What changed between the draft committee report and the plenary report

Removed:5. Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union;

Removed:SHORT JUSTIFICATION

Added:Recital 14: (14) Relying on digital technologies has led to new hazards in toys. Radio toys are to comply with essential requirements for the protection of privacy and internet-connected toys are to incorporate safeguards towards cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council30 . Toys which include artificial intelligence are to comply with Regulation (EU) …/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial intelligence]31 . Therefore, such toys should comply with standards of safety, security and privacy by design. Particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should be dealt with within the specific legislation.

Removed:The Council position at first reading reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second-reading stage.

Added:Recital 14 a (new): (14a) Under Regulation (EU) …/…[OJ insert serial number for Regulation laying down harmonised rules on artificial intelligence] toys containing AI systems as safety components are considered as high-risk AI. Furthermore, under the Cyber Resilience Act internet connected toys that have social interactive features (e.g. speaking or filming) or that have location tracking features are considered important products with digital elements (Class I). On the basis of those Regulations, such toys require a third party conformity assessment, unless the manufacturer has applied relevant harmonised standards.

Added:Recital 14 b (new): (14b) The safety assessment should take into account the health risk posed by digitally connected toys, where appropriate, including any risk posed to mental health. Therefore, when assessing the safety of digitally connected toys likely to have an impact on children, manufacturers should ensure that the products they make available on the market meet the highest standards of safety, security and privacy by design, in the best interests of children.

Added:Recital 15: (15) Toys should comply with physical and mechanical requirements that prevent children from getting physically injured when playing with toys and should not pose a risk of choking or suffocation to children. In order to protect children from the risk of impaired hearing, maximum values should be set out taking into account studies and the recommendations of medical experts for both impulse noise and continuous noise emitted by toys which are designed to emit a sound. Toys or their parts and their packaging which can be reasonably expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council32 . In addition, it is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys in food, since the association of a toy and food could cause a risk of choking which is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measure at Union level. Toys should also ensure sufficient protection as regards flammability or electric properties, in particular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene standards to avoid microbiological risks or other risks of infection or contamination.

Added:Recital 16: (16) Chemicals that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances), chemicals that affect the endocrine system, the respiratory system or that are toxic to a specific organ or are mobile, persistent, bioaccumalative and toxic are particularly harmful for children and the environment and should be specifically addressed in toys. Given the essential role of the endocrine system during human development, early exposure during critical periods, such as early childhood, to endocrine disruptors can lead to adverse effects even at very low doses and affect health at a later stage of life. Respiratory sensitisers can lead to an increase of childhood asthma and neurotoxic substances are particularly harmful to the developing brain of children, which is inherently more vulnerable to toxic injury than the adult brain. Persistence and bioaccumulation lead to continuous exposure and therefore enhance the risk of adverse effects. Some toxic chemicals are also mobile in the environment. Children should also be adequately protected from allergenic substances and certain metals. The requirements for chemical substances set out in Directive 2009/48/EC need to be updated and strengthened. Toys are to comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European Parliament and of the Council33. In order to provide further protection of children, who are a vulnerable group of consumers, and other persons, that legal fra…

Added:Recital 20: (20) As batteries are regulated by Regulation (EU) …/…[P.O. insert serial number for Regulation on batteries and waste batteries]35 , the requirements regarding chemical substances in toys should not apply to the batteries included in toys. However, toys that include batteries should be designed in such a way that the batteries are difficult for children to access. In situations where, due to the nature, size or form factor of the toy, or of the small electronics contained within, it would not be possible to design the toy in a way that the internal battery would be removable and replaceable by the end-user while also ensuring the safety of the child and the safe continued use of the toy, the toy could be designed in such a way as to make the battery removable and replaceable by independent operators.

Added:Recital 22 a (new): (22a) Per- and polyfluorinated alkyl substances (PFASs) are a large family of more 10 000 man-made chemicals. Since their emergence in the late 1940s, PFASs have been used in an increasingly wide range of consumer products. Exposure to the most studied PFASs has been associated with a range of adverse health effects, including thyroid disease, liver damage, obesity, diabetes and reduced response to routine vaccinations, as well as increased risk of breast, kidney and testicular cancer. Toys should not contain any per- and polyfluorinated alkyl substances (PFASs).

Added:Recital 24: (24) Where the hazards that a toy may present cannot be completely addressed by design, the residual risk should be addressed by product-related information directed at the supervisors of the children in the form of warnings, taking into account the capacity of those supervisors to take the necessary precautions. In order to make sure the information is displayed efficiently, the manufacturer can add a QR-code that provides a link to the instruction in a digital format, but should always mark warnings on the toy, on an affixed label or on the packaging.

