Toy Safety (CE) Certification

The Toy Safety Directive (2009/48/EC) governs the safety of products designed or intended for use in play by children under 14. Its scope is broad: mechanical and physical properties, flammability, chemical properties (heavy-metal migration and prohibited substances), electrical properties, hygiene and radioactivity. Its chemical requirements are particularly strict and are regularly updated.

• Toy manufacturers and designers
• Toy importers and retailers selling under their own brand
• Firms distributing toys as promotional or gift items
• Manufacturers of children's play equipment and activity toys

Mandatory for all toys within scope. Notified-body involvement is conditional: when the manufacturer fully applies the harmonised standards, it can self-declare through internal production control (Module A); a notified body is involved through EU type examination (Module B) when there is no standard, it is only partly applied, or the competent authority considers it necessary.

• Scope and the list of products not regarded as toys (Annex I)
• Essential safety requirements and specific safety requirements (Annex II)
• Physical and mechanical properties: small parts, sharp edges and points, cords, choking and swallowing risk
• Flammability requirements
• Chemical properties: migration limits for 19 elements, CMR substances, allergenic fragrances, nitrosamines
• Electrical properties and voltage limits
• Hygiene and cleanability
• Radioactivity
• Warnings and usage restrictions (e.g. not suitable for children under 36 months)
• The obligation to carry out a safety assessment
• Conformity-assessment routes: Module A or Module B+C

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• The product description, target age group and use scenario
• Design and manufacturing drawings, the materials and components list
• The safety assessment (chemical, physical, mechanical, electrical, flammability)
• Test reports (the EN 71 series; EN IEC 62115 for electric toys)
• Chemical-analysis reports and supplier declarations
• Samples of the packaging, warning text and instructions for use

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CEMeasuring Instruments
• CENon-Automatic Weighing Instruments
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEMDR
• CEIVDR