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EU: European Commission investigates a possible exemption for the use of cobalt and titanium dioxide in toys


Recently, the European Commission (EC) has requested the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to provide a scientific opinion on the safety of cobalt1 and titanium dioxide2 in toys respectively to determine whether a derogation from their prohibition can be granted.

In an amendment3 to the CLP Regulation (EC) No 1272/2008 in February this year, cobalt (CAS no. 7440-48-4) was classified as carcinogenic category 1B, mutagenic category 2 and toxic for reproduction category 1B. Inhalable titanium dioxide (CAS no. 13463-67-7), which is in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm, was classified as carcinogenic category 2 by inhalation. The classification will take effect from 1 October 20214.

According to the Toy Safety Directive 2009/48/EC, the use of carcinogenic, mutagenic and toxic for reproduction (CMR) substances in toys is prohibited. Permission for the use of a CMR substance can only be given if the relevant Scientific Committee has considered it to be safe, and concluded that there are no suitable alternatives available, provided that the substance is not prohibited in consumer articles under the REACH Regulation (EC) No 1907/2006. Such derogation is laid down in Appendix A of the Toy Safety Directive. At present, Appendix A only includes the use of nickel in toys and toy components made of stainless steel, and toy components that conduct an electric current.

Owing to the concerns raised among toy industry, the Toy Industries of Europe (TIE) has carried out studies on toxicology, risk assessment and analysis of alternatives for these two substances and requested the EC to consider granting a derogation for the uses of cobalt and titanium dioxide in certain toy materials. 

According to TIE, cobalt is present in toy materials such as non-stainless steel electric current-conducting component as an impurity in nickel and in alloys that contain nickel. The concentration is found to be up to slightly exceeding 0.3%. As for titanium dioxide, TIE reported that the majority of titanium dioxide available on the market would be classified. This substance is widely used in toys, including coatings, chalks and powder paints, clays and putties, and polymeric materials. The concentration was found to range between 1% to 30%. In addition, the European Writing Manufacturer’s Association (EWIMA) has also reported the use of titanium dioxide in colour pencils and wax crayons.

The SCHEER will evaluate whether the presence of cobalt and the use of titanium dioxide can be considered safe in certain toys or toy materials after reviewing the available data and assessing their exposure. It is expected that the preliminary and final Opinion would be available in late 2021.

[1]  Request for an opinion on the safety of cobalt in toys with regard to a possible derogation from its prohibition

[2]  Request for an opinion on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition

[3]  Commission Delegated Regulation (EU) 2020/217

[4]  Corrigendum to Commission Delegated Regulation (EU) 2020/217

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