[Home](/)/[Resources](/resources)/EU Toy Safety Regulation EU/CEProduct safety guide # EU Toy Safety Regulation: Chemical Limits, Connected Toys, and the Transition from the 2009 Directive The EU's new Toy Safety Regulation replaces the 2009 Toys Directive with a directly applicable Regulation that tightens chemical safety limits, explicitly addresses connected and digital toys, and strengthens economic operator obligations. Electronics makers building toys or toy-adjacent products need to re-evaluate their BoM chemical screening, conformity assessment routes, and the interaction with RED and cybersecurity requirements for any toy with a radio module. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Feu-toy-safety-regulation-2023) At a glance Replaces Directive 2009/48/EC Form Directly applicable Regulation Standard EN 71 series + EN 62368-1 Mark CE (unchanged) ## Key changes for electronics makers ### Replacing the 2009 Toys Directive The EU's new Toy Safety Regulation replaces Directive 2009/48/EC (the Toys Directive). As a Regulation — not a Directive — it applies directly in all EU member states without national transposition, creating uniform rules. The revision tightens chemical safety requirements, addresses digital and connected toys more explicitly, and aligns substance limits more closely with REACH and other EU chemical legislation. The transition period allows toys compliant with the 2009 Directive to remain on the market for a defined period after the Regulation takes effect. ### Stricter chemical safety requirements The new Regulation introduces lower migration and content limits for certain chemicals, including specific limit values for carcinogenic, mutagenic, and reprotoxic (CMR) substances and endocrine disruptors aligned with REACH's scientific committees. Where a substance is restricted under both REACH and the Toy Safety Regulation, the stricter limit applies. Electronics components used in electronic toys — PCBs, battery contacts, coatings, plastics — must be screened against both frameworks. ### Connected and digital toys The Regulation addresses connected toys — those with wireless connectivity, sensors, cameras, or microphones — more explicitly than the 2009 Directive. Connected toys must comply with applicable cybersecurity and data protection requirements in addition to the physical safety and chemical requirements. This means RED (if the toy contains a radio module) and, from 28 June 2025, the European Accessibility Act (if the toy has an interactive interface) may also apply alongside the Toy Safety Regulation. ### Conformity assessment and technical file Most toys follow the Module A self-assessment route — internal production control with the technical file held by the manufacturer. Toys with specific risks (certain chemicals, electrical components, noise levels above threshold) require third-party assessment by a notified body under Module B+C or similar. The technical file must cover the safety evaluation, test reports against harmonised EN 71 standards and EN 62368-1 (for electrical toy safety), and the Declaration of Conformity. The Regulation reinforces economic operator obligations for importers and distributors. ## Compliance process 01 Determine whether your product is a toy under the Regulation's definition — 'any product or material designed or clearly intended for use in play by children under 14 years' — and check any exclusions for products like Christmas decorations, puzzles for adults, or sports equipment. 02 Identify all applicable EN 71 series standards for your toy category (mechanical, flammability, chemical, electrical, acoustic) plus EN 62368-1 for electrical and electronic toys, and confirm whether third-party notified body assessment is required for your specific toy type. 03 Screen all materials in the toy against the chemical safety requirements of the new Regulation — particularly CMR substance limits, endocrine disruptor restrictions, and any substance also restricted under REACH — using supplier declarations and test data. 04 For connected toys with radio functions, complete RED conformity assessment in parallel — a connected toy is simultaneously a toy and radio equipment and must satisfy both frameworks. 05 Compile the technical file including risk assessment covering all hazard categories (mechanical, chemical, electrical, flammability, hygiene, radioactivity), test reports, and the safety analysis for the target age group. 06 Prepare the EU Declaration of Conformity referencing the Toy Safety Regulation (and RED, if applicable), and affix the CE mark — the Regulation does not introduce a separate toy-specific marking. 07 Monitor the transition timeline: identify whether your current toys comply with the 2009 Directive and plan the re-testing and documentation updates needed to meet the new Regulation's stricter requirements before the transition period ends. ## Frequently asked questions ### When does the new Toy Safety Regulation take effect? The Toy Safety Regulation was adopted and published in the Official Journal of the EU. There is a transition period (typically 24 months from the Regulation entering into force for new products, with a further sell-through period for existing stock). Check the Official Journal publication for the precise application date and any category-specific phasing, as chemical limits may have different transition periods. ### Does CE marking on toys change under the new Regulation? No — CE marking remains the conformity marking for toys in the EU. The new Regulation does not introduce a new mark. The Declaration of Conformity and technical file requirements are updated to reflect the new Regulation's reference, and for connected toys the DoC must also reference RED and any other applicable directives. ### What are the key differences between the old Directive and the new Regulation for electronic toys? The most significant differences for electronic toys are: stricter CMR and endocrine disruptor chemical limits, more explicit treatment of connected toys including cybersecurity and data protection cross-references, strengthened economic operator obligations (particularly for importers and online marketplace operators), and direct applicability as a Regulation removing member state implementation variation. Test standards themselves (EN 71, EN 62368-1) remain referenced but may be revised to align with the new limits. ### Does the Toy Safety Regulation apply to toys sold online from outside the EU? Yes — the Regulation applies to all toys placed on the EU market regardless of the sales channel or origin. Online sellers targeting EU consumers must comply even without an EU physical presence. The Regulation strengthens obligations on online marketplaces to ensure toys offered through them comply, mirroring the approach in GPSR. Non-EU manufacturers selling direct-to-consumer in the EU without an EU authorised representative are exposed to market surveillance action. **Disclaimer:** Educational resource only. Transition timelines and specific requirements depend on the Regulation's final Official Journal publication. Consult the Official Journal text and a qualified toy safety specialist before making compliance decisions. 🇪🇺 CE Marking roadmap for toys Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take toys through 🇪🇺 CE Marking compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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