Added:Recital 25: (25) To prevent misuse of warnings to circumvent the applicable safety requirements, the warnings provided for certain categories of toy should not be allowed if they conflict with the intended use of the toy. To ensure that supervisors are aware of any risks associated with the toy, it is necessary to ensure that the warnings are clearly intelligible, legible and visible.

Added:Recital 25 a (new): (25a) To ensure awareness of any risks associated with the toy, especially in cases where the purchase is made through distance and online sales, it should be ensured that the warnings online are clearly legible and immediately visible.

Added:Recital 32: (32) Economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that the toys they place on the market do not pose risks to the safety and health of children under normal and reasonably foreseeable conditions of use, and that they make available on the market only toys which comply with the relevant Union legislation.

Added:Recital 37: (37) Any natural or legal person that either places a toy on the market under their own name or trademark or modify a toy in such a way that compliance with applicable requirements of this Regulation may be affected, should be considered to be manufacturer for the purposes of this Regulation and should assume the obligations of manufacturer.

Added:Recital 37 a (new): (37a) Online marketplaces play a crucial role in the supply chain, allowing economic operators to reach a large number of customers. Given their important role in intermediating the sale of toys between economic operators and customers, online marketplaces should take responsibility for addressing the sale of toys that do not comply with this Regulation and should cooperate with market surveillance authorities. Directive 2000/31/EC of the European Parliament and of the Council provides the general framework for e-commerce and lays down certain obligations for online platforms. Regulation (EU) 2022/2065 regulates the responsibility and accountability of providers of intermediary services online with regard to illegal content, including products that do not comply with this Regulation.

Added:Recital 38: (38) Ensuring traceability of a toy throughout the whole supply chain, in accordance with Regulation 2023/988, helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non-compliant toys available on the market.

Added:Recital 39: (39) In order to facilitate the assessment of conformity with the requirements of this Regulation it is necessary to provide for a presumption of conformity for toys which are in conformity with the applicable harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council36 and published in the Official Journal of the European Union.

Added:Recital 40: (40) In the absence of relevant harmonised standards, the Commission should be empowered to adopt delegated acts supplementing this Regulation by setting out common specifications for the essential safety requirements of this Regulation, provided that in doing so it duly respects the standardisation organisations’ role and functions, as an exceptional fall back solution to facilitate the manufacturer’s obligation to comply with the essential requirements, when the standardisation process is blocked or when there are delays in the establishment of appropriate harmonised standards.

Added:Recital 42: (42) Manufacturers should create a digital product passport to provide information on the compliance of toys with this Regulation and with any other Union legislation applicable to toys. They should keep the digital product passport up to date according to reasonable best efforts and make any necessary changes when required. The digital product passport should replace the EU declaration of conformity under Directive 2009/48/EC, Directive 2014/53/EU and any other Union legislation applicable to toys. It should also include the elements necessary to assess the conformity of the toy with the applicable requirements and harmonised standards or other specifications or elements. In order to facilitate checks on toys by market surveillance authorities and to allow the actors in the supply chain and consumers to access information on the toy and on communication channels, the information on the digital product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the toy, its packaging or the accompanying documentation. Depending on access rights, market surveillance authorities, customs authorities, economic operators and consumers should have immediate access to the respective information on the toy through the data carrier.

Added:Recital 43: (43) To avoid duplication of investment into digitalisation by all actors involved, including manufacturers, market surveillance authorities and customs authorities, when other Union legislation requires a product passport for toys, a single product passport should be available containing the information required under this Regulation and the other Union legislation. In addition, the digital product passport should be fully interoperable with any product passport required under other Union legislation.

Added:Recital 44: (44) In particular, Regulation (EU) …/… [P.O. insert serial number for the Regulation on ecodesign requirements for sustainable products] of the European Parliament and of the Council37 also lays down requirements and technical specifications for a digital product passport, the establishment of a Commission central registry where passport information is stored and the interconnection of that registry with the customs IT systems. That Regulation may include toys within its scope in the medium term, thus requiring that a digital product passport is available for toys. Therefore, it should be possible in the future to include more precise information in the digital product passport. The digital product passport for toys created under this Regulation should therefore comply with the same requirements and technical elements as those set out in Regulation (EU) …/… [P.O. insert serial number for the Regulation on ecodesign requirements for sustainable products], including the technical, semantic and organisational aspects of end-to-end communication and data exchange.

