Esc

Site search arrives with the platform catalogue. Until then, start from one of these:
TSD CE / Product Safety 12 min

TSD: Toy Safety Directive (Directive 2009/48/EC), explained

The Toy Safety Directive sets the essential safety requirements that toys, meaning products designed or intended for play by children under 14, must meet before being placed on the EU market, with duties for manufacturers, importers and distributors. It has applied since 20 July 2011 and is repealed from 1 August 2030 by the Toy Safety Regulation (EU) 2025/2509.

Try the demo with TSD — freeCheck a product against TSD

Free account · no card · opens in the Demo Company

Reviewed 24 September 2026 by Conphora compliance team · Next review 14 March 2027 · Not legal advice

Open the video page →

Who it applies to

Covered by the act

  • Products designed or intended, whether or not exclusively, for use in play by children under 14 years of age, including toys that are themselves substances or mixtures
  • Toys intended for children under 36 months or intended to be placed in the mouth, which carry the strictest mechanical, chemical and hygiene requirements
  • Chemical toys, olfactory board games, cosmetic kits, gustative games, activity toys, aquatic toys, functional toys, electric toys and toys in or attached to food
  • Toys placed on the market or made available in the Union, whether supplied for payment or free of charge and whether sold in shops or online
  • The economic operators in the chain: manufacturers, authorised representatives, importers and distributors

Derived and downstream products

  • The 19 products of Annex I, such as products for collectors marked for ages 14 and above, sports equipment, bicycles with a saddle height above 435 mm, puzzles with more than 500 pieces, babies' soothers and fashion accessories not for play, are not toys within the meaning of the directive (Art. 2(1) and Annex I)
  • Public playground equipment, public automatic playing machines, toy vehicles with combustion engines, toy steam engines and slings and catapults are toys to which the directive does not apply (Art. 2(2))
  • An importer or distributor that places a toy on the market under its own name or trademark, or modifies a toy in a way that may affect compliance, is treated as the manufacturer (Art. 8)
  • Toys with a radio function are also radio equipment under Directive 2014/53/EU; toys that are cosmetics kits or contain substances must also meet the cosmetics and classification rules referred to in Annex II, Part III (Annex II, Part III, points 2 and 10)
  • The General Product Safety Regulation (EU) 2023/988 applies to toys for what the directive does not cover, and product liability is unaffected (Art. 52; the article cites Directive 2001/95/EC, repealed and replaced by Regulation (EU) 2023/988 from 13 December 2024, and Directive 85/374/EEC, replaced by Directive (EU) 2024/2853 for products placed on the market from 9 December 2026)
  • From 1 August 2030 the directive is replaced by Regulation (EU) 2025/2509; toys placed on the market before that date under the directive may still be made available, and EC-type examination certificates stay valid until 1 February 2031 (Regulation (EU) 2025/2509, Art. 56, Art. 57 and Art. 59)

Roles under the act

Manufacturer (including brand owners)

Any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark; an importer or distributor that sells under its own name or trademark or modifies a toy in a way that may affect compliance is treated as the manufacturer.

Source · Art. 3(3) and Art. 8
Authorised representative

Any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; the mandate cannot cover the duty to design and manufacture to the requirements or to draw up the technical documentation.

Source · Art. 3(4) and Art. 5(2)
Importer

Any natural or legal person established within the Community who places a toy from a third country on the Community market.

Source · Art. 3(5)
Distributor (wholesaler or retailer)

Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market.

Source · Art. 3(6)

Selling from outside the EU? Start here →

Does TSD apply to your product?

Three questions, a first answer from the regulation’s own scope rules. No account needed.

The rules behind this check
  1. Public playground equipment, public automatic playing machine, toy vehicle with combustion engine, toy steam engine, sling or catapult · any · any Not in scope Playground equipment intended for public use, automatic playing machines for public use, toy vehicles equipped with combustion engines, toy steam engines and slings and catapults are toys to which the directive does not apply; other product safety rules, in Denmark the general product safety rules enforced by Erhvervsstyrelsen, cover them instead. Source · Art. 2(2)
  2. Product for collectors visibly marked for ages 14 and above, decorative object for festivities, or fashion accessory not for use in play, Sports equipment, bicycle with saddle height above 435 mm, scooter or electric vehicle for public roads, deep-water aquatic equipment or swimming aid, puzzle with more than 500 pieces, Babies' soother, child-appealing luminaire, toy transformer, fireworks, compressed-gas gun, bow over 120 cm or darts with metallic points · any · any Not in scope Annex I lists 19 products that are not considered toys, including products for collectors provided the product or its packaging bears a visible and legible indication that it is intended for collectors aged 14 and above, sports equipment such as skates and skateboards for children over 20 kg, bicycles with a saddle height above 435 mm, scooters and electric vehicles for public roads, deep-water aquatic equipment and swimming aids, puzzles with more than 500 pieces, compressed-gas guns and bows over 120 cm, fireworks, darts with metallic points, babies' soothers, child-appealing luminaires, toy transformers and fashion accessories not for play. Source · Art. 2(1), second subparagraph, and Annex I
  3. Functional educational product above 24 V sold for teaching, school science equipment, computer or games console with peripherals, or interactive software · any · any It depends Functional educational products above 24 V sold exclusively for teaching under adult supervision, school science equipment used under an adult instructor, and computers, game consoles, peripherals and interactive software are not toys, unless the electronic equipment or peripheral is specifically designed for and targeted at children and has a play value on its own, such as specially designed keyboards, joysticks or steering wheels, which are toys. Source · Annex I, points 12 to 15
  4. Toy intended for children under 36 months or intended to be placed in the mouth (rattles, teethers, bath toys, soft toys for babies) · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Toys clearly intended for children under 36 months and their detachable parts must be too large to be swallowed or inhaled, must be cleanable (textile toys washable), must not release nitrosamines at or above 0,05 mg/kg or nitrosable substances at or above 1 mg/kg, must meet the Appendix C limits for TCEP, TCPP, TDCP, bisphenol A, formamide, isothiazolinones, phenol, formaldehyde and aniline, and other toys must carry the Annex V warning that they are not suitable for children under 36 months where they might be dangerous for that age group. Source · Annex II, Part I, point 4(d), Part III, point 8, Part V, point 2, Appendix C and Annex V, Part B, point 1
  5. Chemical toy, chemistry set, olfactory board game, cosmetic kit or gustative game · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Chemical toys must not contain substances or mixtures that may explode when mixed or that form flammable vapour, their instructions must warn of the dangerous nature of the substances, the precautions and first aid, and their packaging must carry the warning Not suitable for children under (age) years, for use under adult supervision; olfactory board games, cosmetic kits and gustative games may use certain listed fragrances only when labelled with the allergy warning and must not be used by children under 36 months. Source · Art. 3(22) to (25), Annex II, Part II, points 2 and 4, Part III, point 12 and Annex V, Part B, points 4 and 10
  6. Activity toy for domestic use (climbing frame, swing, slide, home trampoline) or aquatic toy for shallow water · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Activity toys must reduce the risk of crushing, trapping, falls, impacts and drowning as far as possible, bear the warning Only for domestic use and come with assembly, checking and maintenance instructions; aquatic toys must limit the loss of buoyancy and support and bear the warning Only to be used in water in which the child is within its depth and under adult supervision. Source · Art. 3(19) and (21), Annex II, Part I, points 5 and 11 and Annex V, Part B, points 2 and 6
  7. Electric or electronic toy, including toys with lights, sound, motors or radio functions · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Electric toys may not be powered by a nominal voltage above 24 V DC or the equivalent AC, accessible and internal voltages are limited to 24 V unless no harmful shock is possible even when the toy is broken, the transformer may not be an integral part of the toy, and the toy must protect against shock, burns, fire, electromagnetic fields and radiation from lasers or LEDs and stay safe when its electronic control system fails; a toy with a radio function is in addition radio equipment under Directive 2014/53/EU. Source · Annex II, Part IV, points 1 to 9 and Annex I, point 18
  8. Toy contained in, co-mingled with or attached to a food product · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope Toys contained in or co-mingled with food must have their own packaging, too large to be swallowed or inhaled and, where spherical, egg-shaped or cylindrical with rounded ends, unable to block the airways; toys firmly attached to a food product so that the food must be consumed to reach the toy are prohibited; the packaging must bear the warning Toy inside, adult supervision recommended. Source · Annex II, Part I, points 4(f) to (h) and Annex V, Part B, point 7
  9. Toy designed or intended for play by children under 14 (plush, dolls, construction sets, board games, ride-ons, outdoor toys) · Manufacturer (including brand owners), Importer, Distributor (wholesaler or retailer), Authorised representative · any In scope A toy may only be placed on the market if it meets the general safety requirement and the particular safety requirements of Annex II; the duties fall on the manufacturer, authorised representative, importer and distributor and contain no company-size threshold. Source · Art. 2(1), Art. 3(7), Art. 4, Art. 6, Art. 7 and Art. 10(1)
  10. any · any · any It depends Whether the directive applies turns on whether a parent or supervisor can reasonably assume from the product's functions, dimensions and characteristics that it is intended for play by children under 14, whether it is an Annex I product or an Article 2(2) exclusion, and which role the operator holds; the Commission's guidance documents on grey-zone products help decide borderline cases. Source · Art. 2 and Art. 3(29)Source

