What the TSD is and why it matters
The Toy Safety Directive (TSD) — formally Directive 2009/48/EC on the safety of toys — is the EU’s dedicated safety law for products designed or intended for use in play by children under 14 years of age. If you make, import or sell toys for the European market, it is the single most important piece of legislation you have to meet. The TSD sets out detailed essential safety requirements that every toy must satisfy before it can carry the CE marking and be placed on the EU market, and it leaves very little room for interpretation: a toy that fails any of its requirements simply cannot be sold legally.
The TSD matters because children are the most vulnerable group of consumers, and toys are among the most heavily scrutinised products in the Union. The Directive translates a broad safety ambition into concrete, testable obligations covering everything from small parts and sharp edges to the chemicals a child might lick, swallow or inhale. For a brand, that means toy compliance is rarely a single tick-box: it is a structured process of risk assessment, testing against harmonised standards, documentation and correct marking.
📄 Official text: Directive 2009/48/EC on the safety of toys — on EUR-Lex →
Who the TSD applies to
The TSD applies across the supply chain, and the duties scale with your role:
- Manufacturers — anyone who makes a toy, or has one made and markets it under their own name or trademark. They carry the heaviest obligations: running the safety assessment, applying the conformity procedure, drawing up technical documentation and the EU declaration of conformity, and affixing the CE marking.
- Importers — businesses bringing toys from outside the EU onto the Union market. They must verify the manufacturer has carried out the correct conformity assessment, that documentation exists, and that the toy is properly marked, before placing it on the market.
- Distributors — wholesalers and retailers who must act with due care, check that the CE marking, warnings and required documents are present, and not supply toys they know or should presume to be non-compliant.
A key scoping point is what counts as a “toy.” The TSD covers products designed or intended, whether exclusively or not, for use in play by children under 14. It explicitly excludes certain categories — for example playground equipment intended for public use, some sports equipment, scale models for collectors, and other items listed in the Directive — which may instead fall under other rules or under the general product safety net.
Key dates and timeline
- 2009 — Directive 2009/48/EC was adopted, replacing the earlier toy safety directive and tightening the regime, particularly on chemicals.
- 2011 onward — the Directive’s requirements became applicable, with the chemical requirements phased in slightly later, giving the toy sector its current baseline.
- 1 January 2026 — the new Toy Safety Regulation (EU) 2025/2509 entered into force. Crucially, it does not apply immediately: it provides a transition period of roughly four and a half years.
- 1 August 2030 — the new Regulation applies from this date and will replace Directive 2009/48/EC. Until then, the TSD remains the law in force, so toys placed on the market today must still meet the Directive. The new Regulation tightens the chemical rules further (for example by extending restrictions on substances such as endocrine disruptors and certain PFAS) and introduces a Digital Product Passport for all toys, alongside a continued reliance on the EN 71 standards.
Core requirements
Essential safety requirements
At the heart of the TSD are the essential safety requirements that every toy must meet. The Directive groups these into a general safety requirement plus a set of particular safety requirements:
- Mechanical and physical — protection against hazards such as small parts that could be swallowed, choking and suffocation risks, sharp edges and points, strangulation from cords, and the structural integrity of the toy in foreseeable use.
- Flammability — toys must not be a dangerous flammable element in a child’s environment, with specific limits on the materials used, particularly for dressing-up costumes and toys a child can enter.
- Chemical — strict limits on hazardous substances. The Directive restricts CMR substances (carcinogenic, mutagenic or toxic for reproduction), sets migration limits for a list of elements (such as lead, cadmium and other heavy metals) that could be released when a child mouths a toy, and regulates substances like nitrosamines in toys intended for young children. This is the area the new 2025 Regulation tightens most.
- Electrical — toys must not present electrical hazards; voltages are limited and parts that could become live must be safe in normal use.
- Hygiene — toys must be designed and made to meet hygiene and cleanliness requirements to avoid risk of infection, sickness or contamination.
- Radioactivity — toys must comply with the relevant EU rules protecting against ionising radiation.