Added:Recital 45: (45) As the digital product passport is to replace the EU declaration of conformity, it is crucial to make clear that by creating the digital product passport for a toy and by affixing the CE marking, the manufacturer declares that the toy is in compliance with the requirements of this Regulation and that the manufacturer takes full responsibility thereof.

Added:Recital 46: (46) Where other information than the elements required for the digital product passport is provided digitally, it is necessary to clarify that the different types of information need to be provided separately and clearly distinguished from each other but through a single data carrier. This will facilitate the work of market surveillance authorities but also provide clarity to consumers regarding the different types of information that are available to them in a digital format.

Added:Recital 46 a (new): (46a) The majority of toy manufacturers subject to the requirements of this Regulation are micro, small and medium sized enterprises (SMEs), for which drawing up a digital product passport is a significant challenge from an administrative and operational perspective. Therefore, the Commission should provide SMEs with additional support in order to assist them in complying with the new requirements set out in this Regulation. To this end, the Commission should publish practical guidelines and tailor-made guidance for SMEs. In particular a direct channel of communication with experts should be set up to help them perform safety assessments and to set up a digital product passport for the toys they produce.

Added:Recital 48: (48) In addition to the framework of controls established by Chapter VII of Regulation (EU) 2019/1020, customs authorities should be able to automatically verify that a digital product passport exists for imported toys subject to this Regulation in order to strengthen the controls at the Union’s external borders and prevent non-compliant toys from entering the Union market.

Added:Recital 49: (49) When toys coming from third countries are placed under the customs procedure of release for free circulation, the reference to a digital product passport for those toys should be made available to the customs authorities by the economic operator. The reference to the digital product passport should correspond to a unique product identifier that is stored in the product passport registry established under Article 12 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products] (the ‘registry’). Customs authorities should carry out an automatic verification of the product passport presented for that toy, so as to ensure that only toys with a valid reference to a unique product identifier as included in the registry are released for free circulation. To carry out that automatic verification, the interconnection between the registry and the customs IT systems as provided for in [Article 13 of Regulation (EU) …/… on ecodesign requirements for sustainable products] should be used.

Added:Recital 51: (51) The information included in the digital product passport allows customs authorities to enrich and facilitate risk management and enables more targeted controls at the Union’s external borders. Therefore, customs authorities should have the possibility to retrieve and use the information included in the digital product passport and the registry for carrying out their tasks in accordance with Union legislation, including for risk management in accordance with Regulation (EU) No 952/2013.

Added:Recital 52: (52) It is appropriate to provide for the publication of a notice in the Official Journal of the European Union indicating the date when the interconnection between the registry and the EU Customs Single Window Certificates Exchange System referred to in Article 13 of [P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable Products] becomes operational in order to facilitate public access to that information. Similar publication should be provided in case further EU customs IT systems become operational.

Added:Recital 53: (53) The automatic verification by customs of the reference to the digital product passport for toys entering the Union market should not replace or modify the responsibilities of the market surveillance authorities but only complement the overall framework for controls on products entering the Union market. Regulation (EU) 2019/1020 should continue to apply to toys so as to ensure that market surveillance authorities carry out checks of the information contained in products passports, checks on toys within the market in accordance with that Regulation and, in case of suspension of release for free circulation by the authorities designated for controls at the Union’s external borders, determine the compliance and risks of toys pursuant to Chapter VII of Regulation (EU) 2019/1020.

Added:Recital 54 a (new): (54a) In order to provide adequate expertise, support, and thorough scientific evaluations, an appropriate and stable funding for ECHA should be ensured.

Added:Recital 58: (58) If a conformity assessment body demonstrates conformity of the toy with the criteria laid down in harmonised standards, the toy should be presumed to comply with the corresponding requirements set out in this Regulation.

Added:Recital 67 a (new): (67a) Under Article 20 of the Regulation (EU) 2023/988 manufacturers are required to notify, through the Safety Business Gateway, of any occurrence of an injury as a result of using a product. On the basis of that information, the Commission should evaluate the need and the feasibility of a Pan-European injury database that could bring additional information and knowledge to economic operators, relevant stakeholders and experts, with a view to assessing the effectiveness of the specific Union regulatory framework for toys.

Added:Recital 69: (69) In order to take into account technical and scientific progress as well as the level of digital readiness of market surveillance authorities and of children and their supervisors, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should also be delegated to the Commission in respect of amending this Regulation with regard to the information that is to be included in the digital product passport and the information that is to be included in the digital product passport registry.

