The implications of the EU ban on titanium dioxide: A comprehensive review of safety concerns and alternatives

Ann Pharm Fr. 2024 Nov 15:S0003-4509(24)00167-6. doi: 10.1016/j.pharma.2024.11.002. Online ahead of print.

Abstract

Titanium dioxide, a naturally occurring compound, has been extensively utilized across various industries such as food, pharmaceuticals, and cosmetics. In the food sector, it was commonly employed as a color and opacity enhancer under the designation E171. However, due to safety concerns, the EU has prohibited its use as a food additive, effective August 2022, following a six-month transition period. The decision was based on scientific research highlighting risks associated with inhaling titanium dioxide nanoparticles and its potential genotoxic effects. This review also summarizes the implications of this ban on the pharmaceutical industry, where titanium dioxide is utilized in drug manufacturing. While the safety of titanium dioxide in tablets remains inconclusive, the EU's regulatory action has prompted a closer examination of alternative options. While alternatives exist, they may not provide the same benefits as TiO2, particularly in pharmaceuticals. Further research is needed to determine the safety and effectiveness of TiO2 and its alternatives in these applications.

Keywords: Additif alimentaire; E171; European Union; Excipient; Food additive; Le dioxyde de titane; Nanoparticles; Nanoparticules; Titanium dioxide; Union européenne.

Publication types

  • Review