Directive 2009/48/EC — Safety of Toys

Can I still place my toy on the EU market without a third-party test — and what does market surveillance do when a product fails chemical limits?

Any toy sold in the EU must meet the essential safety requirements of Directive 2009/48/EC, enforceable since 20 July 2011, with penalties set by each Member State that may include criminal sanctions for serious infringements [Art. 51] — the manufacturer bears primary responsibility [Art. 4].

Short Answer

Directive 2009/48/EC covers all products designed or intended for play by children under 14 [Art. 2]. It imposes cascading obligations on manufacturers, importers and distributors, requires CE marking before placing on the market [Art. 16], and mandates conformity assessment either through internal production control (Module A) or EC-type examination by a notified body (Module B + C) where harmonised standards are incomplete or absent [Art. 19]. Chemical migration limits for 19 elements including lead (2.0 mg/kg dry material), cadmium (1.3 mg/kg) and chromium VI (0.02 mg/kg) are binding in Annex II, Part III, as tightened by successive amendments up to Directive (EU) 2021/903. The latest amendment, Directive (EU) 2026/192, must be transposed by 29 July 2026 and adds a cobalt CMR derogation for stainless steel, electric-current metals and non-swallowable NdFeB magnets [Art. 1 of 2026/192].

Who is affected

Manufacturers, authorised representatives, importers and distributors of toys — defined as products designed or intended for use in play by children under 14 years [Art. 2(1), Art. 3]. Functional toys, chemical toys, aquatic toys, activity toys, cosmetic kits and olfactory board games are in scope with additional requirements. Excluded: playground equipment for public use, toy vehicles with combustion engines, bicycles with saddle height over 435 mm, puzzles with more than 500 pieces, babies' soothers, and 18 further product categories listed in Annex I.

Deadline

29 July 2026 — transposition deadline for Directive (EU) 2026/192 (cobalt CMR derogation in Appendix A of Annex II). Member States must apply the cobalt provisions from 29 August 2026. All other provisions of the consolidated Directive are already permanently enforceable.

Risk

Directive 2009/48/EC does not set EU-wide maximum fines; penalties are determined by each Member State and must be effective, proportionate and dissuasive [Art. 51]. They may include criminal sanctions for serious infringements. National ceilings vary — e.g. Germany imposes up to EUR 30,000 per infringement under ProdSG. Market surveillance authorities may order withdrawal, recall or a prohibition on making the product available [Art. 42].

Proof

Legal status

• In force
• as of 2026-06-07
• Consolidated version of 5 December 2022 (011.001), incorporating 17 amendments (M1-M17) plus Directive (EU) 2026/192 (not yet in consolidated text)

Primary sources

What to do now

Legal / DPO

•Map each national transposition of Directive (EU) 2026/192 (cobalt derogation) for every target market — transposition is due by 29 July 2026 and Member States may impose stricter measures [Art. 54].
•Verify that the EC declaration of conformity under Annex III names all applicable harmonised standards and conformity assessment modules; an incomplete declaration is a formal non-compliance ground allowing market surveillance to order withdrawal [Art. 15, Art. 45].
•Review supply-chain contracts to ensure each economic operator can identify its upstream supplier and downstream recipient for the mandatory 10-year traceability period [Art. 9].

Compliance

•Audit current chemical test reports against the consolidated migration limits in Annex II, Part III, point 13 — chromium VI must not exceed 0.02 mg/kg in dry material and 0.005 mg/kg in liquid material, as amended by Directive (EU) 2018/725.
•Confirm that all 58 prohibited allergenic fragrances (Annex II, Part III, point 11, table 1) are absent from formulations and that all 72+ labelling-required fragrances (table 2, expanded by Directive (EU) 2020/2088) are disclosed if exceeding 100 mg/kg.
•Establish a sample-testing programme for series production as required of manufacturers [Art. 4(2)(c)] and importers [Art. 6(7)], covering physical/mechanical, chemical and flammability properties.

IT / Security

•Ensure electronic control systems in toys with electronic components provide safe fallback behaviour on malfunction or failure, preventing electrical hazards from the power source [Annex II, Part IV, points 4 and 7].
•Validate that lasers, LEDs and any other radiation sources in toys do not pose health hazards or risk eye or skin injury, per Annex II, Part IV, point 8.
•Where toys contain connected or software-controlled features, verify that nominal voltages remain within the 24 V DC ceiling (or equivalent AC) and that internal voltages above 24 V cannot cause harmful electric shock even when the toy is broken [Annex II, Part IV, point 1].