Added:Recital 71: (71) When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert and stakeholder level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making40 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

Added:Recital 72: (72) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish the detailed technical requirements for the digital product passport for toys, and to determine whether a specific product or group of products is to be considered a toy for the purposes of this Regulation. In exceptional cases where it is necessary in order to address new emerging risks that are not appropriately addressed by the particular safety requirements, the Commission should be empowered to adopt implementing acts setting out specific measures against toys or categories of toys made available on the market which present a risk for children. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council41 .

Added:Article 1 – title: Objective and subject matter

Added:Article 1 – paragraph 1: The objective of this Regulation is to improve the functioning of the internal market while providing for a high level of consumer protection and a high level of protection of health and safety of children and other persons.

Added:Article 1 – paragraph 1 a (new): This Regulation lays down rules on the safety of toys and on the free movement of toys in the Union, contributing to strengthening of the internal market.

Added:Article 2 – paragraph 1 – subparagraph 2: For the purposes of this Regulation, a product shall be considered to be intended for use in play by children under 14 years of age, where a parent or supervisor can reasonably assume, by virtue of the functions, dimensions and characteristics of that product, that it is intended for use in play by children of the relevant age group.

Added:Article 2 – paragraph 3: 3. The Commission shall, before the application of this Regulation pursuant to Article 56 and where necessary to address existing safety risks after the application of this Regulation, be empowered to adopt implementing acts determining whether or not specific products or categories of products fulfil the criteria set out in paragraph 1 of this Article and therefore can or cannot be considered toys within the meaning of this Regulation. Those implementing acts shall be adopted in accordance with the procedure set out in Article 50(2).

Added:Article 2 – paragraph 3 a (new): 3a. This Regulation shall be implemented taking due account of the precautionary principle.

Added:Article 3 – paragraph 1 – point 4: (4) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that person’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;

Added:Article 3 – paragraph 1 – point 7: (7) ‘fulfilment service provider’ means fulfilment service provider as defined in Article 3, point 11, of Regulation (EU) 2019/1020;

Added:Article 3 – paragraph 1 – point 8: (8) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with this Regulation;

Added:Article 3 – paragraph 1 – point 9: (9) ‘provider of an online marketplace’ means a provider of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products according to Article 3, point (14), of Regulation (EU) 2023/988;

Added:Article 3 – paragraph 1 – point 11 a (new): (11a) ‘intended for the use by’ means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group;

Added:Article 3 – paragraph 1 – point 12 a (new): (12a) ‘essential safety requirements’ means the ‘general safety requirement’ laid down in Article 5 (2) together with the particular safety requirements set out in Annex II;

Added:Article 3 – paragraph 1 – point 13 a (new): (13a) ‘digital product passport’ means a set of data specific to a product that includes the information specified in Annex VI and that is accessible via electronic means through a data carrier;

Added:Article 3 – paragraph 1 – point 14: (14) ‘data carrier’ means data carrier as defined in Article 2 paragraph 1, point 30 of Regulation (EU) .../...) [OJ insert serial number for Ecodesign Requirements for Sustainable Products;

Added:Article 3 – paragraph 1 – point 15: (15) ‘unique product identifier’ means unique identifier as defined in Article 2 paragraph 1, point 31 of Regulation (EU) .../...) [OJ insert serial number for Ecodesign Requirements for Sustainable Products];

Added:Article 3 – paragraph 1 – point 16: (16) ‘unique operator identifier’ means unique operator identifier as defined in Article 2 paragraph 1, point 32 of Regulation (EU) .../...) [OJ insert serial number for Ecodesign Requirements for Sustainable Products];

Added:Article 3 – paragraph 1 – point 20: (20) ‘conformity assessment’ means the process demonstrating whether the essential safety requirements relating to a toy have been fulfilled;

Added:Article 3 – paragraph 1 – point 28: (28) ‘market surveillance authority’ means an authority designated by a Member State under Article 10 of Regulation (EU) 2019/1020 as responsible for organising and carrying out market surveillance in the territory of that Member State;

Added:Article 3 – paragraph 1 – point 28 a (new): (28a) ‘notifying authority' means an authority designated by a Member State under this Regulation as responsible for the assessment and notification of conformity assessment bodies in the territory of that Member State;

Added:Article 3 – paragraph 1 – point 29: (29) ‘functional toy’ means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, which brings the same level of risk as the product used by adults and which may be a scale model of such product, appliance or installation;

Added:Article 3 – paragraph 1 – point 32: (32) ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult;

Added:Article 3 – paragraph 1 – point 33: (33) ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise or combine different odours or flavours;

Added:Article 3 – paragraph 1 – point 35: (35) ‘gustative game’ means a toy the purpose of which is to allow children to make sweets or dishes through the use of food ingredients, including liquids, powders and aromas without using any heat source;

Added:Article 3 – paragraph 1 – point 36: deleted

Added:Article 4 – paragraph 1: 1. Member States shall not prohibit, restrict or impede, for reasons relating to health and safety or other aspects covered by this Regulation, the making available on the market of toys which comply with this Regulation.

