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EU Ready to Limit the Use of Preservatives and Solvents in Toys

Hong Kong’s toy manufacturers exporting their goods to the EU should be alerted to new toy safety measures that are expected to enter into force towards the end of 2015, although there will be a period of transition thereafter, so as to help industry adjust to the measures.

Recently, the Safety of Toys Committee agreed to an amendment of the Toy Safety Directive (Directive 2009/48/EC), implementing restrictions on the use of certain chemicals in toys which are intended for children under 36 months, and in other toys intended to be placed in the mouth.

The measures concern the incorporation of new limit values, for the use of certain chemicals in toys, within the Toy Safety Directive. As is well-known by now among the toy industry, this Directive establishes requirements with regard to potentially harmful chemical substances (among other matters). It empowers the European Commission to adopt specific limit values for the abovementioned  categories of toys in order to ensure adequate protection against a high degree of exposure to harmful chemical substances.

The chemicals concerned by the future measures are:

(1) Chloromethylisothiazolinone (CMI),
(2) Methylisothiazolinone (MI),
(3) CMI and MI combined in a ratio of 3:1,
(4) Benzisothiazolinone (BIT), and
(5) Formamide.
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 be “extreme contact allergens in humans” and allergic reactions have been observed due to the inclusion of these substances in cosmetics. These allergic reactions have led to notable controversies recently, especially in Denmark.

CMI and MI in a ratio of 3:1 will, according to the relevant draft 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.

BIT is also used as a preservative in water-based toys including hobby paints and finger paints. It 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 EN 71-10:2005 and EN 71-11:2005.

Formamide is used in the plastics and polymers industry as a solvent, plasticiser 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 limit). This is equal to the limit value for Formamide that is already applicable in France.

The transitional period for the Member States to implement the future Directives concerning BIT and Formamide is scheduled to be 18 months from the date of their publication in the Official Journal.

Hong Kong’s toy exporters should be alerted to the fact that the EU’s Safety of Toys Committee might restrict the use of Phenol in the near future, as the vote as regards Phenol was postponed from the Committee meeting held in June, to a future meeting of the Committee. This is because further discussion in the subgroup “Chemicals” was felt to be necessary. The Commission’s proposed restriction in relation to Phenol is as follows:

  • 5 mg/l (migration limit) in polymeric materials,
  • 10 mg/kg (content limit) as a preservative,
  • Compliance with both limits to be determined in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.

All the amendments 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. The amendments will enter into force twenty days after the publication of the respective Directives in the EU’s Official Journal. This publication is likely to take place shortly after a three-month term comes to an end (expected to be this September), in which the Council of Ministers and the Parliament are expected to scrutinise the future measures.

Please click on the following for the latest versions of the respective draft Directives:
1) Draft Directive restricting CMI and MI
2) Draft Directive restricting BIT
3) Draft Directive restricting Formamide
4) Draft Directive restricting Phenol

Content provided by Picture: HKTDC Research
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