Regulation (EU) 2025/2509 of the European Parliament and of the Council of 26 November 2025 on the safety of toys and repealing Directive 2009/48/EC (Text with EEA relevance)

REGULATION (EU) 2025/2509 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 November 2025 on the safety of toys and repealing Directive 2009/48/EC (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Directive 2009/48/EC of the European Parliament and of the Council (3) was adopted to ensure a high level of safety of toys and their free movement on the internal market.

(2) Children are a particularly vulnerable group. It is essential to ensure a high level of safety for children when playing with toys. Children, including children with disabilities, should be adequately protected from possible risks stemming from toys, including from the chemical substances that toys might contain. At the same time, compliant toys should be able to move freely across the Union without additional requirements. Therefore, this Regulation should contribute to strengthening the internal market and improving its functioning while providing a high level of consumer protection. Furthermore, adaptive toys, which are modified versions of toys designed to make play accessible for those with physical or cognitive limitations, constitute an emerging and quickly developing sector, which also requires a high level of safety for children when playing with such toys. Therefore, this Regulation should also apply to adaptive toys.

(3) The Commission evaluation of Directive 2009/48/EC concluded that that Directive is relevant and generally effective in protecting children. However, it also identified a number of deficiencies that have emerged during the practical application of that Directive since its adoption in 2009. In particular, the evaluation identified certain shortcomings with regard to possible risks arising from harmful chemicals in toys. The evaluation also concluded that many non-compliant and unsafe toys remain on the Union market.

(4) In its communication of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability’, the Commission called for strengthening the protection of consumers from the most harmful chemicals and for extending the generic approach, based on generic preventive prohibitions, towards harmful chemicals to ensure that consumers, vulnerable groups and the environment are more consistently protected. In particular, the strategy commits to strengthening Directive 2009/48/EC with regard to protection from risks arising from the most harmful chemicals and possible combination effects of chemicals.

(5) Since the rules setting out the requirements for toys, in particular the essential safety requirements and the conformity assessment procedures, need to be of uniform application across the Union and not allow for divergent implementation by Member States, Directive 2009/48/EC should be replaced by a regulation.

(6) Toys are also subject to Regulation (EU) 2023/988 of the European Parliament and of the Council (4), which applies in a complementary manner in matters not covered by specific sectoral legislation on consumer products. In particular, Chapter III, Section 2, and Chapter IV, which concern online sales, Chapter VI, which concerns the Safety Gate Rapid Alert System and Safety Business Gateway, and Chapter VIII, which concerns the right to information and to a remedy, of that Regulation also apply to toys. Therefore, this Regulation does not include specific provisions on accident reporting by economic operators or on the right to information and to a remedy, but rather requires economic operators providing information on safety issues concerning toys to inform authorities and consumers or other end users in accordance with the procedures set out in Regulation (EU) 2023/988.

(7) Regulation (EC) No 765/2008 of the European Parliament and of the Council (5) lays down rules on the accreditation of conformity assessment bodies, and lays down the general principles of the CE marking. That Regulation should be applicable to toys in order to ensure that toys benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of health and safety of persons, in particular children.

(8) Decision No 768/2008/EC of the European Parliament and of the Council (6) lays down common principles and reference provisions intended to apply across sectoral product legislation in order to provide a coherent basis for such legislation. This Regulation should therefore follow, to the extent possible, those common principles and reference provisions.

(9) This Regulation should lay down essential safety requirements for toys to ensure a high level of protection of health and safety of children when playing with toys as well as the free movement of toys in the Union. This Regulation should be applied taking due account of the precautionary principle.

(10) To facilitate the application of this Regulation, its scope should be clearly defined. It should apply to all products designed or intended for use in play by children under 14 years of age. A product could be considered to be a toy even if it is not exclusively intended for playing purposes and has other additional functions. Whether a product has play value depends on the use envisioned by the manufacturer or on the use of the product reasonably foreseeable by a parent or a supervisor. At the same time, it is necessary to exclude from the scope of this Regulation certain toys which are not intended for domestic use, such as public playground equipment or automatic machines intended for public use, or other toys equipped with combustion or steam engines, as such toys could present risks to the health and safety of children that are not addressed by this Regulation. In addition, a list of products that could be confused with toys but are not to be considered to be toys within the meaning of this Regulation should be provided.

(11) This Regulation should apply to new toys made by a manufacturer established in the Union and to toys, whether new or second-hand, imported from a third country and placed on the Union market. The safety of other second-hand toys which were already on the Union market falls within the scope of Regulation (EU) 2023/988.

(12) To ensure adequate protection of children and other persons, this Regulation should apply to all forms of supply of toys, including distance sales as referred to in Article 6 of Regulation (EU) 2019/1020 of the European Parliament and of the Council (7).

