The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition. The Toy Safety Directive 2009/48/EC prohibits the use of substances in toys if those substances are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). The use of such substances may be permitted under certain conditions, however. To permit the use of a CMR substance of category 2, the substance has to be evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure. An additional condition is that the substance is not prohibited for use in consumer articles under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Titanium dioxide in powder form containing one percent or more of particles with aerodynamic diameter ≤ ten micrometers (μm) has been classified as carcinogenic category 2 by inhalation.
SCHEER has called for scientific information on:
- The chemical and physical specifications of titanium dioxide used in toys;
- The size distribution of pigment grade titanium dioxide used in toys;
- The migration or release of titanium dioxide from toys; and
- Exposure measurements on titanium dioxide used in toys.
Submissions are due April 28, 2021. The call for information will remain open after this date, however, and additional studies (e.g., ongoing studies and research that are not completed by the deadline) may be passed to the working group at a later stage, if needed.
The EC asked SCHEER:
- To review the available data on the use of titanium dioxide leading to inhalation exposure in particular in toys and toy materials; and
- To evaluate whether the uses of titanium dioxide in toys and toy materials can be considered safe in light of the exposure identified, and in light of the classification of titanium dioxide as carcinogenic category 2. Safe toys and toy materials should be indicated.
According to the timeline in the EC’s request, the preliminary opinion is expected in mid-2021, and the final opinion in fall 2021.