What changed between the adopted text of 13 Mar 2024 and the adopted text of 25 Nov 2025

Removed:4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not and, where necessary, propose appropriate measures.

Removed:The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Removed:5. The information referred to in paragraph 3 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.

Removed:Article 45 Commission action concerning toys that present a risk

Removed:1. Where the Commission becomes aware of a toy or a specific category of toys made available on the market which presents a risk to the health and safety of persons but is nonetheless either in compliance with the particular safety requirements or raising doubts about such compliance, it is empowered to adopt implementing acts setting out measures to ensure that the toy or category of toys, when made available on the market, no longer presents that risk, to withdraw it from the market or to recall it where all of the following conditions are met:

Removed:(a) it emerges from prior consultations with the market surveillance authorities that their approaches to dealing with the risk differ from one market surveillance authority to another;

Removed:(b) the risk cannot, in view of its nature, be dealt with under other procedures laid down by this Regulation.

Removed:2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50(3). On duly justified imperative grounds of urgency relating to the protection of the health and safety of persons, the Commission is empowered to adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 50(4).

Removed:CHAPTER VIII DELEGATED POWERS AND COMMITTEE PROCEDURE

Removed:Article 46 Delegated powers

Removed: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. [Am. 171]

Removed:2. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Article 19(1) by setting out that additional information among the information listed in Annex VI or that information on the non-compliance of the toy when measures are taken in accordance with Articles 41(2) or (4) and Article 44(1) is to be stored in the registry.

Removed:When adopting the delegated acts in accordance with the first subparagraph, the Commission shall take into account the following criteria:

Removed:(a) coherence with other relevant Union acts, where relevant;

Removed:(b) the need to allow for the verification of the authenticity of the digital product passport; [Am. 172]

Removed:(c) the relevance of the information for improving the efficiency and effectiveness of market surveillance checks and customs controls for toys;

Removed:(d) the need to avoid disproportionate administrative burden for economic operators.

Removed:3. The Commission is empowered to adopt delegated acts in accordance with Article 47 to supplement this Regulation by determining which of the information stored in the registry is to be controlled by customs authorities, in addition to the information set out in Article 20(3).

Removed:4. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex VII to this Regulation in order to adapt the list of commodity codes and product descriptions to be used for the purposes of Article 20(8). Those adaptations shall be based on the list set out in Annex I to Regulation (EEC) No 2658/87.

Removed:5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex III in order to adapt it to technical and scientific progress.

Removed: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. While assessing the requests for exemption and its duration, the Commission shall take into account the availability of alternatives and any potential adverse impacts on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant. Six months after the entry into force of this Regulation, the Commission shall adopt delegated acts in accordance with Article 47 to amend Part C of the Appendix to Annex II in regard to nickel, in order to set out the validity period for the exemption from the generic prohibition under Part III, point 4, of Annex II, for that substance. The Commission shall justify any exemption granted and make this publicly available in an easily accessible and user-friendly manner. [Am. 251]

Removed: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 may onlyshall not be permitted whenunless all of the following conditions are met: [Am. 174]

Removed:(a) it has been found to be safe by the European Chemicals Agency (ECHA), in particular in view due to the absence of the possibility of exposure, including the overall exposure from other sources, and under reasonably foreseeable conditions of use in accordance with Article 5(2), first subparagraph, taking particular account of the vulnerability of children; [Am. 175]

Removed:(aa) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible; [Am. 176]

Removed:(b) there are no suitable alternative substances or mixtures available, as established by ECHA based on an analysis of alternatives;

Removed:(c) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.

Removed:7a. 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:

Removed:(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;

Removed:(b) elimination or substitution via design changes or the use of other materials or components without such substances or mixtures is not technically possible;

Removed:(c) there are no suitable alternative substances or mixtures available, as established by the ECHA based on an analysis of alternatives;

Removed:(d) the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006. [Am. 177]

Removed:7b. Exemptions from the general prohibition in accordance with paragraphs 7 and 7a shall be time-limited. The validity period for each exemption shall be subject to a review and may be renewed, on a case-by-case basis for each substance or mixture. [Am. 252]

Removed:8. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Parts A and B of the Appendix to Annex II in order to adapt them to technical and scientific progress, by:

Removed:(a) introducing conditions for the presence of substances or mixtures in toys and, in particular, limit values for specific substances or mixtures in toys, including limit values for traces of prohibited substances or mixtures as referred to in Part III, point 4, of Annex II;

Removed:(b) modifying the conditions or limit values for the presence of substances and mixtures in toys.