(13) Essential safety requirements for toys should ensure protection for users and other persons from all relevant health and safety hazards posed by toys. Particular safety requirements should cover the physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity of toys in order to ensure that the safety of children is adequately protected against those specific hazards. Since it is possible that toys which present hazards that are not covered by a particular safety requirement might exist or be developed, it is necessary to maintain a general safety requirement to ensure protection of children in respect of such toys. The safety of toys should be determined by reference to the intended use, while also taking into account the foreseeable use, and bearing in mind the behaviour of children, who do not generally show the same degree of care as the average adult user. Together, the general safety requirement and the particular safety requirements should form the essential safety requirements for toys. The obligation for economic operators to comply with those essential safety requirements does not affect their obligations to comply with other Union law applicable to toys which addresses other aspects such as cybersecurity, environmental protection, the making available of hazardous substances and mixtures, or artificial intelligence.

(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 in relation to cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council (8). Toys with digital elements are to comply with Regulation (EU) 2024/2847 of the European Parliament and of the Council (9). Toys which include artificial intelligence are to comply with Regulation (EU) 2024/1689 of the European Parliament and of the Council (10). Therefore, this Regulation should not lay down particular safety requirements regarding cybersecurity, the protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence into toys.

(15) In accordance with Regulation (EU) 2024/1689, toys with AI systems as safety components that require a third-party conformity assessment are classified as high-risk AI systems. The choice by the manufacturer of the conformity assessment procedures for such toys, if it is possible to opt out of a third-party conformity assessment where harmonised standards have been applied, should not affect the classification as a high-risk AI system in accordance with Article 6(1) of that Regulation. Furthermore, in accordance with Regulation (EU) 2024/2847, internet-connected toys that have social interactive features, such as speaking or filming, or that have location-tracking features are considered to be important products with digital elements (Class I) and require a third-party conformity assessment, unless the manufacturer has applied relevant harmonised standards, common specifications or European cybersecurity certification schemes at assurance level at least ‘substantial’.

(16) 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 toys they make available on the market meet the highest standards of safety, security and privacy by design, in the best interests of children.

(17) 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. Toys, or parts or packaging thereof, 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 Council (11). 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. Specific safety requirements should be laid down to cover the potential hazard associated with the ingestion of strong magnets or expanding toy material that are capable of causing intestinal perforation or blockage. It should also be ensured that there is sufficient protection as regards the flammability or electric properties of toys, 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.

(18) Some toys are designed to emit sound, for example percussion toys, cap-firing toys, rattles and toys that play music or sound. In order to protect children from the risk of impaired hearing, maximum values should be set for both impulse noise and continuous noise emitted by toys which are designed to emit a sound. However, toys that are not clearly designed to emit sound, but do emit a reproducible sound when a child activates a mechanism such as a trigger on a toy gun, should also be designed so as to protect children from the risk of impaired hearing. Current scientific knowledge is not sufficiently precise on the effects on health and safety of children of sound emitted from toys, but research within the World Health Organization has demonstrated the general vulnerability of children to noise-induced hearing loss and the harmful effects for the development of children when developing hearing loss. While noise limits applicable in an occupational context address a different exposure to noise than sound emitted by toys, it should nonetheless be ensured that toys do not lead to the exposure of children to levels of sound higher than those which require employers to take measures for workers in accordance with Directive 2003/10/EC of the European Parliament and of the Council (12). The maximum values for continuous noise and impulse noise in toys should take into account the type of toy and sound produced by the toy, in view of the intended and reasonably foreseeable use.

(19) Chemicals that are classified as carcinogenic, mutagenic or toxic for reproduction (‘CMR substances’), chemicals that affect the endocrine system or the respiratory system and chemicals that are toxic to a specific organ are particularly harmful for children 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 in 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. Children should also be adequately protected from allergenic substances and certain metals. This Regulation should include updated and strengthened requirements for chemical substances replacing those set out in Directive 2009/48/EC. Toys are to comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European Parliament and of the Council (13). In order to provide further protection to children, who are a vulnerable group of consumers, and other persons, that legal framework should be supplemented by generic prohibitions on certain hazardous chemicals in toys, as classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (14). Those generic prohibitions should apply to CMR substances, endocrine disruptors, respiratory sensitisers, substances targeting a specific organ and skin sensitisers, as soon as those substances are classified as hazardous in accordance with Regulation (EC) No 1272/2008.

(20) In order to ensure toy safety, prohibited substances should be acceptable at trace levels, including in recycled materials, only if their presence at such levels is technically unavoidable with good manufacturing practices and if the toy is safe. The non-intended presence level should be in line with the ‘as low as reasonably achievable’ (ALARA) principle. Generic concentration limits triggering classification of mixtures are set in Regulation (EC) No 1272/2008 at 1 000 mg/kg for carcinogenic or mutagenic category 1A or 1B substances, at 3 000 mg/kg for reprotoxic category 1A or 1B substances or at 100 000 mg/kg for specific target organ toxicant category 1. Those limits are not sufficiently protective for children and should not be used as a basis for enforcement of the generic prohibitions.

