Toy Safety Regulation (EU) 2025/2509

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

Regulation (EU) 2025/2509 of the European Parliament and of the Council of [adoption date late 2025] on the safety of toys repeals and replaces Directive 2009/48/EC. The Regulation entered into force and applies from 1 January 2026, with a transitional period during which toys placed on the market before the date of application under Directive 2009/48/EC may continue to be made available. The Regulation maintains the essential structure of the Toy Safety Directive but materially tightens the chemical safety regime, introduces a Digital Product Passport, and aligns enforcement with the General Product Safety Regulation 2023/988 and the market surveillance framework of Regulation (EU) 2019/1020.

Legal status and timeline

• Predecessor: Directive 2009/48/EC on the safety of toys.
• Adoption: late 2025.
• Entry into force: 1 January 2026.
• Date of application: 1 January 2026, with transitional placing on the market under Directive 2009/48/EC for toys produced before that date in conformity with the Directive.
• Status in May 2026: applies. Notified Bodies designated under Directive 2009/48/EC are being redesignated under the Regulation; full Notified Body capacity is expected by mid-2026.

Scope: products covered

Article 3(1) defines a toy as "any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age". Annex I lists products that are not regarded as toys for the purposes of the Regulation: Christmas decorations, scale models for adult collectors, sports equipment, bicycles with maximum saddle height above 435 mm, scooters intended for the public roads, electric vehicles, jigsaw puzzles of more than 500 pieces, weapons (including imitations), playground equipment for collective use, and other specific items.

Borderline products

The Commission's "Toys/Non-Toys" guidance under Directive 2009/48/EC remains a reference for the new Regulation. Frequent borderline cases:

• Products dual-marketed to children and adults — assessed on whether the design or marketing indicates use by children under 14;
• Children's clothing with play-functional components (puppets attached) — clothing is not a toy; the play component may be;
• Stationery with decorative play features — case-by-case assessment;
• Outdoor play structures over 0.5 m — playground equipment under EN 1176, not a toy;
• Electronic gaming devices — toys if designed for children under 14.

Essential safety requirements (Annex II)

Annex II sets out the essential safety requirements, structured as Annex II of Directive 2009/48/EC was, but updated:

• Part I — General safety requirements. Toys, their parts, and packaging must not present any risk to the safety or health of users when used as intended or in a reasonably foreseeable way.
• Part II — Particular safety requirements.
  • Physical and mechanical properties — strength, sharp edges and points, projectiles, small parts (toys for children under 36 months);
  • Flammability — restrictions on materials with high burning rate;
  • Chemical properties — substantially tightened: prohibition of substances that are carcinogenic, mutagenic or toxic to reproduction (CMR Categories 1A and 1B under CLP Regulation 1272/2008); restriction of substances toxic to specific organs after repeated exposure (STOT RE); allergenic fragrances; endocrine disruptors. The Regulation introduces a general prohibition on the most hazardous substances unless explicit derogations are granted via delegated act;
  • Electrical properties — toys must not be powered by a nominal voltage exceeding 24 V DC or the corresponding AC value;
  • Hygiene — risks from microbiological contamination, particularly for toys for children under 36 months;
  • Radioactivity — limits from natural and artificial sources;
  • Connected toys — new section addressing data, privacy, and cybersecurity risks of toys connecting to networks.

Chemical safety: the principal substantive change

The most material substantive change from Directive 2009/48/EC is the broader prohibition of CMR substances. Under the Directive, Categories 1A and 1B substances were restricted by reference to specific Annex II Appendix entries; under the Regulation, the prohibition is generalised, with derogations permitted only where the substance is not accessible to children, no suitable alternative exists, and the substance has been evaluated and approved via delegated act. The Regulation also brings endocrine disruptors and PFAS into restriction.

Conformity assessment procedures

Articles 22–24 of the Regulation provide:

• Module A — Internal production control. Available where the manufacturer has applied harmonised standards covering all essential requirements. This is the route for the great majority of toys.
• Module B + C — EU type-examination + conformity to type. Required where harmonised standards have not been applied, applied only in part, do not cover all essential requirements, or have not been published in the OJEU for the relevant requirement. A Notified Body issues an EU type-examination certificate.

The four-digit Notified Body identification number appears next to the CE marking where Module B + C has been used. See Notified Bodies.

Safety assessment (Article 18)

Article 18 of the Regulation makes the safety assessment a formal document in the technical file. The assessment must analyse: physical and mechanical hazards; chemical hazards (with consideration of all substances present in the toy and possible exposure routes — ingestion, inhalation, dermal contact); electrical and connected-toy hazards; flammability; hygiene; radioactivity. The assessment is updated when standards change, when ingredients change, or when post-market findings indicate revision is required.

