Only toys meeting the essential requirements of TSD 2009/48/EC may be placed in the EEA market and entitled to free movement throughout all Member States. In particular, standards laid down by the European standardization bodies provide evidence of compliance with the essential requirements – toys meeting these requirements bear the CE marking. When a toy is placed on the EEA market, the manufacturer must draw up an EC declaration of conformity, which must be kept by the manufacturer or its authorized representative established within the EU for a period of 10 years after the toy is put on the market and continuously updated if necessary. By doing so, the manufacturer assumes the responsibility for the compliance of the toy with the essential requirements of the TSD 2009/48/EC. Each toy to be placed on the market is subject to a conformity assessment procedure, which demonstrates that a toy placed on the market complies with the requirements of TSD 2009/48/EC. The manufacturer is required to apply one of two possible procedures depending on the nature of the toy:
- Self verification: used in cases where harmonized standards cover all relevant aspects of a toy. In this case, the manufacturer must apply the existing harmonized standards and ensure that the toy is in conformity. The manufacturer must also put in place an internal production procedure in accordance with Module A of Annex II of Decision 768/2008/EC, for which the involvement of a notified body is not required. However, many large retailers still require an independent report as a condition of supply, even though this is not a legal requirement.
- Third party verification / “EC-type examination”: it is required in case harmonized standards do not exist; harmonized standards have not or only partly been applied by a manufacturer; one or more harmonized standards have been published with a restriction; or the manufacturer considers that the nature, design, construction or purpose of the toy requires a third party verification.
In such cases, under Module B of Annex II to Decision 768/2008/EC, the manufacturer submits a model of the toy to a notified body which examines the technical design of a toy and verifies and attests that the toy meets the requirements of TSD 2009/48/EC by issuing an EC-type examination certificate. Under Module C, which covers the production phase, the manufacturer ensures the conformity of the toys with the type described in the EC-type examination certificate and with the relevant requirements. Conformity under Module C is evaluated against an approved EC-type examination certificate and does not require the involvement of a notified body.
However, before submitting the toy to the appropriate conformity assessment and before the toy is placed on the market, the manufacturer must draw up a safety assessment, which has the objective of identifying the potential hazards of a toy and to assess the potential exposure to those hazards – this procedure is mandatory under TSD 2009/48/EC and will determine which conformity assessment procedure is required.
The safety assessment must cover the various chemical, physical, mechanical, electrical, flammability, hygienic and radioactivity hazards that the toy may present, as listed in Annex II of TSD 2009/48/EC. Even though many of these requirements are covered by harmonized standards, the manufacturer must assess whether there may be gaps uncovered.
The safety assessment must be kept as well by the manufacturer in the technical documentation for 10 years after the toy has been placed on the market.