For a number of chemicals, currently applicable limit values are either too high in the light of available scientific evidence or do not exist. Specific limit values should therefore be adopted for them, taking into account the packaging requirements for food as well as the differences between toys and food contact materials.

In order to advise the European Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety. The mission of its subgroup ‘Chemicals’ is to provide such advice with regard to chemical substances which may be used in toys.

The subgroup ‘Chemicals’ further considered a nursery (room volume 30 m³) with a large puzzle mat (1,2 m², 720 g) and several other foam toys (thus adding up to 1 kg of foam toy materials exposed to the air). The air in that nursery (air exchange rate 0,5 h^{– 1}) would contain 20 μg/m³ formamide after 28 days if the formamide content in the foam toy materials were at approximately 200 mg/kg and were completely emitted.

Formamide is classified under Regulation (EC) No 1272/2008 as toxic to reproduction category 1B. According to point 4 of Part III of Annex II to Directive 2009/48/EC, substances toxic to reproduction of category 1B such as formamide may be present in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it, namely 0,5 %, which equals 5 000 mg/kg (content limit), before 1 June 2015, and 0,3 %, which equals 3 000 mg/kg (content limit) thereafter. Directive 2009/48/EC does not currently provide for an emission limit for formamide.

In the light of the above, the subgroup ‘Chemicals’ recommended, at its meeting of 28 November 2013, that emissions of formamide from foam toy materials be limited in Appendix C to Annex II to Directive 2009/48/EC to 20 μg/m³ after a maximum of 28 days from commencement of the emission testing. The subgroup further recommended, at its meeting of 18 February 2015, that emission testing is not necessary when the formamide content is 200 mg/kg or less (cut-off value derived in a worst-case exposure scenario).

There are no known uses of formamide in food contact materials to be considered.

The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 47 of Directive 2009/48/EC,