From studies deemed relevant, the experts found that titanium dioxide as a food additive is poorly absorbed by the gastrointestinal tract of mice and rats, with no adverse effects observed in short-term studies in rodents receiving titanium dioxide in their diets. No observed adverse effect levels (NOAELs) of 15,000 milligrams per kilogram of bodyweight (mg/kg BW) per day and 5,000 mg/kg BW per day—the highest doses tested—were established for mice and rats, respectively.

For a substance that is relatively unknown to the public, it’s amazing how many everyday products TiO2 can be found in. Because of its many varied properties, our skin, cities, cars, homes, food and environment are made brighter, safer, more resilient and cleaner by TiO2. With a legacy of 100 years of safe commercial use, TiO2 is only going to become more vital as our environment faces greater challenges from a growing population.

R-5566:

I don't see the scientific evidence in the literature that would cause people any concern, said Kaminski.

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 30% CAS No. 1345-05-7 / Production Method

While the conclusions of the EU expert panel were considered in this report, Health Canada's Food Directorate conducted its own comprehensive review of the available science. This included evaluating new scientific data that addressed some of the uncertainties identified by the EU expert panel and were not available at the time of their review.