What changed between the draft committee report and the plenary report

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.