Titanium dioxide (TiO2) is a safe and essential substance in pharmaceuticals. This is the conclusion of the position paper titled “Is There a Case for Banning Titanium Dioxide (E171) in Pharmaceuticals” which states there is no case for a ban. The paper was released following a 2-day workshop led by the Product Quality Research Institute (PQRI) in June 2023.
TiO2 is widely used across a range of products including foods, cosmetics, and pharmaceuticals. However, after TiO2 usage in foods, also known as E171, was banned by the European Union in 2021, there is a concern that further bans might follow, including in pharmaceuticals. According to the report, in the event of a ban on TiO2 in pharmaceuticals, some 91,000 medicinal products in the EU would need to be reformulated. Reformulation could take up to 60 months and require a substantial investment of resources including new stability and bioavailability studies. Each individual reformulation would cost up to 1.5 million Euros, not including consideration of EU manufacturing capacities required for products made in the European Union. Many medicinal products would become unavailable in the EU, further exacerbating shortages.
The paper further states “the suppliers of film coating systems and capsule shells have shown that finding a replacement to E171 which has similar opacity, whitening power, and regulatory acceptability will be difficult. In addition, there are other unique and unmatched attributes that TiO2 affords which the alternatives do not have, e.g., inert nature, high melting point, negligible solubility across the pharmaceutical pH range and ability to undergo a specific and reproducible colour change in response to laser irradiation.”
Finding a workable replacement for E171 that meets the functional needs of the pharmaceutical industry and the safety concerns of the regulators will be challenging.
Authors conclude the case for a ban in pharmaceuticals is non-existent, but there would be detrimental consequences should a ban be imposed. The TDMA continues to stand behind the safety of TiO2 in its intended uses and proactively invests in new and robust scientific studies in order to address emerging concerns.