# Selling toys in the EU: Toy Safety Directive essentials
The Toy Safety Directive (2009/48/EC) covers toys: products designed or intended for play by children under 14. Toys must meet safety requirements on physical and mechanical properties, flammability, chemicals, electrical properties, hygiene and radioactivity, carry warnings and traceability labelling, and bear the CE marking after conformity assessment. A recast Toy Safety Regulation introducing a product passport is nearing adoption.
Key facts
- The directive covers products designed or intended, whether exclusively or not, for use in play by children under 14; certain products are explicitly excluded in the annexes.
- Essential safety requirements span physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity, with chemical rules among the strictest in consumer product law.
- Warnings, including age warnings and use limitations, must appear in the languages of each member state of sale and follow prescribed formats.
- Traceability requires the manufacturer's and importer's name and address and batch or serial identification on the toy or packaging.
- Importers must verify the manufacturer's conformity assessment and keep the technical documentation available to authorities.
- The recast Toy Safety Regulation, proposed in 2023 with a provisional political agreement reached in April 2025, will replace the directive, add a digital product passport, and ban additional substances including PFAS and the most dangerous bisphenols.
1. Scope: what counts as a toy
The directive applies to products designed or intended, whether exclusively or not, for use in play by children under 14 years of age. The "whether exclusively or not" matters: a product with a play value for children can be a toy even if it has other functions. Certain products are explicitly excluded from the scope, listed in the directive's annexes, and the exclusion list should be checked rather than assumed.
Borderline products are a recurring enforcement theme. Items marketed to children that look like toys but claim a different primary function, such as novelty lighters, decorative objects or functional miniature appliances, are assessed on their play value and presentation, not on the manufacturer's label alone. When in doubt, assess the product as a toy: the cost of an unnecessary toy assessment is far lower than the cost of an enforcement action for a non-compliant toy.
2. Essential safety requirements
Toys must satisfy the essential safety requirements in Annex II, which cover general safety principles plus specific requirements on physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity. Physical and mechanical requirements address hazards such as small parts, sharp points and edges, and projectiles. Flammability rules restrict materials that ignite readily. Electrical requirements apply to toys with electrical functions, including battery safety.
The chemical requirements are the most demanding part of the regime. The directive restricts carcinogenic, mutagenic and reprotoxic (CMR) substances, sets migration limits for heavy elements, restricts nitrosamines and nitrosatable substances in toys for young children, and controls allergenic fragrances. Compliance is demonstrated through testing against harmonised standards, principally the EN 71 series, and through the chemical safety assessment the recast will formalise. Chemical testing should be planned per material and colour variant, because a single test report rarely covers a whole range.
3. Warnings, instructions and languages
Warnings must be clearly visible, easily legible and understandable, and must appear in the official languages of each member state where the toy is sold. Age warnings follow prescribed wording and formats: toys not intended for children under 36 months carry the specific warning, and small-parts warnings apply where the hazard exists. Warnings on the toy itself are required where the hazard relates to use; packaging warnings alone are not enough where the directive requires the warning on the product.
Instructions for use accompany toys where needed for safe use, in the same language regime. The language requirement is an enforcement staple: authorities routinely check that warnings appear in the national language, and missing or mistranslated warnings are among the most common findings in toy inspections.
4. Traceability, labelling and the CE marking
The toy, its packaging or an accompanying document must carry the manufacturer's name, registered trade name or trademark and contact address, and the importer's name and address where the manufacturer is outside the EU. A type, batch, serial or model number, or other element allowing identification of the toy, must enable traceability. The CE marking is affixed after the conformity assessment, visibly, legibly and indelibly on the toy or its packaging.
Importers have explicit verification duties: they must ensure the manufacturer has carried out the conformity assessment, drawn up the technical documentation and affixed the CE marking, and they must keep a copy of the EU declaration of conformity and ensure the technical documentation can be made available to authorities. Distributors must verify the presence of the CE marking, required documents and traceability information before making toys available, and must act on non-compliance.
