From 20 July 2011, the new Toys Directive (Directive 2009/48/EC) will take effect. This will mean many news to toy manufacturers and importers. The Swedish Chemicals Agency will be the new authority responsible for the chemical requirements; other responsible authorities are the Swedish Consumer Agency (toy safety) and the National Electrical Safety Board (electric aspects).
The new chemical requirements will not take effect until 20 July 2013.
Toys must be designed in a way that there is no risk of damage to human health. This is a general requirement that already exists. But the specific chemical requirements are tightened in the new Toys Directive, which provides added protection especially for children.
The new chemical requirements mean that:
1. New substances are added to the list, i.e. substances that must not leak out from toys. The list has expanded from eight to nineteen substances.
New substances on the list are aluminum, boron, chromium (III) and chromium (VI), cobalt, copper, manganese, nickel, strontium, tin, organic tin and zinc. Antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium are restricted already.
The limitation of leakage will also change. So far, the so-called bioavailability has been measured, i.e. how much of the leakage a child takes up in the body. In the new directive, it is instead the leakage (migration) of the substance itself that is limited. Migration limits depend upon the material used. In the new toys directive, migration levels have been strengthened for most substances and materials.
2. A limit is introduced on how much CMR-substances that are allowed in the accessible parts of toys
The new Toys Directive includes a general ban of the use of substances classified as CMR (carcinogenic, mutagenic or disturbing reproduction) in toys. However, the directive gives some exemption from this ban and allows CMR-substances to be present in low concentrations. There is also an exemption from the total ban if the CMR-substance is inaccessible to the child. The exemptions from the CMR-ban is described in annex II part III in the Toys Directive.
3. Fragrances that are not allowed in cosmetics will be prohibited in toys
55 allergenic fragrances will be prohibited in concentrations above 100 mg/kg (100 ppm). An additional 11 allergenic fragrances have to be mentioned if they are used at levels above 100 mg/kg (100 ppm). These fragrances are listed in the EU cosmetics regulations and have been transferred to the Toys Directive. As the cosmetics rules develop, also the Toys Directive will be amended. The fragrances in question are listed in the Toys Directive under paragraph 11 of Annex III.
Download the Toys Directive 2009/48/EC.
Several of the substances that must not leach out of toys (point 1 above) are also CMRs, for example lead and mercury. This means that these substances are affected by both a maximum migration limit and the CMR ban. The directive states that if this is the case, the most stringent limit shall apply. The most stringent limit is often permitted migration, as the directive allows a certain use of CMR substances.
The chemical requirements of the new Toys Directive is found in Annex 2, Part III.
Several agencies co-operate
The Swedish Chemicals Agency will become the new responsible authority for the chemical requirements of the legislation. Previously, the Swedish Consumer Agency was the competent authority for the Toys Directive. Other agencies co-operating on the safety of toys are the Swedish Consumer Agency and National Electrical Safety Board.
DG Enterprise and Industry - toys website.