(21) In order to provide for flexibility where the safety of children is not compromised, it should be possible to wholly or partly exempt the presence of a prohibited substance from the generic prohibitions of substances in toys. Exemptions from generic prohibitions permitting the presence of prohibited substances should be of general application and should be possible only where the presence of the relevant substance is considered to be safe for children. In addition, there should be no suitable alternatives to the presence of the substance in the toys. The assessment of the suitability of alternatives should consider whether the elimination or substitution of such prohibited substance is possible, including the availability and technical feasibility of alternatives to replace or fulfil the function of the substance in the toy, as well as the safety of any alternative identified. Finally, exemptions should be possible only where the use of the substance is not prohibited in consumer articles pursuant to Regulation (EC) No 1907/2006.

(22) The assessment of the safety of the substance and of the availability of suitable alternatives should be carried out by the relevant scientific committees in the European Chemicals Agency (ECHA) in order to ensure consistency and efficient use of resources in the assessment of substances in the Union. In order to ensure that exemptions to generic prohibitions take into account any new technical or scientific knowledge, ECHA should conduct a periodic review of its opinions. That periodic review should be adapted to the specific substance and exemption granted in toys. ECHA should request the person who submitted the original request or any other third party to submit the information that it considers to be necessary for the periodic review.

(23) It should be possible for economic operators, industry associations or other interested parties to submit a request to ECHA for assessment for a permitted use concerning a certain substance subject to a generic prohibition. ECHA should draw up and make available the format for the submission of requests for assessment. In addition, for reasons of transparency and foreseeability, ECHA should issue technical and scientific guidance on such requests for assessment.

(24) In recent years, ECHA has been entrusted with new tasks set out in several pieces of legislation and ad hoc agreements. Given the important and central role envisaged for ECHA in this Regulation, ECHA should have adequate resources to ensure that it can deliver timely and reliable data and scientific evaluations to support the decision-making process on the chemical safety of toys.

(25) The presence of nickel and cobalt in stainless steel and in components that transmit electric current in toys is considered to be safe by the Scientific Committee on Health, Environmental and Emerging Risks, established by Commission Decision (EU) 2024/1514 (15), and should be allowed. Other substances that are necessary to transmit electric current should be permitted in toys to allow for the making available on the market of electric toys if such substances are completely inaccessible for a child playing with the toy and therefore do not present a risk.

(26) As batteries are regulated by Regulation (EU) 2023/1542 of the European Parliament and of the Council (16), 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 such 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.

(27) Existing limit values for certain chemical substances and their corresponding test methods have proven to be appropriate for the protection of children as regards those substances and should be maintained. In order to adapt to new scientific knowledge, the Commission should be empowered to revise those limit values where necessary. Limit values for arsenic, cadmium, chromium (VI), lead, mercury and organic tin, which are particularly toxic and which should therefore not be intentionally used in toys, should be set at half the values that are considered to be safe by the relevant scientific body, in order to ensure that only traces that are compatible with good manufacturing practice are present in the toy.

(28) Directive 2009/48/EC includes limit values for certain substances in toys intended for children under 36 months or intended to be put in the mouth. Those substances have also been shown to pose a risk to older children, as they could be equally exposed to such chemicals via skin contact or inhalation. Those limit values should therefore apply to all toys. Since the adoption of the limit values for bisphenol A in Directive 2009/48/EC, new scientific data have emerged. The European Food Safety Authority (EFSA) re-evaluated the risks to public health from dietary exposure to bisphenol A in April 2023, concluding that exposure to bisphenol A is a health concern for consumers across all age groups. EFSA has established a new tolerable daily intake of bisphenol A, which is significantly lower than the previous one. In view of that scientific evidence, bisphenol A should fall under the generic prohibition for CMR substances in toys. In order to verify compliance with that prohibition and to ensure that there is no exposure to any non-intended presence of bisphenol A in toys, a migration limit should be provided. The migration limit should be set on the basis of a limit of quantification with existing testing methods. For similar reasons, migration limits should also be introduced for some of the most commonly used monomers in the production of plastics.

