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No. EFSA’s role was limited to evaluating the risks linked to titanium dioxide as a food additive. This included an assessment of relevant scientific information on TiO₂, its potential toxicity, and estimates of human dietary exposure. Any legislative or regulatory decisions on the authorisations of food additives are the responsibility of the risk managers (i.e. European Commission and Member States).

Reasons for listing: Henan Billions Chemical Co., Ltd., a well-known brand of TiO2 factory, a famous trademark in Henan Province, a listed company, a drafting unit of national and industry standards, a high-tech enterprise, advocating the implementation of clean production, focusing on titanium and zirconium fine powder A large-scale inorganic fine chemical enterprise engaged in material R&D and manufacturing.

Australian researchers examined how titanium dioxide as a food additive affected gut microbiota in mice by orally administering it in drinking water. The study, published in the journal Frontiers in Nutrition in 2019, found the treatment could “alter the release of bacterial metabolites in vivo and affect the spatial distribution of commensal bacteria in vitro by promoting biofilm formation. We also found reduced expression of the colonic mucin 2 gene, a key component of the intestinal mucus layer, and increased expression of the beta defensin gene, indicating that titanium dioxide significantly impacts gut homeostasis.” The changes were then linked to colonic inflammation, along with a higher expression of inflammatory cytokines, which are signal proteins that help with regulation. The researchers concluded that titanium dioxide “impairs gut homeostasis which may in turn prime the host for disease development.”

Some dealers quoted prices that were significantly higher than expected, sending the domestic market to an almost three-year high. Meanwhile, a similar scenario was observed in the Indian market, where titanium dioxide prices (rutile grade) for rose by 8% from January to March. The increase was attributed to strong demand from the domestic paints and coatings sector as well as premium cargo from China.

What's the Verdict?

Molecular Weight: 412.207

Titanium dioxide (TiO₂) is considered as an inert and safe material and has been used in many applications for decades. However, with the development of nanotechnologies TiO₂ nanoparticles, with numerous novel and useful properties, are increasingly manufactured and used. Therefore increased human and environmental exposure can be expected, which has put TiO₂ nanoparticles under toxicological scrutiny. Mechanistic toxicological studies show that TiO₂ nanoparticles predominantly cause adverse effects via induction of oxidative stress resulting in cell damage, genotoxicity, inflammation, immune response etc. The extent and type of damage strongly depends on physical and chemical characteristics of TiO₂ nanoparticles, which govern their bioavailability and reactivity. Based on the experimental evidence from animal inhalation studies TiO₂ nanoparticles are classified as “possible carcinogenic to humans” by the International Agency for Research on Cancer and as occupational carcinogen by the National Institute for Occupational Safety and Health. The studies on dermal exposure to TiO₂ nanoparticles, which is in humans substantial through the use of sunscreens, generally indicate negligible transdermal penetration; however data are needed on long-term exposure and potential adverse effects of photo-oxidation products. Although TiO₂ is permitted as an additive (E171) in food and pharmaceutical products we do not have reliable data on its absorption, distribution, excretion and toxicity on oral exposure. TiO₂ may also enter environment, and while it exerts low acute toxicity to aquatic organisms, upon long-term exposure it induces a range of sub-lethal effects.