There is some concern regarding skin and intestinal absorption of titanium dioxide nanoparticles, which are less than 100 nm in diameter.

What Is Titanium Dioxide?

≤12

The committee could not finalize the assessment of some other flavoring agents, requiring further information. JECFA highlighted the importance of receiving complete data submissions from the sponsors for conducting the safety evaluation.

Prof. Maged Younes, Chair of EFSA’s expert Panel on Food Additives and Flavourings (FAF), wrote of the decision: “Taking into account all available scientific studies and data, the Panel concluded that titanium dioxide can no longer be considered safe as a food additive. A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles. After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body.”

What is the FDA limit for titanium dioxide?

Lithopone is a mixed zinc sulfide-barium sulfate brilliant white pigment that contains about 30% zinc sulfide. The original light sensitiveness of this pigment has been mitigated by purification and by the addition of such agents as polythionates and cobalt sulfate.

The uses and applications of Titanium Dioxide may vary according to its specification. The main forms of Titanium Dioxide are dependent on particle sizes, surface treatment, and crystalline forms.

Additionally, the committee noted that the available data did not provide convincing evidence of genotoxicity for titanium dioxide as a food additive, but recognized the limitations in current methodologies with respect to the testing of poorly soluble particulate materials. Although there were uncertainties in the genotoxicity data, the experts took into account the fact that the additive was not carcinogenic in adequately conducted two-year studies in mice and rats at doses of up to 7,500 mg/kg BW per day for mice, and 2,500 mg/kg BW per day for rats, the highest doses tested. There was also no evidence of reproductive or developmental toxicity in studies in rats at doses up to 1,000 mg/kg BW per day, the highest doses tested.  

As a food additive, titanium dioxide and its nanoparticles in particular have been associated with DNA damage and cell mutations, which in turn, have potential to cause cancer. When used as a food coloring, it is known as E171.

Animal studies show exposure to titanium dioxide is linked to immunotoxicity, inflammation and neurotoxicity. 

Although the evidence for general toxic effects was not conclusive, on the basis of the new data and strengthened methods our scientists could not rule out a concern for genotoxicity and consequently they could not establish a safe level for daily intake of TiO₂ as a food additive.

Though the regulated use of titanium dioxide in food products is legal in the U.S. and Canada, it's banned in some other countries, notably throughout Europe. In May 2021, the European Food Safety Authority announced that titanium dioxide can no longer be considered safe as a food additive.