What changed between the plenary report and the adopted text

Added:(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. [Am. 22]

Added:(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. [Am. 23]

Added:(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. [Am. 24]

Added:(47) Chapter VII of Regulation (EU) 2019/1020, setting up the rules for of controls on products entering the Union market applies to toys. The authorities in charge of controls, which in almost all Member States are the customs authorities, are to perform them on the basis of risk analysis as referred to in Articles 46 and 47 of Regulation (EU) No 952/2013 of the European Parliament and of the Council, its implementing legislation and the corresponding guidance. This Regulation therefore does not modify in any way Chapter VII of Regulation (EU) 2019/1020 and the way the authorities in charge of controls on products entering the Union market organise themselves and perform their activities.

Added:(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. [Am. 25]

Added:(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. [Am. 26]

Added:(50) Where other information than the unique product identifier and the unique operator identifier is stored in the registry, the Commission should be empowered to adopt delegated acts allowing customs authorities to verify the consistency between that additional information and the information made available by the economic operator to customs, in order to ensure the compliance of toys placed under the customs procedure of release for free circulation with this Regulation.

Added:(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. [Am. 27]

Added:(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. [Am. 28]

Added:(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. [Am. 29]

Added:(54) Children are daily exposed to a wide range of different chemicals originating from various sources that have negative effects as individual substances or mixtures, but also through combined exposure. Significant progress has been made to close some knowledge gaps on the impact of the combination effect of those chemicals. However, the safety of chemicals is currently usually assessed through the evaluation of single substances and in some cases of mixtures intentionally added for particular uses. Further efforts are needed to better understand the impact of the combination effect of chemicals. In order to provide the highest protection for children and the environment in general, the most harmful substances should be generally banned in toys to ensure that there is no exposure to them in toys. The specific limit values for chemicals in toys should account for combined exposure from different sources to the same chemical substance. In addition, manufacturers should be required to carry out an analysis of the various hazards that the toy may present and an assessment of the potential exposure to such hazards and, as part of the assessment of chemical hazards, to consider known cumulative or synergistic effects of the chemicals present in the toy, to ensure that risks from simultaneous exposure to multiple chemicals are taken into account. Furthermore, toys are to comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European Parliament and of the Council; this Regulation does not modify the obligations for the assessment of the safety of the chemical substances or mixtures themselves that may be applicable in accordance with that Regulation. [Am. 250]

Added:(54a) In order to provide adequate expertise, support, and thorough scientific evaluations, an appropriate and stable funding for ECHA should be ensured. [Am. 30]

Added:(55) Manufacturers should prepare the technical documentation describing all relevant aspects of toys including the safety assessment of all hazards that the toy may present and how they have been addressed, to allow market surveillance authorities to perform their tasks efficiently. The manufacturer should be required to make that technical documentation available to national authorities on request or to notified bodies in the context of the relevant conformity assessment procedure.

Added:(56) To ensure that toys comply with the essential requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Internal production control based on the manufacturer’s own responsibility for the conformity assessment is adequate where it has followed the harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all the particular safety requirements for the toy. In cases where such harmonised standards or common specifications do not exist, the toy should be submitted to third party verification, in this case EU-type examination. The same should apply if one or more such standards has been published with a restriction in the Official Journal of the European Union, or if the manufacturer has not followed such standards or specifications completely, or only in part. The manufacturer should submit the toy to EU-type examination in cases where it considers that the nature, design, construction or purpose of the toy necessitates third party verification.

Added:(57) Since it is necessary to ensure a uniformly high level of performance of bodies performing conformity assessment of toys throughout the Union, and since all such bodies should perform their functions to the same level and under conditions of fair competition, requirements should be set for conformity assessment bodies wishing to be notified in order to provide conformity assessment services under this Regulation.

Added:(58) If a conformity assessment body demonstrates conformity of the toy with the criteria laid down in harmonised standards, itthe toy should be presumed to comply with the corresponding requirements set out in this Regulation. [Am. 31]

Added:(59) The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should be used for the purposes of notification. In particular, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be the only means of demonstrating the technical competence of conformity assessment bodies.

Added:(60) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for toys to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries. In particular, excessive recourse to subsidiaries and subcontractors, in a manner that would call into question the competence of the notified body or its supervision by the notifying authority should be avoided.

Added:(61) In order to ensure a consistent level of quality in the performance of conformity assessment of toys, it is necessary not only to consolidate the requirements that conformity assessment bodies wishing to be notified must fulfil, but also, in parallel, to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies must fulfil.

Added:(62) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies. The Commission should by way of implementing acts request the notifying Member State to take the necessary corrective measures in respect of a notified body that does not meet the requirements for its notification.

Added:(63) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies. Such coordination and cooperation should respect the Union competition rules.

