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

Removed: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]

Removed: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.

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

Removed:Article 50 Committee procedure

Removed: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.

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

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

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

Removed:CHAPTER IX CONFIDENTIALITY AND PENALTIES

Removed:Article 51 Confidentiality

Removed: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]

Removed:(a) personal data;

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

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

Removed: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.

Removed: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.

Removed: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.

Removed:Article 52 Penalties

Removed: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.

Removed:CHAPTER IXA AMENDMENTS

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

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

Removed:‘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]

Removed:CHAPTER X FINAL PROVISIONS

Removed:Article 53 Repeal

Removed: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].

Removed: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.

Removed:Article 54 Transitional provisions

Removed: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]

Removed: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]

Removed:2. Chapter VII 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 30 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 3050 months after the date of entry into force of this Regulation]. [Am. 197]

Removed: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 4224 months after the date of entry into forceapplication of this Regulation], unless they expire before that date. [Am. 245]

Removed:Article 55 Evaluation and review

Removed:1. By … [OP please insert the date = the first day of the month following 6068 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. The report shall assess:

Removed:(1) whether this Regulation, and in particular the provisions in Chapter IV, achieved the objective of ensuring a high level of protection of health and safety of children and shall assess the possibility to include adaptive toys in the scope of this Regulation;

Removed:(2) the Regulation’s effect on the safety of toys' users and the proper functioning of the internal market, as well as a detailed summary of the effects on businesses, including costs of operations and competitiveness, in particular for SMEs;

Removed:(3) the presence of chromium, cadmium, mercury and lead in toys and their effect on the safety of toys’ users. [Am. 199]

Removed:2. Where the Commission finds it appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.

Removed:Article 56 Entry into force and application

Removed:This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Removed:It shall apply 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].

Removed:However, Articles 2(3), 17(10), 24 to 40, and 46 to 52, shall apply from … [OP: please insert the date of entry into force of this Regulation]. [Am. 200]

Removed:This Regulation shall be binding in its entirety and directly applicable in all Member States.

Removed:Done at …,

Removed:For the European Parliament For the Council

Removed:The President The President

Removed:Annex I

Removed:PRODUCTS TO WHICH THIS REGULATION DOES NOT APPLY

Removed:Part I – Toys excluded from the scope of this Regulation

Removed:1. Playground equipment intended for public use;

Removed:2. automatic playing machines, whether coin operated or not, intended for public use;

Removed:3. toy vehicles equipped with combustion engines;

Removed:4. toy steam engines

Removed:Part II – Products that are not considered as toys within the meaning of this Regulation

Removed:1. Decorative objects for festivities and celebrations;

Removed:2. products for collectors, provided that the product or its packaging bears a visible and legible indication that it is intended for collectors of 14 years and above. Examples of this category are:

Removed:(a) detailed scale models;

Removed:(b) kits for the assembly of detailed scale models;

Removed:(c) folk dolls and decorative dolls and other similar articles;

Removed:(d) historical replicas of toys; and