The New Toy Regulation: greater safety, more obligations

With Regulation (EU) 2025/2509 dealing with the safety of toys (“Toy Regulation”), European legislators have fundamentally revised toy legislation. The Toy Regulation completely repeals the previously applicable Toy Directive 2009/48/EC (“Toy Directive”) and replaces it with a directly applicable regulation. The aim is to ensure a uniform, higher level of protection throughout the EU. For affected economic operators, this means that existing processes must be reviewed and, in some cases, significantly modified.

Scope

The Toy Regulation applies

• to all economic operators along the supply chain. This includes manufacturers, importers, distributors, fulfilment service providers and, unlike under the previous Toys Directive, for the first time also providers of online marketplaces.
• to toys, i.e. all products designed or intended, whether exclusively or not, for use in play by children under 14 years of age.

 

Increased obligations

Although the Toy Regulation has been in force since December 2025, most of the obligations will not apply until 1 August 2030. The relevant dates of application and the key obligations of economic operators are summarised below.

Safety requirements in conjunction with chemicals legislation and the General Product Safety Regulation (“GPSR”)

Toys may only be placed on the market if they meet the so-called essential safety requirements (Article 5 Toy Regulation). While the general safety requirements have hardly changed – contrary to the draft Toy Regulation – there have been significant changes to the specific toy requirements.

Chemical properties

In particular, the Toy Regulation contains significantly stricter requirements for chemical substances (Annex II, Part 3). In addition to carcinogenic, mutagenic or reprotoxic substances (CMR), endocrine disruptors, certain bisphenols and per- and polyfluorinated alkyl substances (PFAS) are now also subject to significantly stricter regulations – ranging from the reduction of numerous limit values to a complete ban on these substances.

Allergenic fragrances may no longer be intentionally used in toys for children under 36 months and in toys intended to be placed in the mouth. Unless prohibited, these substances must be labelled separately.

Other limit values for certain substances known from the previous Toy Directive – e.g. the limit values for aluminium or aniline – are now extended to all toys. This is because these substances pose a risk to children regardless of their specific age due to exposure to these chemicals through skin contact or inhalation.

Relationship to EU chemicals legislation

The Toy Regulation is closely linked to chemical safety legislation. Toys must therefore continue to comply with the requirements of Regulation (EC) No 1907/2006 (the REACH Regulation). At the same time, the Toy Regulation tightens this framework by generally prohibiting chemicals classified as hazardous under Regulation (EC) No 1272/2008 (“CLP Regulation”), such as certain skin sensitizers.

Relationship to the GPSR

Where the Toy Regulation does not lay down specific safety requirements for toys, Regulation (EU) 2023/988 (“GPSR”) applies in addition. Specifically, this applies, among other things, to:

• the obligations of economic operators in distance selling (Chapter III, Section 2 GPSR),
• the obligations of online marketplace providers (Chapter IV),
• the rapid alert system Safety Gate and Safety Business Gateway (Chapter VI GPSR),
• the right to information and redress (Chapter VIII GPSR).

Unlike the draft, the final Toy Regulation now contains a separate chapter on the obligations of distance and online sellers (Chapter III Toy Regulation). However, the GPSR remains applicable in addition – Article 14(2), (3) and (4) of the Toy Regulation refers to Article 22 of the GPSR.

Control through safety assessment and digital product passport

Safety assessment

In addition to the conformity assessment procedures already known from other European Union legislation, such as the GPSR (Article 7(2) UA 1 Toy Regulation), the manufacturer must carry out a safety assessment (Article 25 Toy Regulation). This must be done before the toy is placed on the market and, in addition to analysing potential hazards, also includes an assessment of possible exposure to these hazards. This applies to all chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and, in the area of chemical safety, also to combined exposures.

Digital product passport

Manufacturers must issue a digital product passport (“DPP”) for each toy (Article 7(2) UA 2 lit. a in conjunction with Article 19 of the Toy Regulation). This allows market surveillance authorities and customs authorities to easily verify the conformity of the toy with the requirements of the Toy Regulation. In addition to the product identification of the toy, it must contain information on the manufacturer, the customs tariff number, the CE marking and a list of allergenic fragrances, among other things. Even if, at first glance, the DPP only imposes additional obligations on the manufacturer, it also has some advantages: In some cases, the DPP may replace the previous EU declaration of conformity in future, e.g. for electrical and electronic equipment covered by Directive 2011/65/EU (“RoHS”). In addition, safety information, warnings and instructions for use can be optionally included in the DPP.

If such a DPP already exists on the basis of other EU legislation, such as Regulation (EU) 2024/1781 (“Ecodesign Regulation”), the manufacturer must issue a uniform DPP for toys (Article 19(9) of the Toy Regulation). Typical applications are electronic, networked or digitally controlled toys such as educational computers, toy robots, smart toys or remote-controlled vehicles. The DPP must then contain the information required by the Toys Regulation and all data required by the relevant legislation.