Removed:9. For the purposes of paragraphs 6 and 7- 8, the Commission shall systematically and regularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In those evaluations, the Commission shall take into account reports of market surveillance bodies and scientific evidence presented by Member States and stakeholders. [Am. 178]

Removed:Article 47 Exercise of the delegation

Removed:1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Removed: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 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 of time. [Am. 179]

Removed:3. The delegation of powers referred to in Article 46 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Removed: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. [Am. 180]

Removed:5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Removed: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 twothree 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 twothree months at the initiative of the European Parliament or of the Council. [Am. 181]

Removed:Article 48 Requests for assessment for the purposes of Article 46(6)

Removed:1. Requests for an assessment of a substance or mixture prohibited under Part III, point 4, of Annex II for the purposes of Article 46(6) shall be submitted to ECHA using the format and submission tools referred to in paragraph 3 of this Article. The requests shall be made publicly available in an easily accessible and user-friendly manner. [Am. 182]

Removed:2. Without prejudice to the second subparagraph of this paragraph, any person submitting a request for assessment under paragraph 1 may request that certain confidential business information is not to be made publicly available in accordance with the relevant Union law. The request for confidentiality shall be accompanied by a justification as to why the disclosure of the information could be harmful to the commercial interests of the person submitting the request for assessment or of any other party concerned.

Removed:The following information held by the ECHA shall be made publicly available, free of charge, and in a user-friendly format:

Removed:(a) the name of the legal person making the request;

Removed:(b) the name of the substance or mixture for which there is a request for an exemption;

Removed:(c) type of toy or toy component;

Removed:(d) the substitution plan, where relevant; [Am. 183]

Removed:3. Before … [the first day of the month following 1 month after the date of entry into force of this Regulation], the ECHA shall draw up and make publicly available a format and tools for the submission of requests for assessment referred to in paragraph 1 as well as technical and scientific guidance on how to submit such requests. [Am. 184]

Removed:Article 49 Opinions from ECHA

Removed:1. For the purposes of Article 46(6), ECHA shall provide opinions to the Commission on the use in toys of substances or mixtures that are prohibited under Part III, point 4 of Annex II, where a request for an assessment is submitted to it in accordance with Article 48(1). ECHA shall assess in its opinions whether the criteria set out in Article 46(6), second subparagraph, points (a) and (b)46(7) and Article 46(7a), are met for a specific use. [Am. 185]

Removed:1a. The Commission shall issue guidelines as to how this assessment shall be conducted, in particular as regards the availability of alternative substances or mixtures and how to address the combined exposure effects under this Regulation. [Am. 186]

Removed:2. The ECHA may request the person submitting the request for assessment or any third party to submit additional information within a specified period. The ECHA shall take into account any information submitted by third parties. When the ECHA considers it necessary for the determination of an adequate validity period for the exemption, it may also request the person submitting the request for assessment to submit a substitution plan. [Am. 187]

Removed:3. The opinions referred to in paragraph 1 shall be sent to the Commission and made publicly available in an easily accessible and user-friendly manner within a period of 12 months from the receipt of the request for an assessment. [Am. 188]

Removed:4. That period may be extended once by a period of up to 6 months if ECHA needs to request information from a third party or if a high number of requests for assessment are submitted to ECHA under Article 48(1).

Removed:5. ECHA shall re-evaluate its opinions on the use in toys of substances or mixtures listed in Part C of the Appendix to Annex II at least every 5 years from the date of entry into force of a delegated act adopted in accordance with Article 46(6).

Removed:6. The Commission shall request an opinion from ECHA on the use in toys of substances or mixtures listed in Part C of the Appendix to Annex II as soon as new scientific information or technical developments that may affect the permitted use of a specific substance or mixture in toys becomes known to the Commission. [Am. 189]