Changes from plenary report to plenary report

RemovedArticle 48 – paragraph 1: 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.

RemovedArticle 48 – paragraph 2: 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. / The following information held by the ECHA shall be made publicly available, free of charge, and in a user-friendly format: / (a) the name of the legal person making the request; / (b) the name of the substance or mixture for which there is a request for an exemption; / (c) type of toy or toy component; / (d) the substitution plan, where relevant;

RemovedArticle 48 – paragraph 3: 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.

RemovedArticle 49 – paragraph 1: 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(7) and Article 46(7a), are met for a specific use.

RemovedArticle 49 – paragraph 1 a (new): 1a. TheCommission 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.

RemovedArticle 49 – paragraph 2: 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.

RemovedArticle 49 – paragraph 3: 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.

RemovedArticle 49 – paragraph 6: 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.

RemovedArticle 49 – paragraph 7: 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

RemovedArticle 49 – paragraph 8 a (new): 8a. The ECHA shall be provided with the adequate resources to support its work.

RemovedArticle 51 – paragraph 1 – introductory part: 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:

RemovedArticle 51 – paragraph 1 – point b a (new): (ba) the effective implementation of this Regulation, in particular for the purpose of investigations, inspections or audits.

RemovedChapter IX a (new) – Article 52 a (new): Chapter IXa / AMENDMENTS / Article 52a / Amendment to Directive 2014/53/EU / In Article 10(3) of the Directive 2014/53/EU the following text is 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.’

RemovedArticle 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 50 months after the date of entry into force of this Regulation].

RemovedArticle 54 – paragraph 1 a (new): 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.

RemovedArticle 54 – paragraph 2: 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 … [the first day of the month following 50 months after the date of entry into force of this Regulation].

RemovedArticle 54 – paragraph 3: 3. EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [the first day of the month following 50 months after the date of entry into force of this Regulation], unless they expire before that date.

RemovedArticle 55 – paragraph 1: 1. By … [the first day of the month following 68 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: / 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; / 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; / 3) the presence of chromium, cadmium, mercury and lead in toys and their effect on the safety of toys’ users.

RemovedArticle 56 – paragraph 3: However, Articles 2(3), 17(10), 24 to 40, and 46 to 52, shall apply from … [the date of entry into force of this Regulation].

RemovedAnnex I – Part II – point 3: 3. sports equipment, including roller skates, inline skates, and other means of transport, such as skateboards and scooters intended for children with a body mass of more than 20 kg;

RemovedAnnex I – Part II – point 5: deleted

RemovedAnnex I – Part II – point 14: 14. electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals or components, unless the electronic equipment or the associated peripherals or components are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels;

RemovedAnnex I – Part II – point 19 a (new): 19a. Books intended for children older than 36 months, that are made entirely of paper or cardboard, without additional materials or components.

RemovedAnnex II – Part I – point 9: 9. Toys that are designed to emit a sound 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 limit values shall be set through a delegated act, while the maximum values shall not exceed those set in Directive 2003/10/EEC.

RemovedAnnex II – Part II – point 2 – point a – point 5: (5) hazard classes 3.9, 3.10 and 3.11;

RemovedAnnex II – Part III – point 2: 2. Toys that are themselves substances or mixtures shall comply also with Regulation (EC) No 1272/2008 as well as with the labelling requirements laid down in Regulation (EC) No 1223/2009.

RemovedAnnex II – Part III – point 4 – introductory part: 4. The use in toys, components of toys or micro-structurally distinct parts of toys, of substances or mixtures meeting the criteria laid down in Article 57 of this Regulation and being identified in accordance with Article 59(1) of Regulation (EC) No 1907/2006, classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or meeting the criteria for classification in any of the following categories is prohibited:

RemovedAnnex II – Part III – point 4 – point b: (b) endocrine disruption category 1 or 2, for human health and the environment;

RemovedAnnex II – Part III – point 4 – point d a (new): (da) skin sensitisation category 1;

RemovedAnnex II – Part III – point 4 – point d b (new): (db) persistent, bioaccumulative and toxic;

RemovedAnnex II – Part III – point 4 – point d c (new): (dc) very persistent, very bioaccumulative;

RemovedAnnex II – Part III – point 4 – point d d (new): (dd) persistent, mobile and toxic;

RemovedAnnex II – Part III – point 4 – point d e (new): (de) very persistent, very mobile.

