2025年12月03日

European Union Adopts a New Toy Safety Regulation

分享

The European Parliament approved the co-legislators' political agreement over new toy safety rules and, on 25 November 2025, adopted the Toy Safety Regulation ('TSR'). The TSR is now awaiting publication in the Official Journal of the European Union and will enter into force on the twentieth day following its publication.

The new framework introduces stricter requirements on chemicals in toys, new rules for the assessment of toys before placing them on the market, obliges the manufacturers to create digital product passports for all toys placed on the EU market and also, contains new rules related to online marketplaces.

The TSR does not modify the definition of what is a "toy" materially. Similarly to Directive 2009/48/EC on the safety of toys ('TSD'), it provides that toys are "products which are designed or intended, whether or not exclusively, for use in play by children under 14 years of age." (Article 2(1) of the TSR) The phrase 'intended' in this definition, however, is further detailed by the TSR, which adds that "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 2(1) of the TSR)

Background

On 28 July 2023, the European Commission adopted a proposal to introduce a new regulation and to repeal the TSD. The Commission's evaluation of the effectiveness, efficiency and relevance of the TSD on 19 November 2020 found that dangerous toys continued to appear on the EU market, and that a revision was warranted.

Although the provisions of the TSR will enter into force in the near future, the regulation provides for a transitional period of four and a half years, in order to give time to the industry to implement the new rules efficiently, and related to the rules that will be directly relevant to businesses (see the five most important ones below). As a result, the TSD will remain applicable for a further four and a half years, after which the TSR will apply. Only a few provisions will apply from the TSR's entry into force, these include obligations for Member States and their national conformity assessment bodies (Articles 24-40) and the rules on the Commission's delegated powers, also Member States' obligation to lay down the rules on penalties under the TSR and other administrative matters (Articles 46-52).

The TSR addresses the rise of online shopping and the increased use of digital technologies. It seeks a higher level of child protection and a reduction of the number of non-compliant toys placed on the EU market by extending the existing bans on substances and strengthening the traceability of toys.

1. What is New in the TSR?

Some of the TSR's key provisions include:

  • Prohibition of endocrine disruptors, respiratory and skin sensitisers and PFAS. The TSD's existing ban on carcinogenic and mutagenic substances and substances toxic for reproduction (CMR chemicals) is extended to other categories of chemicals that are considered to be particularly harmful for children. The new ban targets substances falling under additional hazard categories of the Classification, Labelling and Packaging Regulation (CLP), and includes endocrine disruptors, substances that harm the respiratory system and chemicals that are toxic for the skin and other organs.

    The TSR also bans the use of per- and polyfluorinated alkyl substances (PFAS) in toys, components of toys or micro-structurally distinct parts of toys, provided that these substances were used intentionally.

    The presence of bisphenols in toys, components of toys or micro-structurally distinct parts of toys, is also prohibited.

    Lastly, certain fragrance allergens are prohibited in toys for use by children under 36 months or other toys intended to be placed in the mouth, with some exceptions.

  • Safety assessment. Unlike the TSD, the TSR contains specific rules on the safety assessment of toys before placing them on the market.

    Such assessment should cover all the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to such hazards.

    In relation to chemical hazards, this assessment should take account of the possible exposure to individual chemicals, and any known additional hazards from combined exposure to the different chemicals present in the toy, in line with the obligations under the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

    The safety assessment will have to be included in the technical documentation of products. Such documentation, containing a wide range of data in general (Annex V of the TSR), will have to be drawn up in one of the official languages of the EU. Upon request from a Member State authority, a translation of the relevant parts of the documentation will have to be provided to that authority.

  • Digital product passports. According to the TSR, before placing a toy on the market, its manufacturer should create a digital product passport for that toy, containing a statement on the compliance of the toy with the TSR's requirements and other data, all available in the language(s) required by the respective Member State.

    By creating the digital product passport, the manufacturer assumes responsibility for the toy's compliance with the TSR. Such digital passports should be accurate, complete and kept up-to-date.

    Consumers, economic operators and different authorities should be given access to the digital product passport free of charge.

  • Online marketplaces. Any information referring to an offer of toys sold or promoted in online marketplaces which are not compliant with the TSR, will be considered illegal content for the purposes of the Digital Services Act ('DSA') and subject to the measures established in that act. For the purposes of the TSR, online marketplaces will have to comply with Articles 30-32 of the DSA on traceability of traders, compliance by design and right to information. The General Product Safety Regulation's ('GPSR') current applicability to toys will be complemented with the GSPR's specific obligations to online marketplaces related to product safety (Article 22 of the GPSR). The Commission is empowered to issue guidelines to assist online marketplace providers in the application of these rules of the TSR.

    Providers of online marketplaces should ensure that their online interface is designed and organised in a way to allow economic operators to provide the CE marking, clearly visible warnings to consumers, and the data carrier or link through which the digital product passport is accessible.

  • Compliance with the GSPR. Any toy that will not comply with the particular safety requirements, or that complies but poses a risk to the health and safety of children and other persons, will be considered a dangerous product and should comply with the specific obligations set by the GSPR in relation to product safety for online marketplaces. For example, Article 22 of the GPSR provides that online marketplaces should have single points of electronic contact allowing for communication with authorities and customers on product safety issues and that they should have internal processes to comply with the GPSR's requirements.

2. Final Observations

The revised toy safety framework – into which several Commission strategies are incorporated – aims to ensure a higher level of child protection and to reduce the number of non-compliant and unsafe toys in the EU market. That said, as industry commentary highlights, implementing the TSR will be demanding.

How we can help?

The Mayer Brown regulatory team has extensive experience in chemicals legislation, products legislation and safety and sustainability requirements, as well as in preparing companies for legislative changes.

We represent a broad range of companies, industries and trade associations, ensuring that they keep up-to-date with regulatory developments and are able to meet the challenges posed by an ever-shifting regulatory environment. Our team stands ready to advise on the potential implications of the CLP, GPSR, TSD, TSR and other regulations that are part of the EU's chemicals and products legislation for your companies’ specific operations and products.

及时掌握我们的最新见解

见证我们如何使用跨学科的综合方法来满足客户需求
[订阅]