China toy exporters should be alerted to the publication of three new EU Directives related to the safety of toys. 

While all three laws are scheduled to enter into force on the twentieth day after their publication, they will become applicable in the Member States after fairly lengthy transition periods, as explained below. This should allow companies some time to adjust their production processes to the new requirements.

The three new laws amend a particular part of the EU’s framework Toy Safety Directive (Directive 2009/48/EC), namely, restrictions on the use of certain chemicals in toys that are intended for children under 36 months, and in other toys intended to be placed in the mouth.

Commission Directive 2015/2117:This new Directive regulates the substances Chloromethylisothiazolinone (CMI), Methylisothiazolinone (MI), and CMI and MI combined in a ratio of 3:1. 

CMI and MI combined in a ratio of 3:1, as well as CMI and MI individually, are mainly used as preservatives in water-based toys such as hobby paints, finger paints, window/glass paints, glues and soap bubbles. They are considered to constitute extreme contact allergens in humans. The EU’s expert group on toy safety recommended to the Commission that the substances should not be used in toys.

Thus, CMI and MI in a ratio of 3:1 will, according to this new Directive, have a limit value of 1 mg/kg (content limit) in aqueous toy materials. Furthermore, CMI individually will have a limit value of 0.75 mg/kg (content limit) in aqueous toy materials, while MI individually will have a limit value of 0.25 mg/kg (content limit) in aqueous toy materials.

The transitional period for the Member States to implement this future Directive is 24 months from the publication of the Directive in the Official Journal. Therefore, Member States must apply the provisions from 24 November 2017.

Commission Directive 2015/2116: This new Directive regulates the substance Benzisothiazolinone (BIT).  BIT is used as a preservative in water-based toys including hobby paints and finger paints. Such uses were found pursuant to results of a market survey involving economic operators and their trade associations, consumer representatives and allergy centres, as well as through internet searches and shop visits. BIT is considered to be a major contact allergen for consumers. In cosmetics, the use of BIT is already prohibited.
The limit value for the use of BIT will be 5 mg/kg in aqueous toy materials, in accordance with the methods laid down in Standards EN 71-10:2005 and EN 71-11:2005. The transitional period for the Member States to apply the provisions of this new Directive concerning BIT is 18 months from the date of its publication. Therefore, the relevant date of application is 24 May 2017.

Commission Directive 2015/2115: This new law covers the substance formamide. Formamide is used in the plastics and polymers industry as a solvent, plasticizer or as a substance associated with a blowing agent used in the production of foam. It is used in a range of foam toys, such as puzzle mats. It can be inhaled by children, as it can be emitted into the air. 

The limit value for formamide will be 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). This is equal to the limit value for formamide that is already applicable in France. 

China sellers of toys should also know that formamide is already restricted elsewhere in the framework Toy Safety Directive (2009/48/EC). The substance is currently classified by the EU as toxic to reproduction category 1B. According to the framework Toy Safety Directive, substances toxic to reproduction of category 1B such as formamide may be present in toys in only miniscule amounts. In the case of formamide, this amount was a concentration of 0.5%, which equals 5000 mg/kg (content limit), before 1 June 2015, and 0.3%, which equals 3000 mg/kg (content limit) thereafter. Directive 2009/48/EC has not – until now, that is – provided for an emission limit for formamide.

The transitional period for Directive 2015/2115 restricting the emission limit of formamide is 18 months from the date of its publication. Therefore, the relevant date of application by the Member States, of the new provisions, is 24 May 2017.

All the amendments to the framework Toy Safety Directive (2009/48/EC) mentioned above are to be introduced in Appendix C of the Toy Safety Directive’s Annex II. This appendix sets out 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.