On 24 November 2015, the EU Offical Journal published three new directives (EU) 2015/2115, (EU) 2015/2116 and (EU) 2015/2117, amending Appendix C of the Toy Safety Directive 2009/48/EC. The following restrictions have now been added to Appendix C:
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Appendix C Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth |
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Substance |
CAS No |
Limit value |
Effective date |
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Formamide |
75-12-7 |
20 μg/m3 (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content) |
24 May 2017 |
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1,2-benzisothiazol-3(2H)-one(BIT) |
2634-33-5 |
5 mg/kg (content limit) in aqueous toy materials, in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005 |
24 May 2017 |
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reaction mass of: 5-chloro-2- methyl-4-isothiazolin- 3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1) |
55965-84-9 |
1 mg/kg (content limit) in aqueous toy materials |
24 November 2017 |
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5-Chloro-2-methyl-isothiazolin-3(2H)-one(CMI) |
26172-55-4 |
0,75 mg/kg (content limit) in aqueous toy materials |
24 November 2017 |
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2-methylisothiazolin-3(2H)-one(MI) |
2682-20-4 |
0,25 mg/kg (content limit) in aqueous toy materials’ |
24 November 2017 |
Formamide (CAS number 75-12-7) is used, among others, in the plastics and polymers industry, particularly as a solvent, plasticiser or as a substance associated with a blowing agent used in the production of foam. In 2010, several Member States identified formamide in a range of foam toys, such as puzzle mats, which gave rise to concerns for the health of children through inhalation. Some Member States took or were considering taking regulatory action.
1,2-Benzisothiazol-3(2H)-one (1,2-benzisothiazolin-3-one, BIT, CAS number 2634-33-5) is used as a preservative in water-based toys including hobby paints and finger paints; 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) in a ratio of 3:1 (CAS number 55965-84-9) as well as its individual components CMI (CAS number 26172-55-4) and MI (CAS number 2682-20-4) are used as preservatives in water-based toys including hobby paints, finger paints, window/glass paints, glues and soap bubbles. These preservatives may trigger contact allergic reactions.