5. Conformity assessment and the technical file
Most toys follow self-assessment: the manufacturer applies the essential safety requirements, tests against the harmonised standards, draws up the technical documentation and issues the EU declaration of conformity. Where harmonised standards do not cover all applicable requirements, or the manufacturer has not applied them, EC type-examination by a notified body is required.
The technical documentation must contain a description of the toy, the design and manufacturing information, the list of harmonised standards applied, the test reports, and the safety assessment. It must be kept for ten years after the last toy of the type is placed on the market and made available to authorities on request. For importers, holding this file, or guaranteed rapid access to it, is the core of the verification duty.
6. The recast: Toy Safety Regulation and the digital product passport
The Commission proposed a Toy Safety Regulation in July 2023 to replace the directive, and Parliament and Council reached a provisional political agreement in April 2025. The recast converts the instrument from a directive to a directly applicable regulation, strengthens the chemical rules, and introduces a digital product passport for every toy, replacing the EU declaration of conformity with passport data accessible via a data carrier.
The agreed text expands the substance bans: beyond CMR substances, it bans the intended use of PFAS and the most dangerous bisphenols, adds endocrine disruptors and other child-specific hazard categories, and bans allergenic fragrances in toys for children under 36 months and in toys intended to be placed in the mouth. Manufacturers will have to carry out a documented safety assessment covering chemical, physical, mechanical and electrical hazards, flammability, hygiene and radioactivity, taking children's specific vulnerabilities into account. Online marketplaces receive defined duties aligned with the General Product Safety Regulation.
The regulation will enter into force on the twentieth day after publication in the Official Journal, with application dates and transition periods set in the final text. New entrants should build documentation systems that can accommodate the passport now: product identifiers, conformity data, standards references and complaint channels in structured, digital form.
| Topic | Toy Safety Directive 2009/48/EC | Toy Safety Regulation (recast) |
|---|---|---|
| Legal form | Directive, transposed nationally | Regulation, directly applicable |
| Declaration | EU declaration of conformity | Digital product passport replacing the declaration |
| Chemical bans | CMR substances, listed restrictions | Adds PFAS, dangerous bisphenols, endocrine disruptors, more fragrance bans |
| Safety assessment | Required via essential requirements | Formal documented safety assessment for all hazards |
| Online marketplaces | General duties | Defined duties aligned with the GPSR |
| Status | In force | Provisional agreement April 2025; formal adoption pending |
FAQs
Is a product with play value but another main function a toy?
It can be. The directive covers products designed or intended, whether exclusively or not, for play by children under 14. Assess play value and presentation; check the annex exclusions rather than relying on the product's marketing category.
Which warnings are mandatory?
Age warnings for toys not suitable for under-36-month-olds, small-parts warnings where applicable, and warnings for specific hazards such as projectiles, functional toys and chemical toys, in the prescribed formats and in the languages of each member state of sale.
How long must the technical documentation be kept?
For ten years after the last toy covered by the documentation is placed on the market. Importers must keep the declaration of conformity and ensure the technical documentation can be produced.
Do we need a notified body for every toy?
No. Self-assessment against the harmonised standards is the normal route. EC type-examination by a notified body is required where harmonised standards do not cover all applicable requirements or have not been applied.
What will the digital product passport change?
It replaces the paper declaration of conformity with structured digital data on the toy, accessible via a data carrier, carrying conformity information, standards references and complaint channels. Build product data systems to supply it.
How does the GPSR relate to toy safety?
The Toy Safety Directive, and later the Toy Safety Regulation, sets the sector-specific requirements and takes precedence for the risks it covers. The GPSR adds horizontal duties such as traceability, accident reporting and marketplace obligations.
Official sources
- Directive 2009/48/EC on EUR-Lex (Toy Safety Directive)
- European Commission: Toy safety
- Regulation (EU) 2023/988 on EUR-Lex (General Product Safety)
Last verified: 2026-09-29. The recast regulation's final text and application dates should be confirmed on EUR-Lex and the Commission's toy safety pages before planning the transition.