Key dates

  1. Directive 2009/48/EC adopted by the European Parliament and the Council Source · title
  2. Entry into force, the twentieth day after publication in OJ L 170 of 30 June 2009 Source · Art. 56
  3. Deadline for Member States to bring their transposing laws into force Source · Art. 54
  4. National measures apply; Directive 88/378/EEC repealed except Article 2(1) and Section 3 of Part II of Annex II; toys conforming to the old directive and placed on the market before this date may still be made available; Member States notify their penalty rules Source · Art. 51, Art. 53(1), Art. 54 and Art. 55
  5. Chemical requirements of Annex II, Part III apply; the remaining parts of Directive 88/378/EEC are repealed; toys meeting the new directive except Part III and the old chemical rules could be placed on the market until this date; the cadmium limits of Directive 2012/7/EU apply and Regulation (EU) No 681/2013 on barium enters into force Source · Art. 53(2) and Art. 55Source · Art. 2(1)Source · Art. 2
  6. Directive 2014/84/EU applies: Appendix A permits nickel (CMR 2) in stainless-steel toys and components and in components intended to conduct an electric current Source · Art. 1 and Art. 2(1)
  7. Directives 2014/79/EU and 2014/81/EU apply: Appendix C sets 5 mg/kg content limits for the flame retardants TCEP, TCPP and TDCP and a 0,1 mg/l migration limit for bisphenol A in toys for children under 36 months or intended to be placed in the mouth Source · Art. 1 and Art. 2(1)Source · Art. 1 and Art. 2(1)
  8. Directives (EU) 2015/2115 and 2015/2116 apply: Appendix C limits for formamide (20 μg/m3 emission from foam toy material above 200 mg/kg content) and 1,2-benzisothiazol-3(2H)-one (5 mg/kg in aqueous toy materials) Source · Art. 1 and Art. 2(1)Source · Art. 1 and Art. 2(1)
  9. End of the fallback in Annex II, Part III, point 7: materials complying with the food-contact rules of Regulation (EC) No 1935/2004 are no longer exempt from the CMR rules unless Appendix C sets a specific limit Source · Annex II, Part III, point 7
  10. Directive (EU) 2015/2117 applies: Appendix C content limits for the CMI/MI 3:1 mixture (1 mg/kg), CMI (0,75 mg/kg) and MI (0,25 mg/kg) in aqueous toy materials Source · Art. 1 and Art. 2(1)
  11. Council Directive (EU) 2017/738 applies: lead migration limits lowered to 2,0, 0,5 and 23 mg/kg for dry, liquid and scraped-off toy material Source · Art. 1 and Art. 2(1)
  12. Directive (EU) 2017/774 applies: Appendix C limits for phenol, 5 mg/l migration from polymeric materials and 10 mg/kg content as a preservative Source · Art. 1 and Art. 2(1)
  13. Directive (EU) 2017/898 applies: bisphenol A migration limit tightened to 0,04 mg/l Source · Art. 1 and Art. 2(1)
  14. Directive (EU) 2018/725 applies: chromium (VI) migration limits lowered to 0,02, 0,005 and 0,053 mg/kg Source · Art. 1 and Art. 2(1)
  15. Directive (EU) 2019/1922 applies: aluminium migration limits lowered to 2 250, 560 and 28 130 mg/kg Source · Art. 1 and Art. 2(1)
  16. Directive (EU) 2019/1929 applies: Appendix C limits for formaldehyde in polymeric, resin-bonded wood, textile, leather, paper and water-based toy material Source · Art. 1 and Art. 2(1)
  17. Directives (EU) 2020/2088 and 2020/2089 apply: atranol, chloroatranol and methyl heptine carbonate join the prohibited fragrances (58 in total) and 61 fragrances join the list that must be labelled above 100 mg/kg (71 in total) Source · Art. 2(1) and AnnexSource · Art. 2(1) and Annex
  18. Directive (EU) 2021/903 applies: Appendix C limits for aniline, 30 mg/kg after reductive cleavage in textile and leather toy material and in finger paints and 10 mg/kg as free aniline in finger paints Source · Art. 1 and Art. 2(1)
  19. Regulation (EU) 2025/2509 on the safety of toys enters into force; its Articles 28 to 44 on notified bodies and Articles 49 to 55 on delegated acts, committee procedure, confidentiality and penalties apply from this date Source · Art. 59
  20. Directive (EU) 2026/192 applies: Appendix A permits cobalt (CMR 1B) as an impurity in the nickel of stainless steel, in components conducting an electric current and in neodymium magnets that cannot be swallowed or inhaled; the Danish order nr. 574 of 24 June 2026 enters into force the same day Source · Art. 1 and Art. 2(1)Source
  21. Directive 2009/48/EC repealed; Regulation (EU) 2025/2509 applies in full; toys placed on the market in conformity with the directive before this date may continue to be made available Source · Art. 56, Art. 57(1) and Art. 59
  22. EC-type examination certificates issued under Article 20 of the directive cease to be valid, unless they expire earlier Source · Art. 57(3)

