Titanium Dioxide under Global Surveillance

Titanium dioxide is a highly effective whitening and opacifying agent used in food and beverages, as well as pharmaceutical and nutraceutical products. Due to its highly concentrated nature as well as its stability under a variety of heat, light, and acidic conditions, titanium dioxide (TiO₂) is popular with developers for its simplicity and cost-effective efficiency across applications.

Whilst the ingredient is banned in Europe in food, beverage, and nutraceutical products since 2022, no legal action has yet been taken by the US FDA or Health Canada due to a lack of scientific evidence supporting any legitimate safety issues. However many North American brands are looking for proactive alternatives to meet rising consumer concerns around the ingredient. On December 5th, 2022, the Center for Science in the Public Interest (CSPI) released news rating titanium dioxide as a food additive that consumers should avoid. “…The prospect of titanium dioxide nanoparticles damaging DNA is concerning enough for us to recommend consumers avoid foods that have it,” commented CSPI principal scientist for additives and supplements Thomas Galligan in their press release.

In Europe, the European Food Safety Authority highly recommends the pharmaceutical industry to accelerate the research and development of alternatives to replace titanium dioxide in both new and already authorized products. In North America, proposed bills in California and New York aim to prohibit titanium dioxide in foods. In April 2023, the Food and Drug Administration (FDA) has filed a color additive petition proposing to revoke the color additive listing for use of titanium dioxide in food. The closer the scrutiny on the ingredient, the more likely is an even higher interest to replace it in applications across the globe.

The versatility and efficacy of titanium dioxide make it difficult to replace with a single solution. The demands from formulators and brands in North America, Europe, and around the world are increasing. As Sensient has been following the global shift away from titanium dioxide closely over the years, Sensient developed a total suite of solutions including Sensient’s Avalanche™ for matrix constituents with coloring and opacity and Sensient’s Spectrablend™ as an opacifying coating. The portfolio of options addresses a variety of processing conditions and application-specific needs for whitening and opacity on the pharmaceutical and nutraceutical market. It can help developers and manufacturers to close the gap on key technical challenges and innovate across the full spectrum of applications, such as two-piece hard capsules, soft capsules, instant powders, vitamin gummies, hard lozenges or tablets.

As it is a challenge to replace titanium dioxide across all applications, and no single product can replace it across every application, we would recommend getting in touch early on in the formulation process to get your project started. Our team of technical experts can give personalized guidance on successful implementation of Avalanche or Spectrablend solutions to ensure minimum impact on your process and guide you through the formulation, testing, and scale-up process. Be prepared for the event of possible regulatory actions. We’d be glad to support.