Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys

Key facts

Scope and who must comply

A "toy" is any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age. The directive applies to manufacturers, authorised representatives, importers and distributors of toys placed on the EU market, with the standard NLF division of responsibilities.

Excluded products include playground equipment for public use, automatic playing machines for public use, toy vehicles with combustion engines, toy steam engines, slings and catapults, and certain other categories listed in Annex I. Products such as children's books, puzzles above certain piece counts and sports equipment fall outside the toy definition where they are not intended for play by under-14s.

Because it is a directive, the binding rules are the national transpositions in each member state, but the requirements are harmonised and the directive's text is the authoritative reference. Note: the Commission has proposed replacing the directive with a directly applicable Toy Safety Regulation (proposal of July 2023), which would introduce stricter chemical rules and a digital product passport for toys. Businesses should track that proposal alongside the current directive.

Key obligations

Essential safety requirements (Annex II). Toys must satisfy the general safety obligation and the particular safety requirements covering:

• Physical and mechanical properties: no sharp edges or points, protection against strangulation, suffocation and choking (including small-parts rules for toys intended for children under 36 months), projectile requirements, and stability.
• Flammability: toys must not constitute a dangerous flammable element; specific rules apply to beards, wigs, masks, costumes and toys children can enter.
• Chemical properties: migration limits for 19 elements (including lead, cadmium, mercury and chromium), restrictions on CMR substances (carcinogenic, mutagenic or toxic for reproduction), nitrosamine and nitrosatable substance limits for rubber toys for under-3s, and fragrance allergen rules.
• Electrical properties: limited to nominal voltages of 24 V DC (or equivalent AC), with requirements on insulation, heat and battery safety.
• Hygiene and radioactivity: toys must meet hygiene and cleanliness requirements; radioactivity must comply with Euratom standards.

Warnings (Article 11). Toys must carry warnings where needed for safe use, including:

• Toys not intended for children under 36 months (or 3 years) must bear a warning such as "Not suitable for children under 36 months" or "Not suitable for children under 3 years", with a brief indication of the specific hazard. This is one of the most frequently enforced labelling rules in the EU.
• Category-specific warnings apply to functional toys, chemical toys, skates and skateboards, aquatic toys, toys in food and similar categories.
• Warnings must be clearly visible, easily legible, in the language(s) of the member state of sale, and must not conflict with the intended use of the toy.

Conformity process

1. Safety assessment: the manufacturer must carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards the toy may present, and assess exposure to such hazards (Article 18).
2. Harmonised standards: compliance with harmonised standards published in the Official Journal (the EN 71 series, covering mechanical/physical properties, flammability, migration of certain elements and other aspects) gives presumption of conformity with the corresponding essential requirements.
3. [Conformity assessment](/glossary/conformity-assessment): where harmonised standards covering all relevant safety requirements have been applied, the manufacturer may use internal production control (Module A, self-declaration). Where standards have not been applied, or only partly, or where no standards exist, EC-type examination (Module B) by a notified body plus conformity to type (Module C) is required.
4. [CE marking](/glossary/ce-marking): the manufacturer affixes the CE marking before placing the toy on the market, draws up the EU Declaration of Conformity and keeps the technical documentation (including the safety assessment) for 10 years.

Importers must verify that the manufacturer has carried out the assessment, that the toy bears the CE marking and required warnings, and that traceability details are present. Distributors must exercise due care before making toys available.

Documentation and labelling

• EU Declaration of Conformity following the model structure, kept with the technical documentation for 10 years.
• Technical documentation including the design and manufacturing description, the safety assessment, test reports, and the list of harmonised standards applied.
• Traceability: type, batch, serial or model number plus the manufacturer's name, registered trade name or trademark and contact address on the toy (or packaging/documents where size or nature requires); importer's details added where applicable.
• Instructions and safety information in the language(s) of the member state where the toy is made available.

Enforcement and penalties

• National market surveillance authorities test toys routinely; toys are consistently among the most-notified product categories in the Safety Gate rapid alert system, particularly for choking hazards, chemical exceedances and missing warnings.
• Non-compliant toys can be ordered withdrawn or recalled, and serious risks trigger EU-wide alerts.
• Penalties are set by member states and must be effective, proportionate and dissuasive; they include fines and, in some member states, criminal sanctions.

Obligations by operator role

Chemical requirements in practice

The chemical regime is where most toy compliance effort goes. Key elements include:

• Migration limits: Annex II, Part III sets migration limits for 19 elements from toy materials, differentiated by material type (dry, liquid, scraped-off). Lead, cadmium and mercury limits are particularly strict, and limits for toys intended for children under 36 months or intended to be placed in the mouth are tighter.
• CMR substances: substances classified as carcinogenic, mutagenic or toxic for reproduction of category 1A, 1B or 2 are generally prohibited in toys, in components and in micro-structurally distinct parts, with limited exemptions subject to strict conditions.
• Fragrance allergens: Annex II lists prohibited allergenic fragrances and those requiring labelling when present above 100 mg/kg. The list has been expanded by amendments, so the consolidated text is the only safe reference.
• Nitrosamines: strict limits apply to toys for children under 36 months and toys intended to be placed in the mouth that are made of rubber or contain rubber parts.

Because limits and listed substances change through amendments, testing strategies should be built against the current consolidated directive and the applicable EN 71 parts, not against a printed copy of the original 2009 text.

Staying current

1. Check the consolidated version of the directive on EUR-Lex before relying on chemical limits; Annex II has been amended many times (elements, allergenic fragrances, CMR substances).
2. Track the proposed Toy Safety Regulation, which would convert the rules into a regulation and add a digital product passport.
3. Follow the EN 71 series updates; new or revised harmonised standards change the presumption of conformity.
4. Monitor Safety Gate notifications for toys to see which hazards authorities are targeting.

Frequently asked questions

What counts as a toy? Any product designed or intended, whether exclusively or not, for use in play by children under 14. Products listed in Annex I (such as public playground equipment and certain sports goods) are excluded. Borderline products should be assessed against Commission guidance and, where uncertain, expert review.

When is a notified body required for toys? When harmonised standards covering all applicable safety requirements have not been used (or do not exist), the manufacturer must use EC-type examination (Module B) by a notified body together with conformity to type (Module C). Full application of the EN 71 standards allows self-declaration under Module A.

What is the "under 36 months" warning rule? Toys that are not intended for children under 36 months but might appeal to them must carry the warning "Not suitable for children under 36 months" (or equivalent), with a brief statement of the hazard. Misuse of this warning, including omitting it where required, is a frequent cause of enforcement action.

Are the chemical limits the same as [REACH](/glossary/reach)? No. The Toy Safety Directive has its own chemical regime in Annex II (migration limits for 19 elements, CMR restrictions, fragrance rules), which applies in addition to REACH restrictions such as those in Annex XVII. Both must be satisfied.

Is the directive being replaced? The Commission proposed a Toy Safety Regulation in July 2023 to replace the directive. Until it is adopted and applies, the directive remains the binding law. Businesses should track the proposal because it would introduce stricter chemical provisions and a digital product passport for toys.

Sources

• Directive 2009/48/EC on the safety of toys (official text): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009L0048
• European Commission: toy safety: https://single-market-economy.ec.europa.eu/sectors/toys_en
• EU Safety Gate rapid alert system: https://ec.europa.eu/safety-gate/