Product / Engineering

•Run the mandatory pre-market safety assessment covering chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards before placing any toy on the market [Art. 18].
•Where harmonised standards do not cover all applicable essential safety requirements, route the toy through EC-type examination (Module B) by a notified body plus conformity to type (Module C) — internal production control alone is insufficient [Art. 19(3)].
•For toys intended for children under 36 months or toys designed to be placed in the mouth, apply the additional Appendix C limits — including formaldehyde (1.5 mg/l migration in polymeric material), aniline (10 mg/kg free in finger paints), and bisphenol A (0.04 mg/l migration) [Annex II, Appendix C, as amended by Directives 2019/1929 and 2021/903].

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Key Terms

CE marking: Marking by which the manufacturer indicates that a toy is in conformity with the applicable requirements of Directive 2009/48/EC and other relevant Union harmonisation legislation; must be affixed visibly, legibly and indelibly before placing the toy on the market [Art. 3(16), Art. 17].
Placing on the market: The first making available of a toy on the EU market in the course of a commercial activity, whether for payment or free of charge; triggers the full set of manufacturer and importer obligations [Art. 3(2)].
Economic operator: Collective term for manufacturer, authorised representative, importer and distributor — each carrying distinct obligations under the Directive [Art. 3(7)].
EC-type examination: Conformity assessment procedure (Module B) whereby a notified body examines the technical design of a toy and issues a certificate attesting that it meets the essential safety requirements; the certificate must be reviewed at least every 5 years [Art. 20].
Essential safety requirements: The safety requirements set out in Annex II covering physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity that a toy must fulfil before being placed on the market [Art. 10].
CMR substance: A substance classified as carcinogenic, mutagenic or toxic for reproduction under the CLP Regulation (EC) No 1272/2008; generally prohibited in toys unless a specific derogation applies [Annex II, Part III, points 3-5].
Migration limit: Maximum quantity of a chemical element that may migrate from toy material into a simulated body fluid under standardised test conditions (EN 71-3); limits differ by material type — dry/brittle/pliable, liquid/sticky, or scraped-off [Annex II, Part III, point 13].

Frequently Asked Questions

When can a manufacturer self-certify a toy without a notified body?

Only when all applicable harmonised standards have been applied and those standards cover all essential safety requirements of Annex II. In that case the manufacturer may use internal production control (Module A) and self-declare conformity [Art. 19(2)]. If harmonised standards are missing, partially applied, published with a restriction, or the manufacturer considers third-party verification necessary, EC-type examination by a notified body is mandatory [Art. 19(3)].

What are the lead migration limits for toys?

Lead migration must not exceed 2.0 mg/kg for dry, brittle, powder-like or pliable toy material, 0.5 mg/kg for liquid or sticky material, and 23 mg/kg for scraped-off material [Annex II, Part III, point 13].

Are CMR substances completely banned in toys?

As a general rule, substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of categories 1A, 1B or 2 under the CLP Regulation shall not be used in toys [Annex II, Part III, point 3]. However, derogations exist: CMR 1A/1B substances may be permitted if concentrations are below the classification threshold, if the substance is inaccessible to children, or if the Commission has granted a specific derogation listed in Appendix A following a Scientific Committee evaluation [points 4 and 5]. Cobalt, for instance, is permitted in stainless steel, electric-current metals and non-swallowable NdFeB magnets under Directive (EU) 2026/192.

How long must technical documentation be retained?

Manufacturers and authorised representatives must keep the technical documentation and the EC declaration of conformity for 10 years after the toy has been placed on the market [Art. 4(6), Art. 5]. Importers must retain a copy of the declaration of conformity for the same 10-year period [Art. 6(9)].

What products that look like toys are excluded from the Directive?

Annex I excludes 19 product categories from the definition of toy, including decorative objects for festivities, collector products for those aged 14+ (if clearly indicated), sports equipment for children over 20 kg, bicycles with saddle height over 435 mm, puzzles with more than 500 pieces, babies' soothers, fashion accessories not for play, and interactive software such as computer games [Art. 2(1), Annex I].

What is the maximum voltage allowed in electric toys?

The nominal voltage of electric toys must not exceed 24 V DC or the equivalent AC voltage. Internal voltages may exceed this limit only if the voltage and current combination cannot cause harmful electric shock, even when the toy is broken [Annex II, Part IV, point 1].

What changed with the cobalt amendment in 2026?

Directive (EU) 2026/192 adds cobalt to Appendix A of Annex II as a CMR 1B substance with three permitted uses: as an impurity in nickel contained in stainless steel, in toy components intended to conduct electric current, and in NdFeB magnets that cannot be swallowed or inhaled. Cobalt remains prohibited in cosmetic toys, chalks, paints, inks, textiles, leather, 3D pen materials and batteries. Member States must transpose by 29 July 2026 and apply from 29 August 2026.

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