Added:Article 5 – title: Essential safety requirements

Added:Article 5 – paragraph 2 – subparagraph 1: Toys shall not present a risk to the safety or health of users or third parties, when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children.

Added:Article 5 – paragraph 2 – subparagraph 1 a (new): When assessing the risk referred to in the first subparagraph, a manufacturer of digitally connected toys shall, where appropriate, according to reasonable best efforts, also take into account any risk posed to mental health, as well as the cognitive development, of children, that may arise when such toys are used in accordance with their intended use.

Added:Article 5 – paragraph 2 – subparagraph 1 b (new): A manufacturer shall apply the second subparagraph in a manner that is proportionate to its capability in relation to adequately assessing those risks.

Added:Article 6 – paragraph 1: 1. Where necessary to ensure their safe use and the health of children, toys shall bear a warning specifying appropriate user limitations. The user limitations shall include at least the minimum age of the user and, where appropriate, the required abilities of the user, the maximum weight or minimum weight of the user and the need to ensure that the toy is used only under adult supervision.

Added:Article 6 – paragraph 2 – subparagraph 1 – introductory part: The categories of toys set out in Annex III shall bear warnings:

Added:Article 6 – paragraph 2 – subparagraph 1 – point a: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point b: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point c: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point d: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point e: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point f: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point g: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point h: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point i: deleted

Added:Article 6 – paragraph 2 – subparagraph 1 – point j: deleted

Added:Article 6 – paragraph 3 – subparagraph 1: The manufacturer shall mark warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Toys which are sold without packaging shall have appropriate warnings affixed to them if the surface of the toy allows. If this is not possible, the warnings shall be placed on the label. The manufacturer may add a QR-code which provides a link to the instructions in a digital format, but shall always mark warnings on the toy, on an affixed label or on the packaging.

Added:Article 6 – paragraph 3 – subparagraph 2: Warnings which determine the decision to purchase the toy shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made through distance and online sales. Warnings shall be of sufficient size to ensure that they are also immediately visible and legible online. The Commission shall adopt implementing acts determining criteria related to the visibility and legibility of warnings, including for online sales, 12 months after the date of entry into force of this Regulation.

Added:Article 6 – paragraph 4: 4. Labels and instructions for use shall draw the attention of children or their supervisors to the inherent hazards and risks to the health and safety of children considering the age group of children for which the toys are intended, and to the ways of avoiding such hazards and risks.

Added:Article 7 – paragraph 2 – subparagraph 2 – point a: (a) create a digital product passport for the toy in accordance with Article 17;

Added:Article 7 – paragraph 2 – subparagraph 2 – point b: (b) affix the data carrier in accordance with Article 17(5);

Added:Article 7 – paragraph 2 – subparagraph 2 – point d: (d) upload the unique product identifier and the unique operator identifier of the toy in the digital product passport registry referred to in Article 19(1), as well as any other additional information determined by a delegated act adopted in accordance with Article 46(2).

Added:Article 7 – paragraph 3: 3. Manufacturers shall keep the technical documentation up to date and the digital product passport for a period of 10 years after the last item of the toy model covered by that documentation and digital product passport has been placed on the market.

Added:Article 7 – paragraph 4 – subparagraph 2: When deemed appropriate with regard to the risks presented by a toy, for the protection of health and safety of consumers, manufacturers shall, carry out sample testing of marketed toys.

Added:Article 7 – paragraph 6: 6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal or electronic address at which they can be contacted on the toy or, where that is not feasible, on its packaging or in a document accompanying the toy or in the digital product passport. Manufacturers shall indicate a single point at which they can be contacted.

Added:Article 7 – paragraph 7: 7. Manufacturers shall ensure that the toy is accompanied by instructions for use and safety information in a language or languages easily understood by consumers and other end-users including persons with disabilities if feasible, as determined by the Member State concerned. Such instructions and information shall be clear, understandable and legible.