What you must do

Obligations by role

Manufacturer (including brand owners)15
  • Design and manufacture toys to the general safety requirement, so that they do not jeopardise the safety or health of users or third parties when used as intended or in a foreseeable way bearing in mind the behaviour of children, and to the particular requirements of Annex II on physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity, throughout the foreseeable and normal period of use. Art. 4(1), Art. 10 and Annex II
  • Before placing a toy on the market, analyse the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards it may present and assess the potential exposure to them; keep this safety assessment in the technical documentation. Art. 18 and Annex IV, point (b)
  • Run the conformity assessment: internal production control (Module A of Decision No 768/2008/EC) where harmonised standards published in the Official Journal cover all relevant safety requirements and were applied; otherwise EC-type examination by a notified body (Module B) followed by conformity to type (Module C), including where standards were applied only in part, were published with a restriction, or the nature of the toy calls for third-party verification. Art. 4(2), Art. 13, Art. 19 and Art. 20
  • Draw up the Annex IV technical documentation (design and manufacture description, components and materials with safety data sheets, the safety assessment, the conformity procedure, places of manufacture and storage, test reports and notified-body documents) in an official language of the Union. Art. 4(2), Art. 21 and Annex IV
  • Draw up the EC declaration of conformity in the Annex III model, translated into the languages the Member State of sale requires. Art. 4(2), Art. 15 and Annex III
  • Keep the technical documentation and the EC declaration of conformity for 10 years after the toy was placed on the market. Art. 4(3)
  • Affix the CE marking visibly, legibly and indelibly to the toy, an affixed label or the packaging before placing it on the market, on a label or leaflet for small toys or toys made of small parts, and at least on the packaging where it is not visible from outside; it may be followed by a pictogram indicating a special risk or use. Art. 4(2), Art. 16 and Art. 17
  • Mark the warnings that Article 11 and Annex V require, preceded by the word Warning or Warnings, clearly visible, legible, understandable and accurate on the toy, an affixed label or the packaging and where appropriate in the instructions, using the exact wording of Annex V, Part B, points 2 to 10; warnings that determine the purchase decision, such as minimum and maximum ages, must be visible before purchase, including online; do not use a Part B warning that conflicts with the toy's intended use. Art. 11 and Annex V
  • Give each toy a type, batch, serial or model number or other identifier, and indicate your name, registered trade name or trade mark and a single contact address on the toy or, where not possible, on its packaging or in an accompanying document. Art. 4(5) and Art. 4(6)
  • Supply instructions and safety information in the language or languages the Member State of sale determines. Art. 4(7)
  • Keep procedures in place for series production to remain in conformity, taking account of design changes and changes to the harmonised standards. Art. 4(4)
  • Where the risks warrant it, sample-test marketed toys, investigate complaints, keep a register of complaints, non-conforming toys and recalls, and keep distributors informed. Art. 4(4)
  • If you consider or have reason to believe that a toy you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities of the Member States where you made it available, giving details of the non-compliance and the corrective measures. Art. 4(8)
  • On a reasoned request, provide the authority with all information and documentation demonstrating conformity in a language it easily understands, translate the relevant parts of the technical documentation within 30 days unless a serious risk justifies less, and cooperate on risk-elimination measures. Art. 4(9) and Art. 21(3)
  • Be able to identify on request any economic operator who supplied you with a toy or to whom you supplied one, for 10 years. Art. 9
Authorised representative3
  • Act under a written mandate that at least lets you keep the EC declaration of conformity and the technical documentation at the disposal of the national surveillance authorities for 10 years after the toy was placed on the market, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures for the toys covered by the mandate. Art. 5(1) and Art. 5(3)
  • Do not take over the manufacturer's duty to ensure design and manufacture to the requirements of Article 10 and Annex II or to draw up the technical documentation; those duties cannot form part of the mandate. Art. 5(2)
  • Identify on request any economic operator who supplied you with a toy or to whom you supplied one, for 10 years after you were supplied with it. Art. 9
Importer10
  • Place only compliant toys on the market, and before doing so check that the manufacturer carried out the appropriate conformity assessment, drew up the technical documentation, affixed the CE marking, supplied the required documents and applied the identification number and the name and contact address; where you believe a toy does not conform, hold it back until it does, and where it presents a risk inform the manufacturer and the market surveillance authorities. Art. 6(1) and Art. 6(2)
  • Indicate your name, registered trade name or trade mark and a contact address on the toy or, where not possible, on its packaging or in an accompanying document. Art. 6(3)
  • Ensure the toy is accompanied by instructions and safety information in the language or languages the Member State of sale determines. Art. 6(4)
  • Ensure that storage and transport conditions while the toy is under your responsibility do not jeopardise its compliance with Article 10 and Annex II. Art. 6(5)
  • Where the risks warrant it, sample-test marketed toys, investigate complaints and keep a register of complaints, non-conforming toys and recalls, and keep distributors informed of the monitoring. Art. 6(6)
  • If a toy you placed on the market does not conform, immediately take corrective measures, withdraw or recall it, and where it presents a risk inform the competent authorities of the Member States where you made it available, with details of the non-compliance and the corrective measures. Art. 6(7)
  • Keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities for 10 years after the toy was placed on the market, and ensure the technical documentation can be made available on request. Art. 6(8)
  • On reasoned request, provide the information and documentation demonstrating the toy's conformity in a language the authority easily understands, and cooperate on risk-elimination measures. Art. 6(9)
  • Be able to identify on request any economic operator who supplied you with a toy or to whom you supplied one, for 10 years. Art. 9
  • If you place a toy on the market under your own name or trademark, or modify a toy already placed on the market in a way that may affect compliance, you carry the manufacturer's obligations under Article 4. Art. 8
Distributor (wholesaler or retailer)7
  • Act with due care and, before making a toy available, verify that it bears the CE marking, that it is accompanied by the required documents and by instructions and safety information in a language easily understood by consumers in the Member State of sale, and that the manufacturer and importer have applied the identification number, name and contact address; where you believe a toy does not conform, hold it back until it does, and where it presents a risk inform the manufacturer or importer and the market surveillance authorities. Art. 7(1) and Art. 7(2)
  • Show the warnings that determine the purchase decision, such as age limits, to the consumer before the purchase, including when selling online. Art. 11(2), third subparagraph
  • Ensure that storage and transport conditions while the toy is under your responsibility do not jeopardise its compliance with Article 10 and Annex II. Art. 7(3)
  • If a toy you made available does not conform, make sure corrective measures are taken to bring it into conformity, withdraw or recall it, and where it presents a risk immediately inform the competent authorities of the Member States where you made it available. Art. 7(4)
  • On reasoned request, provide the information and documentation demonstrating the toy's conformity in a language the authority easily understands, and cooperate on risk-elimination measures. Art. 7(5)
  • Be able to identify on request any economic operator who supplied you with a toy or to whom you supplied one, for 10 years. Art. 9
  • If you sell a toy under your own name or trademark, or modify it in a way that may affect compliance, you take on the manufacturer's obligations. Art. 8

TSD in plain terms

The Toy Safety Directive (TSD), formally Directive 2009/48/EC, is the EU’s CE-marking law for toys. It lays down rules on the safety of toys and on their free movement (Art. 1), and it does so through a general safety requirement, that toys including the chemicals they contain must not jeopardise the safety or health of users or third parties when used as intended or in a foreseeable way bearing in mind the behaviour of children (Art. 10(2)), and the particular safety requirements of Annex II on physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity. Member States may not impede the making available of toys that comply (Art. 12), and toys bearing the CE marking are presumed to comply (Art. 16(3)).

As a directive it works through national law: Member States had to transpose it by 20 January 2011 and apply it from 20 July 2011, when it replaced Directive 88/378/EEC, with the chemical requirements of Annex II, Part III following on 20 July 2013 (Art. 53 to Art. 55). Since then the Commission and the Council have amended Annex II eighteen times, almost always to add or tighten a chemical limit, most recently with the cobalt entry that applies from 29 August 2026. The directive’s own end date is now fixed: Regulation (EU) 2025/2509 on the safety of toys entered into force on 1 January 2026 and repeals the directive with effect from 1 August 2030 (Regulation (EU) 2025/2509, Art. 56 and Art. 59).

Official text Read the directive on EUR-Lex: Directive 2009/48/EC (CELEX 32009L0048), or the consolidated text of 29 August 2026 that includes all eighteen amendments to Annex II, and the Toy Safety Regulation (EU) 2025/2509 that replaces it from 1 August 2030.

Scope

A toy is any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age (Art. 2(1)). Intended for use by an age group means that a parent or supervisor can reasonably assume so from the toy’s functions, dimensions and characteristics (Art. 3(29)), which is why the age grading of a toy is a compliance decision and not a marketing one. Making available and placing on the market are the trigger events, whether the toy is supplied for payment or free of charge (Art. 3(1) and (2)).

Two lists narrow the scope. Annex I names 19 products that are not toys, among them decorative objects for festivities, products for collectors provided the product or its packaging visibly states that it is for collectors aged 14 and above, sports equipment including skates and skateboards for children over 20 kg, bicycles with a saddle height above 435 mm, scooters and electric vehicles for public roads, deep-water aquatic equipment and swimming aids, puzzles with more than 500 pieces, compressed-gas guns and bows over 120 cm, fireworks, darts with metallic points, functional educational products above 24 V sold for teaching, school science equipment, computers and game consoles with their peripherals and interactive software, babies’ soothers, child-appealing luminaires, toy transformers and fashion accessories not for play (Art. 2(1) and Annex I). Electronic equipment and peripherals that are specifically designed for children and have a play value of their own remain toys (Annex I, point 14). Article 2(2) then removes five kinds of toy from the directive: playground equipment and automatic playing machines for public use, toy vehicles with combustion engines, toy steam engines, and slings and catapults.

The duties fall on the economic operators: manufacturer, authorised representative, importer and distributor (Art. 3(3) to (7)). A manufacturer is whoever manufactures a toy or has it designed or manufactured and markets it under his own name or trademark, and an importer or distributor that sells under its own brand or modifies a toy in a way that may affect compliance takes on the manufacturer’s obligations (Art. 8). The General Product Safety Regulation applies to toys for what the directive does not cover, and product liability is unaffected (Art. 52, which still cites Directive 2001/95/EC, repealed and replaced by Regulation (EU) 2023/988 from 13 December 2024, and Directive 85/374/EEC, replaced by Directive (EU) 2024/2853 for products placed on the market from 9 December 2026), and toys with a radio function are also radio equipment under Directive 2014/53/EU.

