Toy Safety Regulation (EU) 2025/2509

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

Regulation (EU) 2025/2509 of the European Parliament and of the Council of 26 November 2025 on the safety of toys and repealing Directive 2009/48/EC was published in the OJEU on 12 December 2025 and entered into force on 1 January 2026. It applies from 1 August 2030 (Article 59); only the provisions on notified bodies and on delegated and implementing powers apply from 1 January 2026. Until 1 August 2030, toys continue to be placed on the market under Directive 2009/48/EC, and toys lawfully placed on the market under the Directive before that date may continue to be made available (Article 57). 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: 26 November 2025; published in the OJEU on 12 December 2025.
• Entry into force: 1 January 2026.
• Date of application: 1 August 2030; Articles 28 to 44 (notification of conformity assessment bodies) and Articles 49 to 55 apply from 1 January 2026 (Article 59).
• Repeal of Directive 2009/48/EC: 1 August 2030 (Article 56). Toys placed on the market in conformity with the Directive before that date may continue to be made available; EC type-examination certificates issued under the Directive remain valid until 1 February 2031 unless they expire earlier (Article 57).
• Status in October 2026: in force but not yet generally applicable; toys are placed on the market under Directive 2009/48/EC. The notification provisions already apply so that conformity assessment bodies can be notified under the Regulation ahead of 1 August 2030.

Scope: products covered

Article 2(1) applies the Regulation to "products that are designed or intended, whether or not exclusively, for use in play by children under 14 years of age (toys)". Annex I excludes certain toys (Part I — for example playground equipment and automatic playing machines intended for public use) and lists products that are not considered toys (Part II): decorative objects for festivities without play value, detailed scale models and other products for collectors aged 14 and above, sports equipment, bicycles with a maximum saddle height above 435 mm, scooters and electrically driven vehicles for use on public roads, puzzles of more than 500 pieces, compressed-gas guns and pistols (other than water guns), 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 (Article 5 and Annex II)

Article 5 sets out the essential safety requirements: the general safety requirement in Article 5(2) and the particular safety requirements in Annex II, structured as Annex II of Directive 2009/48/EC was, but updated:

• General safety requirement (Article 5(2)). Toys must not present a risk to the safety or health of users or other persons when used as intended or in a foreseeable way, bearing in mind the behaviour of children.
• Particular safety requirements (Annex II, Parts I–VI).
  • 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 classified under CLP Regulation 1272/2008 as CMR (Categories 1A, 1B and 2), endocrine disruptors for human health (Categories 1 and 2), specific target organ toxicants (Category 1, single or repeated exposure), respiratory sensitisers (Category 1) and skin sensitisers (Category 1A); prohibition of intentionally used PFAS and of listed bisphenols; restrictions on allergenic fragrances. Derogations are possible only by listing in Part C of the Appendix to Annex II via delegated act;
  • Electrical properties — toys must not be powered by electricity of a nominal voltage exceeding 24 V DC or the equivalent AC voltage;
  • Hygiene — risks from microbiological contamination, particularly for toys for children under 36 months;
  • Radioactivity — limits from natural and artificial sources.

Chemical safety: the principal substantive change

The most material substantive change from Directive 2009/48/EC is the extension of the generic prohibition. The Directive already prohibited CMR substances (Categories 1A, 1B and 2) subject to derogations; the Regulation extends the generic prohibition to endocrine disruptors, specific target organ toxicants, and respiratory and skin sensitisers (Annex II, Part III, point 4), and adds prohibitions on intentionally used PFAS (point 5) and listed bisphenols (point 6). Derogations are granted only by delegated act under Article 49(6) adding the substance to Part C of the Appendix to Annex II, following an ECHA opinion (Articles 51 and 52).

Conformity assessment procedures

Article 26 and Annex IV 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 or common specifications covering all relevant safety requirements do not exist, have not been applied or have been applied only in part, have been published with a restriction applicable to the toy, or where the manufacturer considers third-party verification necessary. A Notified Body issues an EU type-examination certificate, to be reviewed whenever necessary and in any case every five years (Article 26(4)).