(29) To avoid situations where one hazardous bisphenol is replaced with another that might be equally harmful, ECHA assessed available evidence of bisphenols as a group. To protect people and the environment, ECHA concluded that 34 bisphenols would need further regulatory risk management as part of Union chemicals legislation as they might interfere with endocrine systems and affect reproduction. That number could change as more information is generated for those bisphenols and others where currently available evidence is inconclusive. Given that toys are aimed at a highly vulnerable group that should be protected from the exposure to harmful bisphenols, those 34 bisphenols identified by ECHA should not be present in toys. Some of those bisphenols are subject to harmonised classification in accordance with Regulation (EC) No 1272/2008 as toxic for reproduction or as endocrine disruptors. Therefore, they are already covered by the generic prohibition on harmful chemicals in toys set out in this Regulation. It is necessary to prohibit the presence of the remaining bisphenols identified by ECHA but not already covered by other provisions of this Regulation prohibiting their use. When new information becomes available, the provisions of this Regulation concerning bisphenols should be updated.

(30) Per- and polyfluorinated alkyl substances (PFAS) are a large family of more than 10 000 man-made chemicals. PFAS have been used in an increasingly wide range of products, including consumer products. A core concern is the persistency of all PFAS leading to increasing environmental concentrations. Exposure to the most studied PFAS has been associated with a range of adverse health effects. The intentional use of PFAS in toys, components of toys or micro-structurally distinct parts of toys should be prohibited.

(31) To ensure adequate protection from specific chemical substances when new scientific knowledge emerges, the Commission should be empowered to adopt delegated acts establishing specific limit values for any chemical substance used in toys. If justified in the case of toys where there is a higher degree of exposure, those delegated acts should set specific limit values for toys intended for use by children under 36 months and in other toys intended to be put in the mouth, taking into account the requirements set out in Regulation (EC) No 1935/2004 and the differences between toys and materials which come into contact with food or articles from which risks might arise due to oral contact through their use as a food contact material. Fragrances in toys entail special risks for human health. Therefore, specific rules should be set for the use of fragrances in toys, including a prohibition on the intentional use of certain allergenic fragrances in toys, in particular in toys intended for use by children under 36 months or other toys intended to be placed in the mouth, and for the labelling of certain allergenic fragrances. The Commission should be empowered to adopt delegated acts to amend those rules to allow for adaptations to technical and scientific progress.

(32) When the hazards that a toy might 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. Warnings should always be marked 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 should have appropriate warnings affixed to them if the surface of the toy allows. If this is not possible, the warnings should be placed on the label. It should also be possible for manufacturers to include warnings in digital format through the digital product passport.

(33) To prevent the misuse of warnings to circumvent the applicable safety requirements, the warnings provided for certain categories of toys should not be allowed if they conflict with the intended or reasonably foreseeable 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.

(34) 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 visible.

(35) Economic operators should act responsibly and in full accordance with the legal requirements applicable when placing or making toys available on the market.

(36) In order to ensure a high level of protection of the health and safety of children and fair competition in the internal market, economic operators should be responsible for the compliance of toys with this Regulation, in relation to their respective roles in the supply chain.

(37) As certain tasks can be executed only by the manufacturer, it is necessary to distinguish clearly between the obligations of the manufacturer and those of the operators further down the distribution chain. It is also necessary to distinguish clearly between the obligations of the importer and those of the distributor, as the importer introduces toys from third countries to the Union market. The importer should make sure that those toys comply with the applicable Union requirements.

(38) In order to facilitate communication between economic operators, market surveillance authorities and consumers or other end users, manufacturers and importers should indicate a website, email address or other digital contact in addition to the postal address.

(39) The manufacturer, having detailed knowledge of the design and production process, is responsible for the compliance of the toy with the requirements of this Regulation and is best placed to carry out the complete conformity assessment procedure for toys. Conformity assessment should therefore remain the obligation of the manufacturer alone.

(40) To facilitate compliance of the manufacturers with their obligations set out in this Regulation, manufacturers should be allowed to appoint an authorised representative to carry out specific tasks on their behalf. Moreover, to ensure a clear and proportionate distribution of tasks between the manufacturer and the authorised representative, it is necessary to set out a list of tasks that manufacturers should be allowed to entrust the authorised representative with. Furthermore, to ensure the enforceability of and compliance with this Regulation, where a manufacturer established outside the Union appoints an authorised representative, the mandate should include the tasks set out in Article 4 of Regulation (EU) 2019/1020.

(41) 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 health or safety of children under the intended and reasonably foreseeable conditions of use, and that they make available on the market only toys which comply with the applicable Union law.

(42) It is necessary to ensure that toys from third countries entering the Union market comply with all applicable Union requirements, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those toys. Importers should therefore ensure that the toys they place on the market comply with the applicable requirements, that conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers are available for inspection by the competent market surveillance authorities.

(43) When placing a toy on the market, importers should indicate their name on the toy and the address at which they can be contacted. Exceptions should be provided for in cases where the size or nature of the toy does not allow for such an indication, including where importers would have to open the packaging to put their name and address on the toy. In such cases, the name and address should be indicated on the packaging or an accompanying document.

