A toy manufacturer has the main responsibility for ensuring product safety. The manufacturer must ensure that the products for sale in the EU are safe and conform with all legal requirements. A manufacturer must provide evidence that the toy has undergone the conformity assessment and complies with all applicable legal requirements. This evidence is compiled in a ‘technical file’.
The key piece of law for toys in the EU is the Toy Safety Directive. This Directive strictly mandates the manufacturer to have the technical file in place before the CE mark is applied on a product. Affixing the CE mark is the very final step which a manufacturer of toys must take before a product is ready for sale. Everything else must have been completed before.
What is a technical file?
1) There must be a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used. These will need to be obtained from the manufacturer’s chemical suppliers.
2) Details of the safety assessment which was undertaken by the manufacturer.
3) A description of the conformity assessment procedure which was followed by the manufacturer, either through self-verification or third-party verification.
4) A signed copy of the declaration of conformity
5) The address of the place of manufacture.
6) Any test reports following any testing to the harmonised standards.
7) If the toy was submitted for approval to a notified body, a copy of the examination certificate.
It is quite common for manufacturers to contract a test laboratory to help them with the testing. Many manufacturers value this second opinion, for example when bringing a new toy to the market. This will also provide the manufacturer with a critical review of the design.
Confidentiality
There is no need for manufacturers to worry that competitors will have access to the technical file as it is recognised that it might contain confidential information regarding product and production matters. It is only market surveillance authorities, who have the power to enforce the toy safety rules, have a right to see the technical file. The manufacturer is not obliged to publish the file or give it to customers.
The authorities will first contact the importer of the goods or the appointed economic operator, so the communication with these business partners must be very efficient to ensure that the authority will get a reply within the given deadline.