RemovedAnnex II – Part III – point 4 a (new): (4a) The use in toys, components of toys or micro-structurally distinct parts of toys, of per- and polyfluoroalkyl substances (PFAS) and of bisphenols is prohibited. Toys intended for use by children under 36 months or other toys intended to be placed in the mouth shall not contain any fragrances.

RemovedAnnex II – Part III – point 7 – point c: (c) toy components necessary for electronic or electric functions of the toy where the substance or mixture is fully inaccessible to children, including by inhalation, when the toy is used as specified in the first subparagraph of Article 5(2).

RemovedAnnex II – Part III – point 8: 8. Cosmetic toys, such as play cosmetics for dolls or children, slime, finger-paint or modelling clay shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the Council43 .

RemovedAnnex II – Part IV – point 1 – paragraph 2: Internal voltages shall not exceed 24 volts DC or the equivalent AC voltage unless it is ensured that the voltage and the current combination generated do not lead to any risk for health and safety or any harmful electric shock, even when the toy is broken.

RemovedAnnex 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.

Removed2. N-nitrosamines and N-nitrosatable substances are prohibited in toys where the migration of those substances is equal to or higher than:

RemovedAnnex 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 10 mg/kg:

RemovedAnnex 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 digital product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 10 mg/kg:

RemovedAnnex III – point 1 – paragraph 2 – introductory part: All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram such as the following pictogram, which shall be displayed in a prominent way:

RemovedAnnex III – point 2 – paragraph 3: The pictogram shall be at least 10 mm diameter in size and shall contain a red circle with a white background and with the text and face in black colour. These warnings shall be accompanied by a brief indication, which may appear in the instructions for use, of the specific hazard calling for this precaution.

RemovedAnnex III – point 8 – paragraph 2 – introductory part: Packaging of food containing toys or packaging of food or co-mingled with toys shall bear the following warning:

RemovedAnnex IV – Part I – point 4 – introductory part: 4. CE marking and digital product passport

RemovedAnnex IV – Part I – point 4 – point 4.2: 4.2. The manufacturer shall draw up the digital product passport for a toy model and ensure that together with the technical documentation, it remains available for 10 years after the last item of the toy model has been placed on the market. The digital product passport shall identify the toy for which it has been drawn up.

RemovedAnnex IV – Part II – point 9: 9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the last item of the toy model has been placed on the market.

RemovedAnnex IV – Part III – title: III Module C: Conformity to type based on internal production control

RemovedAnnex IV – Part III – point 3 – introductory part: 3. CE marking and digital product passport

RemovedAnnex IV – Part III – point 3 – point 3.2: 3.2. The manufacturer shall create a digital product passport for a toy model and ensure that it remains available for 10 years after the last item of the toy model has been placed on the market. The digital product passport shall identify the toy for which it has been drawn up.

RemovedAnnex V – point 5: (5) Copies of documents that the manufacturer has submitted to any notified body, where relevant;

RemovedAnnex VI – subheading 1: DIGITAL PRODUCT PASSPORT

RemovedAnnex VI – Part I – title: I Information to be included in the digital product passport

RemovedAnnex VI – Part I – point d: (d) object of the passport (identification of toy allowing traceability);

RemovedAnnex VI – Part I – point j a (new): (ja) the communication channel as provided for in Article 7(11);

RemovedAnnex VI – Part I – point j b (new): (jb) if the toy includes radio equipment the information provided for in Annex VI of Directive 2014/53/EU of the European Parliament and of the Council;

RemovedAnnex VI – Part I – point j c (new): (jc) a link to the Safety Business Gateway and to the section of the Safety Gate Portal referred to in Articles 27 and 34(3) of Regulation 2023/988 for the transmission of information about toys that might present a risk to the health and safety of consumers.

RemovedAnnex VI – Part I – point k: deleted

RemovedAnnex VI – Part II – title: II Information that may be included in the digital product passport

RemovedAnnex VI – Part II – point b a (new): (ba) image or drawing of the toy.