By Kathy Van Zyl, Regulatory Consultant
Titanium dioxide is a versatile mineral that is used across a wide variety of consumer products, mainly as a pigment for lending whiteness and opacity. Its uses range from food and beverages to pharmaceuticals, cosmetics, industrial uses, paints and even solar paneling.
The use as a food additive is purely aesthetic, making foods more visually appealing for a whiter, brighter or more opaque appearance but without adding nutritional value. From milk, candy, baking ingredients, sauces, chewing gum and many processed foods, titanium dioxide is listed as E171, INS 171 or simply as an artificial colorant.
Health Concerns from Titanium Dioxide
Titanium dioxide (TiO2) is produced mainly from naturally occurring minerals. The benefits used in food products are however not without controversies. Several lobby groups are calling for a ban on use in food due to the possibility of carcinogenicity in humans and animals, and damage to the immune system. It is also considered by some associations to irritate the mucous membranes, cause lung cancer in animals and even to be potentially genotoxic. The central element of the controversy surrounds the fact that TiO2 contains nanoparticles that are generated during the manufacturing process. Alternatives as a whitener in foods also exist.
The toxicity and the use as a food additive is currently a matter of debate and conflicting decisions, with food agencies and authorities across the world having different stances, views and rules. This conflict leaves consumers confused and unsure about consumption of foods with TiO2.
Global Regulatory Actions on Titanium Dioxide
The United States Food & Drug Administration (FDA) (2023), Health Canada, Food Standards Australia, New Zealand (FSANZ) and the Food Safety and Standards Authority of India, to name a few, found no safety concerns for the use of titanium dioxide as an additive at its intended level of use. Many states in the US have proposed bills to ban titanium dioxide but none have yet been passed. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) (2023) concluded that titanium dioxide (INS 171) did not pose significant effects to necessitate a ban.
The European Food Safety Authority (EFSA) deemed TiO2 (E171) as not safe as a food or feed additive, due to concerns regarding genotoxicity (from 8 August 2022). Although oral ingestion of particles is low, they can accumulate in the body. The Saudi Food & Drug Authority issued a ban in 2022 and all the member countries of the Gulf Cooperation Council (GCC) followed suit, causing TiO2 to be removed from the Additives Permitted for Use in Foodstuffs in 2023.
After the European Union classified TiO2 as a carcinogen, category 2 by inhalation in Delegated Regulation (EU) 2020/217, several manufacturers took the matter to General Court, who annulled the Commission’s decision. The French Government and the Commission have both taken the matter on appeal. On February 12, 2025, the Advocate General issued a non-binding opinion that the European Court of Justice (ECJ) set aside the ruling. The matter will be heard by the ECJ in May or June 2025 and the outcome will be of tremendous interest for the future of TiO2 as a food additive and many more of the current uses.