(44) As the distributor makes a toy available on the market after the toy has been placed on the market by the manufacturer or the importer, the distributor should act with due care to ensure that the handling of the toy does not adversely affect the compliance of that toy with this Regulation.

(45) Distributors and importers are close to the market place and should therefore be involved in market surveillance tasks carried out by competent national authorities, and should be required to participate actively in such tasks and to provide those authorities with all necessary information relating to the toy concerned.

(46) In order to increase compliance with the obligations set out in this Regulation and to improve market surveillance, where fulfilment service providers have reason to believe, on the basis of the information provided by authorities or economic operators, that a toy is not in conformity with this Regulation, they should not support the making available of the toy on the market until it has been brought into conformity. Pursuant to this Regulation, fulfilment service providers do not bear responsibility for the conformity assessment of the toy. However, they should act with due care and ensure that the conditions during warehousing, packaging, addressing or dispatching do not jeopardise the toy’s conformity with the essential safety requirements. The Commission could issue guidelines to assist fulfilment service providers in the application of obligations that they are subject to pursuant to this Regulation.

(47) Any natural or legal person that either places a toy on the market under that person’s name or trademark or carries out a substantial modification of a toy already placed on the market in such a way that compliance with applicable requirements of this Regulation might be affected should be considered to be a manufacturer for the purposes of this Regulation and should assume the obligations of the manufacturer. A consumer or other end user who carries out a substantial modification to his or her toy should not be considered to be a manufacturer for the purposes of this Regulation and should not be subject to the obligations of the manufacturer.

(48) Information referring to an offer of toys placed on the market or made available on the market which are not compliant with this Regulation should be considered to be illegal content within the meaning of Regulation (EU) 2022/2065 of the European Parliament and of the Council (17) and trigger the specific due-diligence obligations set out in that Regulation for providers of intermediary services online. The important role played by providers of online marketplaces when intermediating the sale of products between economic operators and consumers has justified the establishment of recent sets of rules, imposing new due-diligence obligations to online marketplaces. Firstly, Regulation (EU) 2022/2065 regulates the responsibility and accountability of providers of intermediary services online with regard to illegal content, including dangerous products. Secondly, Regulation (EU) 2023/988 establishes specific responsibilities in tackling the sale of dangerous products online. Building on the horizontal legal framework provided by those Regulations, this Regulation should specify the requirements, in relation to toy safety, with which providers of online marketplaces are to comply in order to ensure compliance with certain provisions of Regulation (EU) 2022/2065. Those requirements should be consistent with the horizontal framework for online marketplaces pursuant to Regulations (EU) 2022/2065 and (EU) 2023/988. Furthermore, those requirements should not affect the application of Regulation (EU) 2022/2065, which continues to apply to the providers of online marketplaces.

(49) Ensuring traceability of a toy throughout the whole supply chain 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.

(50) In order to ensure efficient market surveillance of toys made available on the market, economic operators should be required to keep the compliance information and documentation of a toy for a period of 10 years after it has been placed on the market. This overall period is considered to last until 10 years after the last item of that toy model was placed on the market.

(51) 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 Council (18) and published in the Official Journal of the European Union.

(52) In the absence of relevant harmonised standards, the Commission should be empowered to adopt implementing acts setting out common specifications for the essential safety requirements of this Regulation, provided that in doing so it respects the standardisation organisations’ role and functions, as an exceptional fallback solution to facilitate the manufacturer’s obligation to comply with the essential safety requirements, where the standardisation process is blocked or there are delays in the establishment of appropriate harmonised standards. If such delay is due to the technical complexity of the standard in question, this should be considered by the Commission before contemplating the establishment of common specifications. With a view to establishing, in the most efficient way, common specifications that cover the essential safety requirements of this Regulation, the Commission should consult relevant stakeholders in the process.

(53) The CE marking, indicating the conformity of a toy, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Specific rules governing the affixing of the CE marking with regard to toys should be laid down in this Regulation. Those rules should ensure sufficient visibility of the CE marking in order to facilitate the market surveillance of toys.

(54) Manufacturers should create a digital product passport to provide information on the compliance of toys with this Regulation and with other Union law applicable to toys. They should keep the digital product passport up to date and make any necessary changes when required. The digital product passport should replace the EU declaration of conformity pursuant to Directive 2009/48/EC and include the elements necessary to assess the conformity of the toy with the applicable requirements and harmonised standards or other specifications. Furthermore, in order to reduce the administrative burden, it should be possible to use the digital product passport pursuant to this Regulation to comply with the obligation to draw up an EU declaration of conformity for toys which fall within the scope of other Union law requiring an EU declaration of conformity. Where the digital product passport is used as an EU declaration of conformity pursuant to other Union law applicable to the toy, manufacturers and other economic operators should be deemed to comply with their respective obligations in relation to the EU declaration of conformity pursuant to that other Union law.

