The Toy Safety Directive (2009/48/EC) is the European Union's core legislation governing the safety of toys placed on the EU market. Its objective is to ensure a high level of protection for children, who are among the most vulnerable consumers, by setting strict safety and compliance requirements for manufacturers, importers, and distributors.
What is the Toy Safety Directive?
The directive applies to toys designed or intended for use in play by children under 14 years of age. It covers a wide range of physical, mechanical, chemical, and hygiene-related risks, and defines requirements that toys must meet before being marketed in the EU.
In force since 20 July 2011, the directive replaced the earlier Directive 88/378/EEC, introducing stricter chemical limits, clearer labeling requirements, and reinforced obligations for economic operators.
Scope of the Toy Safety Directive
The directive applies to most consumer toys, such as:
- Dolls, action figures, and soft toys
- Puzzles, board games, and educational kits
- Ride-on toys, building sets, and toy vehicles
- Digital and electronic toys (with or without sound/light functions)
However, it does not apply to:
- Toy-like decorations (e.g. Christmas decorations)
- Collectibles not intended for play
- Puzzles with more than 500 pieces for older users
- Sports equipment, bicycles with a saddle height above 435 mm
- Video games and software
Essential Safety Requirements
Annex II of the directive outlines General and Specific Safety Requirements, including:
- Mechanical and physical properties: No sharp edges, entrapment risks, or choking hazards
- Flammability: Materials must not pose a fire hazard
- Chemical properties: Strict limits on substances like lead, phthalates, nickel, and other restricted chemicals
- Electrical safety: Limits on voltage, current, and overheating for battery-operated toys
- Hygiene and microbiological risks: Especially relevant for toys used in the mouth or for infants
The directive also mandates a risk assessment for each toy, covering all potential hazards during foreseeable use and misuse.
Conformity Assessment and CE Marking
Before placing a toy on the market, the manufacturer must ensure the toy complies with all relevant safety requirements by:
- Performing a conformity assessment—either through internal production control or third-party testing for toys that involve specific hazards
- Preparing a technical documentation file, including test reports, safety assessments, and design details
- Drafting an EU Declaration of Conformity
- Affixing the CE mark visibly and legibly on the toy, packaging, or accompanying documents
Toys presenting particular risks (e.g. those using certain chemicals, or with functional aspects similar to real products) may require assessment by a Notified Body.
Harmonised Standards and Presumption of Conformity
Compliance with harmonised EN standards, such as those from the EN 71 series, provides a presumption of conformity with the directive. Key standards include:
- EN 71-1: Mechanical and physical properties
- EN 71-2: Flammability
- EN 71-3: Migration of certain hazardous elements
- EN 62115: Electrical safety for electronic toys
These standards support manufacturers in ensuring that toys are safe under normal and foreseeable conditions of use.
Responsibilities of Economic Operators
Each operator in the supply chain has defined obligations:
- Manufacturers: Must ensure compliance, keep documentation for 10 years, and take corrective action if risks arise
- Importers: Must verify that third-country toys comply with EU rules before placing them on the market
- Distributors: Must act with due care and ensure products are appropriately CE marked and labeled
All operators must cooperate with market surveillance authorities and take swift action when unsafe toys are detected.
Upcoming Revisions
The European Commission is preparing a revision of the Toy Safety Directive to address concerns related to digital features in toys, endocrine disruptors, and alignment with the Green Deal. Enhanced chemical safety and digital labeling tools may be introduced. Stakeholders should monitor these developments closely.
Contact Us
Ensuring compliance with the Toy Safety Directive is not just a regulatory duty—it’s a moral obligation to protect children and earn parents’ trust. From product testing and CE marking to risk assessments and technical documentation, our team provides end-to-end support to help you bring safe, compliant toys to the EU market.
Contact us today to ensure your toys meet all safety and regulatory requirements with confidence, reliability, and care.
