The TSR significantly expands chemical restrictions beyond the CMR substances (carcinogenic, mutagenic, and toxic for reproduction) previously regulated.

Generic prohibitions now explicitly include endocrine disruptors (Category 1 or 2), specific target organ toxicants (Category 1), and respiratory and skin sensitizers (Category 1). The regulation also bans intentional use of PFAS (“forever chemicals”) and 10 high-risk bisphenols, with potential expansion to 34 related substances. Migration limits have been drastically tightened: the Bisphenol A (BPA) limit drops to 0.005 mg/L (an 87.5% reduction from the previous 0.04 mg/L), allergenic fragrances thresholds decrease by 90% (from 100 mg/kg to 10 mg/kg), and specific limits are introduced for slime and putty products (0.02 mg/kg for nitrosamines).

The Digital Product Passport (DPP) is the key mechanism for improving transparency and traceability, replacing the physical Declaration of Conformity (DoC). The DPP is mandatory for each toy model and must be traceable through a data carrier such as a QR code visible on the product, packaging, or instructions. It serves a dual purpose: facilitating consumer access to safety information and, critically, streamlining customs controls.

Customs authorities must be able to automatically verify the existence and validity of the DPP before imported toys enter the EU market, acting as a digital gateway to prevent non-compliant products. The DPP must remain available for 10 years and include product identification, regulatory conformity data (CE marking, harmonized standards used), chemical safety declarations (SVHCs), and safety warnings accessible at point of sale including online.

The TSR incorporates a response to the inherent risks of toy digitalization, including drones, smart dolls, and AI-integrated products. Manufacturers must specifically assess cybersecurity risks, data protection, and privacy as part of their pre-market safety evaluation. This includes explicit consideration of children’s vulnerabilities, ensuring that the use of digital functions does not pose risks to children’s mental health or development.

This area represents convergence with other European regulations, such as the new RED Standards (EN 18301), future Cyber Resilience Act (CRA) and data protection rules, requiring a security-by-design approach for digital features.

The TSR aims to close loopholes that allowed non-compliant toys to be sold through online platforms by third-country sellers. Every toy sold in Europe, whether in physical stores or online platforms (such as Amazon or AliExpress), must have a responsible economic operator established in EU territory.

This ensures there is a legally identifiable entity subject to EU jurisdiction to answer for product safety. Online marketplace providers have explicit obligations to ensure toys sold through their services meet relevant requirements and must cooperate with authorities by removing non-compliant products. These obligations align with the General Product Safety Regulation (GPSR), which entered into force in December 2024.

The TSR requires manufacturers to conduct a comprehensive and documented safety assessment before placing products on the market. This assessment must cover not only classic mechanical, physical, and electrical risks, but also an expanded review of new risk vectors including flammability, hygiene, radioactivity (where applicable), and risks arising from digital functions. The chemical risk review must be significantly deeper than under the old Directive, including detection and control of substances such as PFAS, bisphenols, and other newly restricted compounds. All this risk assessment documentation must be available and referenced in the Digital Product Passport.