CONSUMER PRODUCTS AND RETAIL E-SSENTIALS

EU: European Commission launches public consultation on the preliminary opinion on the safety of Titanium Dioxide in toy

JUNE 2022 - TOYS AND CHILDREN'S PRODUCTS

On 3 June 2022, the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published a preliminary opinion¹ on the safety of titanium dioxide (TiO2) in toys. This opinion describes the risk assessment for the use of pigmentary TiO2 as colouring agent in toys and/or materials used to produce toys. Interested parties are invited to submit comments before 4 July 2022.

Inhalable titanium dioxide which is in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm, is classified² as carcinogenic category 2 by inhalation. 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.

Below are the highlights of the opinions:

• Based on the information provided by the toy industry, TiO2 is used in white pigments with inhalable particles below a size of 10 µm in toy production.
• The application of TiO2 as a colouring agent for polymers used to produce toys is considered to pose “no or negligible risk” to children because the release of pigment is considered negligible to non-existent due to the fixation of the TiO2 within the polymer. The potential exposure is still possible when pieces of the toy break off due to mouthing.
• When considering exposures to TiO2, SCHEER selected four (4) inhalation scenarios and three (3) direct ingestion scenarios to encompass the use of toys with the highest potential for exposure.
• On the inhalation exposure, SCHEER concluded that toys containing TiO2 can be used safely in the realistic high- and upper-bound exposure scenarios considered. However, safe use is not indicated if an “ultrafine fraction” is present.
  
  

  	Fine Particles	Ultrafine Particles
  Inhalation Exposure
  Casting Kit	Safe	Not safe
  Chalk	Safe	Not safe
  White colour pencil	Safe	Safe
  Powder plant	Safe	Not safe

• On the oral exposure, with the “high uncertainty” in hazard characterisation regarding immunotoxic, genotoxic and carcinogenic activity, it cannot be concluded children can safely use toys containing TiO2.

• To determine the safety of using pigmentary TiO2 particles in toys, SCHEER:
  
  • points out it’s essential to know the number size distribution of the particles, including both primary particles and agglomerates/aggregates. In addition, it should be demonstrated that plausibly no or a negligible ultrafine fraction is present in the TiO2 preparations; and
  • recommends further studies on migration and TiO2 release from toys and/or toy materials.

Note:
Throughout this opinion, nanoscale/nanosized particles (1-100 nm) will be indicated as ultrafine particles in line with conventions in inhalation toxicology. Microscale particles with an aerodynamic diameter between 0.1 and 2.5 µm will be indicated as fine particles.

[1]  Public consultation on the Preliminary Opinion

[2]  Request for an opinion on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition, December 2020