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Titanium Dioxide

Medically reviewed by Drugs.com. Last updated on Jun 27, 2024.

Excipient (pharmacologically inactive substance)

What is it?

Titanium dioxide (TiO2) is an abundant, naturally occurring inorganic mineral that is mined from the earth, processed and refined. After processing, it exists as white, powdery solid. Titanium dioxide is used as a bright white pigment for paint, in the food industry as a coloring, in sunscreens and cosmetics, and for other industrial uses. The pharmaceutical, food and cosmetic industries are estimated to occupy 10% of the market share of titanium dioxide use.

In the pharmaceutical industry, titanium dioxide is commonly used as pigment for pharmaceutical products such as gelatin capsules, tablet coatings and syrups. It is also used in sunscreens to block UVA and UVB rays, similar to zinc oxide. Titanium dioxide has excellent ultraviolet (UV) resistant qualities and acts as a UV absorbent. It is also used as a component of orthopedic implant biomaterials for hip and knee replacements and in dental products like implants.

In the cosmetics industry, it is used in toothpaste, lipsticks, creams, ointments and powders. Titanium and zinc oxides may be made into the nanoparticle size (0.2-100 nanometers) to reduce the white appearance of sunscreens when applied topically, but retain the UV blocking properties. It can be used as an opacifier to make translucent pigments opaque.[1]

In the food industry, it is used to enhance color and sheen in baked goods, carbonated drinks, coated candy, dairy products, cheeses, icings, frozen desserts, chewing gum, non-dairy creamers, dried soups, pet food and tattoo ink.

In the United States, the US Food and Drug Administration (FDA) has approved the safety of titanium dioxide for use as a colorant in food, drugs and cosmetics, including sunscreens. However, controversy exists as to the safety of titanium dioxide nanoparticles used in these various industries, especially when ingested.

Research suggests that titanium dioxide nanoparticles may be toxic to several organs when consumed, especially the liver, although further studies are needed.[2][3] Investigators report that oral ingestion of titanium dioxide nanoparticles results in accumulation in the liver, elevated liver enzymes, oxidative stress, inflammation and pathological changes in the liver tissue. In 2010, inhaled titanium dioxide nanoparticles were classified as potential cancer-causing agents by the International Agency for Research on Cancer (IARC).

However, some animal studies have reported little to no toxicity. In 2016 and 2018, the European Food Safety Authority (EFSA) reevaluated the oral use of titanium dioxide and at first concluded that there were no concerns for genotoxicity (gene mutations) or carcinogenicity (cancer).

But in 2021, the EFSA reversed this position stating that titanium dioxide could no longer be considered safe as a food additive and genotoxicity could not be ruled out due to accumulation.

In 2020, the use of titanium dioxide in the food industry was suspended in France. On August 7, 2022, the European Commission fully banned titanium dioxide (E171) as a food and pharmaceutical additive in the European Union (EU) (after a previous 6-month phase out period) due to a possible risk of genotoxicity. A review by the European Food Safety Authority (EFSA) could not rule out that it might cause chromosomal damage in humans.

Other countries that ban titanium dioxide in food products include Jordan, Saudi Arabia, Yemen, Qatar, Turkey and Israel.

In the United States, United Kingdom (UK), Canada, Japan, Australia and New Zealand, titanium dioxide still remains an approved agent (as of May 2024) due to lack of conclusive evidence of risk to human health.

List of medications using Titanium Dioxide

References

  1. Risk Analysis and Regulated Products Service: Regular update FSA 23-12-07. Nov. 30, 2023. Food Standards Agency (FSA) - UK. Accessed June 27, 2024 https://www.food.gov.uk/board-papers/risk-analysis-and-regulated-products-service-regular-update
  2. European Union: Titanium Dioxide Banned as a Food Additive in the EU. Foreign Agricultural Service. (US Dept of Agriculture). March 3, 2022. Accessed June 27, 2024 at https://fas.usda.gov/data/european-union-titanium-dioxide-banned-food-additive-eu
  3. Titanium dioxide: E171 no longer considered safe when used as a food additive. May 6, 2021. EFSA (European Food Safety Authority). Accessed June 27, 2024 at https://www.efsa.europa.eu/en/news/titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive
  4. Khan J, Kim ND, Bromhead C, et al. Hepatotoxicity of titanium dioxide nanoparticles. J Appl Toxicol. 2024 May 13. Accessed June 27, 2024 at doi: 10.1002/jat.4626.
  5. Myers, I. What is titanium dioxide? EWG. Accessed June 27, 2024 at https://www.ewg.org/news-insights/news/2023/08/what-titanium-dioxide#
  6. Banned in Europe, this controversial ingredient is allowed in foods here. CBC News. Feb 16, 2024. Accessed June 27, 2024 at https://www.cbc.ca/news/business/snack-food-ingredient-banned-europe-available-canada-1.7115568
  7. Titanium Dioxide, banned in Europe, is one of the most common food additives in the U.S. U.S. Right to Know. Oct. 23, 2023. Accessed June 27, 2024 at https://usrtk.org/chemicals/titanium-dioxide/

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.