Technical documentation of Directive 2009/48/EC on the Safety Toys - Rev. 1.5 2016

Guidance document on the application of Directive 2009/48/EC on the Safety Toys

Technical documentation

In order to ensure compliance with the essential safety requirements, it was necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer.

Internal production control based on the manufacturer's own responsibility for the conformity assessment has proven adequate in cases where he has followed the harmonised standards, the reference number of which has been published in the Official Journal of the European Union (OJEU), covering all the safety requirements for the toy. In cases where such harmonised standards do not exist the toy should be submitted to third party verification, in this case EC-type examination.

The same should apply if one or more of such standards has been published with a restriction in the Official Journal of the European Union, or if the manufacturer has not followed such standards completely, or only in part. The manufacturer can submit the toy to EC-type examination in cases where it considers that the nature, design, construction or purpose of the toy necessitates third party verification.

To complete the legal obligations of the manufacturer which aim at ensuring the safety of toys, an explicit obligation to carry out an analysis of the various hazards that the toy may present and an assessment of the potential exposure to them, is included in the new Toy Safety Directive 2009/48/EC (TSD).

With regards to chemicals, this includes in particular an assessment of the likelihood of the presence in the toy of prohibited or restricted substances. Manufacturers are obliged to keep this safety assessment in the technical documentation to allow market surveillance authorities to perform their tasks efficiently.

This guidance document aims at providing necessary information in order to elaborate an adequate technical documentation. Focus is the safety assessment to be carried out by manufacturers – including SMEs.

This document must ensure that, when correctly applied, the Directive leads to the removal of obstacles and difficulties related to the free circulation (free movement) of goods within the European Union. It should be noted that the statements in these guidelines refer only to the application of Directive 2009/48/EC unless otherwise indicated.

Rev. 1.5 2016