Before toys can be placed on the EU market, a manufacturer (whether located in the EU or outside the EU) has to take the following steps:
- Carry out a safety assessment: an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards, as well as an assessment of the potential exposure to those hazards.
- Go through one of two possible conformity assessment procedures to demonstrate that the toy complies with essential safety requirements:
- Self-verification: the manufacturer applies the harmonised standards covering all relevant safety requirements for the toy and makes sure that his manufacturing process ensures compliance ('internal production control procedure'). More information can be found in Decision No 768/2008/EC.
- Third party certification: the manufacturer submits an application for the EC-type examination to a notified body. The notified body examines the toy and issues an EC-type examination certificate if the toy meets EU safety requirements. Manufacturers must ensure their manufacturing processes ensure that their toys are compliant with the approved type – more on 'conformity to type procedure'.
- Draw up technical documentation with all relevant details that ensure their toy complies with the essential safety requirements.
- Draw up the EC Declaration of Conformity stating that the fulfilment of the essential safety requirements has been demonstrated. By drawing up this document, the manufacturer assumes responsibility for the compliance of the toy with the essential safety requirements.
- Affix the CE marking to the toy, either directly on the toy, on an affixed label or on the packaging.
- Affix their name and address, as well as an element allowing identification of the toy for traceability (e.g. a batch or serial number).
- Ensure that the toy is accompanied by instructions and safety information and bears the required warnings.
Importers may only place toys compliant with safety requirements on the EU market. An importer has to take the following steps:
- Ensure that the manufacturer has carried out the appropriate conformity assessment procedure to demonstrate that the toy complies with essential safety requirements.
- Ensure that the manufacturer has drawn up technical documentation that shows the toy complies with the essential safety requirements.
- Keep a copy of the EC Declaration of Conformity that states the fulfilment of the essential safety requirements has been demonstrated. By drawing up this document, the manufacturer assumes responsibility for the compliance of the toy with safety requirements.
- Ensure that the CE marking is affixed either directly on the toy, on an affixed label or on the packaging.
- Affix his own name and address.
- Ensure that the manufacturer has affixed his name and address, as well as an element allowing identification of the toy for traceability (e.g. a batch or serial number).
- Ensure that the toy is accompanied by instructions and safety information and bears the required warnings.
Distributors have to act with due care when making toys available on the EU market. A distributor has to verify that:
- the CE marking is affixed either directly on the toy, on an affixed label or on the packaging
- the manufacturer has affixed his name and address, as well as an element allowing identification of the toy for traceability (e.g. a batch or serial number)
- the importer has affixed his name and address
- the toy is accompanied by instructions and safety information and bears the required warnings.