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In a 2020 study published in the Journal of Trace Elements in Medicine and Biology, researchers conducted an in vitro experiment to analyze the effects of TiO2 nanoparticles on a human neuroblastoma (SH-SY5Y) cell line. The scientists evaluated “reactive oxygen species (ROS) generation, apoptosis, cellular antioxidant response, endoplasmic reticulum stress and autophagy.” The results showed that exposure to the nanoparticles “induced ROS generation in a dose dependent manner, with values reaching up to 10 fold those of controls. Nrf2 nuclear localization and autophagy also increased in a dose dependent manner. Apoptosis increased by 4- to 10-fold compared to the control group, depending on the dose employed.” 

Some consumer advocacy groups and health agencies — particularly, those at the Environmental Working Group — have been pushing federal officers at the Food and Drug Administration (FDA) to reconsider their existing rules on the additive, which is commonly found in processed snacks and sweets.

However, humans are not exposed to E171 in drinking water at any significant quantity over a long duration, so this potential effect is irrelevant to the human experience. It’s important to understand that a potential hazard is not the same thing as an actual risk. 

Key Points/Overview

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According to the EFSA's Expert Panel on Food Additives and Flavorings 2021 opinion regarding titanium dioxide, it could not rule out a concern for genotoxicity from ingestion of the material based on a perceived gap in data on this risk, which serves as the basis for current ban, said a March report on the decision.

Assessment of biocompatibility

What is the FDA limit for titanium dioxide?

Furthermore, Lomon's R996 grade titanium dioxide is manufactured using advanced production techniques to ensure consistency and quality in every batch. The company's state-of-the-art facilities and rigorous quality control measures guarantee that customers receive a reliable and high-performing product every time.

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Although the evidence for general toxic effects was not conclusive, on the basis of the new data and strengthened methods we could not rule out a concern for genotoxicity and consequently we could not establish a safe level for daily intake of the food additive, commented Matthew Wright, member of the EFSA's Food Additives and Flavourings Panel in a press statement.

In an early study Jani et al. administred rutile TiO₂ (500 nm) as a 0.1 ml of 2.5 % w/v suspension (12.5 mg/kg BW) to female Sprague Dawley rats, by oral gavage daily for 10 days and detected presence of particles in all the major gut associated lymphoid tissue as well as in distant organs such as the liver, spleen, lung and peritoneal tissue, but not in heart and kidney. The distribution and toxicity of nano- (25 nm, 80 nm) and submicron-sized (155 nm) TiO₂ particles were evaluated in mice administered a large, single, oral dosing (5 g/kg BW) by gavage. In the animals that were sacrificed two weeks later, ICP-MS analysis showed that the particles were retained mainly in liver, spleen, kidney, and lung tissues, indicating that they can be transported to other tissues and organs after uptake by the gastrointestinal tract. Interestingly, although an extremely high dose was administrated, no acute toxicity was observed. In groups exposed to 80 nm and 155 nm particles, histopathological changes were observed in the liver, kidney and in the brain. The biochemical serum parameters also indicated liver, kidney and cardiovascular damage and were higher in mice treated with nano-sized (25 or 80 nm) TiO₂ compared to submicron-sized (155 nm) TiO₂. However, the main weaknesses of this study are the use of extremely high single dose and insufficient characterisation of the particles.