Upon request by the European Commission (EC), the European Food Safety Authority (EFSA) has updated its 2016 safety assessment of the food additive titanium dioxide (TiO2, E171). On May 6, 2021, EFSA concluded that E171 can no longer be considered safe as a food additive. On January 14, 2022, the EC has adopted a regulation banning the use of TiO2 as a food additive.

Now there will be a transition period in which “foods that contain titanium dioxide (E 171) used in accordance with the rules applicable before the date of entry into force of this Regulation, may be placed on the market until six months after that date. Those foods may then continue to be marketed until their date of minimum durability or ‘use by’ date”, stated the EC.

This regulation becomes effective in the European Union, and the decision has been notified to the World Trade Organization (WTO). Whether the Codex Alimentarius Commission (CAC) may or may not consider potential consequences to international food standards is yet to be seen. The United Kingdom (UK) will not immediately be affected and TiO2 remains a permitted food additive in that region. The UK’s Foods Standards Agency (FSA) will initiate their own evaluation of the additive and further considerations will take place throughout the course of the year.

Read the full commission regulation here

What does it mean for the Nutraceutical and Pharmaceutical segments?

The EU regulation is applicable to foods and food supplements from which TiO2 will need to be removed. In the pharmaceutical segment, TiO2 will provisionally remain accepted “to allow its use in medicinal products as a color, pending the development of adequate alternatives to replace it while ensuring the quality, safety and efficacy of the medicinal products concerned.

The EC states its commitment to review the need for usage of TiO2  in medicines within the next three years and points out that “the pharmaceutical industry should make any possible efforts to accelerate the research and development of alternatives to replace titanium dioxide in both new and already authorized products.” EFSA’s full Q&A on TiO2  can be read here.

As Sensient has been following the global shift away from titanium dioxide closely over the years, we have been innovating solutions for nutraceutical and pharmaceutical manufacturers interested in cleaner ingredient alternatives. These innovations include a global suite of solutions to best match the performance of TiO2 while addressing cleaner ingredient needs and making product innovation easy for brands.

Sensient’s solutions include Avalanche™ for matrix constituents with coloring and opacity and Spectrablend™ as an opacifying coating.

Titanium dioxide has a few key advantages over many alternatives that can present challenges for replacement opportunities. But high-performing alternative portfolios like Sensient’s Avalanche or Spectrablend 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.