What changed between the adopted text of 13 Mar 2024 and the adopted text of 25 Nov 2025

Removed:P9_TA(2024)0144

Added:P10_TA(2025)0279

Safety of toys and repealing Directive 2009/48/EC

Committee on the Internal Market and Consumer Protection

Removed:PE754.649

Added:PE779.456

Changed:European Parliament legislative resolution of 1325 MarchNovember 20242025 on the proposalCouncil forposition at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC (COM(2023)0462(09663/1/2025 – C9-0317/2023C10-0251/2025 – 2023/0290(COD))

Changed:(Ordinary legislative procedure: firstsecond reading)

The European Parliament,

Changed:– having regard to the CommissionCouncil proposalposition toat Parliamentfirst andreading the(09663/1/2025 Council– (COM(2023)0462),C100251/2025),

Removed:– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90317/2023),

Removed:– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 13 December 2023,

Removed:– having regard to Rule 59 of its Rules of Procedure,

Added:– having regard to its position at first reading on the Commission proposal to Parliament and the Council (COM(2023)0462),

Changed:– having regard to theArticle opinion294(7) of the CommitteeTreaty on the Environment, PublicFunctioning Healthof andthe FoodEuropean Safety,Union,

Changed:– having regard to the reportprovisional ofagreement approved by the Committeecommittee onresponsible theunder InternalRule Market75(4) andof Consumerits ProtectionRules (A9-0044/2024),of Procedure,

Change 1

Removed:1. Adopts its position at first reading hereinafter set out;

Added:– having regard to Rule 68 of its Rules of Procedure,

Removed:2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

Added:– having regard to the recommendation for second reading of the Committee on the Internal Market and Consumer Protection (A10-0227/2025),

Added:1. Approves the Council position at first reading;

Added:2. Takes note of the declaration by the Commission annexed to this resolution, which will be published in the C series of the Official Journal of the European Union;

Added:3. Notes that the act is adopted in accordance with the Council position;

Added:4. Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union;

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

6. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 2

Removed:P9_TC1-COD(2023)0290

Added:ANNEX TO THE LEGISLATIVE RESOLUTION

Removed:Position of the European Parliament adopted at first reading on 13 March 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC

Added:DECLARATION FROM THE COMMISSION ON THE OCCASION OF THE ADOPTION OF REGULATION (EU) 2025/2509

Removed:(Text with EEA relevance)

Added:The Commission regularly and systematically evaluates the occurrence of hazardous chemicals in toys, taking into account available scientific evidence, with a view to adapting the limit values or the conditions for the presence of specific chemical substances or mixtures in toys in accordance with Article 46 of Regulation (EU) 2025/2509 on the safety of toys. For that purpose, the Commission will request an opinion from the European Chemicals Agency on the safety of nitrosamines and nitrosatable substances in toys, in view of the overall exposure, within 12 months of the entry into force of this Regulation. For the same purpose, the Commission will request an opinion from the European Chemicals Agency on the safety of lead, cadmium, mercury and chromium vi in toys, in view of the overall exposure, within 24 months of the entry into force of this Regulation.

Removed:THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Removed:Having regard to the proposal from the European Commission,

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

Removed:Having regard to the opinion of the European Economic and Social Committee,

Removed:Acting in accordance with the ordinary legislative procedure,

Removed:Whereas:

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

Removed:(2) Children are a particularly vulnerable group. It is essential to ensure a high level of safety of children when playing with toys. Children, including children with disabilities, should be adequately protected from possible risks stemming from toys, in particularincluding from the chemical substances that toys may contain. At the same time, compliant toys should be able to move freely across the internal market without additional requirements. [Am. 1]

Removed:(3) The Commission evaluation of Directive 2009/48/EC concluded that the 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 the 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.

Removed:(4) The Chemicals Strategy for Sustainability called for strengthening the protection of consumers from the most harmful chemicals and to extending the generic approach towards harmful chemicals (based on generic preventive bans) to ensure that consumers, vulnerable groups and the environment are more consistently protected. In particular, the strategy commits to strengthen Directive 2009/48/EC with regard to the protection from the risks of the most harmful chemicals and possible combination effects of chemicals.

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

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

Removed:(7) Regulation (EC) No 765/2008 of the European Parliament and of the Council 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 and in particular children.

Removed:(8) Decision No 768/2008/EC of the European Parliament and of the Council 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 be drafted, to the extent possible, in accordance with those common principles and reference provisions.

Removed:(9) This Regulation should lay down essential 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 appliedimplemented taking due account of the precautionary principle. [Am. 2]

Removed:(10) To facilitate the application of this Regulation by manufacturers and national authorities, 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 may be considered as 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 its scope 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 may 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 toys within the meaning of this Regulation should be provided.

Removed:(11) This Regulation should apply to toys which are new to the Union market when placed on the market, i.e. either new toys made by a manufacturer established in the Union or toys, whether new or second hand, imported from a third country. The safety of other second hand products falls within the scope of Regulation (EU) 2023/988 of the European Parliament and of the Council.

Removed:(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.

