The European Union has formally adopted Regulation (EU) 2025/2509 on the safety of toys, replacing the long-standing Toy Safety Directive 2009/48/EC. The Regulation was adopted on 26 November 2025 and published in the Official Journal of the European Union, with the objective of strengthening child protection while ensuring harmonised enforcement across Member States .
Unlike a directive, the new regulation will be directly applicable across the EU, removing national transposition differences and establishing uniform safety requirements for toys intended for children under 14 years of age.
Expanded Chemical Safety Provisions
The Regulation introduces generic prohibitions on the presence of certain hazardous chemical substance categories in toys, toy components, or micro-structurally distinct parts. These include:
- Carcinogenic, mutagenic, or reprotoxic (CMR) substances classified as category 1A, 1B, or 2
- Endocrine disruptors for human health (category 1 or 2)
- Specific target organ toxicants (STOT) category 1 (single or repeated exposure)
- Respiratory sensitisers category 1
- Skin sensitisers category 1A
- Per- and polyfluoroalkyl substances (PFAS)
- Bisphenols, including bisphenol A and other bisphenols identified as substances of concern
These restrictions are intended to complement existing EU chemicals legislation, including REACH and CLP, while applying a more precautionary approach for products intended for children .
Introduction of Digital Product Passport (DPP)
A key structural change introduced by the Regulation is the requirement for a Digital Product Passport (DPP) for toys. The DPP will replace the traditional EU Declaration of Conformity and will contain essential compliance and safety information in digital form. Authorities, customs officials, economic operators, and consumers will be able to access relevant data via a data carrier affixed to the toy, its packaging, or accompanying documentation .
The DPP is expected to support:
- Enhanced market surveillance
- Improved traceability across the supply chain
- More effective customs controls, particularly for imported toys
Broader Scope and Enforcement
The Regulation applies to all toys placed on the EU market, including those sold online and imported from third countries. It also explicitly covers adaptive toys designed for children with physical or cognitive disabilities. Market surveillance obligations will continue to align with Regulation (EU) 2019/1020 and the General Product Safety Regulation (EU) 2023/988 .
Transition Period
A transitional period is provided for, allowing toys compliant with Directive 2009/48/EC to continue to be placed on the market for a limited time, giving manufacturers and other economic operators time to adapt to the new requirements.
Why this matter?
Regulation (EU) 2025/2509 represents a significant regulatory shift in EU toy safety, particularly in relation to chemical risk management, digital traceability, and market surveillance enforcement. Its implementation is expected to have wide implications for toy manufacturers, importers, testing laboratories, and regulatory compliance professionals operating in or exporting to the EU.
