TiO₂ comes in many different forms. However, only a few of these forms are considered food-grade (acceptable to be added to food). Many studies that raised concern about the safety of TiO₂, including the concern for genotoxicity, used forms of TiO₂ that are not considered acceptable for use in food and have different properties than food-grade TiO₂. Other studies did use food-grade TiO₂, but took steps to break the material down into smaller particles than what would normally be found in food.

What titanium dioxide is really emblematic of ... is the failure of FDA to look back at these old decisions and ask whether its decisions that were made in this case ... 56 years ago (in the 1966 approval) still hold up, he said.

In their role as risk managers, the European Commission and Member States will now reflect on EFSA’s scientific advice and decide upon any appropriate regulatory measures or advice for consumers.

The mineral appears to have low skin penetration, but it is a greater concern when inhaled frequently over time.

No acute effects of nano-sized TiO₂ were observed in Danio rerio (zebrafish) embryos. Exposure of rainbow trout to TiO₂ NPs triggered lipid peroxidation, influence on the respiratory tract, disturbance in the metabolism of Cu and Zn, induction of intestinal erosion  and accumulation in kidney tissue. Linhua et al. exposed juvenile carp to 100 and 200 mg/ml of particles and TiO₂ observed no mortality. However, the fish suffered from oxidative stress and pathological changes in gill and liver. In the infaunal species Arenicola marina, exposure to TiO₂ NPs in sediment caused sub-lethal effects including decrease in casting rate and increase in cellular and DNA damage. Aggregated particles were visible in the lumen of the gut, but no uptake through the gut or the skin was observed.

Nano-sized TiO₂ generally shows low or no acute toxicity in both invertebrates and vertebrates. However, exposure of Daphnia magna to 20 ppm TiO₂ for 8 consecutive days was found to cause 40 % mortality. Zhu et al. showed minimal toxicity to D. magna after 48 h exposure, while upon chronic exposure for 21 days, D. magna suffered severe growth retardation and mortality. A significant amount of nano-sized TiO₂ was found also accumulated in the body of the animals. Similar findings with coated nano-sized TiO₂ (T-Lite™ SF, T-Lite™ SF-S and T-Lite™ MAX; BASF SE) were reported by Wiench et al. Biochemical measurements showed that exposure to TiO₂ NPs induces significant concentration-dependent antioxidant enzyme activities in D. magna. Lee et al. showed that 7 and 20 nm-sized TiO₂ induced no genotoxic effect in D. magna and in the larva of the aquatic midge Chironomus riparius.

The evidence also suggests that the toxicity of TiO₂ particles may be reduced when eaten as part of the diet. This is because proteins and other molecules in a person's diet can bind to the TiO₂ particles. This binding alters the physical and chemical properties of the particles, which influences how they interact with cells, tissues and organs.

History

Lithopone 30% CAS No. 1345-05-7 / Physical data

The FDA is reviewing the safety of titanium dioxide in response to an April petition from EWG and other environmental and public health groups. This is the FDA’s first comprehensive review of titanium dioxide since 1973.

Our scientific experts applied for the first time the 2018 EFSA Scientific Committee Guidance on Nanotechnology to the safety assessment of food additives. Titanium dioxide E 171 contains at most 50% of particles in the nano range (i.e. less than 100 nanometres) to which consumers may be exposed.