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EU – New Amendments to Appendix C of the EU Toys Safety Directive 2009-48-EC
Vol. 874 | December 01, 2015
Appendix C of Annex II of 2009/48/EC lists specific limit values for chemicals used in toys intended for children under 36 months or in other toys intended to be placed in the mouth. Recently the EU has published 3 Directives that amend Appendix C by including within it formamide (Directive 2015/2115), benzisothiazolinone (Directive 2015/2116) and chloromethylisothiazolinone and methylisothiazolinone (Directive 2015/2117).
From 24 May 2017, toys subject to Appendix C that include foam material containing more than 200 mg/kg of formamide (CAS No. 75-12-7) shall not be placed on the market if that material exceeds an emission limit of 20 µg/m3 of formamide.
From 24 May 2017, toys subject to Appendix C that include aqueous toy material shall not be placed on the market if that aqueous material contains more than 5 mg/kg of 1,2-benzisothiazol-3(2H)-one (BIT) (CAS No.2634-33-5) when tested by the methods in EN 71-10 and EN 71-11.
From 24 November 2017, toys subject to Appendix C that include aqueous toy material shall not be placed on the market if that aqueous material contains more than:
0.75 mg/kg of 5-Chloro-2-methyl-isothiazolin-3(2H)-one (CMI)(CAS No.26172-55-4),or
0.25 mg/kg of 2-methylisothiazolin-3(2H)-one (MI)(CAS No. 2682-20-4),or
1 mg/kg of a mixture of CMI and MI in a ratio of 3:1 (CAS No.55965-84-9).Trade names include Kathon, Acticide and Microcare.
Formamide is used as a solvent or a plasticiser and is also associated with a blowing agent used in the production of foam and may be harmful through inhalation.
BIT, CMI and MI are used as preservatives in such water based toys as paints, glues and bubble solutions. They are either contact allergens or skin sensitisers.