Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided a Preliminary Opinion on the safety of titanium dioxide in toys in light of the exposure identified, and in light of the classification of titanium dioxide as carcinogenic category 2 after inhalation.

Interested parties are invited to submit their comments on the scientific evidence online until 4 July 2022.

This Opinion describes the risk assessment for the use of pigmentary TiO₂ as colouring agent in toys and/or toy materials used to produce toys.

To address the terms of reference of this Opinion, scientific data on the toxicity of TiO₂ and information regarding approaches to derive NOAEL values were collected from available open literature, websites and from documents of other Scientific Committees and International Organisations (e.g. WHO, EPA, EFSA, JECFA). In addition, 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. In its scientific work, the SCHEER relies on its Memorandum on Weight of Evidence (WoE).

On the inhalation exposure, when it can be demonstrated with high certainty that no ultrafine fraction is present in 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.

On the oral exposure, based on the Margin-of-Safety values only, it might be concluded that toys containing 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 uncertain for the hazard characterisation and weak to moderate for the exposure assessment.

It should be recognised that the safety evaluation as presented is limited to the levels of TiO₂ in the toys used for the various evaluated exposure scenarios. In addition, aggregated exposure due to other sources of TiO₂ exposure, e.g., via food, cosmetics etc. is not considered.

More information:

• Commission's independent scientific committees