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EU: European Commission proposes to regulate aniline in toys

SEPTEMBER 2020 - TOY PRODUCTS

On 8 September 2020, the European Commission (EC) notified the World Trade Organisation (WTO) of the draft Directive¹ amending Appendix C to Annex II to the Toy Safety Directive 2009/48/EC in order to add new limit values for aniline in certain toy materials. 

Aniline (CAS no.: 62-53-3), which has been classified as carcinogenic category 2 and mutagenic category 2, is considered a non-threshold carcinogen, implying that it may cause cancer at even the slightest level of exposure. Based on various scientific studies, evidence of its presence in toys and experts’ discussions, the Commission now proposes to regulate aniline in toys for use by children under 3 years old or in other mouthable toys as follows:

According to previous studies, including the position paper published by the ANEC², aniline could be found in coloured textiles and leather toy material after subjecting the material to the reductive cleavage test provided for in REACH Regulation (EC) 1907/2006. The Commission also took an investigation from a German consumer magazine into account, noting that aniline could be present in finger paints both after reductive cleavage and as an impurity of the colourants. Owing to its risk presents to children and occurrence in toys, the Expert Group on Toys Safety determined that limit values for aniline should be set at the lowest concentration possible. A restriction in other material is not investigated this time as there is too little information available at present.

Currently, aniline in certain toys is being restricted by the toy safety standard EN 71-7³ and EN 71-9⁴. A revised version of standard EN 71-7 was published⁵ in April this year.

EN 71-7 specifies requirements for finger paints: concentration of aniline must not exceed 10 mg/kg, together with other carcinogenic primary aromatic amines must not exceed 20 mg/kg;

EN 71-9 specifies requirements of organic chemical compounds (voluntary): concentration of aniline must not exceed the action limit, which is 5 mg/kg, in certain toy components, including accessible textiles and leather material in toys for children under 3, accessible coloured liquids, wood and paper in toys for children under 3 and with a mass of 150 g or less, etc.

[1]  Draft Directive amending 2009/48/EC as regards specific limit values for aniline in certain toys

[2]  ANEC Position Paper: Aniline – Proposed requirement for Appendix C of the Toy Safety Directive

[3]  EN 71-7:2014+A3:2020

[4]  EN 71-9:2005+A1:2007

[5]  EU: Toy Finger Paint Standard EN 71-7:2014+A3:2020 Published, May 2020