Because neither route involves a Notified Body in the production phase, no Notified Body identification number follows the CE marking on toys; where a Notified Body has issued a certificate, its name and number are recorded in the Digital Product Passport (Annex VI, Part I, point (j)). See Notified Bodies.

Safety assessment (Article 25)

Article 25 of the Regulation requires the manufacturer to carry out a safety assessment before placing a toy on the market and to include it in the technical documentation. The assessment must cover all chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to them; for chemical hazards it must take account of exposure to individual chemicals and known combined effects; for toys within the scope of the AI Act, the Cyber Resilience Act or the Radio Equipment Directive it must take account of children's particular vulnerabilities. The assessment must be updated whenever additional relevant information becomes available.

Technical documentation

Article 27 and Annex V set the technical documentation contents. Required elements include the safety assessment, descriptions of the design and manufacture, information on the substances present, and references to harmonised standards applied. Retention: the technical documentation and the Digital Product Passport must be kept for 10 years after the toy has been placed on the market (Article 7(3)). See technical documentation.

EU Declaration of Conformity

The Regulation does not provide for a separate EU Declaration of Conformity for toys: the Digital Product Passport replaces it. By creating the passport, the manufacturer states that compliance has been demonstrated and assumes responsibility for the toy's compliance (Article 19(2)(b) and (4)). Where the passport contains all the information required by the declaration of conformity under the RED, EMC Directive, LVD, RoHS Directive, AI Act or Cyber Resilience Act, the manufacturer is deemed to comply with those declaration obligations too (Article 19(5)). Until 1 August 2030, toys placed on the market under Directive 2009/48/EC still require the EC declaration of conformity under Article 15 of that Directive. See EU Declaration of Conformity.

Marking, labelling, and Digital Product Passport

Articles 17 and 18 govern the CE marking, which must be affixed visibly, legibly and indelibly to the toy or an affixed label (or, where that is not possible, to the packaging or accompanying documents) and also to the packaging where it is not visible from outside. Beyond the CE mark, the toy must bear (Articles 6 and 7):

• Type, batch, or serial number, or another element allowing identification;
• Manufacturer's name, registered trade name or registered trade mark, and postal and electronic address;
• Where applicable, importer's contact details;
• Warnings required by Article 6 and Annex III 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

Articles 19 to 23 and Annex VI of the Regulation introduce a Digital Product Passport (DPP) for each toy model, which the manufacturer must create before placing the toy on the market. The DPP is connected through a data carrier to a persistent unique product identifier. Its mandatory content (Annex VI, Part I) includes: the unique product identifier; the manufacturer's and, where applicable, Authorised Representative's name, address and unique operator identifier; the economic operator responsible under Article 4 of Regulation (EU) 2019/1020; the Union law the toy complies with; harmonised standards or common specifications applied; Notified Body and certificate details where applicable; the CE marking; and allergenic fragrances subject to labelling. Safety information, warnings and instructions for use may be added (Part II). The unique identifiers are uploaded to the ESPR digital product passport registry (Article 22), which is also used for customs controls (Article 23). The DPP obligation applies to toys placed on the market from 1 August 2030; its technical requirements are to be set by delegated acts under Article 49(1).

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 will need to be revised and cited under the Regulation to give a presumption of conformity from 1 August 2030.
• The Commission is to adopt delegated acts under Article 49(1) setting the technical requirements of the toy DPP (data carriers, access rights, data updating), applying no earlier than 18 months after their entry into force.
• Delegated acts under Article 49(6) may permit specific prohibited substances by listing them in Part C of the Appendix to Annex II, following ECHA opinions.

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 August 2030 for new placings on the market. The transitional regime covers toys placed on the market before that date; toys placed on the market from 1 August 2030 must comply with the Regulation.
• No Digital Product Passport. A toy placed on the market from 1 August 2030 without a DPP 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 25 requires a structured safety assessment in the file; verbal statements are insufficient.
• Affixing a Notified Body number next to the CE marking. Neither Module A nor Module B + C involves a Notified Body in the production phase, so no identification number follows the CE marking on toys.
• Missing warnings in the language of destination. Warnings required by Article 6 and Annex III 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.