SCHEER - Scientific Opinion on the safety of titanium dioxide in toys

SCHEER WG on Toys
SCHEER members: Wim de Jong (Chair), Theo Vermeire (rapporteur), Peter Hoet, Rodica Ion, Renate Krätke, Ana Proykova, Marian Scott (WoE)
SCCS members: Laurent Bodin, Maria Dusinska, Maciej Stepnik, Susan Wijnhoven
External experts: Herman Autrup, Natalie von Goetz
Contact: SANTE-SCHEERec [dot] europa [dot] eu (SANTE-SCHEER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 9 June 2023

A corrigendum is adding one sentence on additional data sent during public consultation, on page 27.

Following the mandate from the European Commission, this scientific Opinion evaluates whether the uses of 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. Safe toys and toy materials, for which derogation is possible, should be indicated. Scientific data on the toxicity of TiO2 from primary and secondary sources and additional information on the use of TiO2 in toys, provided by the Toys Industries of Europe (TIE), was evaluated and included in the Opinion where appropriate. Several uses of TiO2 in toys with the highest possible exposures were evaluated. In its scientific work, the SCHEER relies on its Memorandum on Weight of Evidence (WoE).

Inhalation exposure

When it can be demonstrated with high certainty that no ultrafine fraction is present in pigmentary TiO2 preparations used in toys and toy materials, safe use with no or negligible risk for all products with a TiO2 content above 1% is indicated based on the exposure estimations of this Opinion. However, if an ultrafine fraction is assumed to be present, safe use is not indicated for the use of casting kits (exposure scenario 1, realistic high and upper bound estimate), chalk (exposure scenario 2, upper bound estimate) and powder paints (exposure scenario 4, upper bound estimate). White colour pencils can be used with no or negligible risk (safe) by children of different age groups independent whether an ultrafine fraction is present in the TiO2 preparation. The WoE for the inhalation risk characterisation is strong and for the exposure assessment weak to moderate.

Oral exposure

Based on the Margin-of-Safety values only, it can be concluded that toys containing pigmentary TiO2 can be used with no or negligible risk in the worst-case exposure scenarios considered. However, the WoE for the oral risk characterisation is weak for the hazard characterisation and weak to moderate for the exposure assessment. Safe use is only indicated when the absence of an ultrafine fraction in the TiO2 pigments can be demonstrated by an appropriate methodology.

Keywords:

Titanium dioxide, pigment, toys, risk assessment, inhalation, oral, carcinogenicity 

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Opinion on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition, 9 June 2023.