Toys play an important role in children’s development. In the European Union, it is essential that toys are safe for children and that all possible risks are minimized. Therefore, the assessment of toys is a crucial process and competent authorities might request experts’ opinions regularly.
Safety of titanium dioxide in toys
On June 3, 2022, the European Commission launched on their website a public consultation on the safety of titanium dioxide (TiO2). The public consultation followed the Preliminary Opinion on the safety of titanium dioxide (TiO2) in toys of the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER).
This public consultation is needed to discuss the outcome of the Preliminary Opinion on the safety of this material which is often used in toys and other products. In particular, the Scientific Committees are waiting for feedback from stakeholders and the scientific community on its Opinion, following the rules of the Stakeholders Dialogue Procedures.
What is Titanium Dioxide (TiO2)?
According to the FAO (Food and Agriculture Organization) definition, Titanium dioxide (also known as TiO2 or E171) is “produced by either the sulphate or the chloride process. Processing condition determines the final product’s form (anatase or rutile structure).” Also, it is stated that commercial titanium dioxide can be coated with small amounts of alumina and silica to improve the technological properties of the product.
This substance has been used for over 100 years in many industrial processes and as a component of food, medicines, cosmetics, etc. It is primarily utilised as a colourant.
Studies from past years on possible hazards
In recent years, some studies and data showed that this material could be carcinogenic if inhaled in high quantities. Therefore, in 2019 the European Commission classified titanium dioxide a category 2 suspected by inhalation under EU Regulation on classification, labelling and packaging (CLP) of substances and mixtures and banned its use as a food additive.
Use of Titanium Dioxide in toys
Titanium dioxide is mainly used as a colouring agent in toys or toy materials used to manufacture toys. For this reason, the Preliminary Opinion of the SCHEER Committee addresses specifically titanium dioxide’s safety when used in toys and related materials.
Preliminary Opinion’s outcome and next steps
The Preliminary Opinion’s outcome includes the following aspects:
· On the inhalation exposure, the study showed that children can safely use toys when it is possible to demonstrate with high certainty that no ultrafine fraction is present in TiO2 preparations. On the other hand, if it is assumed that an ultrafine fraction is present, safe use is not indicated for certain products (e.g., casting kits, chalk, and powder paints).
· On oral exposure, on the contrary, the study showed that toys containing TiO2 could be used safely.
The scientific community and stakeholders will have time until July 4, 2022, to submit their written comments via the website. It is possible to submit written comments accessing the European Commission’s website.
Are you a manufacturer planning on placing your product on the EU market?
Regulatory Affairs Department
European Commission. (2022). Public consultation on the Preliminary Opinion on the safety of titanium dioxide in toys. Retrieved on 10/06/2022 from https://ec.europa.eu/health/consultations/public-consultation-preliminary-opinion-safety-titanium-dioxide-toys_en
Food and Agriculture Organization. (2012). Titanium Dioxide. Retrieved on 10/06/2022 from https://www.fao.org/fileadmin/user_upload/jecfa_additives/docs/monograph3/additive-466.pdf
European Coatings. (2020)., EU publishes official regulation on titanium dioxide. Retrieved on 10/06/2022 from https://www.european-coatings.com/articles/archiv/eu-publishes-official-regulation-on-titanium-dioxide
European Commissio.n (2022). Goodbye E171: The EU bans titanium dioxide as a food additive. Retrieved on 10/06/2022 from https://ec.europa.eu/newsroom/sante/items/732079/en
European Food Safety Authority. (2021). Titanium dioxide: E171 no longer considered safe when used as a food additive. Retrieved on 10/06/2022 from https://www.efsa.europa.eu/en/news/titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive
Scientific Committee on Health, Environmental, and Emerging Risks. (2022). Preliminary Opinion on the safety of titanium dioxide in toys. Retrieved on 10/06/2022 from https://ec.europa.eu/health/system/files/2022-06/scheer_o_040_0.pdf