Is titanium dioxide illegal in other countries?

Following the EU’s ban on E171, the FDA told the Guardian that, based on current evidence, titanium dioxide as a food additive is safe.  “The available safety studies do not demonstrate safety concerns connected to the use of titanium dioxide as a color additive.”

Lithopone 30% CAS No. 1345-05-7 / Application

The skin of an adult person is, in most places, covered with a relatively thick (∼10 μm) barrier of keratinised dead cells. One of the main questions is still whether TiO₂ NPs are able to penetrate into the deeper layers of the skin. The majority of studies suggest that TiO₂ NPs, neither uncoated nor coated (SiO₂, Al₂O₃ and SiO₂/Al₂O₃) of different crystalline structures, penetrate normal animal or human skin. However, in most of these studies the exposures were short term (up to 48 h); only few long-term or repeated exposure studies have been published. Wu et al.83 have shown that dermal application of nano-TiO₂ of different crystal structures and sizes (4–90 nm) to pig ears for 30 days did not result in penetration of NPs beyond deep epidermis. On the other hand, in the same study the authors reported dermal penetration of TiO₂ NPs with subsequent appearance of lesions in multiple organs in hairless mice, that were dermal exposed to nano-TiO₂ for 60 days. However, the relevance of this study for human exposure is not conclusive because hairless mice skin has abnormal hair follicles, and mice stratum corneum has higher lipid content than human stratum corneum, which may contribute to different penetration. Recently Sadrieh et al. performed a 4 week dermal exposure to three different TiO₂ particles (uncoated submicron-sized, uncoated nano-sized and coated nano-sized) in 5 % sunscreen formulation with minipigs. They found elevated titanium levels in epidermis, dermis and in inguinal lymph nodes, but not in precapsular and submandibular lymph nodes and in liver. With the energy dispersive X-ray spectrometry and transmission electron microscopy (TEM) analysis the authors confirmed presence of few TiO₂ particles in dermis and calculated that uncoated nano-sized TiO₂ particles observed in dermis represented only 0.00008 % of the total applied amount of TiO₂ particles. Based on the same assumptions used by the authors in their calculations it can be calculated that the total number of particles applied was 1.8 × 10¹³ /cm² and of these 1.4 x10⁷/cm² penetrated. The surface area of skin in humans is around 1.8 m²  and for sun protection the cream is applied over whole body, which would mean that 4 week usage of such cream with 5 % TiO₂ would result in penetration of totally 2.6 × 10¹⁰ particles. Although Sadrieh et al.concluded that there was no significant penetration of TiO₂ NPs through intact normal epidermis, the results are not completely confirmative.

Lithopone B301, Lithopone B311 powder, brilliant white pigment used in paints, inks, leather, paper, linoleum, and face powder. It was developed in the 1870s as a substitute or supplement for lead carbonate (white lead), to overcome its drawbacks of toxicity, poor weathering, and darkening in atmospheres that contain sulfur compounds. Lithopone B301, Lithopone B311 powder is an insoluble mixture of barium sulfate and zinc sulfide that precipitates upon mixing solutions of barium sulfide and zinc sulfate. The precipitate is recovered by filtration, then calcined (roasted) at temperatures above 600° C (1,112° F). Although Lithopone B301, Lithopone B311 powder has been replaced in many applications by titanium dioxide, it is still widely used in a number of products, such as water paints.

Lithopone

Drivers

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.

zinc oxide content, %

To be added to food, this additive must achieve 99% purity. However, this leaves room for small amounts of potential contaminants like lead, arsenic, or mercury (1Trusted Source).

This precipitate is not suitable for a pigment until it is filtered, dried, crushed, heated to a high temperature and quenched in cold water. The second heating in a muffle furnace at 725 °C produces crystals of the right optical size.

There's also evidence that inhaling titanium dioxide particles can be dangerous. That's mainly a concern for industrial workers. In places where it's produced, or where it's used to make other products, workers can breathe it in as a dust. The Occupational Health and Safety Administration has exposure standards manufacturers must meet.

Titanium dioxide is an insoluble mineral, meaning it cannot dissolve in water. Known for its bright, white pigment, manufacturers use titanium dioxide in many different capacities, including in cosmetics, foods, and drugs.