Added:Article 7 – paragraph 8 – subparagraph 1: Where manufacturers consider, or have reason to believe, on the basis of the information in that manufacturer´s possession, that a toy which they have placed on the market is not in conformity with this Regulation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate.

Added:Article 7 – paragraph 8 – subparagraph 2 – introductory part: Where manufacturers consider, or have reason to believe, on the basis of the information in that manufacturer´s possession, that a toy presents a risk, they shall immediately provide information thereof to:

Added:Article 7 – paragraph 8 – subparagraph 2 – point a: (a) the market surveillance authorities of the Member States in which they have made the toy available, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988, giving details, in particular, of any non-compliance and of any corrective measures taken and if available, of the quantity, by Member State, of the toys still circulating on the market; and

Added:Article 7 – paragraph 10: 10. Manufacturers shall ensure that other economic operators, the economic operator referred to in Article 4(1) of Regulation (EU) 2019/1020, and providers of online marketplaces, in the supply chain concerned, are kept informed in a timely manner of any non-conformity that the manufacturers have identified.

Added:Article 7 – paragraph 11: 11. Manufacturers shall make publicly available communication channels such as a telephone number, an electronic address, a dedicated section of their website, allowing consumers or other end-users to submit complaints concerning the safety of toys and to inform the manufacturers of any accident or safety issue they have experienced with such toys. In doing so, the manufacturers shall take into account the accessibility needs for persons with disabilities. The communication channel shall include a link to the section of the Safety Gate Portal referred to in Article 34(3) of Regulation 2023/988 for the transmission of information about toys that may present a risk to the health and safety of consumers.

Added:Article 8 – paragraph 1: 1. A manufacturer may appoint an authorised representative by written mandate. When manufacturers terminate the mandate of their authorised representative, they shall inform the market surveillance authority. A manufacturer established in the Union may also appoint an authorised representative.

Added:Article 8 – paragraph 3 – point a: (a) keep the technical documentation at the disposal of national surveillance authorities and ensure that the digital product passport is available, in accordance with Article 17(2), for a period of 10 years after the last item of the toy model covered by those documents has been placed on the market;

Added:Article 8 – paragraph 3 – point b: (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy in an official language, which can be understood, by that authority;

Added:Article 8 – paragraph 3 – point c: (c) cooperate with the competent national authorities, at their request, on any action taken to eliminate in an effective manner the risks posed by toys covered by the written mandate.

Added:Article 8 – paragraph 3 – point c a (new): (ca) inform the competent national authorities about any action taken to eliminate the risks posed by toys covered by their mandate through a notification in the Safety Business Gateway, where the information has not been already provided by the manufacturer or upon instruction of the manufacturer.

Added:Article 9 – paragraph 2 – subparagraph 1 – point b: (b) the toy is accompanied by instructions for use and safety information in accordance with in Article 7(7) in a language or languages which can be easily understood by consumers or other end-users, as determined by the Member State concerned;

Added:Article 9 – paragraph 2 – subparagraph 1 – point c: (c) the manufacturer has created a digital product passport for the toy in accordance with Article 7(2);

Added:Article 9 – paragraph 2 – subparagraph 1 – point d: (d) a data carrier is affixed in accordance with Article 17(5);

Added:Article 9 – paragraph 2 – subparagraph 1 – point e: (e) the relevant information in the digital product passport has been included in the digital product passport registry in accordance with Article 19(1);

Added:Article 9 – paragraph 2 – subparagraph 2: Where importers consider, or have reason to believe, on the basis of the information in that importer´s possession, that a toy is not in conformity with the essential safety requirements, they shall inform the manufacturer and refrain from placing the toy on the market until it has been brought into conformity by the manufacturer.

Added:Article 9 – paragraph 2 – subparagraph 3 – introductory part: Where importers consider, or have reason to believe, on the basis of the information in that importer´s possession, that the toy presents a risk, they shall immediately provide information thereof to:

Added:Article 9 – paragraph 2 – subparagraph 3 – point c: deleted

Added:Article 9 – paragraph 6 – subparagraph 2: Where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk to health and safety of consumers and other end-users, they shall immediately inform the manufacturer and the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken and inform consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.

Added:Article 9 – paragraph 7: 7. Importers shall, for a period of 10 years after the last item of the toy model has been placed on the market, keep the unique product identifier of the toy at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Article 23 can be made available to those authorities, upon request.

