EU Scientific Committee (SCHEER) - Final Opinion on the safety of titanium dioxide in toys

According to the opinion of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the safety of titanium dioxide (TiO2) in toys, the application of TiO2 as a coloring agent in polymer toys is considered safe for children, as the potential release of TiO2 from the polymers is negligible due to fixation within the polymer.

Inhalation exposure is safe for toys containing TiO2 without ultrafine fractions in high and upper-bound exposure scenarios. However, when an ultrafine fraction is present, safe use is not indicated for certain scenarios.

The main uncertainty lies in genotoxicity results, which may pose a risk for both ultrafine and non-ultrafine forms of TiO2 genotoxicity. For toys with TiO2 content above 1%, safe use is indicated when no ultrafine fraction is present. Oral exposure is uncertain due to potential immunotoxic, genotoxic, and carcinogenic activity of TiO2, especially at lower doses.

Safe use for oral exposure is possible when pigmentary fine TiO2 is used and the absence of an ultrafine fraction is demonstrated.

Future work is recommended to determine the safety of pigmentary TiO2 in toys, including studies on genotoxicity, particle size distribution, and release of TiO2 from toys and materials.

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