Added:(64) Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Union legislation. Regulation (EU) 2019/1020 sets out the framework for market surveillance of products subject to Union harmonisation legislation, including toys. Since this Regulation replaces Directive 2009/48/EC, the rules on market surveillance and controls on products entering the Union market set out in Regulation (EU) 2019/1020, including the specific requirement set out in Article 4 of that Regulation that toys are to be placed on the market only if there is an economic operator established in the Union responsible for the tasks specified in that Article, continue to apply to toys. Member States should therefore organise and carry out market surveillance of toys in accordance with that Regulation.

Added:(65) Directive 2009/48/EC provides for a safeguard procedure allowing the Commission and other Member States to examine the justification for a measure taken by a Member States against toys that the Member State considers to be non-compliant. That procedure ensures that interested parties are informed of measures intended to be taken with regard to toys posing a risk to the health or safety of persons and that such toys are consistently addressed by all market surveillance authorities in the Union market The procedure should therefore be maintained.

Added:(66) Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required. Where there are objections to such a measure, the Commission should, by means of implementing acts, determine whether a national measure in respect of a toy is justified.

Added:(67) Experience with Directive 2009/48/EC has shown that new toys available on the market which were compliant with the applicable particular safety requirements when placed on the market have in specific cases posed a risk to children and therefore do not comply with the general safety requirement. Provisions should be made to ensure that market surveillance authorities can take action against any toy presenting a risk to children, even when it is compliant with the particular safety requirements. The Commission should, by means of implementing acts, determine whether a national measure in respect of compliant toys which a Member State finds to pose a risk to the health and safety of children or other persons is justified.

Added:(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. [Am. 32]

Added:(68) In order to take into account technical and scientific progress or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Regulation by adapting the specific warnings to be affixed on toys, adopting specific requirements concerning chemical substances in toys and granting derogations to include specific uses allowed in toys of substances subject to generic prohibitions.

Added:(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. [Am. 33]

Added:(70) In order to facilitate the work of customs authorities in relation to toys and their compliance with the requirements set out in this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of supplementing this Regulation by determining the additional information stored in the registry to be controlled by customs authorities, and in respect of amending the list of commodity codes and product descriptions to be used for customs controls in accordance with this Regulation on the basis of Annex I to Regulation (EEC) No 2658/87 of the European Parliament and of the Council.

Added:(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-Making. 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. [Am. 34]

Added:(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 Council. [Am. 35]

Added:(73) Member States should provide for penalties applicable to infringements of this Regulation. Those penalties should be effective, proportionate and dissuasive.

Added:(74) In order to allow manufacturers and other economic operators sufficient time to adapt to the requirements laid down by this Regulation, it is necessary to provide for a transitional period during which toys which comply with Directive 2009/48/EC may be placed on the market. In addition, the period during which t toys already placed on the market in compliance with that Directive may continue to be made available on the market after this Regulation becomes applicable should be limited.

Added:(75) Since the objective of this Regulation, namely to ensure a high level of safety of toys with a view to ensuring the health and safety of children whilst guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

Added:HAVE ADOPTED THIS REGULATION:

Added:CHAPTER I GENERAL PROVISIONS

Added:Article 1 Objective and subject matter [Am. 36]

Added:The objective of this Regulation lays down rules on the safety of toys, ensuringis 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, and on the free movement of toys in the Union. [Am. 37]

Added: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. [Am. 38]

Added:Article 2 Scope

Added:1. This Regulation applies to products which are designed or intended, whether or not exclusively, for use in play by children under 14 years of age (‘toys’).

Added: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, or by children of any other specific age group below 14 years, 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. [Am. 39]

Added:2. This Regulation does not apply to the products listed in Annex I.

Added: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). [Am. 40]

Added:3a. This Regulation shall be implemented taking due account of the precautionary principle. [Am. 41]

Added:Article 3 Definitions

Added:For the purposes of this Regulation the following definitions apply:

Added:(1) ‘making available on the market’ means any supply of a toy for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

Added:(2) ‘placing on the market’ means the first making available of a toy on the Union market;

Added:(3) ‘manufacturer’ means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under that person’s name or trademark;

Added:(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; [Am. 42]

Added:(5) ‘importer’ means any natural or legal person established within the Union who places a toy from a third country on the Union market;

Added:(6) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;

Added:(7) ‘fulfilment service provider’ means fulfilment service provider as defined in Article 23, point 11, of Regulation (EU) 2019/1020; [Am. 43]

Added:(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; [Am. 44]

Added:(9) ‘provider of an online marketplace’ means a provider of an intermediary service using an online marketplace as defined ininterface 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; [Am. 45]

Added:(10) ‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1), of Regulation (EU) No 1025/2012;

Added:(11) ‘Union harmonisation legislation’ means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies;

Added:(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; [Am. 46]

Added:(12) ‘CE marking’ means a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;