What you must do

Essential safety requirements

Beyond the general safety requirement, Annex II sets the particular requirements. Part I on physical and mechanical properties covers strength and stability, edges and cords, moving parts, strangulation and asphyxiation, small parts in toys for children under 36 months or intended to be placed in the mouth, packaging, toys in food, buoyancy of aquatic toys, exits from enclosed toys, braking and design speed of ride-ons, projectiles, surface temperatures, noise and activity toys. Part II on flammability requires materials that do not burn, are not readily flammable, burn slowly or delay combustion, and bans explosive substances and mixtures that become flammable or explosive in chemical toys. Part IV limits electric toys to 24 V, requires insulation, protection against burns, fire, fault conditions, electromagnetic fields and radiation from lasers and LEDs, and keeps the transformer outside the toy. Part V requires hygiene and, for toys for children under 36 months, cleanability, with textile toys washable. Part VI refers to the Euratom radiation rules. Toys must meet the requirements during their foreseeable and normal period of use (Art. 10(3)), and conformity with harmonised standards published in the Official Journal gives a presumption of conformity for the requirements they cover (Art. 13).

Chemical properties

Part III of Annex II is the part that the amendments have reshaped. Substances classified CMR category 1A, 1B or 2 under Regulation (EC) No 1272/2008 may not be used in toys, their components or micro-structurally distinct parts, unless they stay at or below the classification concentrations for mixtures, are inaccessible to children in any form including inhalation, or have been evaluated and listed with permitted uses in Appendix A, which today names nickel (CMR 2, stainless steel and current-conducting components) and, from 29 August 2026, cobalt (CMR 1B, as an impurity in the nickel of stainless steel, in current-conducting components and in neodymium magnets that cannot be swallowed or inhaled); nickel in stainless steel is exempt outright (Annex II, Part III, points 3 to 7 and Appendix A). Toys that are substances or mixtures must also be classified, packaged and labelled under the CLP rules, and cosmetic toys must meet the cosmetics rules (points 2 and 10).

Point 13 sets migration limits for 19 elements in three material categories: dry, brittle, powder-like or pliable material; liquid or sticky material; and scraped-off material. Lead is limited to 2,0, 0,5 and 23 mg/kg, chromium (VI) to 0,02, 0,005 and 0,053 mg/kg, cadmium to 1,3, 0,3 and 17 mg/kg, aluminium to 2 250, 560 and 28 130 mg/kg and barium to 1 500, 375 and 18 750 mg/kg; the limits do not apply to parts that, because of their accessibility, function, volume or mass, clearly exclude sucking, licking, swallowing or prolonged skin contact. Toys for children under 36 months or intended to be placed in the mouth must not release nitrosamines at or above 0,05 mg/kg or nitrosable substances at or above 1 mg/kg (point 8) and must meet the specific limit values of Appendix C: 5 mg/kg for the flame retardants TCEP, TCPP and TDCP, 0,04 mg/l migration for bisphenol A, 20 μg/m3 emission for formamide from foam containing more than 200 mg/kg, 5 mg/kg for benzisothiazolinone, 1, 0,75 and 0,25 mg/kg for the isothiazolinone mixture, CMI and MI in aqueous materials, 5 mg/l migration and 10 mg/kg preservative content for phenol, six formaldehyde limits by material, and 30 mg/kg after reductive cleavage in textile, leather and finger paints plus 10 mg/kg free aniline in finger paints. Point 11 prohibits 58 allergenic fragrances above technically unavoidable traces of 100 mg/kg and requires 71 others to be named on the toy, label, packaging or leaflet when added above 100 mg/kg; olfactory board games, cosmetic kits and gustative games may use certain listed fragrances if they are labelled with the allergy warning and are not for children under 36 months (point 12).

Safety assessment, conformity assessment and technical documentation

Before placing a toy on the market the manufacturer analyses the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards the toy may present and assesses the potential exposure (Art. 18). Where harmonised standards published in the Official Journal cover all the relevant safety requirements and were applied, the manufacturer uses internal production control, Module A of Decision No 768/2008/EC (Art. 19(2)). Where such standards do not exist, were not applied or applied only in part, were published with a restriction, or the manufacturer considers that the nature, design, construction or purpose of the toy needs third-party verification, the toy goes to EC-type examination by a notified body under Module B, followed by conformity to type under Module C (Art. 19(3) and Art. 20). The notified body evaluates the manufacturer’s hazard analysis, the certificate contains a colour image, a description with dimensions and the tests performed, and it is reviewed whenever the process, raw materials or components change and in any case every five years (Art. 20(3) and (4)).

The technical documentation contains the Annex IV elements: a detailed description of design and manufacture with the list of components and materials and the safety data sheets from the chemical suppliers, the safety assessment, the conformity procedure, a copy of the declaration, the addresses of the places of manufacture and storage, documents submitted to a notified body, test reports and the means of ensuring conformity of production, and any EC-type examination certificate (Art. 21(1) and Annex IV). It is drawn up in an official language of the Union, translated in relevant parts within 30 days of a reasoned request, or sooner in case of serious and immediate risk, and where it is not supplied the authority can order a notified-body test at the manufacturer’s expense (Art. 21(2) to (4)). The manufacturer and the authorised representative keep it with the declaration for 10 years (Art. 4(3) and Art. 5(3)).

Declaration of conformity, CE marking and warnings

The EC declaration of conformity states that the requirements of Article 10 and Annex II have been demonstrated, contains the Annex III elements including a colour image of the toy, is continuously updated and is translated into the languages the Member State of sale requires; by drawing it up the manufacturer assumes responsibility for the toy (Art. 15). The CE marking is affixed visibly, legibly and indelibly to the toy, an affixed label or the packaging before the toy is placed on the market; for small toys and toys made of small parts it may go on a label or leaflet, for counter displays on the display, and where it is not visible from outside the packaging it must at least appear on the packaging (Art. 17). Non-compliant toys may be shown at trade fairs only with a sign saying so (Art. 16(4)).

Warnings specify the user limitations of Annex V, Part A, at least the minimum or maximum age and where appropriate abilities, weight limits and adult supervision, and use the exact wording of Annex V, Part B for its ten categories: toys not suitable for children under 36 months, activity toys, functional toys, chemical toys, skates, skateboards, scooters and toy bicycles, aquatic toys, toys in food, imitation protective masks and helmets, cot toys on strings and fragrance packaging in olfactory, cosmetic and gustative games (Art. 11(1) and Annex V). They are preceded by the word Warning, marked clearly and legibly on the toy, a label or the packaging and where appropriate in the instructions, and warnings that determine the purchase decision, such as age limits, must be visible before the purchase, including online (Art. 11(2)). Each toy also carries a type, batch, serial or model number and the manufacturer’s name and single contact address, importers add their own, and instructions and safety information come in the languages the Member State determines (Art. 4(5) to (7) and Art. 6(3) and (4)).

Obligations by role

Manufacturers carry the design, safety assessment, conformity assessment, documentation, declaration, marking, warning, production control, corrective action and 10-year retention duties (Art. 4). Authorised representatives act under a written mandate that must at least cover keeping the documents and cooperating with the authorities, but cannot take over design and manufacture or the technical documentation (Art. 5). Importers verify the manufacturer’s work before placing a toy on the market, add their identification, guard compliance in storage and transport, sample-test where the risks warrant it, take corrective action and keep the declaration for 10 years (Art. 6). Distributors verify the CE marking, documents, instructions and identification before making a toy available, protect it in storage and transport and see that corrective action is taken (Art. 7). Every operator identifies its suppliers and customers for 10 years (Art. 9), and importers and distributors that sell under their own brand or modify a toy become manufacturers (Art. 8).

The hand-over to Regulation (EU) 2025/2509

The Toy Safety Regulation of 26 November 2025 entered into force on 1 January 2026; its rules on notified bodies (Articles 28 to 44) and on delegated acts, committee procedure, confidentiality and penalties (Articles 49 to 55) apply from that date, and everything else applies from 1 August 2030, when Directive 2009/48/EC is repealed (Regulation (EU) 2025/2509, Art. 56 and Art. 59). Toys placed on the market in conformity with the directive before 1 August 2030 may continue to be made available, the regulation’s market surveillance chapter then applies to them instead of Articles 42, 43 and 45 of the directive, and EC-type examination certificates issued under Article 20 of the directive remain valid until 1 February 2031 unless they expire earlier (Art. 57). The biggest structural change is the digital product passport: before placing a toy on the market the manufacturer creates a passport for the toy model that states its compliance, contains at least the Annex VI data, stays available for 10 years and replaces the EC declaration of conformity, connected through a data carrier on the toy, label or packaging to a unique product identifier that is visible before purchase, including in distance sales; the operator placing the toy on the market uploads the identifiers to the registry under Regulation (EU) 2024/1781, and customs verify the unique registration identifier before release for free circulation (Art. 19, Art. 22 and Art. 23). The Commission must publish SME guidelines on the passport by 1 August 2029 (Art. 24).

