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.

In its deliberations on phenol the subgroup ‘Chemicals’ took European standards EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005 as the basis. Those standards refer to the presence of phenol in toy materials (EN 71-9:2005+A1:2007) and provide specific methods of sample preparation (EN 71-10:2005) and measurement (EN 71-11:2005). EN 71-11:2005 repeats and details the limit values for phenol in toy materials set in EN 71-9:2005+A1:2007, namely 15 mg/l (migration limit) for phenol as a monomer and 10 mg/kg (content limit) for phenol as a preservative in liquid toy materials.

Phenol is classified under Regulation (EC) No 1272/2008 as mutagenic category 2. According to point 5 of Part III of Annex II to Directive 2009/48/EC, mutagenic substances of category 2 such as phenol may be present in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it, namely 1 %, which equals 10 000 mg/kg (content limit). Directive 2009/48/EC does not currently provide for a migration limit for phenol.

In the light of the above, the subgroup ‘Chemicals’ recommended at its meetings of 26 March 2014 and 18 February 2015 that phenol be limited in toys to 5 mg/l (migration limit) when analysed in polymeric materials, and to a maximum concentration of 10 mg/kg (content limit) when analysed as a preservative, it being understood that 10 mg/kg (content limit) are a de facto use ban. Analyses should be carried out in accordance with European standards EN 71-10:2005 and EN 71-11:2005.

While there is a generic migration limit for phenol as a monomer for use in certain food contact materials, the basic assumptions for deriving that migration limit are different from those for the migration limit for phenol as a monomer in toys. The use of phenol as a preservative is not regulated for food contact materials.

In view of the above, Appendix C to Annex II to Directive 2009/48/EC should be amended to include a migration limit as well as a content limit for phenol in toys.

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,