Technical documentation

Article 19 and Annex IV set the technical documentation contents. Required elements include the safety assessment, descriptions of the design and manufacture, the chemical composition analysis, references to harmonised standards applied, and the Digital Product Passport identifier. Retention: 10 years from the last unit placed on the market (Article 19(5)). See technical documentation.

EU Declaration of Conformity

Article 17 and Annex V set the Declaration's contents. The Declaration must include the unique identifier of the toy's Digital Product Passport. The Declaration may be made available via the Digital Product Passport rather than as a separate paper document. See EU Declaration of Conformity.

Marking, labelling, and Digital Product Passport

Article 16 requires the CE marking. Article 17 requires the Notified Body identification number where applicable. Beyond the CE mark, the toy must bear:

• Type, batch, or serial number, or another element allowing identification;
• Manufacturer's name, registered trade name or trade mark, postal address, and electronic contact (website or email);
• Where applicable, importer's contact details;
• Warnings required by Annex VI in the language(s) of the Member State of destination (e.g., "Not suitable for children under 3 years" with the corresponding pictogram for toys with small parts);
• Age suitability information.

Digital Product Passport for toys

Article 17 and Article 41 of the Regulation introduce a Digital Product Passport (DPP) for each toy. The DPP is a structured data record accessible via a data carrier (typically a QR code or similar) on the toy or its packaging. It contains: identification of the toy; identification of the manufacturer and Authorised Representative; compliance information (Declaration of Conformity, harmonised standards applied); safety warnings; chemical composition information necessary for risk assessment in the value chain; instructions and information for safe use. The DPP feeds into the Commission's EU Toy Information System, which serves market surveillance authorities. Toys placed on the market from 1 January 2026 must have a DPP; the Commission's implementing acts under Article 41(7) specify the technical architecture and data format.

See Digital Product Passport for the broader DPP framework, which extends beyond toys to products covered by the Ecodesign Regulation and the Battery Regulation.

Recent and upcoming changes

• The harmonised standard EN 71 series is being updated to align with the Regulation's tightened chemical and connected-toys provisions; new dated editions will appear in the OJEU progressively through 2026 and 2027.
• The Commission is preparing implementing acts under Articles 22 (conformity assessment), 41 (DPP technical architecture), and 47 (penalties guidance).
• Delegated acts under Article 39 will list specific CMR substances permitted under derogation.

Related legislation

• General Product Safety Regulation 2023/988 — applies as a fallback to consumer products not covered by harmonisation; toys are CE-marked under the Toy Safety Regulation, but GPSR's traceability and incident-notification provisions complement the Toy Regulation where the latter is silent.
• REACH Regulation (EC) 1907/2006 — applies to chemical substances in toys, in parallel to the Toy Regulation's chemical provisions.
• CLP Regulation (EC) 1272/2008 — for classification of substances used in toys.
• Low Voltage Directive 2014/35/EU — does not apply (toys are below the LVD's 50 V AC / 75 V DC threshold).
• EMC Directive 2014/30/EU — applies to electronic toys with EMC-relevant emissions.
• Radio Equipment Directive 2014/53/EU — applies to toys with intentional radio emission.
• Battery Regulation 2023/1542 — applies to battery-powered toys.
• RoHS Directive 2011/65/EU — applies to toys that are also electrical/electronic equipment.

Common errors

• Continuing under Directive 2009/48/EC after 1 January 2026 for new placings on the market. The transitional regime covers stock placed on the market before that date; production placed on the market from 1 January 2026 must comply with the Regulation.
• No Digital Product Passport. A toy without a DPP identifier from 1 January 2026 is not in compliance, even if all other requirements are met.
• Reliance on the older EN 71 editions. The harmonised standard list is updated to align with the Regulation; outdated EN 71 dated editions may no longer produce the presumption of conformity.
• Missing safety assessment. Article 18 requires a structured safety assessment in the file; verbal statements are insufficient.
• Affixing Notified Body number where Module A applies. Toys for which harmonised standards cover all essential requirements use Module A; no Notified Body number.
• Missing warnings in the language of destination. Warnings from Annex VI must be translated into the official language of each Member State where the toy is made available.

Sources

• Regulation (EU) 2025/2509 on the safety of toys — EUR-Lex.
• Directive 2009/48/EC on the safety of toys (predecessor) — EUR-Lex.
• European Commission — Toys sector.
• European Commission — Toys/Non-Toys guidance (under Directive 2009/48/EC, applied as reference) — Commission.
• Commission Notice — Blue Guide 2022 — EUR-Lex.