Enforcement and penalties

Member States organise market surveillance of toys under Articles 15 to 29 of Regulation (EC) No 765/2008 as cited in Article 40, read as Regulation (EU) 2019/1020 since 16 July 2021, and they take due account of the precautionary principle (Art. 39 and Art. 40). Where an authority has sufficient reason to believe that a toy presents a risk to health or safety, it evaluates the toy against all the requirements, requires corrective action, withdrawal or recall within a reasonable period commensurate with the risk, informs the notified body and, if the operator does not act, takes provisional measures to prohibit or restrict the making available, withdraws or recalls the toy and informs the Commission and the other Member States; a measure that draws no objection within three months is deemed justified (Art. 42). The Commission decides disputed national measures through the safeguard procedure (Art. 43), measures can be notified through the rapid alert system (Art. 44), and authorities can instruct a notified body to withdraw or review an EC-type examination certificate (Art. 41). Formal non-compliance, namely CE marking affixed in violation of Articles 16 or 17 or not affixed, an EC declaration of conformity not drawn up or drawn up incorrectly, or technical documentation not available or incomplete, must be ended and otherwise leads to restriction, prohibition, withdrawal or recall (Art. 45).

Penalties are set nationally: Member States lay down effective, proportionate and dissuasive penalties for infringements of their transposing laws, which may include criminal sanctions for serious infringements and may be increased for repeat offenders (Art. 51). In Denmark, the directive is implemented by bekendtgørelse nr. 815 of 7 June 2022 om legetøj, amended by nr. 59 of 23 January 2023 for aniline and nr. 574 of 24 June 2026 for cobalt, issued under the act on products and market surveillance (lovbekendtgørelse nr. 22 of 8 January 2026), whose section 9 makes Erhvervsstyrelsen the control authority. The former Sikkerhedsstyrelsen has been part of Erhvervsstyrelsen as the department Markedsovervågning since January 2026 and checks the toys on the Danish market, while Miljøstyrelsen controls the chemical properties of toys (section 57 of the order). The order also sets the Danish language requirements: instructions and safety information must be in Danish (§ 9, stk. 2), warnings and safety instructions must be in Danish (§ 28), distributors must check that the Danish documentation accompanies the toy (§ 20), and the EC declaration of conformity must be in Danish or English (§ 39). Section 58 of the order punishes with a fine, among other things, placing on the market or making available a toy that does not meet the safety requirements, missing technical documentation or conformity assessment, missing warnings, instructions or identification and failure to take corrective measures or notify the authority, and placing non-compliant toys on the market under aggravating circumstances, such as danger to health, an accident with serious injury or death, repeat offences or systematic infringement for financial gain, can be punished with imprisonment of up to 2 years.

How Conphora helps

Conphora monitors the Toy Safety Directive, its Annex II amendments and the Toy Safety Regulation and maps your toys against the requirements, flagging gaps in the safety assessment, the conformity route, the chemical limits, the warnings and the technical documentation before they become enforcement problems. The platform helps you build and keep the EC declaration of conformity and the 10-year records, and alerts you when a limit changes or a deadline approaches, such as the cobalt entry from 29 August 2026 and the digital product passport from 1 August 2030.

See how Conphora works · See plans and pricing

Sources

This guide is for general information and is not legal advice.

Penalties

Enforced by National market surveillance authorities enforce the national laws transposing the directive; Article 40 still cites Articles 15 to 29 of Regulation (EC) No 765/2008, read as Regulation (EU) 2019/1020 since 16 July 2021, with the directive listed in its Annex I; the directive is also among the acts listed in Article 4(5) of Regulation (EU) 2019/1020, so a toy may only be placed on the Union market if a manufacturer, importer, authorised representative or fulfilment service provider established in the Union is responsible for the Article 4 tasks. In Denmark the directive is implemented by bekendtgørelse nr. 815 of 7 June 2022 om legetøj (amended by nr. 59 of 23 January 2023 and nr. 574 of 24 June 2026) under the act on products and market surveillance (lovbekendtgørelse nr. 22 of 8 January 2026), whose section 9 makes Erhvervsstyrelsen the control authority; the former Sikkerhedsstyrelsen has been part of Erhvervsstyrelsen as the department Markedsovervågning since January 2026 and checks toys on the Danish market, while Miljøstyrelsen controls the chemical properties of toys under section 57 of the order. The order also sets the Danish language requirements: instructions and safety information must be in Danish (§ 9, stk. 2), warnings and safety instructions must be in Danish (§ 28), distributors must check that the Danish documentation accompanies the toy (§ 20), and the EC declaration of conformity must be in Danish or English (§ 39). The toolkit is corrective action, withdrawal or recall within a period commensurate with the risk, provisional prohibition or restriction of the making available, orders to end formal non-compliance such as missing CE marking, a missing or incorrect EC declaration of conformity or incomplete technical documentation, instructions to a notified body to withdraw or review an EC-type examination certificate, a test by a notified body at the manufacturer's expense where the documentation is deficient, and national penalties that must be effective, proportionate and dissuasive and may include criminal sanctions for serious infringements.

Member States lay down the rules on penalties for economic operators that infringe their national transposing laws, which may include criminal sanctions for serious infringements; the penalties must be effective, proportionate and dissuasive and may be increased for a repeat infringement. Market surveillance follows Regulation (EC) No 765/2008 as cited in Article 40, read as Regulation (EU) 2019/1020 since 16 July 2021: where a toy presents a risk or does not comply, the authority evaluates it against all the requirements, requires corrective action, withdrawal or recall within a reasonable period commensurate with the risk, and if the operator fails to act takes provisional measures to prohibit or restrict the making available, withdraw or recall the toy and informs the Commission and the other Member States. Formal non-compliance, namely CE marking affixed in violation of Articles 16 or 17 or not affixed, an EC declaration of conformity not drawn up or drawn up incorrectly, or technical documentation not available or incomplete, must be ended and otherwise leads to restriction, prohibition, withdrawal or recall; the authority can instruct a notified body to withdraw or review an EC-type examination certificate and can order a test by a notified body at the manufacturer's expense where the technical documentation or its translation is not supplied. In Denmark, Erhvervsstyrelsen is the control authority under section 9 of the act on products and market surveillance (lovbekendtgørelse nr. 22 of 8 January 2026); the former Sikkerhedsstyrelsen has been part of Erhvervsstyrelsen as the department Markedsovervågning since January 2026 and checks toys on the Danish market, Miljøstyrelsen controls the chemical properties of toys (section 57 of bekendtgørelse nr. 815 of 7 June 2022 om legetøj), and section 58 of that order punishes with a fine, for example, placing on the market or making available a toy that does not meet the safety requirements, failing to draw up technical documentation or carry out the conformity assessment, missing warnings, instructions or identification, and failing to take corrective measures or notify the authority, with imprisonment of up to 2 years for placing non-compliant toys on the market under aggravating circumstances such as danger to health, an accident causing serious injury or death, repeat offences or systematic infringement for financial gain.

Source · Art. 51, Art. 40, Art. 41, Art. 42, Art. 45 and Art. 21(4)SourceSourceSource

What changed

Entry into force, amendments and Compliance Radar entries for TSD, newest first.

  1. Applies

    EC-type examination certificates under the directive expire

    EC-type examination certificates issued in accordance with Article 20 of Directive 2009/48/EC remain valid until this date unless they expire earlier; after it, toys need conformity assessment under Regulation (EU) 2025/2509.

    Source · Art. 57(3)
  2. Amendment

    Directive 2009/48/EC repealed; the Toy Safety Regulation applies

    Regulation (EU) 2025/2509 repeals the directive with effect from this date and applies in full, including the digital product passport that replaces the EC declaration of conformity; toys placed on the market in conformity with the directive before 1 August 2030 may continue to be made available, and the regulation's market surveillance chapter applies to them instead of Articles 42, 43 and 45 of the directive.