(55) 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 relevant information on the toy through the data carrier.

(56) To avoid duplication of investment in digitalisation by all actors involved, including manufacturers, market surveillance authorities and customs authorities, when other Union law requires a digital product passport for toys, a single digital product passport should be available containing the information required pursuant to this Regulation and the other Union law. In addition, the digital product passport should be fully interoperable with any digital product passport required pursuant to other Union law.

(57) In particular, Regulation (EU) 2024/1781 of the European Parliament and of the Council (19) lays down requirements and technical specifications for a digital product passport and provides for the setting-up by the Commission of a digital registry (the ‘registry’) where digital product passport information is stored and for the interconnection of that registry with the European Union Customs Single Window Certificates Exchange System (EU CSW-CERTEX) established by Regulation (EU) 2022/2399 of the European Parliament and of the Council (20). Regulation (EU) 2024/1781 might 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, in particular information related to environmental sustainability. The digital product passport for toys created pursuant to this Regulation should therefore comply with the same requirements and technical elements as those set out in Regulation (EU) 2024/1781, including the technical, semantic and organisational aspects of end-to-end communication and data exchange.

(58) 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 for such compliance.

(59) 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 or other end users regarding the different types of information that are available to them in a digital format.

(60) Most toy manufacturers subject to the requirements of this Regulation are micro-, small and medium-sized enterprises (SMEs). 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 on how to perform safety assessments and create a digital product passport for the toys they produce.

(61) Chapter VII of Regulation (EU) 2019/1020, setting out the rules for 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 in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (21), 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.

(62) 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.

(63) 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 registration identifier communicated to the economic operator by the registry. Customs authorities should verify as a minimum that a valid reference to the unique registration identifier and the relevant commodity code for the toy provided or made available to them corresponds to the data that are stored in the registry. This would allow customs authorities to verify that a digital product passport for imported toys exists. To carry out that automatic verification, the interconnection between the registry and EU CSW-CERTEX as provided for in Article 15(3) of Regulation (EU) 2024/1781 should be used.

(64) The data included in the digital product passport are intended to allow customs authorities to enhance and facilitate risk management and enable the controls at the border to be better targeted. Therefore, customs authorities should be able to retrieve and use the data included in the digital product passport and the registry for carrying out their tasks in accordance with Union law, including for risk management in accordance with Regulation (EU) No 952/2013.

(65) The automatic verification by customs authorities 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 on the information contained in the digital product passports and checks on toys within the market in accordance with that Regulation and, in the event of the 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.

(66) Children are exposed on a daily basis 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, currently, the safety of chemicals is 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 to children, the most harmful substances should be generally prohibited 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 might 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, in order to ensure that risks from simultaneous exposure to multiple chemicals are taken into account. Furthermore, toys are to comply with general legislation in relation to chemicals, in particular Regulation (EC) No 1907/2006, and this Regulation does not change the obligations for the assessment of the safety of the chemical substances or mixtures themselves that are applicable pursuant to that Regulation.

(67) Manufacturers should prepare the technical documentation describing all relevant aspects of toys, including the safety assessment of all hazards that the toy might present and how they have been addressed, in order 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.

(68) In the safety assessment, manufacturers should assess the chemical substances present in the toy and possible non-intended presence of substances subject to generic prohibitions or other restrictions and determine whether their presence at such levels is technically unavoidable with good manufacturing practices and whether the toy is safe. The assessment should determine the scope of possible testing, especially for those substances that can reasonably be expected, under good manufacturing practices, to appear in the toy, including as traces.

(69) To ensure that toys comply with the essential safety 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 references of which have 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 have 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 has followed them 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.

(70) 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 in accordance with this Regulation.

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

(72) 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.

(73) 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.

(74) 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 are to fulfil, but also, in parallel, to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies are to fulfil.

(75) Since notified bodies can 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 authority to take the necessary corrective measures in respect of a notified body that does not meet the requirements for its notification.

(76) 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. Such consistency can best be achieved through appropriate coordination and cooperation between notified bodies. Such coordination and cooperation should respect the Union competition rules.

(77) Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Union law. 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.

(78) 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 State 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 dealt with by all market surveillance authorities in the Union market. That procedure should therefore be maintained.

(79) 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 that measure, the Commission should, by means of implementing acts, determine whether such a national measure in respect of a toy is justified.

(80) 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. Therefore, this Regulation should ensure that market surveillance authorities can take action against any toy presenting a risk to children, even where it is compliant with the particular safety requirements.

(81) In accordance with Regulation (EU) 2019/1020, market surveillance authorities are required to communicate, through the information and communication system on market surveillance, information on toys for which an in-depth inspection has been conducted, including measures or corrective action taken as well as available information on injuries caused by such toys. Furthermore, in accordance with Regulation (EU) 2023/988 manufacturers are required to notify, through the Safety Business Gateway, any occurrence of an injury as a result of using a product. Such information should be taken into consideration as part of the evaluation process, for the purpose of assessing the effectiveness of this Regulation.

