Relevant for: Toys
On 24 December 2015, The European Commission (EC) published the directives to amend the Appendix C to Annex II of the Toy Safety Directive, the inclusion of specific limit values for 5 chemicals used in toys intended for children under 3 years old or in other toys that can be placed in the mouth. The new requirements will apply in 2017 respectively. A summary of the new requirements are given in Table 1.
Table 1: Summary of the new chemical restrictions under Toy Directive
| Substance||CAS No.||Regulation (EC) No. 1272/2008 Classification||Limit value||Effective date|
|Formamide||75-12-7 ||Toxic to reproduction category 1B||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|
*The emission test is not necessary when the formamide content is 200 mg/kg or less
|24 May 2017|
|Skin sensitiser||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|
|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|
|Skin sensitiser||1 mg/kg (content limit) in aqueous toy materials||24 November 2017|
|5-Chloro-2-methyl-isothiazolin-3(2H)-one||26172-55-4||Not classified||0,75 mg/kg (content limit) in aqueous toy materials||24 November 2017|
|Not classified||0,25 mg/kg (content limit) in aqueous toy materials||24 November 2017|
Formamide is used 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, especially puzzle mats, which gave rise to concerns for the health of children through inhalation.
1,2-Benzisothiazol-3(2H)-one (1,2-benzisothiazolin-3-one) is used as a preservative in water-based toys including hobby paints and finger paints. There was a lot of discussions on the limit values are much lower than the ones set in EN 71-9 in order to carry out adequate quantitative analysis. Member states therefore agreed to exchange opinion regarding the test method in order to have the harmonised application of this new requirement.
CMI and MI in a ratio of 3:1 as well as its individual components CMI and MI are used as preservatives in water-based toys including hobby paints, finger paints, window/glass paints, glues and soap bubbles. Due to their contact allergic reactions were observed in cosmetics, the Scientific Committee on Health and Environmental Risks (SCHER) noted that these substances are not recommended for use in toys.