What changed between the plenary report and the adopted text

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

Added: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]

Added: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:

Added:(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;

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

Added: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]

Added:Article 47 Exercise of the delegation

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

Added: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]

Added: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.

Added: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]

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

Added: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]

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

Added: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]

Added: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.

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

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

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

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

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

Added: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]

Added:Article 49 Opinions from ECHA

Added: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]

Added: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]

Added: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]

Added: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]

Added: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).

Added: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).

Added: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]

Added:7. For the purposes of Article 46(7), (7a) and (8), the Commission may request an opinion from ECHA on the safety of a specific substance or mixture in toys, which shall take into consideration the overall exposure to the substance or mixture from other sources and the vulnerability of children. [Am. 190]

Added:8. When preparing an opinion in accordance with the provisions set out in this Article, ECHA shall make publicly available the information on the start of the assessment, the adoption of the opinion as well as any intermediate steps in the assessment procedure. In particular, ECHA shall make the draft opinions publicly available and provide an opportunity for any interested party to comment on those opinions within a period of at least 4 weeks.

Added:8a. The ECHA shall be provided with the adequate resources to support its work. [Am. 191]

Added:Article 50 Committee procedure

Added:1. The Commission shall be assisted by a Committee on Toy Safety. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Added:2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Added:3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Added:4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Added:CHAPTER IX CONFIDENTIALITY AND PENALTIES

Added:Article 51 Confidentiality

Added:1. Competent national authorities, notified bodies, the 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: [Am. 192]

Added:(a) personal data;

Added:(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless disclosure is in the public interest.

Added:(ba) the effective implementation of this Regulation, in particular for the purpose of investigations, inspections or audits. [Am. 193]

Added:2. Without prejudice to paragraph 1, information exchanged on a confidential basis between the competent national authorities and between competent national authorities and the Commission shall not be disclosed without taking into account the opinion of the originating competent national authority.

Added:3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to the exchange of information and the dissemination of warnings, or the obligations of the persons concerned to provide information under criminal law.

Added:4. Member States and the Commission may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.

Added:Article 52 Penalties

Added: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.. 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.

Added:CHAPTER IXA AMENDMENTS

Added:Article 52a Amendment to Directive 2014/53/EU

Added:In Article 10(3) of the Directive 2014/53/EU the following text is added:

Added:‘If the radio equipment is in a toy, the digital product passport established by Regulation (EU) 2024/... of the European Parliament and of the Council of ... on the safety of toys includes also the elements set out in Annex VI and Annex VII of this Directive.’ [Am. 194]

Added:CHAPTER X FINAL PROVISIONS

Added:Article 53 Repeal

Added:Directive 2009/48/EC is repealed with effect from … [OP: please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation].

Added:References to the repealed Directive 2009/48/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VIII.

Added:Article 54 Transitional provisions

Added: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 4250 months after the date of entry into force of this Regulation]. [Am. 195]

Added:1a. Toys placed on the market in conformity with Directive 2009/48/EC and compliant with this Regulation shall not be considered non-compliant solely due to the absence of a digital product passport, provided that the same information contained in the passport is made available by the manufacturer upon the request of the parties entitled to have access to the digital product passport under this Regulation. [Am. 196]