Toys Certification Service Toy Directive Introduction & Product Scope (2009/48/EC Safety of Toys)

What is the Toys Directive?

The new EU Toy Safety Directive 2009/48/EC was issued on June 30, 2009, and entered into force on July 20, 2009. It began phasing out the old Directive 88/378/EEC from July 20, 2011, with new chemical requirements taking effect in July 2013.

The former EU Toy Safety Directive 88/378/EEC, issued in 1988, effectively ensured toy safety and eliminated trade barriers across EU member states. However, emerging challenges including insufficient safety criteria, low enforcement efficiency, ambiguous definitions, and the widespread use of new toy materials exposed its limitations. In 2003, the EU initiated a revision and launched public consultations. The amendment proposal COM(2008)9 was released on January 25, 2008, adopted by the European Parliament on December 18, 2008, and officially published in the EU Official Journal as Directive 2009/48/EC on June 30, 2009.

Toys Certification Scope

01 Plush toys
02 Electric toys
03 Plastic toys
04 Children’s vehicles and other toy products

Key Requirements of the Toy Directive

EU Standard Compliance Within 18 months after the release of the new directive (before January 20, 2011), all EU member states transposed its provisions into national laws. A two-year transition period was granted: products complying with the old directive could still be placed on the market until July 20, 2011. For chemical provisions, a four-year transition allowed products meeting old chemical standards to remain marketable until July 20, 2013. The revised definition of a "toy": products designed or intended for play by children under 14 years of age, whether exclusively for recreational use or not.

Obligations for Economic Operators

01 Manufacturer Obligations

A. Ensure toy design complies with EU general and specific safety requirements.

B. Establish technical documentation and complete conformity assessment procedures, and issue the EC Declaration of Conformity upon successful evaluation.

C. Retain technical files and the EC Declaration of Conformity for 10 years after product launch.

D. Maintain consistent production control procedures and update compliance status for design modifications or revised harmonized standards.

E. Mark product type, batch number, serial number or model identifier on toys; mark on packaging or manuals if limited by product size.

F. Print manufacturer name, registered trademark and contact address on toys or packaging, or in user guides for compact products.

G. Provide instructions and safety information in languages understandable to local consumers in member states.

H. Take corrective actions, withdrawals or recalls immediately if non-compliance is identified, and notify competent authorities for hazardous products.

I. Submit compliance documents to authorities upon request and cooperate in risk mitigation actions.
02 Importer & Distributor Obligations

The directive requires layered inspection by importers and distributors:

- Importers shall verify manufacturer compliance, including complete technical documentation and valid conformity assessment, and conduct random sampling inspections when necessary;

- Mark importer information on toys or packaging for traceability;

- Ensure user manuals and safety documents are provided in consumer-readable languages;

- Guarantee product safety during transportation and storage.
03 Strengthened Chemical Requirements

A. Comply with EU regulations on restricted substances and mixtures, including the REACH regulation;

B. Ban CMR substances (carcinogenic, mutagenic and reprotoxic materials) in toys and components;

C. Meet regulatory provisions if the toy itself is classified as a substance or mixture;

D. Tighten limits on heavy metal migration.
04 Updated Mechanical Safety Rules

A. Prohibit toys permanently attached to food;

B. Toys sold with food must be individually packaged to prevent ingestion or inhalation, with clear warning labels;

C. Limit peak and continuous noise levels of sound-emitting toys to protect children’s hearing.
05 Enhanced Hygiene Standards

A. Toys shall meet hygiene and cleanliness requirements to avoid contamination and infection risks;

B. Toys for children under 36 months must be washable and easy to clean.

Revised toy definition under the new directive: products designed or intended for play by children under 14 years of age. Strengthened supervision obligations are also imposed on importers and distributors:

1 Updated warning label rules: clear, prominent and legible warnings must be displayed at all sales outlets, including online stores.

2 Warnings conflicting with the intended use of the toy are prohibited.

3 Warnings shall be printed on toys, labels, packaging or user manuals as applicable.

4 Unpackaged toys must bear permanently affixed warning markings.