Titanium Dioxide: updates

THE CURRENT SITUATION
In May 2021, the European Food Safety Authority (EFSA) published an Opinion that titanium dioxide (TiO2) (E171) could “no longer be considered safe when used as a food additive” (2), and a ban on its use in foods was quickly proposed. On review, the conclusion of the EFSA Opinion is not based on any hazard being proven, rather it is due to insufficient data to rule out a potential risk from genotoxicity, despite the requested animal studies showing no adverse effects at high doses. In January 2022 legislation was published requiring the removal of E171 from foods; as no immediate health risk was identified a transition period of 6 months is permitted, ending in August 2022. As consumption of foods is unrestricted, intake levels of titanium dioxide by consumers cannot be accurately predicted, using the precautionary principle it is perhaps understandable that a ban on foods is applied. The Committee on Toxicology (COT) advising the Food Standards Agency in the UK does not agree with the EFSA conclusions based on the science (1) and Health Canada (3) and Food Standards Australia and New Zealand (FSANZ) (4) have recently published their reports which state that there is no conclusive scientific evidence that the food additive titanium dioxide is a concern for human health. The continued use of titanium dioxide is permitted in the UK, Canada, Australia and New Zealand.

WHAT IS THE ROLE OF TIO2 IN PHARMACEUTICALS AND IS THIS AFFECTED?
The ban on the use of TiO2 in foods does have the potential to affect the health of patients, through the impact on the pharmaceutical industry and the availability of medicines in Europe. While TiO2 is widely used as a white pigment, it is also used as an opacifier (i.e., it prevents light from passing through it) and it is this function that is important to the pharmaceutical and dietary supplement industry. TiO2 is used in tablet film coatings and capsule shells, where it prevents light transmission that could degrade sensitive active materials, additionally, it helps to provide colour consistency during the shelf-life of the product and imparts brand colour which aids recognition of medicines and prevents medication errors (5). The legislation banning TiO2 in foods (EC 2022/63) (6) in Europe also requires pharmaceutical companies to investigate alternatives and to make changes to existing medicines while the European Medicines Agency (EMA) completes a second review on its use in medicines. The conclusion from EMAs first review (7) is that replacement of TiO2 in medicines can currently not be achieved without a negative impact on the quality and quantity of medicines in the EU.