Added:Article 9 – paragraph 9: 9. Importers shall verify whether the manufacturer has made communication channels as referred to in Article 7(11) publicly available to consumers or other end-users, allowing them to present complaints concerning the safety of toys and provide information on any accident or safety issue they have experienced with the toy. If communication channels are not available, importers shall provide for them, taking into account accessibility needs for persons with disabilities.

Added:Article 9 – paragraph 10 – subparagraph 2: Importers shall keep the manufacturer, distributors and, where relevant, providers of online marketplaces informed in a timely manner of the investigation performed and of the results of the investigation.

Added:Article 10 – paragraph 2 – subparagraph 1 – point a: (a) the toy is accompanied by instructions for use and safety information in a language or languages which can be easily understood by consumers or other end-users as determined by the Member State in which the toy is to be made available on the market;

Added:Article 10 – paragraph 2 – subparagraph 2: Where distributors consider, or have reason to believe, on the basis of the information in that distributor´s possession, that a toy is not in conformity with the essential safety requirements, they shall inform the manufacturer and refrain from making the toy available on the market until it has been brought into conformity by the manufacturer.

Added:Article 10 – paragraph 2 – subparagraph 3 – introductory part: Where distributors consider, or have reason to believe, on the basis of the information in that distributor´s possession, that the toy presents a risk, they shall immediately provide information thereof to:

Added:Article 10 – paragraph 2 – subparagraph 3 – point c: deleted

Added:Article 10 – paragraph 4 – subparagraph 1: Where distributors consider, or have reason to believe, on the basis of the information in that distributor´s possession, that a toy which they have made available on the market is not in conformity with this Regulation, they shall ensure that the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate, are immediately taken.

Added:Article 10 – paragraph 4 – subparagraph 2: Where distributors consider, or have reason to believe, that a toy that they have made available on the market presents a risk, they shall immediately inform the manufacturer or the importer, as applicable and the market surveillance authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken and inform consumers or other end-users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988, or both.

Added:Article 11 – title: Cases in which obligations of manufacturers apply to other persons

Added:Article 11 – paragraph 1: A natural or legal person shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 7, where such a natural or legal person places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected.

Added:Chapter II a (new) – Article 12 a (new): Chapter IIa / Obligations of online marketplaces / Article 12a / For the purposes of this Regulation, providers of online marketplaces shall comply with the requirements set out in Article 22 of Regulation (EU) 2023/988.

Added:Article 13 – title: Presumption of conformity of toys

Added:Article 14 – paragraph 2 – subparagraph 1 – introductory part: The Commission may, by means of delegated acts supplementing this Regulation, establish common specifications for the essential safety requirements only where the following conditions are fulfilled:

Added:Article 14 – paragraph 2 – subparagraph 1 – point a: (a) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or revise European standards for those requirements and: / (i) the request has not been accepted; or / (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or / (iii) the harmonised standards do not comply with the request; and

Added:Article 14 – paragraph 2 – subparagraph 1 – point b – introductory part: (b) no reference to harmonised standards covering the product requirements has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Added:Article 14 – paragraph 2 – subparagraph 1 – point b – point 1: deleted

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

Added:Article 14 – paragraph 2 – subparagraph 2: deleted

Added:Article 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.

Added:Article 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.

Added:Chapter IV – title: DIGITAL PRODUCT PASSPORT

Added:Article 17 – title: Digital Product passport

Added:Article 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.

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

Added:Article 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;

Added:Article 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;

Added:Article 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;

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 17 – paragraph 8: deleted

Added:Article 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:

Added:Article 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.

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

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

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 19 – title: Digital product passport registry

Added:Article 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.

Added:Article 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.

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

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 21 – paragraph 2: deleted / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 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;

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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;

Added:Article 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;

Added:Article 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.

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

Added:Article 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.

Added:Article 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.

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

Added:Article 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);

Added:Article 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.

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

Added:Article 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.

Added:Article 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:

Added:Article 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;

Added:Article 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;

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 47 – paragraph 6: 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 three 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 three months at the initiative of the European Parliament or of the Council.

Added:Article 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.

Added:Article 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;

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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.

Added:Article 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

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

Added:Article 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:

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

Added:Chapter 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.’

Added:Article 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].

Added:Article 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.

Added:Article 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].

Added:Article 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.

Added:Article 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.

Added:Article 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].

Added:Annex 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;

Added:Annex I – Part II – point 5: deleted

Added:Annex 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;

Added:Annex 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.

Added:Annex 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.

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

Added:Annex 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.