    Source · Art. 19, Art. 56, Art. 57 and Art. 59
  3. Guidance

    Guide rewritten from the consolidated text of 29 August 2026

    The guide was rebuilt on the SPEC-62 model from consolidated text 02009L0048-20260829, all eighteen amending acts, Regulation (EU) 2025/2509 and the Danish orders; the earlier body's statements that the new regulation entered into force on 1 January 2026 and applies from 1 August 2030 were kept, and the transitional rules, the cobalt amendment and the exact chemical limits were added.

    Source
  4. Applies

    Cobalt permitted uses apply

    Member States apply the measures transposing Directive (EU) 2026/192: cobalt, classified CMR 1B, may be present as an impurity in the nickel of stainless-steel toys and components, in components intended to conduct an electric current and in neodymium-based magnets that cannot be swallowed or inhaled; in Denmark bekendtgørelse nr. 574 of 24 June 2026 enters into force the same day.

    Source · Art. 1 and Art. 2(1)Source
  5. Amendment

    Directive (EU) 2026/192 in force: cobalt added to Appendix A

    The Commission directive of 28 January 2026, published on 29 January 2026, adds cobalt to the list of CMR substances with permitted uses in Appendix A to Annex II; Member States transpose by 29 July 2026 and apply the rules from 29 August 2026.

    Source · Art. 1, Art. 2 and Art. 3
  6. Amendment

    Regulation (EU) 2025/2509 on the safety of toys in force

    The regulation of 26 November 2025, published in OJ L 2025/2509 on 12 December 2025, enters into force on the twentieth day after publication; its Articles 28 to 44 on notified bodies and Articles 49 to 55 on delegated acts, committee procedure, confidentiality and penalties apply from this date, while the rest applies from 1 August 2030 when the directive is repealed.

    Source · Art. 56 and Art. 59
  7. Applies

    Aniline limits apply

    Member States apply the measures transposing Directive (EU) 2021/903: aniline limited to 30 mg/kg after reductive cleavage in textile and leather toy material and in finger paints and 10 mg/kg as free aniline in finger paints, for toys for children under 36 months or intended to be placed in the mouth; in Denmark bekendtgørelse nr. 59 of 23 January 2023 implements it.

    Source · Art. 1 and Art. 2(1)Source
  8. Applies

    Allergenic fragrance rules apply: 58 prohibited, 71 to be labelled

    Member States apply the measures transposing Directives (EU) 2020/2088 and 2020/2089: atranol, chloroatranol and methyl heptine carbonate are prohibited in toys above unavoidable traces of 100 mg/kg, and 61 further fragrances must be named on the toy, label, packaging or leaflet when added above 100 mg/kg; in Denmark bekendtgørelse nr. 815 of 7 June 2022 om legetøj enters into force the same day.

    Source · Art. 2(1) and AnnexSource · Art. 2(1) and AnnexSource
  9. Amendment

    Directive (EU) 2021/903 in force: aniline added to Appendix C

    The Commission directive of 3 June 2021, published in OJ L 197 on 4 June 2021, adds aniline to Appendix C to Annex II; Member States transpose by 4 December 2022 and apply the limits from 5 December 2022.

    Source · Art. 1, Art. 2 and Art. 3
  10. Applies

    Formaldehyde limits apply

    Member States apply the measures transposing Directive (EU) 2019/1929: formaldehyde limited to 1,5 mg/l migration from polymeric toy material, 0,1 ml/m3 emission from resin-bonded wood, 30 mg/kg in textile, leather and paper toy material and 10 mg/kg in water-based toy material, for toys for children under 36 months or intended to be placed in the mouth.

    Source · Art. 1 and Art. 2(1)
  11. Applies

    Lower aluminium migration limits apply

    Member States apply the measures transposing Directive (EU) 2019/1922: aluminium limited to 2 250 mg/kg in dry, brittle, powder-like or pliable toy material, 560 mg/kg in liquid or sticky material and 28 130 mg/kg in scraped-off material.

    Source · Art. 1 and Art. 2(1)
  12. Amendment

    Directives (EU) 2020/2088 and 2020/2089 in force: allergenic fragrances

    The two Commission directives of 11 December 2020, published in OJ L 423 on 15 December 2020, amend the fragrance lists in Annex II, Part III, point 11; Member States transpose by 4 July 2022 and apply the rules from 5 July 2022.

    Source · Art. 1, Art. 2 and Art. 3Source · Art. 1, Art. 2 and Art. 3
  13. Amendment

    Directive (EU) 2019/1929 in force: formaldehyde added to Appendix C

    The Commission directive of 19 November 2019, published in OJ L 299 on 20 November 2019, adds formaldehyde limits for six toy materials to Appendix C; Member States transpose by 20 May 2021 and apply them from 21 May 2021.

    Source · Art. 1, Art. 2 and Art. 3
  14. Amendment

    Directive (EU) 2019/1922 in force: aluminium limits lowered

    The Commission directive of 18 November 2019, published in OJ L 298 on 19 November 2019, replaces the aluminium entry in the migration table of Annex II, Part III, point 13; Member States transpose by 19 May 2021 and apply it from 20 May 2021.

    Source · Art. 1, Art. 2 and Art. 3
  15. Applies

    Lower chromium (VI) migration limits apply

    Member States apply the measures transposing Directive (EU) 2018/725: chromium (VI) limited to 0,02 mg/kg in dry, 0,005 mg/kg in liquid and 0,053 mg/kg in scraped-off toy material.

    Source · Art. 1 and Art. 2(1)
  16. Applies

    Bisphenol A migration limit of 0,04 mg/l applies

    Member States apply the measures transposing Directive (EU) 2017/898, which tightened the Appendix C limit for bisphenol A from 0,1 mg/l to 0,04 mg/l, measured under EN 71-10:2005 and EN 71-11:2005.

    Source · Art. 1 and Art. 2(1)
  17. Applies

    Phenol limits apply

    Member States apply the measures transposing Directive (EU) 2017/774: phenol limited to 5 mg/l migration from polymeric materials and 10 mg/kg content as a preservative in toys for children under 36 months or intended to be placed in the mouth.

    Source · Art. 1 and Art. 2(1)
  18. Applies

    Lower lead migration limits apply

    Member States apply the measures transposing Council Directive (EU) 2017/738: lead limited to 2,0 mg/kg in dry, 0,5 mg/kg in liquid and 23 mg/kg in scraped-off toy material.

    Source · Art. 1 and Art. 2(1)
  19. Amendment

    Directive (EU) 2018/725 in force: chromium (VI) limits lowered

    The Commission directive of 16 May 2018, published in OJ L 122 on 17 May 2018, replaces the chromium (VI) entry in Annex II, Part III, point 13; Member States transpose by 17 November 2019 and apply it from 18 November 2019.

    Source · Art. 1, Art. 2 and Art. 3
  20. Applies

    Isothiazolinone limits apply

    Member States apply the measures transposing Directive (EU) 2015/2117: the 3:1 reaction mass of chloromethylisothiazolinone and methylisothiazolinone limited to 1 mg/kg, CMI to 0,75 mg/kg and MI to 0,25 mg/kg in aqueous toy materials.

    Source · Art. 1 and Art. 2(1)
  21. Amendment

    Directive (EU) 2017/898 in force: bisphenol A limit tightened

    The Commission directive of 24 May 2017, published in OJ L 138 on 25 May 2017, replaces the bisphenol A entry in Appendix C with 0,04 mg/l; Member States transpose by 25 November 2018 and apply it from 26 November 2018.

    Source · Art. 1, Art. 2 and Art. 3
  22. Amendment

    Directive (EU) 2017/774 in force: phenol added to Appendix C; formamide and benzisothiazolinone limits apply

    The Commission directive of 3 May 2017 on phenol, published in OJ L 115 on 4 May 2017, enters into force, to be transposed by 4 November 2018; on the same day Member States apply the measures transposing Directives (EU) 2015/2115 and 2015/2116: formamide limited to 20 μg/m3 emission from foam toy materials containing more than 200 mg/kg and 1,2-benzisothiazol-3(2H)-one to 5 mg/kg in aqueous toy materials.

    Source · Art. 2 and Art. 3Source · Art. 1 and Art. 2(1)Source · Art. 1 and Art. 2(1)
  23. Amendment

    Council Directive (EU) 2017/738 in force: lead limits lowered

    The Council directive of 27 March 2017, published in OJ L 110 on 27 April 2017, replaces the lead entry in Annex II, Part III, point 13; Member States transpose by 28 October 2018 and apply it from the same date.

