Client information - Regulation on the safety of toys

Dear clients, ladies and gentlemen,

we would like to inform you about the latest changes to the Regulation on the Safety of Toys (EU) 2025/2509 (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; hereinafter referred to as Toy Regulation), which was published in the Official Journal of the European Union on 12 December 2025. The new regulation will replace the previous Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys). The latter has been transposed into national law in Germany in the form of the 2nd ProdSV (Product Safety Act). It is a sectoral product harmonisation act based on the regulatory principle of the new legislative framework. This means that abstract safety requirements are laid down in the regulation, which can be specified in more detail by harmonised standards. In particular, the manufacturer is responsible for checking the requirements on his own and declaring conformity with the requirements of the legal act once he has it established. The personal responsibility of economic operators is accompanied by the activities of market surveillance authorities, which check products that have already been placed on the market and, if necessary, impose measures of market surveillance.

The evaluation of the Toy Directive has shown that the regulation provided a suitable instrument for regulating the safety of toys. However, numerous unsafe toys were still found on the EU market, and particularly the protection of children from hazardous chemicals was deemed insufficient.

Although the basic regulatory concept remains largely unchanged, the new regulation introduces some important changes to the obligations of economic operators. The focus is laid upon chemical safety requirements and the introduction of the digital product passport (DPP).

We hope you find this information useful. Please do not hesitate to contact us if you have any further questions. 

Best regards

Your FN Product Law Team

1. What is the subject matter of the Toy Regulation?

The Toy Regulation deals with the safety of toys. Toys are defined as products intended or designed to be used for play by children under 14 years of age (Art. 2 (1) Toy Regulation). Exceptions to the ambit are specified in Annex I of the regulation (Annex I, Part I) while products, that are not considered toys, are found in Annex I, Part II. Excluded from the ambit are, for example, toy vehicles equipped with combustion engines or playground equipment for public use. In addition, reading books and textbooks for children over the age of 36 months that have no value of game are not considered toys within the meaning of the Toy Regulation. However, slings and slingshots are now covered by the Toy Regulation and are no longer excluded from its ambit. It is also now clarified that used toys that have already been placed on the market in the EU are not covered by the new Toy Regulation. They are only subject to the legal framework of the EU Product Safety Regulation (Regulation (EU) 2023/988 on general product safety, hereinafter: GPSR) (Recital 11 Toy Regulation). Although the latter was undisputed, it had not been explicitly mentioned in the Toy Directive until now.

2. Who is the addressee of the Toy Regulation?

The Toy Regulation is primarily aimed at economic operators, although it also contains regulations relating to notified and market surveillance authorities.

In addition to the "traditional" economic operators such as manufacturers, authorised representatives, importers and distributors, fulfilment service providers are now also considered economic operators. In addition, obligations are also imposed on online marketplace providers. They are being held more accountable in order to make direct sales via online trade safer. In a lot of these cases there are no importers involved who can act as an additional responsible instance for monitoring product law requirements.

3. What (new) material requirements does the Toy Regulation impose on toys?

Toys may only be placed on the market if they comply with the essential safety requirements. These requirements are specified in Annex II of the regulation. These, among other things, relate to physical and mechanical properties, flammability, chemical and electrical properties as well as hygiene and radioactivity. For digitally connected toys, risks to mental health must also be taken into account. Regarding chemical properties, there is a particular focus on limiting harmful substances such as CMR substances (i.e. carcinogenic, mutagenic or reprotoxic chemicals) and chemicals that are harmful to the endocrine system or the respiratory tract. General bans on certain hazardous substances apply, therefore traces are only permitted in technically unavoidable and safe concentrations. In the future, the threshold for certain substances will apply to all age groups. The intentional use of PFAS in toys is prohibited. The exceptional authorisation of substances or mixtures that are generally prohibited in toys is made possible in Annex II, Part III, as it provides the opportunity for the European Chemicals Agency (ECHA) to deem the substance or mixture as safe, while taking the vulnerability of children and the possible alternatives into account.

4. What new formal requirements does the Toy Regulation impose on toys?

The Toy Regulation contains several new formal obligations, especially for manufacturers. While also affecting other things, this primarily affects both labelling and the provision of information in a digital product passport.

In addition to the “classic” labelling, manufacturers are now obliged to indicate their electronic address on the product for identification purposes (Art. 7 (6) Toy Regulation). They must also provide communication options such as a telephone number, the aforementioned electronic address or a special website so that consumers and other users can report accidents or any safety issues they encounter. It must be ensured that these channels are accessible and can therefore also be used by people with disabilities (Art. 7 (12) of the Toy Regulation).

Warning labels continue to play a central role in toy safety and have been further concretised in Regulation (EU) 2025/2509. While other regulations often provide less detailed rules on warnings, Annex III of the Toy Regulation sets out mandatory warnings for various toy categories, such as water toys or imitations of protective masks and helmets. Annex III also provides detailed descriptions of the criteria for the visibility and legibility of these warnings. A new feature is that the word "Warning" can be replaced by a pictogram (black exclamation mark in a black triangle).

Another key requirement is that manufacturers must issue a DPP. The requirements for the DPP are regulated in Articles 19 and 20 of the Toy Directive. The information contained in the DPP replaces the declaration of conformity (Article 19 (4) of the Toy Directive) among other things. The data must be available in all languages required in the specific Member State where the toy is made available on the market. Any further data that must be included is specified in Annex VI, Part I of the Toy Directive. This data can be accessed by consumers, users or authorities via a data carrier that must be affixed to the product.

5. When do the new requirements come into force and how are they implemented in national law?

The new Toy Regulation will come into force on 1 January 2026. However, the obligations for economic operators will only apply from 1 August 2030.

Due to this new version taking the form of a regulation rather than a directive, the new Toy Regulation will directly apply in the respective Member States. Any implementing acts will therefore be limited to, for example, the determination of sanctions and national rules on market surveillance.