Added:Annex 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:

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

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

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

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

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

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

Added:Annex 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.

Added:Annex 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).

Added:Annex 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 .

Added:Annex 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.

Added:Annex 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.

Added:2. N-nitrosamines and N-nitrosatable substances are prohibited in toys where the migration of those substances is equal to or higher than:

Added:Annex 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:

Added:Annex 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:

Added:Annex 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:

Added:Annex 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.

Added:Annex 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:

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

Added:Annex 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.

Added:Annex 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.

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

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

Added:Annex 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.

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

Added:Annex VI – subheading 1: DIGITAL PRODUCT PASSPORT

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

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

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

Added:Annex 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;

Added:Annex 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.

Added:Annex VI – Part I – point k: deleted

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

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

Added:The EU single market for safe toys has been a major achievement for the protection of children while removing the barriers to the free movement of toys within the Union to the benefits of companies, which are mostly constituted by small and medium sized enterprises.

Added:While it must be recognized that the framework built by Directive 2009/48/EC - the ‘Toy Safety Directive’ - has made the EU the safest place for toys in the world, new challenges have arisen, for example, from the changes in the purchasing habits brought by online marketplaces and from new technologies. Greater efforts must be undertaken to overcome these challenges, and reduce the number of unsafe toys circulating in the single market (toys are still amongst the most notified categories of products in the EU Safety Gate system for non-food dangerous products).

Added:The current Toy Safety Directive should therefore be revised to ensure that consumers can count on a high level of safety for all products and that this safety is effectively monitored. This revision should also prioritise the removal of potential barriers to the development of disruptive technologies, as stated by the European Parliament in its resolution of 25 November 2020 on addressing product safety in the single market (2019/2190(INI)). Furthermore, the Parliament called for a broader approach for this revision through its resolution of 16 February 2022 on the implementation of the Toy Safety Directive (2021/2040(INI)), in order to enhance its effectiveness and efficiency and avoid implementation inconsistencies among Member States and market fragmentation.

Added:The rapporteur is satisfied that the Commission has chosen a Regulation on toy safety to replace the Directive. This will not just strengthen the level of protection of children from possible risks but will also strengthen a harmonised protection system while providing for a level playing field between toys manufactured in the EU and abroad.

Added:The key principle of the Rapporteur in drafting the report was therefore the protection of children as the most vulnerable consumers. With this perspective, the Rapporteur welcomes the ban on CMRs and endocrine disruptors, and, with regard to other chemicals, suggests a proportionate approach if children are not exposed to them.

Added:With regard to the obligations for the economic operators, the rules for manufacturers, importers and distributors need to be coherent with currently adopted legislation, in particular the General Product Safety Regulation. Further to that, administrative burdens should be avoided, since they might create barriers to market access and will not help to improve toy safety. Additionally, SMEs need more help to comply with the future new set of rules set out by the Regulation. In particular, the product passport might cause an administrative burden to SMEs. The Rapporteur therefore suggests for the Commission to provide SMEs with tailor-made guidance on how to set up a product passport for their toys and also an automatic translation tools for the different languages of the Member States in which the SMEs want to make available their toys.

Added:Issues may arise due to the fact that the new Ecodesign for sustainable products Regulation is not yet adopted, while this proposal refer to that Regulation when it comes to the use of the digital product passport. In any case, even if the uncertainties concerning the digital product passport are addressed, the relevant information requirements in the context of the toy safety regulation should be applied only with regard to toy safety related matters and should not cover other elements, such as those related to the substances of concern. The specific environmental issues are subject to other pieces of legislation. Therefore, overlapping should be avoided, to allow legal certainty in the interest of consumers, companies and market surveillance authorities who will have to enforce the new rules.

Added:Within this context, the product passport is an interesting solution as an effective tool for the market surveillance of products, including products entering the territory of the Union, but it could also do more than that. The Rapporteur has identified four specific aspects with regard to the product passport:

Added:a) it should allow consumers to get the information needed in case they want to complain about the safety of a product;

Added:b) it should replace all declarations of conformity, also the one foreseen in radio equipment directive;

Added:c) it should be organised in different sections with different access rights for market surveillance authorities and consumers, since sensitive commercial information and trade secrets should be protected;

Added:d) its technical specifications should be set out through delegated acts and at least 12 months after the entry into force of the legislation, to give the toy industry 18 months to adapt to the new system.

Added:Furthermore, in general, industry needs enough time to adapt to new legislation, in particular because of the standards that need to be updated, the possible derogations and transitional period. The transitional period therefore should be modified.