    Source · Art. 1, Art. 2 and Art. 3
  24. Applies

    Flame retardant and bisphenol A limits of Appendix C apply

    Member States apply the measures transposing Directives 2014/79/EU and 2014/81/EU: TCEP, TCPP and TDCP limited to 5 mg/kg content and bisphenol A to 0,1 mg/l migration in toys for children under 36 months or intended to be placed in the mouth.

    Source · Art. 1 and Art. 2(1)Source · Art. 1 and Art. 2(1)
  25. Amendment

    Directives (EU) 2015/2115, 2015/2116 and 2015/2117 in force: formamide, benzisothiazolinone and isothiazolinones

    The three Commission directives of 23 November 2015, published in OJ L 306 on 24 November 2015, add specific limit values to Appendix C; Member States apply the formamide and benzisothiazolinone limits from 24 May 2017 and the isothiazolinone limits from 24 November 2017.

    Source · Art. 2 and Art. 3Source · Art. 2 and Art. 3Source · Art. 2 and Art. 3
  26. Applies

    Nickel permitted uses apply

    Member States apply the measures transposing Directive 2014/84/EU: nickel, classified CMR 2, may be used in toys and toy components made of stainless steel and in components intended to conduct an electric current.

    Source · Art. 1 and Art. 2(1)
  27. Amendment

    Directive 2014/84/EU in force: nickel added to Appendix A

    The Commission directive of 30 June 2014, published in OJ L 192 on 1 July 2014, replaces Appendix A to Annex II with the nickel entry; Member States transpose and apply it by 1 July 2015.

    Source · Art. 1, Art. 2 and Art. 3
  28. Amendment

    Directive 2014/81/EU in force: bisphenol A added to Appendix C

    The Commission directive of 23 June 2014, published in OJ L 183 on 24 June 2014, replaces Appendix C to add a 0,1 mg/l migration limit for bisphenol A; Member States transpose and apply it by 21 December 2015.

    Source · Art. 1, Art. 2 and Art. 3
  29. Amendment

    Directive 2014/79/EU in force: TCEP, TCPP and TDCP in Appendix C

    The Commission directive of 20 June 2014, published in OJ L 182 on 21 June 2014, replaces Appendix C to Annex II with 5 mg/kg content limits for the three flame retardants; Member States transpose and apply it by 21 December 2015.

    Source · Art. 1, Art. 2 and Art. 3
  30. Applies

    Chemical requirements apply; cadmium and barium limits in force

    Annex II, Part III applies to all toys placed on the market from this date and Directive 88/378/EEC is fully repealed; the cadmium limits of Directive 2012/7/EU apply and Regulation (EU) No 681/2013 replacing the barium limits with 1 500, 375 and 18 750 mg/kg enters into force and applies directly.

    Source · Art. 53(2) and Art. 55Source · Art. 2(1)Source · Art. 1 and Art. 2
  31. Amendment

    Directive 2012/7/EU in force: cadmium limits lowered

    The Commission directive of 2 March 2012, published in OJ L 64 on 3 March 2012, replaces the cadmium entry in Annex II, Part III, point 13 with 1,3, 0,3 and 17 mg/kg; Member States transpose by 20 January 2013 and apply it from 20 July 2013.

    Source · Art. 1, Art. 2 and Art. 3
  32. Applies

    Toy Safety Directive applies; Directive 88/378/EEC largely repealed

    Member States apply their transposing measures from this date and Directive 88/378/EEC is repealed except Article 2(1) and Section 3 of Part II of Annex II, which survive until 20 July 2013; toys conforming to the old directive and placed on the market before 20 July 2011 may continue to be made available, and Member States notify their penalty rules to the Commission.

    Source · Art. 51, Art. 53(1), Art. 54 and Art. 55
  33. In force

    Directive 2009/48/EC enters into force

    Adopted on 18 June 2009 and published in OJ L 170 on 30 June 2009, the directive entered into force on the twentieth day after publication; Member States had until 20 January 2011 to transpose it.

    Source · Art. 54 and Art. 56

Tools and training

What Conphora offers for TSD.

Start from the problem

A marketplace wants our declaration and test report uploaded

A marketplace asks for a declaration of conformity and a test report per listing. What the law requires, what is its own rule, and what to upload.

Product validation → Documentation generator

We do not know if our product needs CE marking

When CE marking is required: only where an EU harmonisation act provides for it, how to test scope under LVD, EMC, RED and toys, and what to do if not.

Free compliance checker → Regulation guides

We do not know which languages the instructions must be in

Language rules for instructions, safety information, warnings and contact details under the GPSR, LVD, EMC, RED, the Toy Safety Directive and cosmetics.

Regulation guides → Knowledge & insights

We are unsure whether our product counts as a toy

The toy test in Directive 2009/48/EC and Regulation (EU) 2025/2509: play by children under 14, the Annex I exclusions, and what follows either way.

Regulation guides → Free compliance checker

We sell a product for babies or small children

Baby and childcare products: when toy rules apply, the GPSR check for vulnerable users, food contact limits for infants, and baby monitors under the RED.

Regulation guides → Product validation

We have never written a declaration of conformity

How to draw up an EU declaration of conformity: the model in the annex of each act, the standards with dates, who signs, languages and updates.

Documentation generator → Regulation guides

All problems for TSD →

Questions people ask about TSD

When did the Toy Safety Directive start to apply?

Directive 2009/48/EC entered into force on 20 July 2009, the twentieth day after publication in OJ L 170 of 30 June 2009. Member States had to transpose it by 20 January 2011 and apply their measures from 20 July 2011, when Directive 88/378/EEC was largely repealed. The chemical requirements of Annex II, Part III applied from 20 July 2013; until then toys meeting the new directive and the old chemical rules could still be placed on the market, and toys conforming to the old directive placed on the market before 20 July 2011 may continue to be made available.

Source · Art. 53, Art. 54, Art. 55 and Art. 56
Which products count as toys?

Any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age; a product is intended for a stated age group when a parent or supervisor can reasonably assume so from its functions, dimensions and characteristics. Annex I lists 19 products that are not toys, among them products for collectors marked for ages 14 and above, sports equipment, bicycles with a saddle height over 435 mm, scooters and electric vehicles for public roads, swimming aids, puzzles with more than 500 pieces, compressed-gas guns, fireworks, darts with metallic points, functional educational products above 24 V, school science equipment, computers and game consoles and their software, babies' soothers, child-appealing luminaires, toy transformers and fashion accessories not for play. Public playground equipment, public automatic playing machines, toy vehicles with combustion engines, toy steam engines and slings and catapults are toys to which the directive does not apply.

Source · Art. 2, Art. 3(29) and Annex I
Do I need a notified body for a toy?

Not when harmonised standards whose references are published in the Official Journal cover all the relevant safety requirements and you have applied them: then you use internal production control, Module A of Decision No 768/2008/EC. EC-type examination by a notified body followed by conformity to type is compulsory where such standards do not exist, where you did not apply them or applied them only in part, where a standard was published with a restriction, or where you consider that the nature, design, construction or purpose of the toy needs third-party verification. The EC-type examination certificate is reviewed whenever the process, raw materials or components change and in any case every five years.

Source · Art. 13, Art. 19 and Art. 20(4)
What are the chemical limits for toys?

Substances classified CMR category 1A, 1B or 2 may not be used in toys, their components or micro-structurally distinct parts unless they stay below the classification concentrations, are inaccessible to children in any form including inhalation, or are permitted in Appendix A, which lists nickel and, from 29 August 2026, cobalt; nickel in stainless steel is exempt. Point 13 sets migration limits for 19 elements in three material categories, for example lead at 2,0, 0,5 and 23 mg/kg and chromium (VI) at 0,02, 0,005 and 0,053 mg/kg for dry, liquid and scraped-off material, and these do not apply to parts that clearly exclude sucking, licking, swallowing or prolonged skin contact. Toys for children under 36 months or intended to be placed in the mouth must not release nitrosamines at or above 0,05 mg/kg or nitrosable substances at or above 1 mg/kg and must meet the Appendix C limits for TCEP, TCPP, TDCP, bisphenol A, formamide, the isothiazolinones, phenol, formaldehyde and aniline. 58 allergenic fragrances are prohibited above unavoidable traces of 100 mg/kg and 71 others must be named on the toy, label, packaging or leaflet when added above 100 mg/kg.

Source · Annex II, Part III, points 3 to 8, 11 and 13, Appendix A and Appendix C
Which warnings must a toy carry?