(82) 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 (TFEU) 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 allow specific uses in toys of substances subject to generic prohibitions.

(83) 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 TFEU should be delegated to the Commission in respect of supplementing this Regulation by determining the technical requirements of the digital product passport, and 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 registry.

(84) 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 TFEU should be delegated to the Commission 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 Council Regulation (EEC) No 2658/87 (22).

(85) When adopting delegated acts pursuant to 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 (23). 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.

(86) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to determine whether a specific product or group of products is to be considered to be 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. The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the protection of the health and safety of persons, imperative grounds of urgency so require.

(87) The implementing powers that are conferred on the Commission by this Regulation should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (24).

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

(89) 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 can be placed on the market.

(90) Since the objective of this Regulation, namely to ensure the safety of toys with a view to ensuring a high level of protection of the health and safety of children while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, 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 as set out in Article 5 of the Treaty on European Union. 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,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation lays down rules on the safety of toys in order to ensure a high level of protection of the health and safety of children and other persons, taking due account of the precautionary principle, and rules on the free movement of toys in the Union.

Article 2

Scope

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 a relevant age group.

Article 3

Definitions

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

(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;

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

(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;

(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 manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;

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

(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;

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

(8) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and the fulfilment service provider;

(9) ‘provider of an online marketplace’ means a provider of an online marketplace as defined in Article 3, point (14), of Regulation (EU) 2023/988;

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

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

(12) ‘intended for 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 specified age group;

(13) ‘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;

(14) ‘essential safety requirements’ means the general safety requirement set out in Article 5(2) together with the particular safety requirements set out in Annex II;

(16) ‘data carrier’ means data carrier as defined in Article 2, first paragraph, point (29), of Regulation (EU) 2024/1781;

(17) ‘digital product passport’ means a set of data specific to a toy that contains the information set out in Annex VI and that is accessible via electronic means through a data carrier in accordance with Chapter V of this Regulation;

(18) ‘unique product identifier’ means a unique product identifier as defined in Article 2, first paragraph, point (30) of Regulation (EU) 2024/1781;

(19) ‘unique operator identifier’ means a unique operator identifier as defined in Article 2, first paragraph, point (31), of Regulation (EU) 2024/1781;

(20) ‘digital product passport service provider’ means a natural or legal person that is an independent third party authorised by the economic operator required to create a digital product passport for a toy and that processes the digital product passport data for that toy for the purpose of making such data available to economic operators and other relevant actors with a right to access those data under this Regulation or other Union law;

(21) ‘release for free circulation’ means the customs procedure laid down in Article 201 of Regulation (EU) No 952/2013;

(22) ‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013;

(23) ‘European Union Customs Single Window Certificates Exchange System (EU CSW-CERTEX)’ means the system established by Article 4 of Regulation (EU) 2022/2399;

(24) ‘Safety Business Gateway’ means the web portal referred to in Article 27 of Regulation (EU) 2023/988;

(25) ‘conformity assessment’ means the process demonstrating whether the essential safety requirements relating to a toy have been fulfilled;

(26) ‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;

(27) ‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC) No 765/2008;

(28) ‘national accreditation body’ means a national accreditation body as defined in Article 2, point (11), of Regulation (EC) No 765/2008;

(29) ‘hazard’ means a potential source of harm;

(30) ‘risk’ means the combination of the probability of an occurrence of a hazard and the degree of severity of the harm caused by that hazard;

(31) ‘recall’ means any measure aimed at achieving the return of a toy that has already been made available to the end user;

(32) ‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from being made available on the market;

(33) ‘market surveillance authority’ means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;

(34) ‘notifying authority’ means an authority designated by a Member State pursuant to this Regulation as responsible for the assessment and notification of conformity assessment bodies in the territory of that Member State;

(35) ‘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, and which may be a scale model of such product, appliance or installation;

(36) ‘aquatic toy’ means a toy that is intended for use in shallow water and which is capable of carrying or supporting a child in the water;

(37) ‘activity toy’ means a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for climbing, jumping, swinging, sliding, rocking, spinning, crawling or creeping, or any combination thereof;

(38) ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures;

(39) ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise different odours or flavours;

(40) ‘cosmetic kit’ means a toy the purpose of which is to assist a child in learning to make cosmetic products such as fragrances, soaps, creams, shampoos, conditioners, bath foams and toothpastes, as well as glosses, lipsticks, nail polish and other make-up;

(41) ‘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;

(42) ‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).

Article 4

Free movement

During fairs, exhibitions and demonstrations, adequate measures shall be taken by economic operators to ensure the protection of persons.