Harmonised standards: the EN 71 series
Manufacturers demonstrate that a toy meets the essential safety requirements largely by testing against harmonised standards, above all the EN 71 series. EN 71 is split into parts addressing different hazards — for example mechanical and physical properties, flammability, the migration of certain elements, and other chemical aspects — together with related standards such as EN 62115 for electric toys. A toy that conforms to the relevant harmonised standards benefits from a presumption of conformity with the corresponding essential requirements, which is why most toy compliance work is organised around the applicable EN 71 parts.
Conformity assessment and the CE marking
Before placing a toy on the market, the manufacturer must carry out the appropriate conformity assessment. Where harmonised standards cover all relevant requirements and have been applied, the manufacturer can use internal production control (self-assessment). Where they do not, or have only been partly applied, the toy must undergo EC-type examination by a notified body followed by conformity to the approved type. After a successful assessment, the manufacturer draws up the EU declaration of conformity and affixes the CE marking, which must be visible, legible and indelible.
Technical documentation and the EU declaration of conformity
Manufacturers must compile technical documentation that allows the conformity of the toy to be assessed, including a safety assessment covering the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards. They must also draw up an EU declaration of conformity stating that the toy meets the requirements of the Directive. Both must be kept available for market surveillance authorities for a defined retention period (ten years after the toy is placed on the market) and produced on request.
Warnings and age marking
Toys must carry the warnings the Directive requires, where relevant, to ensure safe use — for example the well-known warning that a toy is not suitable for children under 36 months because it contains small parts, together with the reason for the restriction. Warnings must be clearly visible, legible, accurate and understandable, and provided in a language easily understood by consumers in the Member State where the toy is sold. They must appear on the toy, an affixed label or the packaging, and accompanying instructions where appropriate.
Obligations by role
- Manufacturers — run the safety assessment, apply the conformity procedure, hold technical documentation and the EU declaration of conformity, affix CE marking and warnings, ensure traceability and take corrective action.
- Importers — verify the manufacturer’s conformity assessment and marking, add their own identification, refuse non-compliant toys and cooperate with authorities.
- Distributors — check that CE marking, warnings and documents are present, store and transport toys with due care, and stop supply of toys they believe to be non-compliant.
Enforcement
Each Member State designates market surveillance authorities to enforce the TSD. In Denmark, the Danish Safety Technology Authority (Sikkerhedsstyrelsen) is the competent authority for toy safety. Authorities can require corrective action, order withdrawals and recalls, and prohibit the sale of toys that do not meet the Directive.
Dangerous toys are shared EU-wide through the Safety Gate rapid alert system, and toys are consistently among the most frequently notified product categories. A problem found in one country can trigger action across the Union, and the consequences for non-compliance — set at national level — range from sales bans and mandatory recalls to fines and serious reputational damage, which weighs especially heavily for a children’s brand.
Getting compliant
- Confirm your product is a “toy” within the TSD’s scope and identify which EN 71 parts and other harmonised standards apply.
- Carry out a documented safety assessment covering all the hazard categories (mechanical, flammability, chemical, electrical, hygiene, radioactivity).
- Test against the relevant harmonised standards, using a notified body for EC-type examination where required.
- Compile and retain technical documentation and the EU declaration of conformity.
- Apply the CE marking, the correct warnings and age marking, and traceability details.
- Provide instructions and warnings in the right languages for each market.
- Plan ahead for the new Toy Safety Regulation (EU) 2025/2509 applying from 1 August 2030, including tighter chemical limits and the Digital Product Passport.
Related guides
- GPSR - Regulation (EU) 2023/988
- Personal Protective Equipment (PPE)
- Radio Equipment Directive (RED)
- Toys and children’s products: EN 71 and the new toy regulation
How Conphora helps
Conphora monitors the TSD and maps your toys against its requirements, flagging gaps in the safety assessment, EN 71 testing, warnings, CE marking and documentation before they become enforcement problems. The platform helps you generate and keep the right documentation, and alerts you to changes — including the transition to the new Toy Safety Regulation — so your compliance stays current.
See how Conphora works · Start free with Conphora
Sources and further reading
- Directive 2009/48/EC on the safety of toys — EUR-Lex
- Sikkerhedsstyrelsen (Danish Safety Technology Authority) — sik.dk
This guide is for general information and is not legal advice.
Last updated: 12 June 2026