Where appropriate for safe use, the warnings must state the user limitations of Annex V, Part A: at least the minimum or maximum age and where relevant the abilities, weight limits and the need for adult supervision. Annex V, Part B prescribes the wording for ten categories: toys not suitable for children under 36 months with a brief indication of the hazard, activity toys (Only for domestic use), functional toys (To be used under the direct supervision of an adult), chemical toys, skates, skateboards, scooters and toy bicycles (Protective equipment should be worn, not to be used in traffic), aquatic toys, toys in food (Toy inside, adult supervision recommended), imitation protective masks and helmets (This toy does not provide protection), cot toys on strings and fragrance packaging in olfactory, cosmetic and gustative games (Contains fragrances that may cause allergies). Warnings are preceded by the word Warning, must be clearly visible, legible, understandable and accurate on the toy, a label or the packaging, and warnings that determine the purchase decision must be visible before the purchase, including online, in the languages the Member State determines.

Source · Art. 11 and Annex V
What must an importer or a shop check before selling a toy?

An importer must make sure the manufacturer carried out the right conformity assessment, drew up the technical documentation, affixed the CE marking, supplied the required documents and applied the identification number and its name and contact address, must add its own name and address, ensure instructions and safety information in the required language, keep a copy of the EC declaration of conformity for 10 years and be able to obtain the technical documentation. A distributor must act with due care and verify the CE marking, the accompanying documents, instructions and safety information in the language of the country of sale and the manufacturer's and importer's identification. Both must hold back a toy they believe does not conform, inform the authorities where it presents a risk, and take or ensure corrective action; if they sell under their own brand or modify the toy they become the manufacturer. In Denmark, bekendtgørelse nr. 815 of 7 June 2022 requires the instructions and safety information (§ 9, stk. 2) and the warnings and safety instructions (§ 28) to be in Danish, requires the distributor to check that this Danish documentation accompanies the toy (§ 20), and allows the EC declaration of conformity in Danish or English (§ 39).

Source · Art. 6, Art. 7 and Art. 8Source · § 9, § 20, § 28 and § 39
What changes with the new Toy Safety Regulation (EU) 2025/2509 and when?

Regulation (EU) 2025/2509 of 26 November 2025 entered into force on 1 January 2026 and repeals Directive 2009/48/EC with effect from 1 August 2030, when it applies in full; only its rules on notified bodies (Articles 28 to 44) and on delegated acts, committee procedure, confidentiality and penalties (Articles 49 to 55) apply from 1 January 2026. Toys placed on the market in conformity with the directive before 1 August 2030 may continue to be made available, and EC-type examination certificates issued under the directive remain valid until 1 February 2031 unless they expire earlier. From 1 August 2030 the manufacturer must create a digital product passport for each toy model before placing it on the market, connected through a data carrier on the toy, label or packaging to a unique product identifier, available for 10 years and replacing the EC declaration of conformity, and the operator placing the toy on the market must upload the identifiers to the registry under Regulation (EU) 2024/1781 so that customs can verify the unique registration identifier at release for free circulation.

Source · Art. 19, Art. 22, Art. 23, Art. 56, Art. 57 and Art. 59
How long must I keep the technical documentation and the declaration of conformity?

Manufacturers keep the technical documentation and the EC declaration of conformity for 10 years after the toy was placed on the market, authorised representatives keep both at the disposal of the authorities for the same period, and importers keep a copy of the declaration for 10 years and ensure the documentation can be produced. Every economic operator must be able to identify who supplied them with a toy and whom they supplied, for 10 years after placing on the market in the case of the manufacturer and 10 years after being supplied for the others. On a reasoned request the manufacturer must translate the relevant parts of the documentation within 30 days, or sooner in case of serious and immediate risk, failing which the authority can order a notified-body test at the manufacturer's expense.

Source · Art. 4(3), Art. 5(3), Art. 6(8), Art. 9 and Art. 21(3) and (4)

Follow TSD — one mail a week when it changes

Corrigenda, guidance, Safety Gate trends and new articles for the regulations you follow. Nothing else.

Updates from Conphora ApS about the regulations and topics you follow — by e-mail, weekly by default. You confirm by e-mail and can unsubscribe in one click. We measure whether our e-mails are opened and which links are used, and you can switch that off on the preferences page. Stored in the EU, never sold. Privacy policy. Free account? Choose notifications there instead.

Related

Related regulations

ATEXCIREMCExplDGARGPSRLiftDLVDPEDPPEPyroDREDSPVD

Sources

  1. Directive 2009/48/EC on the safety of toys, consolidated text of 29 August 2026 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20260829
  2. Directive 2009/48/EC as published in OJ L 170, 30 June 2009 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009L0048
  3. Document information, dates and relationships for CELEX 32009L0048 (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009L0048
  4. Regulation (EU) 2025/2509 on the safety of toys and repealing Directive 2009/48/EC (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R2509
  5. Commission Directive 2012/7/EU, cadmium (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012L0007
  6. Commission Regulation (EU) No 681/2013, barium (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0681
  7. Commission Directive 2014/79/EU, TCEP, TCPP and TDCP (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0079
  8. Commission Directive 2014/81/EU, bisphenol A (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0081
  9. Commission Directive 2014/84/EU, nickel (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0084
  10. Commission Directive (EU) 2015/2115, formamide (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L2115
  11. Commission Directive (EU) 2015/2116, benzisothiazolinone (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L2116
  12. Commission Directive (EU) 2015/2117, chloromethylisothiazolinone and methylisothiazolinone (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L2117
  13. Council Directive (EU) 2017/738, lead (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017L0738
  14. Commission Directive (EU) 2017/774, phenol (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017L0774
  15. Commission Directive (EU) 2017/898, bisphenol A (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017L0898
  16. Commission Directive (EU) 2018/725, chromium VI (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018L0725
  17. Commission Directive (EU) 2019/1922, aluminium (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019L1922
  18. Commission Directive (EU) 2019/1929, formaldehyde (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019L1929
  19. Commission Directive (EU) 2020/2088, labelling of allergenic fragrances (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020L2088
  20. Commission Directive (EU) 2020/2089, prohibition of allergenic fragrances (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020L2089
  21. Commission Directive (EU) 2021/903, aniline (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021L0903
  22. Commission Directive (EU) 2026/192, cobalt (EUR-Lex) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026L0192
  23. Toy safety (European Commission, DG GROW) https://single-market-economy.ec.europa.eu/sectors/toys/toy-safety_en
  24. Guidance documents on the Toy Safety Directive (European Commission, DG GROW) https://single-market-economy.ec.europa.eu/sectors/toys/toy-safety/guidance_en
  25. Love og regler om legetøj og udstyr til børn og babyer (Sikkerhedsstyrelsen, Erhvervsstyrelsen) https://www.sik.dk/erhverv/produkter/legetoej/love-og-regler/love-og-regler-om-legetoej-og-udstyr-boern-og-babyer
  26. Bekendtgørelse nr. 815 af 7. juni 2022 om legetøj (Retsinformation) https://www.retsinformation.dk/eli/lta/2022/815
  27. Bekendtgørelse nr. 59 af 23. januar 2023 om ændring af bekendtgørelse om legetøj, aniline (Retsinformation) https://www.retsinformation.dk/eli/lta/2023/59
  28. Bekendtgørelse nr. 574 af 24. juni 2026 om ændring af bekendtgørelse om legetøj, cobalt (Retsinformation) https://www.retsinformation.dk/eli/lta/2026/574
  29. Lovbekendtgørelse nr. 22 af 8. januar 2026 af lov om produkter og markedsovervågning (Retsinformation) https://www.retsinformation.dk/eli/lta/2026/22

About this guide

Reviewed by
Conphora compliance team, Compliance editors, Conphora
Reviewed
24 September 2026
Next review
14 March 2027

Written from the official text on EUR-Lex and the Commission’s guidance, with a source for every fact. It is not legal advice.

Summary PDF JSON
Cite this page 
Conphora (2026). TSD: Toy Safety Directive (Directive 2009/48/EC), explained. Retrieved 13 October 2026 from https://www.conphora.com/regulations/tsd/
Reviewed
Demo Company

See TSD handled end to end

Thirteen products, the documents retailers ask for, supplier requests and this year's deadlines — a complete, read-only example. Open it with a free account; no card, no trial clock.

Try the demo with TSD — freeCompare plans

Free account · no card · opens in the Demo Company