FDA Reaffirms Safety of Titanium Dioxide for Use in Foods

The United States Food and Drug Administration (FDA) recently communicated to the Titanium Dioxide Manufacturers Association (TDMA) that FDA continues to consider the use of titanium dioxide (TiO₂) as a color additive in foods to be safe. The FDA statement on the use of TiO₂ in foods, which is posted in full on TDMA’s website, concludes that “[t]he available safety studies do not demonstrate safety concerns connected to the use of titanium dioxide as a color additive.”

FDA’s position on TiO₂ follows from the Agency’s review of the European Food Safety Authority’s (EFSA) 2021 Opinion, which updated its 2016 safety assessment of titanium dioxide as a food additive. As previously reported, the EFSA Panel on Food Additives and Flavorings concluded in its 2021 Opinion that because “a concern for genotoxicity could not be ruled out, and given the many uncertainties,” titanium dioxide “can no longer be considered safe when used as a food additive.”  

Following FDA’s review of the ESFA Opinion, FDA pointed out that “[s]ome of the genotoxicity tests included test materials not representative of the color additive, and some tests included administration routes not relevant to human dietary exposure.” FDA’s statement highlights that EFSA’s latest opinion continues to confirm “no general and organ toxicity as well as no effects on reproductive and developmental toxicity.” 

The FDA statement to TDMA attests that the “available safety studies do not demonstrate safety concerns connected to the use of titanium dioxide as a color additive,” and concludes that “[t]he FDA continues to allow for the safe use of titanium dioxide as a color additive in foods generally according to the specifications and conditions, including that the quantity of titanium dioxide does not exceed 1% by weight of the food, found in FDA regulations at 21 CFR 73.575.”  

TDMA remarked that FDA’s position on the continued safe use of TiO₂ in foods is consistent with that of other global regulatory bodies, including Health Canada, Food Standards Australia New Zealand (FSANZ), and the UK Food Standards Agency. 

The European Commission withdrew the authorization for TiO₂ (E171) as a food additive in the EU in early 2022, with a six month phase-out that ended on August 7, 2022. In November 2022, the EU General Court annulled a European Commission regulation regarding the classification and labelling of titanium dioxide as carcinogenic by inhalation in certain forms, although this does not impact the EU ban on the pigment’s use as a food additive. France recently appealed the General Court’s ruling.