The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) announced the release of its final opinion on the safety of titanium dioxide in toys on June 27, 2023. Following the mandate from the EC, the scientific opinion evaluates whether the uses of pigmentary titanium dioxide in toys and toy materials can be considered to be safe in light of the exposure identified and in light of the classification of titanium dioxide as carcinogenic category 2 after inhalation. SCHEER notes that it should be recognized that the safety evaluation as presented is limited to the levels of titanium dioxide in the toys used for the various evaluated exposure scenarios. Although the evaluated exposure scenarios have the highest possibility for titanium dioxide exposure, SCHEER states that some toys containing titanium dioxide may result in exposures for children that were not evaluated in the opinion. In addition, SCHEER did not consider aggregated exposure due to other sources of titanium dioxide exposure, e.g., via food or cosmetics. The opinion states that nanoscale/nanosized particles (1-100 nanometers (nm)) are indicated as ultrafine particles in line with conventions in inhalation toxicology. Microscale particles with an aerodynamic diameter above 0.1 micrometers (μm) are indicated as fine particles. When referring to studies performed with titanium dioxide as nanomaterials, the opinion retains the original wording of nanoparticle/nanomaterial/nanofraction.
The opinion concludes that:
- Release from Toy Materials/Toys: The application of titanium dioxide as a coloring agent for polymers used to produce toys is considered to pose no or negligible risk to children, as the potential release of the titanium dioxide from the polymers is considered negligible to non-existent due to the fixation of the titanium dioxide within the polymer. Potential exposure is only possible when pieces of the toy break off due to mouthing.
- Inhalation Exposure: SCHEER states that based on the margin-of-safety (MoS) values, it can be concluded that toys containing titanium dioxide can be used safely in the realistic high- and upper-bound exposure scenarios considered, when this titanium dioxide does not contain ultrafine fractions. When an ultrafine fraction is assumed to be present, safe use is not indicated for exposure scenario 1 (casting kit, realistic high- and upper-bound estimate), scenario 2 (chalk, upper-bound estimate), and scenario 4 (powder paint, upper-bound estimate). The final opinion states that it can be concluded that white color pencil (scenario 3, weak weight of evidence (WoE) for particle size distribution, but strong WoE for exposure and for the hazard characterization) can be used safely by children of different age groups even when an ultrafine fraction is present in the titanium dioxide preparation, with regard to possible inhalation exposure.
- Oral Exposure: Based on the MoS values only, it might be concluded that toys containing titanium dioxide can be used with no or negligible risk in the worst-case oral exposure scenarios considered. The WoE for the oral risk characterization is uncertain for the hazard characterization and weak to moderate for the exposure assessment. SCHEER states that when the absence of an ultrafine fraction can be demonstrated with appropriate methodology, pigmentary titanium dioxide in toys can be considered to show safe use with no or negligible risk after oral exposure.
SCHEER states that to determine the safety of using pigmentary titanium dioxide particles in toys, “it is essential to know the number size distribution of the particles, including both constituent particles and agglomerates/aggregates.” In addition, it should be demonstrated that plausibly no or a negligible ultrafine fraction is present in the pigmentary titanium dioxide preparations. According to SCHEER, in view of the uncertainty on the potential genotoxicity of pigmentary fine titanium dioxide, further studies of the genotoxicity of fine titanium dioxide are recommended, including clear demonstration of the absence of an ultrafine fraction in the preparations investigated. SCHEER notes that in view of the lack of data on the release of titanium dioxide from toys and/or toy materials, migration and titanium dioxide release studies are recommended. In view of the uncertainty of the oral hazard characterization of pigmentary titanium dioxide, further toxicity studies after oral exposure are warranted.