, analyse or use any usage information for purposes other than what is absolutely and strictly necessary for providing the information on the digital product passport online.

AddedArticle 19 – title: Digital product passport registry

AddedArticle 19 – paragraph 1: 1. Before placing a toy on the market, and following the adoption of delegated acts in accordance with Article 17(10) of this Regulation, economic operators shall upload, in the registry established under Article 12(1) of Regulation (EU) …/… [OJ insert serial number for Ecodesign Requirements for Sustainable Products] (the ‘registry’), the unique product identifier and unique operator identifier for that toy.

AddedArticle 19 – paragraph 2: 2. The Commission, market surveillance authorities and customs authorities shall have efficient access to the information stored in the registry referred to in paragraph 1 for carrying out their duties pursuant to this Regulation.

AddedArticle 20 – title: Customs controls relating to the digital product passport

AddedArticle 20 – paragraph 7: 7. Customs authorities may retrieve and use the information on toys included in the digital product passport and in the registry for carrying out their duties pursuant to Union legislation, including for risk management in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.

AddedArticle 20 a (new): Article 20a / Assistance for SMEs / 1. The Commission shall provide comprehensive assistance, in cooperation with the relevant national authorities, to SMEs that are required to establish a digital product passport for toys, by providing them with tailor-made guidance on how to efficiently set up and operate a digital product passport for toys and an automatic translation tool for the languages referred to in Article 17(2) point (e). / This support, referred to in the first subparagraph, shall be provided no later than ....[12 months after the entry into force of this Regulation]. / 2. The Commission shall evaluate the possibility of setting up an online tool to provide SMEs with the basic information and functions necessary to establish a digital product passport for their products.

AddedArticle 21 – paragraph 1: 1. In order to demonstrate that a toy complies with the essential safety requirements, manufacturers shall, before placing a toy on the market, carry out a safety assessment which shall at least the following: / (a) cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards; / (b) in relation to chemical hazards, take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, taking into account the obligations under Regulation (EC) No 1907/2006 and the conditions set out therein; / (c) be updated whenever additional relevant information is available. / The safety assessment shall be included in the technical documentation referred to in Article 23.

AddedArticle 21 – paragraph 2: deleted / (deleted) / (deleted) / (deleted) / (deleted)

AddedArticle 22 – paragraph 3 – point c: (c) where one or more of the harmonised standards referred to in point (a) has been published with a restriction, in the event that the restriction is relevant to the toy in question;

AddedArticle 26 – paragraph 4: 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, nor shall they offer or provide consultancy services on a commercial or competitive basis, however the notifying authority shall provide information to the economic operators about the procedures for the assessment and the conformity assessment bodies if requested to do so.

AddedArticle 26 – paragraph 6: 6. A notifying authority shall have a sufficient number of competent personnel and adequate resources at their disposal for the efficient performance of their tasks.

AddedArticle 28 – paragraph 6 – subparagraph 3: A conformity assessment body shall have the resources necessary to efficiently perform the technical and administrative tasks connected with the conformity assessment activities and shall have access to all necessary equipment or facilities.

AddedArticle 28 – paragraph 7 – point b: (b) in-depth knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

AddedArticle 28 – paragraph 7 – point c: (c) in-depth knowledge and understanding of the requirements set out in this Regulation, of the applicable harmonised standards referred to in Article 13 of this Regulation and the common specifications referred to in Article 14 of this Regulation;

AddedArticle 28 – paragraph 10: 10. The personnel of a conformity assessment body shall respect professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Intellectual property rights and trade secrets, in accordance with Directive (EU) 2016/943, shall be protected.

AddedArticle 41 – title: National measures concerning toys which are not compliant with the particular safety requirements

AddedArticle 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 children, they shall carry out an evaluation in relation to the toy concerned covering all the requirements laid down in this Regulation. They shall immediately inform the relevant economic operator, in accordance with Article 4(1) and (2) of Regulation (EU) 2019/1020, of the procedure they have initiated and of the possible risk they have identified in the toy, and give the economic operator the opportunity to react. The relevant economic operators shall cooperate, as necessary, with the market surveillance authorities for that purpose.

AddedArticle 41 – paragraph 9: 9. The information referred to in paragraphs 2, 4, 6 and 8 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation on market surveillance authorities to notify measures taken against products presenting a serious risk in accordance with Article 20 of Regulation (EU) 2019/1020 and strictly enforce Article 19 of that Regulation given the vulnerability of children to defective, unsafe or counterfeit products.

AddedArticle 43 – paragraph 1 – point c: (c) the digital product passport has not been drawn up in accordance with Article 17;

AddedArticle 43 – paragraph 1 – point d: (d) the data carrier through which the digital product passport is accessible has not been affixed in accordance with Article 17(5);

AddedArticle 46 – paragraph 1: 1. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VI as regards the information to be provided in the digital product passport, in order to adapt it to technical and scientific progress and to the level of digital readiness of market surveillance authorities and of users and their supervisors.

AddedArticle 46 – paragraph 2 – subparagraph 2 – point b: (b) the need to allow for the verification of the authenticity of the digital product passport;

AddedArticle 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 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. When developing such delegated acts, the Commission shall take into account the availability of viable alternative substances or mixtures and any potential adverse impact that such a delegated act could have on innovation and on relevant manufacturers.

AddedArticle 46 – paragraph 7 – introductory part: 7. The use in toys of a substance or mixture prohibited under Part III, point 4, points (a), (b), (db), (dc), (dd) and (de) of Annex II shall not be permitted unless all of the following conditions are met:

AddedArticle 46 – paragraph 7 – point a: (a) it has been found to be safe by the European Chemicals Agency (ECHA) due to the absence of the possibility of exposure under reasonably foreseeable conditions of use in accordance with Article 5(2), first subparagraph, taking particular account of the vulnerability of children;

AddedArticle 46 – paragraph 7 – point a a (new): (a a) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible;

AddedArticle 46 – paragraph 7 a (new): 7 a. The use in toys of a substance or mixture prohibited under Part III, point 4, points (c), (d) and (da) of Annex II shall not be permitted unless all of the following conditions are met: / (a) it has been found to be safe by the ECHA, in particular in view of exposure, including the overall exposure from all potential sources as well as any known additional hazards from combined exposure to the different substances and mixtures present in the toy, and taking into account, in particular, the vulnerability of children; / (b) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible; / (c) there are no suitable alternative substances or mixtures available, as established by the ECHA based on an analysis of alternatives; / (d) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.

AddedArticle 46 – paragraph 9: 9. For the purposes of paragraphs 6 - 8, the Commission shall systematically and regularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In those evaluations, the Commission shall take into account reports of market surveillance bodies and scientific evidence presented by Member States and stakeholders.

AddedArticle 47 – paragraph 2: 2. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for five 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 no later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period.

AddedArticle 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.