The Toy Safety Directive 2009/48/EC
The Directive lays down the safety criteria that toys must meet before they can be marketed in the EU. Toys must also comply with any other EU legislation applicable to them. The essential safety requirements cover:
- general risks: the health and safety of children, as well as other people such as parents or caregivers
- particular risks: physical and mechanical, flammability, chemical, electrical, hygiene and radioactivity risks
The Toy Safety Directive 2009/48/EC replaced the former Directive 88/378/EEC. It adapted the legal framework to technological developments and previously unknown safety issues. The application and enforcement are aligned with the so-called 'New Legislative Framework'.
The new Directive had to be transposed by the EU Member States into their national legislation by 20 January 2011 and has applied since 20 July 2011. The chemical safety requirements have applied since 20 July 2013.
Stricter requirements for chemical substances
Compared to the former Directive 88/378/EEC, the Toy Safety Directive 2009/48/EC puts in place stricter requirements for chemicals:
- Chemicals that are susceptible to cause cancer, change genetic information, harm fertility or harm an unborn child (so-called CMR substances) are no longer allowed in the accessible parts of toys beyond the concentration limits set in the Regulation on Classification, Labelling and Packaging of substances and mixtures, or unless they are considered safe following a rigorous scientific evaluation.
- 19 so-called 'heavy elements' like mercury and cadmium are not allowed in toy parts accessible to children beyond the limits laid down in Toy Safety Directive 2009/48/EC.
- 55 allergenic fragrances have been banned. However, some of them, and another 11, may be used in certain toys provided that they are indicated on the label and comply with additional requirements.
Placing toys on the EU market
There are two possible conformity assessments allowing toys to be sold in the EU. The manufacturer has to demonstrate the compliance of a toy by:
All toys sold in the EU must carry a CE marking. This is the manufacturer's declaration that the toy satisfies the essential safety requirements. More on placing toys on the EU market.
Harmonised European standards
The Toy Safety Directive does not specify the technical detail of toy safety requirements. The technical details are developed by the European Standardisation Organisations (CEN, CENELEC).
Notified bodies perform EC-type examination and issue EC-type examination certificates. The EC-type examination is one of the two possible conformity assessment procedures allowing toys to be marketed in the EU. Notified bodies have been designated by EU Member States.
Voluntary agreements with stakeholders
Stakeholders have signed voluntary agreements with the European Commission to improve toy safety: