EU Has Formally Adopted New Regulation on the Safety of Toys Repealing Toy Safety Directive 2009/48/EC

Formal Adoption of the New Regulation

After the approval on 26 November 2025 by the European Parliament and Council, the new regulation was published on 12 December 2025 in the Official Journal titled: "Regulation (EU) 2025/2509 on the safety of toys and repealing Directive 2009/48/EC”.

In other words, EU has now formally adopted this new Regulation on the safety of toys, which repeals and replaces the currently used Toy Safety Directive. This new regulation is a major overhaul of the EU toy safety legal framework.

The shift from a directive to a regulation aims to ensure uniform application across all EU Member States and to close gaps and inconsistencies that arose under the old Toy Safety Directive.

It responds to new risks — particularly chemical hazards, digital/connected toy risks, and the rise of online marketplaces — and to commitments under the EU’s Chemicals Strategy for Sustainability.

What’s New / Updated

The Regulation introduces several important changes compared to the Directive:

• Stronger chemical restrictions, including a ban on PFAS and stricter limits on bisphenols and other harmful substances.
• Expanded safety assessments — physical, mechanical, chemical, electrical, hygiene, and radioactivity hazards must all be evaluated.
• Digital Product Passport (DPP) requirements — toys will need a digital passport (e.g. via QR code) showing compliance information.
• New rules for connected and AI-enabled toys, including cybersecurity considerations (aligned with other EU regulations).
• Obligations on online marketplaces and economic operators to ensure safety information and CE markings are clearly visible and accessible.

Obligations for Manufacturers

Safety Assessment & Technical Documentation

•          Conduct a comprehensive safety assessment covering all required hazards — physical, mechanical, chemical, electrical, hygiene, flammability and radioactivity.
•          Document this assessment in a technical file that supports conformity with the Regulation, and keep this documentation for 10 years after the toy is placed on the market.
  
  

Digital Product Passport (DPP)

•          Create a Digital Product Passport for each toy, which becomes the main compliance record for EU authorities and consumers.
•          Include essential compliance data in the DPP — such as unique product identifiers, CE markings, references to applicable legislation/standards, and manufacturer/importer details. The DPP replaces the traditional paper EU Declaration of Conformity.
  
  

CE Marking & Labelling

•          Affix the CE marking on the toy.
•          Ensure warnings and information, including age grading and risk-related instructions, are clear and compliant.
•          The DPP link or data carrier (e.g., QR code) must be visible and accessible.
  
  

Recordkeeping & Accessibility

•          Maintain and update the technical documentation and DPP.
•          Provide these to EU market surveillance authorities upon request.
  
  

Conformity Assessment

Manufacturers must perform a conformity assessment before placing the toy on the market, include:

•          Using applicable harmonised standards.
•          Where no standards exist, documented procedures that demonstrate safety.
•          In some cases, EU-type examination through a notified body may be used.
  
  
  

Markings

Some examples of the required markings and warnings in the Regulations are:

General Rules – Presentation

All warnings shall be preceded by the word ‘Warning’ or, in the form of the generic pictogram, which shall be displayed in a prominent way, without the obligation to repeat it before each warning.

Toys Not Intended for Use by Children under 36 Months

Toys which might be dangerous for children under 36 months shall bear a warning ‘Not suitable for children under 36 months’ or ‘Not suitable for children under three years or a warning in the form of the pictogram.

Timeline & Transitional Rules

Reference

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502509