Removed:(13) Essential safety requirements for toys should ensure protection from all relevant health and safety hazards posed by toys, for users or third parties. Particular safety requirements should cover the physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity 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 requirement of safety to ensure protection of children in respect of such toys. The safety of toys should be determined by reference to the intended use, while taking into account also 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.

Removed:(14) Relying on digital technologies has led to new hazards in toys. Radio toys are to comply with essential requirements for the protection of privacy and internet-connected toys are to incorporate safeguards towards cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council. Toys which include artificial intelligence are to comply with Regulation (EU) …/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial intelligence]. Therefore, such toys should comply with standards of safety, security and privacy by design. Particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should not be set out. However, protecting the health of children should not merely ensure the absence of disease or infirmity and relying on digital technologies may pose risks to children which go beyond their physical healthbe dealt with within the specific legislation. To ensure that children are protected from any risk coming from the use of digital technologies in toys, the general safety requirement should ensure the psychological and mental health, as well as the well-being and cognitive development, of children. [Am. 3]

Removed:(14a) Under Regulation (EU) …/…[OJ insert serial number for Regulation laying down harmonised rules on artificial intelligence] toys containing AI systems as safety components are considered as high-risk AI. Furthermore, under the Cyber Resilience Act internet connected toys that have social interactive features (e.g. speaking or filming) or that have location tracking features are considered important products with digital elements (Class I). On the basis of those Regulations, such toys require a third party conformity assessment, unless the manufacturer has applied relevant harmonised standards. [Am. 4]

Removed:(14b) The safety assessment should take into account the health risk posed by digitally connected toys, where appropriate, including any risk posed to mental health. Therefore, when assessing the safety of digitally connected toys likely to have an impact on children, manufacturers should ensure that the products they make available on the market meet the highest standards of safety, security and privacy by design, in the best interests of children. [Am. 5]

Removed:(15) Toys should comply with physical and mechanical requirements that prevent children from getting physically injured when playing with toys and should not pose a risk of choking or suffocation to children. In order to protect children from the risk of impaired hearing, maximum values should be set out taking into account studies and the recommendations of medical experts for both impulse noise and continuous noise emitted by toys which are designed to emit a sound. Toys or their parts and their packaging which can be reasonably expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council. In addition, it is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys in food, since the association of a toy and food could cause a risk of choking which is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measure at Union level. Toys should also ensure sufficient protection as regards flammability or electric properties, in particular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene standards to avoid microbiological risks or other risks of infection or contamination. [Am. 6]

Removed:(16) Chemicals that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances), chemicals that affect the endocrine system, the respiratory system or that are toxic to a specific organ or are mobile, persistent, bioaccumalative and toxic are particularly harmful for children and the environment and should be specifically addressed in toys. Given the essential role of the endocrine system during human development, early exposure during critical periods, such as early childhood, to endocrine disruptors can lead to adverse effects even at very low doses and affect health at a later stage of life. Respiratory sensitisers can lead to an increase of childhood asthma and neurotoxic substances are particularly harmful to the developing brain of children, which is inherently more vulnerable to toxic injury than the adult brain. Persistence and bioaccumulation lead to continuous exposure and therefore enhance the risk of adverse effects. Some toxic chemicals are also mobile in the environment. Children should also be adequately protected from allergenic substances and certain metals. The requirements for chemical substances set out in Directive 2009/48/EC need to be updated and strengthened. Toys are to comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 of the European Parliament and of the Council. In order to provide further protection of children, who are a vulnerable group of consumers, and other persons, that legal framework should be supplemented by generic prohibitions in toys covering certain hazardous chemicals, as classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council. Those generic prohibitions should apply to CMR substances, endocrine disruptors for human health and the environment, respiratory sensitisers and substances targeting a specific organ or that are mobile, persistent, bioaccumalative and toxic that meet the criteria for classification or that, as soon as those substances are classified as hazardous under Regulation (EC) No 1272/2008. In order to ensure toy safety, prohibited substances should be acceptable at trace levels but only if their presence at such levels is technologically unavoidable with good manufacturing practices and if the toy is safe. [Am. 7]

Removed:(17) In order to provide for flexibility Where the safety of children is not compromised and where it is necessary for making certain toysthere are no suitable alternative substances or mixtures available on the market, it shouldit may be possible to derogateexempt from the generic prohibitions of chemical substances and mixtures in toys. Derogations toExemptions from generic prohibitions permitting the use of prohibited substances and mixtures should be time-limited, of general application and should only be possible where the use of the relevant substance or mixtures is considered safe for children, where elimination or substitution of such prohibited substances via design changes or other materials or components is not technically possible, where there are no commerciallytechnically viable alternatives for the substance or mixture, where a substitution plan upon ECHA request has been submitted and where the use of the substance or mixture is not prohibited in consumer articles under Regulation (EC) No 1907/2006. The assessment of the safety of thethis substance in toys 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 chemical substances and mixtures in the Union. [Am. 247]

Removed:(18) Economic operators, industry associations or other interested parties should have the possibility to submit a request for assessment for a permitted use concerning a certain substance subject to a generic prohibition to ECHA. ECHA should draw up and make available the format and medium 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.