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.