Article 5

Essential safety requirements

When assessing the risk referred to in the first subparagraph, the ability of the users and, where appropriate, their supervisors shall be taken into account. Where a toy is intended for use by children under 36 months or by another specified age group, the ability of users in that age group shall be taken into account.

Article 6

Warnings

Toys shall not bear one or more of the warnings set out in Annex III where such warnings conflict with the intended use or reasonably foreseeable use of the toy, as determined by virtue of its function, dimensions and characteristics.

Warnings shall comply with the visibility and legibility criteria set out in Annex III.

Warnings as set out in paragraphs 1 and 2 shall be clearly visible to the consumer before purchase, including in cases where the purchase is made through distance sales.

CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS

Article 7

Obligations of manufacturers

Where compliance of a toy with the applicable requirements laid down in this Regulation has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall, before the toy is placed on the market:

(a) create a digital product passport for the toy in accordance with Article 19;

(b) affix the data carrier in accordance with Article 19(7);

(c) affix the CE marking in accordance with Article 18(1); and

(d) upload the unique product identifier and the unique operator identifier of the toy, as well as any other additional information determined by a delegated act adopted in accordance with Article 49(3), to the digital product passport registry referred to in Article 22(1).

When deemed appropriate with regard to the risks presented by a toy, manufacturers shall, for the protection of the health and safety of consumers or other end users, carry out sample testing of marketed toys.

Furthermore, where manufacturers consider, or have reason to believe, that a toy presents a risk, they shall immediately inform:

(a) the market surveillance authorities of the Member States in which they have made the toy available, through the Safety Business Gateway, giving details, in particular, of any non-compliance and of any corrective measures taken; and

(b) the consumers or other end users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988 or both.

Manufacturers shall ensure that the fulfilment service providers are provided with the detailed information necessary for ensuring the safe storage, packaging, addressing or dispatch of toys.

Article 8

Authorised representatives

(a) keep the technical documentation at the disposal of competent national authorities and ensure that the digital product passport is available, in accordance with Article 19(2), for a period of 10 years after the toy covered by that documentation and that digital product passport has been placed on the market;

(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 a language which can be easily understood by that authority;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate; and

(d) inform the competent national authorities about any action taken to eliminate the risks posed by toys covered by their mandate through the Safety Business Gateway, where the information has not already been provided by the manufacturer.

Article 9

Obligations of importers

(a) the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation referred to in Article 7(2);

(b) the toy is accompanied by instructions for use and safety information in accordance with Article 7(7) and bears warnings in accordance with Article 6 in a language or languages which can be easily understood by consumers or other end users, as determined by the Member State concerned;

(c) the manufacturer has created a digital product passport for the toy in accordance with Article 7(2), second subparagraph, point (a);

(d) the data carrier is affixed in accordance with Article 19(7);

(e) the relevant information from the digital product passport has been uploaded in the digital product passport registry in accordance with Article 22(1);

(f) the CE marking is affixed in accordance with Article 18(1); and

(g) the manufacturer has complied with the requirements set out in Article 7(5) and (6).

Furthermore, where importers consider, or have reason to believe, that a toy presents a risk, they shall:

(a) immediately inform the manufacturer thereof; and

(b) ensure that the market surveillance authorities are immediately informed through the Safety Business Gateway.

Furthermore, where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk, they shall:

(a) immediately inform the manufacturer thereof;

(b) ensure that consumers or other end users are immediately informed thereof in accordance with Article 35 or 36 of Regulation (EU) 2023/988 or both; and

(c) immediately inform the market surveillance authorities through the Safety Business Gateway, giving details, in particular, of the non-compliance and of any corrective measures taken.

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.

Article 10

Obligations of distributors

(a) the toy is accompanied by instructions for use and safety information in accordance with Article 7(7) and bears warnings in accordance with Article 6 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;

(b) the data carrier is affixed in accordance with Article 19(7);

(c) the CE marking is affixed in accordance with Article 18(1); and

(d) the manufacturer and the importer have complied with the requirements set out in Article 7(2), second subparagraph, and Article 7(5), (6) and (12) and in Article 9(4), respectively.

Furthermore, where distributors consider, or have reason to believe, that a toy presents a risk, they shall:

(a) immediately inform the manufacturer or the importer, as applicable, thereof; and

(b) ensure that the market surveillance authorities are immediately informed through the Safety Business Gateway;

Furthermore, 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:

(a) the market surveillance authorities of the Member States in which they made the toy available, through the Safety Business Gateway, giving details, in particular, of the non-compliance and of any corrective measures taken; and

(b) consumers or other end users, in accordance with Article 35 or 36 of Regulation (EU) 2023/988 or both.

Article 11

Obligations of fulfilment service providers

Article 12

Cases in which obligations of manufacturers apply to other persons